cyrilzakka/clinical-trials huggingface dataset:
Cardiac Output, Cerebral Perfusion and Cognition in Patients Undergoing TAVI

Rationale: Cardiovascular disease and cognitive diseases are closely related. Cognitive impairment is common (21-39%) among patients with severe aortic valve stenosis. The proof-of-concept CP-TAVI study showed that increased cardiac output following transcatheter aortic valve implantation (TAVI) was associated with increased cerebral blood flow. It is hypothesized that increased cerebral blood flow (CBF) subsequently leads to improved cognitive functioning. Additionally, silent micro emboli caused by crushing of the calcified native valve during TAVI may cause cognitive deterioration. If it could be predicted which patients are at risk for TAVI induced cerebral micro emboli, these patients could benefit from cerebral protection devices, preventing cognitive decline.

Objective: The objectives of the CAPITA study are 1A) to identify whether an increase in cardiac output after TAVI is associated with an increase of global CBF; 1B) explore regional differences in CBF after TAVI; 1C) determine whether (global or regional) increased CBF is associated with improved cognitive functioning; 1D) identify patient and procedural characteristics associated with increased cardiac output, CBF and cognitive functioning; 2A) identify the incidence and volume of new white matter hyperintensities after TAVI; 2B) evaluate patient and procedural predictors for the increase in white matter hyperintensities volume, including baseline aortic valve calcification volume, measured with computed tomography; 2C) if aortic valve calcification volume predicts new white matter hyperintensities, define a cut-off value for high-risk patients; 2D) assess whether the increase in white matter hyperintensity volume is associated with deterioration of cognitive scores.

Study design: Prospective observational study, measuring cardiac output (echocardiography), cerebral blood flow (arterial spin labelling magnetic resonance imaging) and cognitive functioning (neuropsychological test battery) prior to TAVI (\<24 hours to \<one week) and at 3 months follow-up. At one year follow-up, cardiac output and cognitive function will be assessed.

Study population: Patients with severe aortic valve stenosis eligible for transfemoral TAVI (n=142).

Main study parameters/endpoints: Cardiac output (L/min), cerebral blood flow (mL/100g/min, change in %, relative to baseline) and cognitive functioning (extensive neuropsychological testing 60-90 minutes).


Eligibility Criteria:
Inclusion Criteria:

* Severe aortic valve stenosis (aortic valve area \<1cm2 and/or mean aortic valve gradient exceeds 50 mmHg) of a native valve
* Eligible for TAVI
* Able and willing to give informed consent
* Age \> 18 years

Exclusion Criteria:

* Presence of MRI contra-indication; inability to lay flat for 30 minutes
* Weight \> 130 kg
* Neurological disease
* Active malignant disease;
* Insufficient mastery of the Dutch language
* Inability to withdraw from alcohol use for 24 hours
* Non-atherosclerotic vascular disease (eg vasculitis)
* Planned surgery with general anesthesia within three months after TAVI.
Cannabis Use Patterns Among Cancer Patients

This study determines patterns of cannabis use among cancer patients. Information collected in this study may help doctors to understand patient use of cannabis therapy, their knowledge and experiences with this therapy, benefits and risks associated with its use, and whether or to what extent they are discussing it with their health care providers.

PRIMARY OBJECTIVES:

I. To identify the frequency, modes, and duration of cannabis use, assess experiences with obtaining and using cannabis, as well as reasons for use and perceived risks and benefits of its use among cancer patients who are undergoing or have recently completed active treatment.

Ia. To uncover disparities in use of cannabis, perceptions of use, and communication with providers among cancer patients who are identify as racial and ethnic minorities, have low health or digital literacy, are of older age or low socioeconomic status.

II. Among cancer patients with a known medical marijuana certification, assess the impact of cannabis on pain management, anxiety, anorexia, and quality of life, as well as their communication with their oncology team about their procurement and use of cannabis.

OUTLINE:

Patients complete a survey about knowledge and awareness of medical cannabis, perceived risks and benefits of cannabis, mode and frequency of use (if applicable), impact on cancer-related symptoms, patient provider discussions about cannabis, and demographic characteristics including health and digital literacy.

Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated informed consent form
* English speaking
* Willing to comply with all study procedures and be available for the duration of the study
* Any individual \>= 18 years old
* At least one medical or radiation oncology appoint within the last 3 years at one of the SKCC cancer center campuses

Exclusion Criteria:

* Non-English speaking
* Not a cancer patient at one of the SKCC campuses
* Deceased
Algorithms in a Simulated Difficult Intubation Scenario

This is a non-human study, conducted in a simulation environment, with simulator manikins, and volunteers from anaesthesia. Trainees in their first 2 years of anaesthetics training will be randomised to a control group, a group following the Difficult Airway Society UK's Guidelines and the Australian Difficult Airway management algorithm. A simulated difficult airway will be created during the induction of anaesthesia. The investigators will examine adherence to guidelines, which would have been provided to participants before the experiment, as well as compare their performance with the guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Anaesthetists in first 2 years of training

Exclusion Criteria:

* Those who decline invitation to participate
Noninvasive Assessment of Metabolic Associated Fatty Liver Disease (MAFLD) in Chinese Population

Attenuation imaging (ATI) technology independently developed by Canon medical is a non-invasive examination technology for quantitative detection and analysis of liver steatosis. The technique is simple, rapid and quantitative diagnosis, and is suitable for screening and popularization of early liver steatosis in MAFLD. As noninvasive and effective detection measures of liver inflammation and liver fibrosis, SWD and SWE are more and more widely used in the quantitative diagnosis of liver inflammation and fibrosis. Therefore, ATI combined with SWD / SWE detection can quantitatively diagnose different pathological stages (steatosis, necrotizing inflammation and liver fibrosis) in the development of MAFLD, so as to provide an important basis for treatment.


Eligibility Criteria:
Inclusion Criteria:

1. being a Chinese citizen aged 18 to 85 years;
2. meeting the diagnostic criteria for MAFLD;
3. willing and able to provide informed consent;
4. having a platelet count of at least 50 × 109/L and prothrombin activity of ≥50%.

Exclusion Criteria:

1. The pregnant.
2. Patients who have received or are undergoing systemic chemotherapy.
3. Patients with hepatitis C, alcoholic liver disease (more than 5 years of drinking history, equivalent to alcohol volume ≥ 40g / D in male and ≥ 20g / D in female), drug-induced liver disease or autoimmune hepatitis.
4. Those who re fuse to sign informed consent;
5. There was a significant risk of bleeding (platelet \< 50x109 / L, prothrombin activity \< 50%).
Inspiratory Muscle Training in Patients With COVID-19

COVID 19 has become a pandemic and has led to high demand on healthcare systems. It can cause a severe acute respiratory syndrome (SARS CoV-2) which leads to a long hospital stay, developing important functional damage and making hospital discharge difficult. Elderly, obese and people with chronic diseases are more susceptible to contracting the disease, this profile of patients already has a predisposition for respiratory muscle weakness and in this context, after clinical stability, it is still necessary in a hospital environment to approach respiratory and motor physiotherapy. to optimize the recovery of these patients. Objective: Improved breathing, functionality, exercise capacity and muscle strength in non-critical patients. Method: Prospective randomized clinical study where one group received motor and respiratory physiotherapy and the other group performed the same therapy associated with inspiratory muscle training. Results: The findings will be compared before and after the approach and will be presented in graphs and tables. Statistical tests will be used considering a significance level of 5%.

Prospective clinical study in patients with COVID-19 admitted to a non-critical unit of a tertiary hospital. They were randomized into a group that received motor and respiratory exercises and another group that received the same exercises associated with respiratory muscle training.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with COVID-19 through PCR aged over 18 years admitted to non-critical units.

Exclusion Criteria:

* patients with changes in the level of consciousness and non-transient understanding, exclusive palliative care without prognosis.
Improving the Management of Drug Resistant Tuberculosis in the UK

The 'rising tide' of antimicrobial resistance is a source of concern across most infectious diseases. In the UK, for example, 6.8% of the \~8,500 tuberculosis patients seen in 2012 were resistant to the cheap and effective first-line drug isoniazid. It is of great importance to prevent the loss of current anti-tuberculosis drugs and preventing the spread of resistance by treating such patients as well as possible.

Currently, guidance on the best treatments for isoniazid resistant tuberculosis is inconsistent globally. Data from randomised controlled trials, the peak quality of evidence, is sparse. It is thus important that studies using pre-existing observational data are undertaken.

The investigators aim to use data and samples collected from Public Health England and National Health Service hospitals to determine a) the best treatments for patients with isoniazid resistant tuberculosis disease (cohort study) and b) how different causes of drug resistance in the infecting bacteria influence a) (nested case-control study). Eligible participants will have had isoniazid resistant tuberculosis (without associated rifampicin resistance) in England between 2009 and 2013 and will have been notified to Public Health England. The study will be conducted at University College London, National Health Service hospitals and Public Health England and will last until December 2017. Patient hospital records and disease surveillance records will be accessed and cultured bacteria from previously stored samples sequenced.


Eligibility Criteria:
Inclusion Criteria:

* Isoniazid resistant non-multidrug resistant tuberculosis patients.
* Notified to Public Health England's Enhanced Tuberculosis Surveillance System between 2009-2013.
* Adults aged 18 years and over.
* Patients not treated at private hospitals.

Exclusion Criteria:

* Non-notified patients.
* Individuals where the site of disease required more than 12 months of treatment.
* Individuals diagnosed post-mortem.
Musculoskeletal Problems During Pregnancy

Aim: This study was conducted to identify the most common musculoskeletal problems according to trimester, experienced by pregnant women.

Material and Methods: A total of 120 pregnant women who admitted to physical medicine and rehabilitation clinic, evaluated retrospectively in this study. Application complaints, the diagnosis and the trimester of the pregnant women and also age, weight, height, number of pregnancy, working status, presence of secondary disease were recorded.


Eligibility Criteria:
Inclusion Criteria:

Pregnant patients who have age, weight, size, employment status, duration of pregnancy, nulli/multi-parity, presence of other disorders, application complaints, the diagnosis information were included to the study

Exclusion Criteria:

Non-pregnant patients and pregnant patients with missing data were excluded from the study
Treatment of Recalcitrant Neovascular AMD Using Brolocizumab With Immediate T&E

The investigator propose to conduct a randomized clinical trial, investigating the safety and efficacy of brolucizumab for treatment of nAMD patients with CNV, and plans to specifically target those who are not responding to standard Treat and Extend (T\&E) treatment. A randomised omized study will be conducted with 2 arms, one with the new drug (brolocizumab) and novel treatment protocol versus a second arm using the current gold standard of aflibercept and the T\&E protocol

In addition, there will also be a rescue option for those in the aflibercept arm who are not responding well to also switch to brolucizumab. The primary outcome is the change in central macular thickness, since we expect the new treatment to be effective in reducing intraretinal and subretinal fluids, which in effect are indicators of disease activity. In addition, investigator will look at the improvement of visual acuity, the reduction of treatment intervals, total number of injections over 1 year, recurrence rate and safety profiles of both drugs.

Eligibility Criteria:
Inclusion Criteria:

* Age 50 and above
* Diagnosis of exudative age-related macular degeneration (subfoveal CNV) as shown on optical coherence tomography (OCT) - presence of intraretinal fluid, subretinal fluid or subretinal hyperreflective material and/or FFA (leakage classified as subfoveal or as juxtafoveal or extrafoveal)
* Actively treated with aflibercept and given 3 monthly loading doses followed by treat and extend
* Maximal interval period is less than or equal to 8 weekly injections
* Patients must understand and sign the ethics board approved consent form

Exclusion Criteria:

* Ocular criteria:

  * Co-existing retinal and/or macular disease (DME, RVO, high myopia of 8 diopters or more, retinal detachment, macular hole stage 2 or above, significant vitreomacular traction or epiretinal membrane, etc.)
  * Co-existing ocular disease (glaucoma, uveitis etc.)
  * History of uveitis or intraocular inflammation, scleritis, or episcleritis
  * History of corneal transplant, pars planar vitrectomy or aphakia
  * History of therapeutic radiation to the region of the study eye
  * Media opacity obstructing investigation or assessment (cataract, corneal scar, vitreous hemorrhage)
  * Treat and extend period beyond 8 weeks
  * Any intravitreal injection of steroid within 3 months before randomization
* Systemic criteria:

  * Poorly controlled systemic disease including hypertension and diabetes
  * Any acute coronary event or stroke within 6 months before randomization
  * Malignancy within 5 years
  * Systemic anti-VEGF treatment
  * Allergy or sensitivity to investigational product, including fluoresceine dye, anesthetics, aflibercept or brolucizumab
Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

This is phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This study is double-blinded in the first year and an open-label for the next three years.


Eligibility Criteria:
Inclusion Criteria:

* Participant is a premenopausal female at the time of Screening.
* Participant has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound \[Transabdominal ultrasound (TAU) and transvaginal ultrasound (TVU)\].
* Participant has Heavy Menstrual Bleeding (HMB) associated with uterine fibroids as evidenced by Menstrual Blood Loss (MBL) \> 80 mL during each of two screening menses as measured by the alkaline hematin method.
* Participant has negative urine and/or serum pregnancy test during Washout (if applicable) and/or Screening and just prior to first dose.
* Participant has an adequate endometrial biopsy performed during Screening, the results of which show no clinical significant endometrial pathology.

Exclusion Criteria:

* Participant has screening pelvic ultrasound or Saline Infusion Sonohysterography (SIS) results that show a clinically significant gynecological disorder.
* Participant has history of osteoporosis or other metabolic bone disease.
* Participant has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
* Participant has a history of major depression or post-traumatic stress disorder (PTSD) episode within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).
* Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over the counter and prescription topical, inhaled, intranasal or intra-articular injectable (for occasional use) corticosteroids are allowed.
Post-Operative Pain After Recovery in Thoracic Surgery

Persistent pain after surgery has significant physical and mental consequences for the patient, as well as a significant economic impact on health systems. Neuropathic pain is caused by direct or indirect damage to the somatosensitive system. In thoracic surgery, chronic neuropathic pain is represented by Post-Thoracotomic Pain Syndrome (PTPS), defined as recurrent or persistent pain in the thoracotomy scar site that persists for more than 3-6 months. Currently, in literature, the prevalence of PTPS is extremely variable. This prospective observational study aims to assess the incidence of pain in the weeks and months following surgery and to assess whether and how the presence of painful symptoms changes the patient's quality of life.

For each patient enrolled in the study, in the pre-operative phase, comorbidities, any chronic analgesic therapy and quality of life (through a dedicated questionnaire - Euro QoL 5D5L1) will be recorded. Surgical data (type of procedure, lobe affected by resection, type of approach and surgical time) and anesthesiological data (intravenous opioid, locoregional technique (s), non-opioid analgesics administered and other medications) will be collected in the perioperative phase. In the 48 hours following the surgery (in the Recovery Room, at 6h, 12h, 24h, 36h and 48h) the patient's pain data will be recorded (static, dynamic and cough-associated NRS) and those relating to any complications. The total amount of morphine administered to the patient in the first 48 hours will also be recorded. Each patient will be evaluated 7 days, 1, 3 and 6 months after the surgery by telephone interview. In this last phase, the possible presence of pain and its characteristics will be assessed, especially if these meet the criteria of neuropathic pain.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient's consent to the trial
* Candidate to resective lung surgery (lobectomy, segmentectomy, atypical resection) with minimally invasive approach (mini-thoracotomy with muscle sparing or video-assisted thoracic surgery, VATS)

Exclusion Criteria:

* neurological and / or cognitive deficits
* inability to obtain informed consent
* surgeries that include wall resections (pleural, muscle, rib or nerve)
* pneumonectomy
* Previous thoracic surgery at the time of enrollment
Evaluation of Physical Activity of Patients Admitted to Addiction Service

Addiction is a public health issue that affects nearly 30% of French people according to INSEE. For several years now, the investigators have known that sport is a real help in the fight against addictions, with recent medical authorization to prescribe physical activities. A study from August 2016 claims that regular physical activity may offset the harmful effects of alcohol. (1) Based on the answers given by 36,370 Britons between 1994 and 2006, the researchers showed the existence of a link between the practice of 150 minutes of physical activity per week and the decrease in deaths linked to consumption. alcohol. These results, compared to 18 other studies (2), reveal the benefits of physical activity in the management of addictions. But what about current practice and addictions and sports practice in general ?


Eligibility Criteria:
Inclusion criteria:

- Any patient entering the addictology service for a reason related to addiction (withdrawal, VMI, etc.) at the CHU de St Eloi between January 01, 2020 and May 31, 2020 aged at least 18 years old

Exclusion criteria:

* Patient whose hospitalization is not related to addictology (accommodation, medical examination, etc.)
* Minor patient (age \<18 years)
Text Messaging to Increase Activity in Midlife

This is a randomized controlled pilot trial of a text message intervention to promote physical activity in midlife adults (MASTERY), compared to an attention-matched control condition. The MASTERY intervention utilizes two-way text message sessions once-weekly for 12 weeks focusing on performing activities to enhance well being, setting physical activity goals, and learning techniques to reduce midlife-specific stress.

This is a randomized controlled pilot trial of a multipronged intervention to promote physical activity in midlife adults (MASTERY), compared to an attention-matched control condition. In MASTERY, participants will have interactive, two-way text message 'sessions' (5-10 minutes of two-way text communication with an automated text-message program) once weekly for 12 weeks. The messages will focus on 3 distinct areas in the same order each week: (1) well-being-based skills and assigned activities, customized for midlife adults, (2) physical activity content focused on setting and reaching weekly activity goals, and (3) specific skills to manage midlife-related stressors that act as barriers to activity. The primary outcome is objectively measured moderate to vigorous physical activity (MVPA). Secondary outcomes include feasibility and acceptability and other activity-related, psychological, and functional outcomes at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Midlife status (age 45-64 at enrollment).
2. Low baseline physical activity (≤150 minutes/week of MVPA\]) as initially self-reported via the well-validated IPAQ and then confirmed via accelerometer after 7 days of wear.

Exclusion Criteria:

1. Existing coronary artery disease (CAD; diagnosed via cardiac catheterization using standard coronary artery stenosis definitions or prior ACS).
2. An unrelated condition limiting physical activity (e.g., ambulation with a cane or walker, recent or planned surgery, or other condition such that ability to increase moderate to physical activity would be limited).
3. Participation in any other programs focused on cardiac prevention or well-being (e.g., cardiac rehabilitation).
4. A cognitive disturbance precluding participation or informed consent, assessed using a six-item screen7 designed to assess suitability for research participation.
5. Inability to speak/write fluently in English.
6. No access to a text message-capable phone.