cyrilzakka/clinical-trials huggingface dataset:
The COACH Project: Combined Online Assistance for Caregiver Health

This study evaluates the effect of a physical exercise + caregiver skills training on feelings of burden, mood, and biological markers of inflammation in persons who provide care for Veterans with a TBI or dementia. Half of the caregivers will participate in a balance and flexibility + caregiver skills training program, while the other half will participate in a moderate/high intensity aerobic and resistance + caregiver skills training program.


Eligibility Criteria:
Inclusion Criteria:

1. individuals aged 18 - 85
2. distress associated with being the primary caregiver of a person with TBI or dementia
3. endorsement of at least two of the following items: felt overwhelmed, felt like needed to cry, angry or frustrated, distant or cut of from family or friends, moderate to high levels of stress, felt their health had declined
4. provide at least one hour of care (supervision or direct assistance) per week over the past three months
5. approval by Primary Care Provider to participate in physical exercise
6. be proficient in spoken and written English

Exclusion Criteria:

1. current or lifetime history of any psychiatric disorder with psychotic features
2. prominent suicidal or homicidal ideation
3. current alcohol or substance abuse
4. diagnosis of probable or possible dementia
5. a Short Portable Mental Status score of ≥ 8
6. participation in another caregiver intervention within the past year
7. lack of regular access to the internet
8. planned transfer of care recipient to another caregiver or nursing home within 12 months; 8) current severe cardiac disease (e.g., uncontrolled atrial fibrillation, defined as mean 24 hour heart rate \>85 beats/min, or 24 hour maximal ventricular rate \>150 beats/min; uncontrolled ventricular arrhythmias, defined as recurrent ventricular tachycardia \>3 beats in succession, or 24 hour PVC count \>20%; active pericarditis or myocarditis; Class III/IV heart failure and / or ejection fraction \< 20%; thrombophlebitis; pulmonary disease with a drop in O2 Sat with exercise to 90% without oxygen; embolism within past 6 months)
9. inability to participate in an exercise stress test
10. morbid obesity (BMI \> 39)
11. inability to read, verbalize understanding and voluntarily sign the Informed Consent.

Caregivers meeting any of these exclusion criteria will be excluded from all aspects of this project.
The Influence of Information Sources on Knowledge and Anxiety in Inflammatory Bowel Disease Patients

Inflammatory Bowel Diseases (IBD) are life-long, incurable illnesses that can have a profound effect on the patients quality of life. Disease education is a corner stone of IBD care to enable patients to take up an active role in their disease management. While patient education is enshrined in the IBD standards, actual patient knowledge is often poor.3 Knowledge is not associated with the level of the patient's educational achievement, but member of patient organisations such as Crohn's and Colitis UK (CCUK) have significantly better knowledge than non-members. This may highlight the positive effects of education offered by CCUK, but it is also conceivable that patients with a greater interest in their disease are more like to join organisations like CCUK. Different sources of patient information may therefore influence what level of disease related knowledge a patient achieves.

Apart from high quality clinical information provided by professional organisation (British Society of Gastroenterology, European Crohn's and Colitis Organisation), the National Health Service and charities (CORE, CCUK), there is also a host of unregulated information available. The emerging dominance of the internet for information gathering has provided easy access for patients to a host of websites providing information on IBD. A number of these provide alternative (not evidence based) views, which could have a potentially negative impact on patient's knowledge. Furthermore patients often share their stories on internet forums and it is likely that those stories share are more likely to represent the extreme ends of disease rather than those experienced by the majority. This could potentially cause anxiety in patients with IBD. The quality of information found on the internet varies widely and up to 50% of websites have been judged as poor. The vast majority of patients with IBD have access to the internet and more than half use to search for health related information.7 We have previously also demonstrated that patients with anxiety have better disease related knowledge of IBD.


Eligibility Criteria:
Inclusion Criteria:

patients attending IBD clinics at Leeds Teaching Hospitals

Exclusion Criteria:

* Individuals who are unable to give informed consent.
* Individuals who do not speak English, as the questionanire is selfadministered.
* Individuals under 18 years of age.
* Individuals who are attending Gastroenterology clinics at Leeds General Infirmary and St. James's University Hospital because of a flare up of disease activity of their ulcerative colitis or Crohn's disease.
* Individuals with Crohn's disease who have a stoma (ileostomy), due to practical difficulties in assessing clinical activity in this patient group (it is not actually possible to calculate the HarveyBradshaw index in patients with an ileostomy).
* Individuals who, in the opinion of the investigator, are not suitable to participate in the study.
* Individuals who refuse to give written, informed consent to be involved.
Comparison of Bed up Head Elevated Intubation Position With Glidescope Assisted Tracheal Intubation

Positioning during the process of tracheal intubation is critical, as optimal positioning can greatly facilitate successful intubation. Many complications can occur as a result of failed intubation, ranging from airway injury, lack of oxygen, with even deaths. Today, the most popular positioning of patients for intubation is in the "sniffing" position. There is however evidence to support that intubation in the bed-up-head-elevated position may be better. In today's technological age, video assisted laryngoscopy (Laryngoscopy is the process of visualizing the vocal cords prior to intubation), a new method where the anaesthetist intubates a patient via aid of an image guided view of the airway, is increasingly popular due to its reliability and superiority to normal intubation. However, it is not widely available, and may suffer from technical breakdowns. The Glidescope is one example of a video laryngoscope, and has been widely researched in the medical literature. In this study, the investigators wish to investigate whether intubation in the bed-up-head-elevated position will be as good as, if not better than Glidescope assisted tracheal intubation, in patients undergoing elective surgery and planned for general anaesthesia.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing elective surgeries under general anaesthesia
2. Patients aged from 18 years old to 75 years old
3. Patients who are able to give informed consent

Exclusion Criteria:

1. Patients with airway obstruction
2. Patients with contraindications to neck extension
3. Patients with small mouth opening (\<3 cm)
4. BMI \> 35 kg/m3
5. Patients with ischemic heart disease, cerebrovascular disease and respiratory diseases
6. Patients in whom rapid sequence induction is indicated
Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil

This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel, cisplatinum (cisplatin) and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity to determine what effects these agents may have on cancer cells.

This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity to determine what effects these agents may have on cancer cells.

Approximately 60 patients will take part at multi-sites with potentially 20 patients participating at the Emory Winship Cancer Institute in Atlanta, Georgia.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven squamous cell carcinoma of the oral cavity.
* Primary tumor sites eligible: oral cavity. Although they are admittedly of squamous cell types, the following tumors will be excluded because their responsiveness to chemotherapy may differ: tumors of the nasal and paranasal cavities and of the nasopharynx. Oral cavity tumors with mandible invasion are excluded because the tumor biology and management of these tumors is more complex and will likely include upfront surgical resection.
* Stage 3 or 4 disease without evidence of distant metastases verified by chest x-ray, abdominal ultrasound, or CT scan (liver function test abnormalities); bone scan in case of local symptoms.
* At least one uni- or bi-dimensionally measurable lesion.
* Age ≥ 18 years.
* World Health Organization (WHO) performance status of 2 or less.
* No active alcohol addiction.
* Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Exclusion Criteria:

* Pregnant or breast feeding
* Previous malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal, or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years.
* Any prior treatment with radiotherapy or chemotherapy is an exclusion criterion.
* Patients who experience an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry.
* Concurrent treatment with any other anti-cancer therapy.
* Participation in an investigational trial within 30 days of study entry.
* Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.
* No previous chemotherapy or radiotherapy for any reason and no previous surgery for SCCHN \[squamous cell carcinoma of the head and neck\] (other than biopsy) are allowed at the time of study entry.
* Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Clinical and Urodynamic Assessment of Bladder Sensation in Multiple Sclerosis

The aim of the study is to assess the association between bladder sensations progression during bladder filling and severity of Overactive bladder (OAB) in patients with multiple sclerosis.

Lower urinary tract symptoms (LUTS) are frequent in central nervous system disorders especially in patients with multiple sclerosis (PwMS). Prevalence of LUTS is important (32 to 96.8%) and increases with multiple sclerosis (MS) duration and the severity of the neurological deficiencies and disabilities. Overactive bladder (OAB) with urgency, frequency, urgency urinary incontinence, is the most common symptom, reported by 37-99% of the PwMS. Voiding difficulties are less common, from 6 to 49%, and usually appear later with the course of the disease.

Urodynamics is a useful test recommended to understand the mechanism of bladder dysfunction, and look for risk factors of upper tract damage.

Detrusor overactivity is the most reported mechanism of overactive bladder, and describes the occurrence of uninhibited contractions of the detrusor during bladder filling. But abnormal bladder sensations, with increased or decreased sensations, have also been described. The prevalence of these abnormalities is not well described, however, in the absence of detrusor overactivity, abnormal afferent information (i.e., abnormal bladder sensations) is the plausible mechanism involved in urinary disorders.

The assessment of bladder sensations is still a poorly explored field. Bladder diary can be used for the collection of the intensity of need to void with a Likert scale or numerical scale.

During cystometry, it is recommended to collect different bladder sensations: first sensation of filling, first desire to void, strong desire to void, urgent desire to void. However, it has been described that bladder sensations progress in 8 to 9 different levels of intensity in healthy subjects.

The aim of the study is to assess the association between bladder sensations progression during bladder filling and severity of OAB in patients with multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* MS according to the 2017 Mac Donald diagnostic criteria
* Bladder disorders supposedly related to MS
* Indication to perform urodynamics
* No current medication for bladder disorders
* Able to understand and right in French
* Affiliated to the "Securite sociale" or "Couverture Medicale Universelle (CMU)", or equivalent organism.

Exclusion criteria:

* Legal protection
* Pregnancy or breastfeeding mother
* MS relapse during the past month
* Other associated neurological disease
* Genuine stress incontinence related to postpartum
* Treatment with antimuscarinics, alpha blockers, beta3 adrenergic, or tibial nerve stimulation in the past 15 days, or with botulinic toxin injection in the past 6 months
* Previous lower urinary tract surgery
* Inability to use the analogic device due to motor, sensory or ataxic disabilities
Accuracy of Lung Ultrasound in the Diagnosis of covid19 Pneumonia

Is Lung Ultrasound really useful in diagnosing COVID19? What can be the usefulness of the Lung Ultrasound in the COVID19 epidemic? In the current state of the art, Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of Lung Ultrasound in the diagnosis of COVID-19 are not yet known.

Alveolar-interstitial lung diseases such as viral pneumonia and ARDS seems to have a specific ultrasound pattern that distinguishes them from bacterial pneumonia, preferentially represented by B lines, morphological irregularity of the pleural line, and small subpleural consolidations, but they could share these patterns with other pathologies, reducing specificity.

In Italy, the Lung Ultrasound represents a consolidated method for the evaluation and management of all patients who come to the ER, and what we are sure of is its high sensitivity in identifying pathological patterns.

Our preliminary data suggest that Lung Ultrasound is highly reliable not to include but to exclude the diagnosis of COVID-19 in patients with respiratory symptoms.

One of the first scientific papers published on the COVID-19 epidemic in China showed that patients still asymptomatic or paucisymptomatic, positive for SARS-CoV-2 on the RT-PCR test, presented chest CT images referring to parenchymal infiltrate with a prevalent appearance at ground-glass compatible with initial COVID-19 pneumonia.

An ongoing study anticipates that the sensitivity of chest CT is higher than that of the RT-PCR molecular test for SARS-CoV-2 (performed on the pharyngeal swab or sputum) (50 out of 51, 98%, 95% CI: 90% -100% vs 36 out of 51, 71%, IC95%: 56% -83%) in the early diagnosis of COVID-19.

Recent work seems to shows that Lung Ultrasound is effective in the clinical evaluation and diagnosis of COVID-19 pneumonia.

In a previous study, in addition, sensitivity and specificity of the Lung Ultrasound in the early diagnosis of H1N1 flu pneumonia was 94.1% (32 out of 34) and 84.8% respectively (28 out of 33), with a positive predictive value of 86.5% (32 out of 37) and a negative predictive value of 93.3% (28 out of 30).

The concordance between the lung ultrasound findings and the lung lesions found on CT has recently been demonstrated ("lobe-specific" concordance equal to 87%; "lung-specific concordance" equal to 92.5 % for the right lung and 83.6% for the left lung).

These data suggest to better explore the diagnostic accuracy of the Lung Ultrasound in SARS-CoV-2 infection.

Eligibility Criteria:
Inclusion Criteria:

* Fever and/or
* Cough and/or
* Dyspnoea

Exclusion Criteria:

* No one
Tackling Pressure Ulcer Via Bee Venom Phonophoresis

This study aimed to investigate the efficiency of topical Bee Venom gel versus phonophoresis of Bee Venom gel to accelerate healing of chronic pressure ulcer

In this study, the Bee Venom gel was prepared in a gel formula. Patients with chronic pressure ulcers were enrolled randomly into two different groups. Group 1 received a topical application of Bee Venom gel, 3 times per weeks. While group 2 received phonophoresis of Bee Venom gel using low frequency ultrasound, 3 times per week. The treatment lasted for 8 consecutive weeks. The Image J Software is used to measure the wound surface area before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

- Patients with stage II and III chronic neuropathic ulcers.

Exclusion Criteria:

* Patients with chronic cardiac,
* Patients with renal, and
* Patients with hepatic diseases and
* Diabetic patients. Additionally,
* Patients with immunosuppressive diseases,
* Patients with HIV, and
* Anemia Patients
The Diabetes and Aquatic Training Study (DATS)

This study evaluates the effects of the combined exercise training (aerobic more resistance) and of the aerobic exercise training isolated compared to control group, which performed only stretching and relaxation, in the treatment of type 2 diabetes (T2DM). The two exercise interventions and the control procedure are performed in aquatic environment.

The fact that aquatic training can provide similar benefits to land training has important clinical implications, because the aquatic environment provides some interesting advantages to this population, such as no impact on walking and running in deep water or reduced, as in water-based exercises. This minor impact and consequent reduced chance of injury allows consider the aquatic environment favorable to the principle of continuity with progression of physiological stimuli and metabolic benefits.

From these peculiarities of the training in aquatic environment, and of the association between T2DM with obesity and hypertension, conditions that create difficulties for individuals performing exercise supporting their own body mass and need both benefits from aerobic and resistance training, is believed to be necessary to carry out physical training programs of the same duration, differing in training mode (aerobic or combined) in the aquatic environment in order to answer of in a adequated duration of training, the diabetes control through training differs between the different mode of exercise.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes;
* Be under medical treatment with oral hypoglycemic agents and / or insulin;
* Not engaged in regular exercise (regular exercise was defined as performing any type of physical training for at least 20 minutes three or more days a week).

Exclusion Criteria:

* Severe autonomic neuropathy;
* Severe nonproliferative and proliferative diabetic retinopathy;
* Decompensated heart failure;
* Limb amputations;
* Severe foot injuries;
* Chronic renal failure (Modification Diet in Renal Disease-MDRD, Glomerular Filtration Rate-GFR \< 30 ml/min);
* Body mass index (BMI) \> 45.0 kg/m2;
* Any muscle or joint impairment which prevented individuals from engaging in physical exercise.
Mild Hypothermia After Endovascular Treatment in Acute Ischemic Stroke

To study safety and feasibility of mild therapeutic hypothermia after successful recanalization by mechanical endovascular treatment in patients with acute ischemic stroke and proximal arterial occlusion.

The current clinical trial is an investigator-initiated one, and it is conducted under the multi-center, randomized, open-label, prospective design. The subjects meeting inclusion/exclusion criteria will be assigned to the treatment group or the control group. The randomization ratio is 1:1. The subjects of the treatment group will receive a 2-day hypothermia therapy followed by the process of recovery of temperature within 30 hours (the recovery phase). After 3 months of the onset of symptoms, mRS scores are measured. This is followed by the closure of the clinical trial.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who submitted a written informed consent prior to the participation in the current clinical trial (If the subjects have conditions that they cannot decide on study participation according to their own will, they would participate in the study after their legal representatives submitted a written informed consent form. During the period of study participation, if patients' medical conditions are improved, the written informed consent should be submitted again.)
2. Patients with ischemic stroke attributed to carotid artery or middle cerebral artery occlusion achieved successful recanalization (TICI 2b or 3) immediately after endovascular treatment within 8 hours of symptom onset: Onset time was defined as the time when patients were lastly seen normal.
3. Patients of both sexes aged between 18 and 80 years old
4. NIHSS scores of 6-25 points at screening
5. mRS 1 prior to the onset of disease, with proximal cerebral artery occlusion (e.g., those with middle cerebral or internal carotid artery)

Exclusion Criteria:

1. No evaluation for cranial artery before endovascular treatment
2. Patient with emergent stenting insertion in intracranial or extracranial artery
3. Transient ischemic attack or lacunar infarction
4. Platelet counts \< 75,000/mm3
5. coagulopathy (INR spontaneously \>1.5)
6. Hemodynamic instability
7. acute myocardial infarction, acute unstable angina or severe cardiac failure (NYHA classification ≥III)
8. Sepsis
9. Pregnant or breastfeeding women
10. Premorbid modified Rankin Scale Scores of \> 2 points
11. Hypersensitivity or allergy to following: buspirone, dexmedetomidine, meperidine
12. Intracranial hemorrhage or hemorrhagic transformation in initial CT scan
13. Brain tumor or CNS infection
14. Patients who participated in other clinical trials within 3 months
15. Life expectancy within 1 year