cyrilzakka/clinical-trials huggingface dataset:
Developing a Shared Decision Making Tool for Patients With Surgically Removed Non-small Cell Lung Cancer

This study observes conversations between non-small cell lung cancer patients and their doctors to support the development of a decision aid that can be used to inform discussions about treatment options for after surgery. Patients who have undergone surgery for their non-small cell lung cancer may have the option of completing additional treatment. Patients contemplating this additional treatment have been shown to be most satisfied with their choice if they perceive an effort by their doctor to share decision making. Shared decision making tools can help doctors guide conversations, offer tailored recommendations, and support deliberation on whether or not to pursue treatment. This study develops a shared decision making tool for patients with surgically removed non-small cell lung cancer contemplating additional treatment.

PRIMARY OBJECTIVE:

I. To develop, in close collaboration with stakeholders, an evidence-based decision aid to inform discussions regarding options for adjuvant treatment in patients with resected non-small cell lung cancer (NSCL) (NSCL adjuvant choice).

OUTLINE:

Patient and clinician discussions are observed to support refinement of a decision aid. Clinicians may use a prototype of the decision aid in discussions with their patients and may complete a questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* PATIENTS:
* Adults \>= 18 years with biopsy proven resected non-small cell lung cancer (NSCLC)
* Appointments to discuss adjuvant treatment of resected NSCLC
* CLINICIANS:
* Clinicians who meet with patients to discuss adjuvant treatment of resected NSCLC
* PAG MEMBERS:
* Adults \>= 18 years
* Member of the Knowledge and Evaluation Research (KER) Unit Patient Advisory Group (PAG)

Exclusion Criteria:

* PATIENTS
* Major barriers to providing informed consent (i.e., dementia, severe hearing or visual impairment)
Non Invasive Assessment of Heart Failure

1. To Identify the role of aldosterone antagonist in patients of heart failure with preserved ejection fraction.
2. Portray the health profile of heart failure patients admitted in internal medicine department either heart failure with reduced ejection fraction or heart failure with preserved ejection fraction.
3. To compare between patients of right and left sided heart failure by biomarkers and parameters of echocardiographgy
4. Vitamin D and its relation to cardiovascular disease and heart failure.

Heart failure (HF) is a growing epidemic related to significant morbidity and mortality.

The prevalence of the disease continuously increases due to the ageing population and success in treating cardiovascular diseases that often precede HF.

Lifetime risk of HF is still high with 20-45% and strongly age-dependent . Structural or functional alterations in the heart lead to reduced cardiac output and rising intracardiac pressures.

The resulting HF syndrome comprises typical symptoms such as dyspnoea, ankle swelling and fatigue .

Heart failure is classified into right sided heart failure and left sided heart failure,the later one is classified to HF with reduced EF (HFrEF) involving patients with an EF\< 40% and heart failure with preserved ejection fraction (HFpEF) The proportion of HFpEF seems to be slightly lower than that of HFrEF .

For patients presenting with breathlessness, there is a need for a reliable biomarker for the early diagnosis of heart failure. Similarly, there is also a need for better monitoring of patients receiving treatment for heart failure. Non-invasive means such as a biomarker have therefore become useful.

There are many potential biomarkers for heart failure, the investigators will discuss the biomarkers that are available for clinical use in patients with heart failure to further assess prognosis and possibly direct HF therapy.

There is evidence that aldosterone antagonists can oppose the effect of aldosterone in promoting cardiac fibrosis.Furthermore, elevated levels of cardiac aldosterone have been demonstrated in a rat model of hypertensive diastolic HF, and use of the aldosterone antagonist, eplerenone, was associated with attenuation of left ventricular diastolic dysfunction and reduction in left ventricular mass and fibrosis in this model.Thus, aldosterone antagonism has the potential to be a beneficial therapeutic strategy in patients with HFpEF.

Vitamin D has the potential to improve the symptoms ofheart failure (HF) and to modulate the disease,Vitamin D supplementation can reduce blood pressure and improve skeletal muscle function and strength.

Animal studies suggest that active vitamin D down-regulates the renin-angiotensin-aldosterone system (RAAS), reduces retention of salt and water, and reduces myocardial hypertrophy.

Eligibility Criteria:
Inclusion Criteria:

1. clinical diagnosed heart failure dyspnea grade III or IV
2. Heart failure with ejecton fraction ≤40

Exclusion Criteria:

1. Acute coronary syndrome.
2. Active infection
3. Chronic kidney diseased patients
4. Conn's disease
Therapeutic Effects of a New Upper Limb Robot Assisted Therapy Device for Persons After Stroke

The purpose of this pilot study is to investigate the clinical effects of a new upper limb robot assisted therapy device that is linked to a virtual therapy environment in patients with stroke.

The number of physically weak individuals is increasing, resulting in a higher burden on health care and health care workers. The use of robot assisted therapy (RAT) might partly solve this problem. Rehabilitation progress highly depends on training intensity and training duration, favouring the use of RAT.

In this pilot study, the clinical effects of using a new upper arm RAT device for upper arm rehabilitation in patients with stroke is investigated. Myo-electrical signals will serve as input for the device, assisting the user in flexion and extension of the elbow. The device is coupled to a virtual environments, creating a stimulating therapy environment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stroke, more than three months post onset
* No or moderate spasticity in the upper limb (maximum score of 3 on Modified Ashworth Scale)
* Observable voluntary muscle activity in biceps and triceps muscle of the affected upper limb (minimal score of 1 on the Medical research council score)
* Able to sit on a chair with adequate trunk stability
* Able to follow verbal instructions
* Able to communicate verbal information to the researchers

Exclusion Criteria:

* Patients who are medically unstable
* Cognitive disorders impeding the intervention
* Visual disorders impeding the intervention
* Subluxation of the shoulder joint
* Pusher syndrome
Pilot Study to Assess the Efficacy of Short Exposure to Defocus to Slow the Progression of Myopia in Children

The objective of this pilot study is to establish whether brief periods of high levels of acutely imposed myopic defocus can be used to slow the progression of myopia in children, as measured by changes in spherical equivalent refraction and axial length.

Recent results on animal models of myopia suggest that the eye has the ability to detect the overall sign of defocus of images falling on the retina, with myopic defocus imposed by the fitting of plus-lenses halting or slowing axial elongation of the eye. In the animal models, these STOP growth signals have been shown to be particularly strong - with brief periods of high myopic defocus able to outweigh the effects of prolonged periods of imposed hyperopic defocus in promoting eye growth. These results therefore suggest a novel strategy for preventing the progression of myopia in children - the imposition of high levels of myopia for brief periods of time. This approach is conceptually distinct from under-correction, which imposes chronic mild myopic defocus.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 6 to 12 years
2. Refractive error of spherical equivalent -1.00 D to -6.00D in each eye as measured by cycloplegic autorefraction
3. Active myopia progression of at least spherical equivalent -0.50 D over the last 12 months as determined or suggested by refractive records or change in lens power
4. Astigmatism of less than or equal to -1.50 D as measured by non-cycloplegic or cycloplegic autorefraction
5. Distance vision correctable to logMAR 0.1 or better in both eyes
6. Normal intraocular pressure of not greater than 21 mmHg
7. Normal ocular health other than myopia
8. In good general health
9. Willing and able to comply with scheduled visits and other study procedures

Exclusion Criteria:

1. Baseline Anisometropia of \> 1.5D
2. Ocular or systemic diseases which may affect vision or refractive error
3. Defective binocular function or stereopsis
4. Amblyopia or manifest strabismus including intermittent tropia
5. Previous or current use of atropine or pirenzepine
6. Any other conditions precluding adherence to the protocol including unwillingness to refrain from contact lens wear for the duration of the study
7. Allergy to cyclopentolate, proparacaine and benzalkonium chloride
Motor-Sparing Femoral Nerve Block Dose

Femoral nerve blocks are commonly used to provide pain control for total knee replacement, anterior cruciate ligament (ACL) reconstruction. Commonly employed local anesthetic concentrations result in motor block of the quadriceps and constitute an inherent risk factor for patient fall.

The aim of this study is to determine the minimum effective concentration of bupivacaine in 90 % of patients (MEC90) required for a motor-sparing, successful sensory block of the femoral nerve.

With the approval of Ethics Committee of the University of Chile Clinical Hospital, approximately 60 patients undergoing ACL repair or TKR will be recruited. All blocks will be conducted preoperatively in an induction room.Dose assignation will be done using an up-and-down sequential method, where the dose of each subsequent patient depends on the response of the previous patient, called the Biased Coin Design.

The assignment of each subsequent concentration will be based on the response of the previous patient.As soon as we recruit 45 patients with random dose assignment, we will terminate the enrollment procedure.

The injectate will be prepared and administered by a research assistant using syringes connected to the block needle. The operator and the patient will be blinded to the concentration injected.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years
* American Society of Anesthesiologists classification 1-3
* Body mass index between 20 and 35

Exclusion Criteria:

* Adults who are unable to give their own consent
* Pre-existing neuropathy (assessed by history and physical examination)
* Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets≤ 100, International Normalized Ratio≥ 1.4 or partial prothrombin time ≥ 50)
* Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
* Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
* Allergy to LA
* Pregnancy
* Prior surgery in the inguinal region
* Chronic pain syndromes requiring opioid intake at home
Music Use and Perceived Psycho-social Benefits of Music of Caregivers of Patients in an Intensive Care Unit

The purpose of this study is to investigate how family caregivers of ICU patients perceive their psycho-social needs and quality of life, how they use music in their everyday life and perceive music as beneficial to themselves. Participants are adult family members of critically ill patients in ICU. After obtaining the informed consent form, a questionnaire will be distributed to each participant.

The purpose of this study is to investigate how family caregivers of ICU patients perceive their psycho-social needs and quality of life, how they use music in their everyday life and perceive music as beneficial to themselves. Participants are adult family members of critically ill patients in ICU. After obtaining the informed consent form, a questionnaire will be distributed to each participant. The questionnaire consists of Beck Depression Index, Quality of Life scale, and the self-reported items on music use in everyday lives and perceived benefits of music. Based on the completed measures, how caregivers of ICU patients use music and perceive music as beneficial media for their psycho-social health will be analyzed in relation to demographic information and the current level of depression and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* primary caregivers (family members) of ICU patients
* aged over 20

Exclusion Criteria:

* the one who have difficulties in verbal communication due to the history of psychiatric illness or cognitive impairment (e.g., dementia)
Effect of Plasmapheresis on Clinical Improvement and Biological Parameters of Patients With Long-haul COVID

Many patients infected with SARS-Cov-2 present in the months following infection with non-specific symptoms such as non-resolving fatigue, cognitive disorders, dyspnea, headaches, myalgias, sleep disorders, anosmia/ ageusia and post exertion malaise. The persistence of these symptoms is called "post covid syndrome" or "long Covid".

According to the literature, the pathophysiological mechanisms involved in post-covid syndromes would include an inadequate immune response, activation of autoimmunity, persistence of pro-inflammatory biomarkers, endothelial dysfunction and alterations in the intestinal microbiota.

In view of the involved pathophysiological mechanisms, linked to the circulation of pro-inflammatory molecules, autoimmunity or endothelial activation, the role of immuno-modulation in the treatment of long Covid need to be evaluated.

Plasma exchange (PE) by decreasing blood levels of pro-inflammatory cytokines and/or autoimmune markers results in moderate to marked clinical improvement in various types of autoantibody-associated inflammatory, autoimmune and neurological diseases.

The goal of our study is to evaluate the effects of plasmapheresis in patients with moderate to severe long-term COVID compared to patients receiving no treatment.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* Who have had confirmed SARS-COV2 infection (RT PCR) for at least 6 months
* Having for more than 6 months at least 3 symptoms among the following: fatigue, post effort malaise, dyspnea, headache, diffuse myalgia/arthromyalgia, neuropathic pain, cognitive disorders, anosmia/ageusia
* Whose above symptoms have an impact on daily activities
* And/or on sick leave for more than 3 months
* And/or having to take to bed for more than 2 hours a day
* Having given free and informed written consent
* Being affiliated with or benefiting from social security

Exclusion Criteria:

* With suspected Covid-19 but not confirmed by RT-PCR test
* Having a known history of any other pathology that could be confused with the diagnosis of long COVID: multiple sclerosis, autoimmune disease (lupus and Gougerot syndrome, inflammatory muscle disease, and myasthenia gravis), untreated hypothyroidism, major depression, use of narcotics regular.
* Unable to perform a cycle ergometer stress test
* With innate or drug-induced coagulation disorders (oral or parenteral anticoagulation)
* With contraindications to plasmapheresis such as: lack of peripheral venous access or unstable cardiac pathology
* Pregnant or breastfeeding woman
Caring for the Sexual Health and Wellbeing of Cancer Survivors and Their Intimate Partners: An Anonymous Survey

The aim of this survey study is to provide broad information as reported by cancer survivors and their intimate partners about both their sexual health and their experiences of care from the United Kingdom hospital cancer team, including their perspectives on factors that may hinder or help care. This information will be analysed and used to inform the questions asked in a separate, subsequent, qualitative study.


Eligibility Criteria:
Inclusion Criteria:

1. Cancer survivors diagnosed with any type of cancer at age 18 years or over
2. A partner of someone diagnosed with any type of cancer at age 18 years or over
3. Cancer diagnosis must be no more than 10 years ago
4. Cancer survivors or their partners who experienced treatment and follow up care in the United Kingdom

Exclusion Criteria:

1. Cancer survivors who were diagnosed with cancer below the age of 18 years
2. Partners of cancer survivors who were diagnosed with cancer below the age of 18 years
3. Cancer diagnosis was more than 10 years ago
4. Cancer survivors/partners of survivors where the cancer treatment and follow up was not in the United Kingdom
5. Previous completion of the survey
Regenerative Medicine in Ocular Surface: Application of Cell Therapy for Ocular Surface Repair Using Progenitor Cells of Sclerocorneal Limbus Amplified ex Vivo

Progenitor limbo sclerocorneal cells have properties of proliferation and differentiation to corneal and conjunctival epithelium. This cells can be isolated and ex vivo expanded using cell culture technics that could permit the biological replacement of damaged ocular surface.


Eligibility Criteria:
principal Inclusion Criteria:

* Serious unilateral limbic insufficiency
* Normal ophthalmological clinical examination in the opposite eye (biopsied eye)

Exclusion Criteria:

* one-eyed
* serious disorders in palpebral dynamics
* bilateral limbic insufficiency, immunological, systemic or local illness like toxical epidermic necrosis or pemphigoid
* breastfeeding or pregnancy
* positive serology of HIV, VLTH, HVC, HVB, CMV, Trypanosoma Cruzi or Treponema Pallidum
A Phase 3 Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Peritoneal Dialysis

This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 in chronic kidney disease and hyperphosphatemia patients on peritoneal dialysis.


Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease patients on peritoneal dialysis
* Hyperphosphatemia
* Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not changed within 28 days.
* Written informed consent

Exclusion Criteria:

* Patients with gastrointestinal surgery or enterectomy
* Patients with severe cardiac diseases
* Patients with severe constipation or diarrhea
* Patients with a history or complication of malignant tumors
* Patients with uncontrolled hypertension
* Patients treated with parathyroid intervention
Dose-ranging Study to Evaluate Efficacy of SLV339 in Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

This study is to estimate the efficacy of a number of doses in patients with pancreatic insufficiency


Eligibility Criteria:
Inclusion Criteria:

* Subject \> 18 years;
* Pancreatic exocrine insufficiency confirmed and documented in medical history by either a pathophysiological direct or indirect pancreatic function test or clinical symptoms of steatorrhea stool fat that resolved or improved substantially upon pancreatic enzyme supplementation;
* Patients on a stable daily dose of pancreatic enzymes for 3 months;
* Subjects with CP with or without partial pancreatectomy due to CP, confirmed in medical history by either CT , ERCP, plain film with pancreatic calcifications, ultra-sonography (calcifications, duct dilatation), magnetic resonance pancreatography, endoscope ultrasound, other radiological diagnosis captured by tools such as Cambridge classification and /or histology;
* CFA \< 80% at time of randomization

Exclusion Criteria:

* Evidence of major surgery (except gall bladder removal or appendectomy) or other relevant diseases as revealed by history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of the study drug or constitute a risk factor when taking the study medication;
* Investigational drug intake within 90 days prior to the pre-assessment visit;
* Ileus or acute abdomen;
* Allergic disease such as hypersensitivity pneumonitis, aspergillus mediated asthma or allergic broncho-pulmonary aspergillosis;
* Stenosis or regurgitation of the esophagus or stomach;
* Known HIV infection, acute phase of CP
Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery

Sleeve gastrectomy (SG) has become the most commonly performed weight loss surgery, accounting for 60% of all bariatric operations worldwide. While technically easier with less side-effects and nutritional risks than other operations, SG is also associated with a higher risk of failure (20 to 40%). In such case, the most effective option consists in adding an intestinal bypass called the Biliopancreatic Diversion with Duodenal Switch (BPD-DS). This surgery is, however, technically challenging and yields a significant risk of complications, nutritional deficiencies or gastro-intestinal side-effects. Recently, a simplified version of the Standard DS, called Single-Anastomosis Duodenoileal Switch (SADI-S) was endorsed by surgical societies as one of the approved bariatric procedures. There is currently no prospective or randomized data to support the effectiveness of this new procedure, especially as a revisional approach. The Overall Objective of this randomized controlled trial project is to establish the clinical benefits of the SADI-S as a revisional surgery after SG, while also considering critical issues related to sex and gender. The investigator Overall Hypothesis is that the SADI-S represents a relevant revisional option for weight loss and metabolic recovery in women and men suffering from severe obesity who had a previous SG. The investigator propose to address the following research question.

Research Question: What are the clinical effects of SADI-S compared to standard DS when used as a revisional procedure after SG, in patients with obesity? Participants who need revisional surgery after SG will be enrolled in a prospective, randomized, double-blind (patient-evaluator), non-inferiority trial comparing SADI-S vs DS. The primary outcome will be 12-month excess weight loss. Secondary outcomes will be perioperative complications, risk of malnutrition, quality of life and gastrointestinal side effects. The investigator hypothesize that SADI-S offers similar weight loss compared to standard DS, but a lower risk of complications and nutritional deficiencies.

With the increase in the number of bariatric operations performed worldwide and the recent endorsement of the SADI-S as a regular procedure, reliable clinical data are urgently needed. The present proposal will directly address this knowledge gap.


Eligibility Criteria:
Inclusion Criteria:

* had sleeve gastrectomy a minimum of 18 months before
* still meet the NIH criteria for bariatric surgery (BMI≥35kg/m2 with major comorbidities or BMI≥40kg/m2) or patients with EWL\<50% or significant weight regain (≥20%EWL)

Exclusion Criteria:

* general contra-indication for bariatric surgery
* BMI\<35kg/m2
* pregnancy
* cirrhosis
* abnormal bowel habits including irritable bowel syndrome and inflammatory bowel disease