cyrilzakka/clinical-trials huggingface dataset:
ATTR Amyloidosis in Elderly Patients With Aortic Stenosis

Severe aortic stenosis is defined with a mean transvalvular pressure gradient (MTPG) \> 40mmHg and a calculated aortic valve area of \< 1cm2. However, a considerable proportion of patients do have a MTPG \< 40mmHg due to a reduced stroke volume (stroke volume indexed to body surface area ≤ 35ml/m2) despite a normal left ventricular ejection fraction (LVEF \> 50%). This entity is termed paradoxical low flow low gradient aortic stenosis (PLFLG AS) and is associated with a worse prognosis.

ATTR amyloidosis is a disease of the elderly and might coexist in patients with severe aortic stenosis. Case reports and small observational studies suggest that senile ATTR amyloidosis could be frequent but underdiagnosed in patients with aortic stenosis. There is significant overlap between PLFLG AS and cardiac amyloidosis with regard to symptoms, increasing prevalence with age, concentric hypertrophy, impaired diastolic filling of the left ventricle (LV), as well as longitudinal LV dysfunction despite preserved ejection fraction - all features, which lead to a reduction in stroke volume, the underlying mechanism of the low flow condition as observed in PLFLG AS patients.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic, severe aortic stenosis

Exclusion Criteria:

* More than mild valvular disease of any other valve
* Other severe disease with a life expectancy \< 1 year
* Participating in trial interfering with routine clinical practice or use of a non-CE marked device
A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study

A phase IV, multicentre, randomised, open-label, pilot clinical trial designed to evaluate HIV-infected, aviremic patients who receive treatment with the combination of DTG/3TC/ABC and who have neuropsychiatric adverse effects that, in the opinion of the investigators, may be related to taking DTG/3TC/ABC, if they improve after switching antiretroviral therapy to the combination of ELV/COBI/FTC/TAF.

we estimate that 64 participants will need to be enrolled in the study to demonstrate symptomatic improvement after switching antiretroviral therapy from DTG/3TC/ABC to ELV/COBI/FTC/TAF.

Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 years of age diagnosed with HIV using normal serology techniques.
* Current antiretroviral therapy with DTG/3TC/ABC.
* HIV viral load \< 50 copies/mL for at least 12 weeks prior to signing the consent form \[(\]confirmed by two assays at least 12 weeks apart with viremia \< 50 copies/mL between both). If the patient has a recent routine blood test available (≤ 4 weeks) that includes determining HIV viral load, these results may be used for the screening visit. If this test is not available, or the test is more than four weeks old, viral load will be determined on the day of screening in order to confirm that the patient meets this criterion.
* Appearance or worsening of the following symptoms compared to when DTG/3TC/ABC was started:

  * Symptoms of anxiety or depression
  * Insomnia or other sleep disturbances
  * Headache
  * Cognitive complaints (attention, concentration or memory)
  * Alterations in behaviour (irritability, aggressiveness or agitation)
  * Dizziness of neurological or neurologically-mediated origin

Exclusion Criteria:

* Determination of at least one HIV viral load ≥ 50 copies/mL in the last 12 weeks.
* Allergy, intolerance or existence of resistance mutations to any of the components of ELV/COBI/FTC/TAF
* History of active CNS infections
* Active psychosis, major depression with psychotic symptoms or autolytic ideation
* Dementia or mental retardation
* Drug use with a diagnosis of abuse or dependence according to DSM-5 criteria
* Illnesses that may interfere with the study procedures
* Claustrophobia
* Presence of magnetisable devices in the body
* Inability to complete any of the study procedures
* Pregnant or nursing women, as well as women of childbearing age who do not agree to use an adequate birth control method.
Practical Application and Evaluation of Fortimel in Oncology Patients

This study is a multicenter registry and is a prospective, observational, real-world study.

Subjects were selected by clinicians for oral ONS nutritional intervention according to the actual clinical situation and the patient's wishes, and the observation period was 4 weeks.

Subjects will receive a ready-to-drink marketed formula for special medical purposes with 4 flavors for free Food liquid preparation (Nengli Yijia, Nutricia in the Netherlands) for rounds of nutritional intervention, providing

1 flavor per week, 1-2 bottles per day, 4 flavors for a total of 28 days. The basic nutritional status and quality of life of patients were mainly evaluated at multiple time nodes before and after nutritional intervention.

In order to improve the compliance of subjects, the all-round guardian platform (hereinafter referred to as the platform) by the China Initial Insurance Foundation was used during the intervention period to provide basic nutrition supervision, education and dietary guidance in routine nutrition support.

Recruitment method: Convenient sampling method is adopted, from the beginning of recruitment to the target sample size.

Follow-up period: After the start of the intervention, it will be carried out according to the plan of the follow-up task to the end of the intervention on the 28th day. The last telephone follow-up visit will complete on the 60th day after the end of the pre-end.


Eligibility Criteria:
Inclusion Criteria:

* Patients signed informed consent and volunteered to participate in the study
* Patients diagnosed with colorectal cancer or primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring, undifferentiated adenocarcinoma) or NSCLC stage I-iv. by histopathological examination of primary biopsy
* Cancer patients who were receiving chemoradiotherapy or immunotherapy were given 2 points for nutritional risk screening, and patients who met the conditions of ONS nutrition intervention were voluntarily enrolled to receive ONS nutrition intervention with Nertronecar
* Basic reading and communication skills
* The expected survival time is greater than 6 months

Exclusion Criteria:

* Combined cognitive dysfunction, mental disorder, impaired consciousness or unwillingness to partner
* Contraindications with chemotherapy or immunotherapy
* Prolonged bed rest, hemiplegia, or coma
* Intolerance of allergies to nutrients or their main components, such as lactose or galactose
* In the case of severe gastrointestinal symptoms of liver and kidney dysfunction, the serum creatinine glutamic pyruvic transaminase glutamic oxalacetic transaminase increases by more than 2.5 times, and the fasting blood glucose is over10mmol
An Innovative Approach to Automated Carbon Dioxide Angiography During Endovascular Abdominal Aortic Aneurysm Repair

The study aims to perform Endovascular Aortic Repair procedures with CO2-Angiography using a standardized an operative Protocol


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Male, female
* Patients with indication for AAA
* Informed consent achievement

Exclusion Criteria:

* Severe COPD (Chronic Obstructive Pulmonary Disease)
* Known atrium- or ventricular septal defect with right-left-shunt
* Severe renal arteries atherosclerosis
* Ruptured AAA
* Current partecipation in other interventional studies
Efficacy of Clean Intermittent Catheterization (CIC) in Multiple Sclerosis (MS) Patients With Bladder Dysfunction

The aims of this prospective, randomized study are:

* To assess the effect of clean intermittent catheterization (CIC)
* To investigate if MS patients will have symptom reduction (urgency, frequency, nocturia and incontinence) when using CIC in combination with anticholinergic drugs
* To identify at what volume of Postvoid Residual (PVR) urine, starting CIC improves bladder control and QoL
* To increase the evidence of CIC, and support clinical guidelines of bladder management in MS patients


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Male and female patients aged 18 years and over
* MS patients that are already currently treated or eligible for treatment with anticholinergic drugs
* Patient with previously confirmed multiple sclerosis according to McDonald Criteria and level of disability less than 6.5 on the Kutzke scale and have been stable for 6 months
* The patient has all or any bladder symptoms; urgency, frequency, incontinence, nocturia, PVR
* The patient has Frequency symptoms \> 8 voiding per 24 h
* The patient has PVR \> 50 ml, measured at two repetitive bladder scan measurements during the screening phase as well as the randomization visit
* Adequate mobility to lower limbs, sufficient hand function and ability to practice CIC at least three times daily

Exclusion Criteria:

* Pregnancy
* Ongoing symptomatic Urinary Tract Infection (UTI) as judged by investigator
* Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site)
* The patient practices CIC prior the study
* The patient has undergone a sphincterectomy
* Progressive "Relapsing- remitting MS" as judged by the investigator
* Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
* The patient is participating in other study that might have an impact on the outcome of this, as judged by investigator
* PVR \> 250 ml, measured at two repetitive bladder scan measurements during the screening phase as well as the randomization visit and or if Bladder Voiding Efficiency (BVE) at visit 2 (randomization) is 50% or less than visit 1 (screening)
Stromal Demarcation Line: is it Predictive for Cross-Linking Efficiency?

To assess the association between stromal demarcation line after collagen crosslinking (CXL) for progressive keratoconus and mid-term (6 month) refractive, topographic and clinical outcomes of CXL

All consecutive patients treated with CXL between March 2014 and March 2015 were included. They all underwent the same procedure: accelerated-CXL protocol (10 minutes UVA irradiation with 9 mW/cm2 intensity), irradiation device (IROC UV-X™ 2000, Medeuronet). One month after the procedure, AS-OCT examination was performed in all patients (RS-3000, NIDEK). The visibility of the stromal demarcation line was scored (0: not visible line; 1: visible line, but measurement not clearly defined; 2: clearly visible line) and its depth was measured centrally at anytime it was possible. Changes in best corrected visual acuity (BCVA), spherical equivalent (SE), Kmax and thinnest pachymetry, were studied preoperatively and at 6 months

Eligibility Criteria:
Inclusion Criteria:

* patients treated with CXL

Exclusion Criteria:

-
Efficacy of Optive Versus Systane Concomitant With Restasis (Cyclosporine A) for the Treatment of Dry Eye Symptoms

The purpose of this study is to evaluate the efficacy of Optive versus Systane used concomitantly with topical cyclosporine for the treatment of dry eye.


Eligibility Criteria:
Inclusion Criteria:

* · Males or females \> 18 years old

  * Score of at least 2 and no more than 4 on the SESOD at the initial screening visit (mild to severe patients)
  * At least Grade 2 conjunctival staining
  * Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

* · Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months and saw no improvements)

  * Current use of topical cyclosporine
  * Known contraindications to any study medication or ingredients
  * Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.
  * Planned use of contact lenses (unless discontinued use ³ 30 days prior to randomization)
  * Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable)
  * Ocular surgery within the past 3 months,
  * Active ocular allergies
Mindfulness in Preparation to Bariatric Surgery

Mindfulness is a common practice already widely used, that has shown benefits in terms of psychological and physical health. It is about learning or learn again to be self present and aware to the environment, across breathing, sensations, emotions and thought centering exercises, in the present moment without any judgement.

The goal is to evaluate the efficacy of "mindfulness" versus an active control group in bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients: over 18 years
* Patients suffering from morbid obesity (BMI ≥ 40 kg/m²), or severe obesity (BMI ≥ 35 kg/m²) associate with at least a comorbidity likely to be improved by surgery
* Patient revised in second-line after the failure of a well conducted medical treatment, nutritional, dietetic and psychotherapeutic during 6 to 12 months : absence of enough weight loss or absence of maintain of weight loss
* Absence of any psychiatric counter-argument

Exclusion Criteria:

* Subjects responding to inclusion criteria of the French National Authority for Health
* Subjects without agoraphobia, or obsessive-compulsive disorder, in post-traumatic stress disorder, alcohol or drugs dependant, without psychotic disorders, major depressive disorder, or suffering from anti-social personality disorder
* Patient registered for social security
* Free, signed and informed consent
Observational Study of Patients With Chronic Hepatitis C Virus (HCV) Infected With HCV Genotype 1 Low Virus Load (LVL 1) and Effect of PegIntron Plus Rebetol Treatment (Study P04793 Part 2)

The purpose of this observational study was to provide summary data from participants who relapsed at the end of the follow-up phase after 24 weeks of treatment with standard care PegIntron plus ribavirin in Part 1 of the study (NCT00709228) and who then received retreatment during Part 2 of the study. Relapse was defined as having a positive virology result at the Week 24 post-treatment follow-up, after a negative result at the Week 24 end-of-treatment time point. Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels were measured at Day 1 and Weeks 12, 24, and 48 of the extension, and at Follow-up Week 24.

All study activities were consistent with the EU Directive 2001/20/EC section for non-interventional studies (i.e. observational studies). Medicinal products are prescribed in the usual manner in accordance with the terms of the marketing authorization. The assignment of the participant to a particular therapeutic strategy is not decided in advance by the trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate
* 18 years or older, either gender, any race
* Participant has relapsed at the end of the Part 1 follow-up phase (defined as having a positive virology result at 24 weeks of follow-up post treatment after a negative result at the Week 24 end-of-treatment time point)
* Participant considered suitable for treatment per local label
* Investigator considers suitable and participant consents to be treated

Exclusion Criteria:

* Pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant
* Participant does not qualify based on contra-indication, special warning, special population, and/or pregnancy \& lactation section of the SmPC
Mental Health Promotion Interventions Among Migrant Workers in China

The goals of this research were to conduct a mental health intervention study for reducing self-reported depression and anxiety among migrant workers in a labor-intensive industry in China and to assess the effectiveness of the integrated mental health interventions aimed at promoting the mental health of migrant workers in labor-intensive industries in China.


Eligibility Criteria:
Inclusion Criteria:

* People who worked in the factory agreed to take participant in this study and could understand the questionnaire.

Exclusion Criteria:

* People who don't want to take participant in the study; People can not understand the questionnaire.
Ocular Surface Reconstruction With Cultivated Autologus Mucosal Epithelial Transplantation

The purpose of this study is to elucidate the appropriate condition of developing cultivated autologous oral mucosal epithelial graft and evaluate the surgical outcome of transplantation of the cultivated cells in the patients.

Ocular surface damage caused by severe ocular surface diseases. Corneal limbal stem cell transplantation has been demonstrated to improve the outcome of ocular surface reconstruction. However, the conventional management of allograft limbal transplantation generally has unsatisfactory outcome because of high risk of rejection and requires long-life immunosuppressive medications. Ocular surface reconstruction with cultivated autologous mucosal epithelial transplantation is served to improve the surgical results of ocular surface reconstruction and decrease the use of immunosuppressive medications

Eligibility Criteria:
Inclusion Criteria:

* Bilateral limbal stem cell deficiency proved by specific clinical features and impression cytology

Exclusion Criteria:

* Age under 18
* Active ocular infection, Severe dry eye, Uncontrolled glaucoma
* Immunocompromised host
* Pregnancy
Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis

Evaluation of the efficacy of different doses of nor UDCA vs. placebo for the treatment of Primary Sclerosing Cholangitis (PSC). Identification of optimal dose(s)for the treatment of PSC.

Double-blind, randomized, multi-center, placebo-controlled, comparative exploratory phase II-finding trial.The study will be conducted with four treatment groups in the form of a parallel-group comparison and will serve to compare oral treatment with either 500 mg/d, 1000 mg/d or 1500 mg/d norursodeoxycholic acid capsules vs. Placebo capsules for the treatment of PSC.

Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent
2. Verified diagnosis of PSC
3. PSC patients with or without IBD
4. Women of childbearing potential have to apply during the entire duration of the study a highly effective method of birth control.

Exclusion Criteria:

1. History or presence of other concomitant liver diseases
2. Treatment with UDCA within 8 weeks prior to baseline visit.
3. Child B/C liver cirrhosis
4. Total bilirubin \> 3.0 mg/dl at screening or baseline.
5. Any relevant systemic disease
6. TSH\>ULN at screening
7. any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder
8. Any active malignant disease
9. Known intolerance/hypersensitivity to study drug
10. Existing or intended pregnancy of brest feeding
11. Simultaneous participation in another clinical trial
Acetaminophen Before Vaccines for Infants Study (AVIS)

The purpose of this study is to see whether giving acetaminophen (the medicine in Tylenol) for routine infant vaccinations is helpful in preventing fever or other symptoms.

Post-vaccination fever occurs in up to 40% of infants receiving routinely recommended childhood vaccinations. Although serious events are rare, post-vaccination fever causes discomfort for the child, can lead to medical utilization, can rarely result in febrile seizure, and can cause a working parent to miss time from their job to care for a febrile infant who cannot attend day care. The benefits of acetaminophen prophylaxis for infants receiving current vaccinations, in terms of reduction of discomfort for the child, improvement of quality-of-life indicators for the parent, or reduction of medical utilization, have not been measured. This randomized, blinded, placebo-controlled trial will assess the efficacy of prophylaxis with acetaminophen in prevention of fever following routine childhood immunizations.

Eligibility Criteria:
Inclusion Criteria:

1. Child is a current Group Health enrollee.
2. Child will be seen at a Group Health clinic for a Well Child visit that is expected to include 2 or more vaccines after 6 wks and before 10 months of age.

Exclusion Criteria:

1. If child was born at less than 36 weeks of gestation, the child is not eligible until 4 months of age or older.
2. If the child's birth weight was less than 5.5 pounds (2500 grams), the child is not eligible until 4 months of age or older.
Risk Factors for Multidrug Resistant Bacteria at ICU Admission

The objective of this single-center prospective observational study is to evaluate possible independent risk factors for multidrug-resistant (MDR) bacteria upon ICU admission by analyzing comorbidities, epidemiological data, and laboratory/microbiological information of the subjects.

Background: Infection is one of the main reason for a patient to be admitted to an intensive care unit (ICU) and it's fundamental to use the right antibiotic as soon as possible, possibly needing broad-spectrum antibiotics. However, the main problem is that widening the spectrum of drugs will generate pressure on the hospital microbiota, leading to the development of multi-drug resistant bacteria

Purpose: A large number of ICU-admitted patients have infection/sepsis as their major problem, requiring treatment with antibiotics. With knowledge of the presumed risk factors for antibiotic resistance, the assistant physician could use broad-spectrum drugs with greater certainty.

Objectives: Our objective will be to evaluate risk factors for infection caused by multi-drug resistant germs upon ICU admission and assess the severity of the disease in comparison to patients infected with susceptible bacteria. Ultimately, we aim to develop and validate a clinical tool to assist physicians in selecting the appropriate antibiotic for their patients

Methods: An observational prospective study with a control group will be conducted, including all patients admitted to the ICU with an infectious disease initiated within 48 hours of hospital admission and with a positive microbiologic result. Patients with isolation of only susceptible bacteria will be allocated to the control group, while patients with MDR bacteria will be assigned to the study group, referred to as the MDR group. The data to be collected will include sex, age, previous use of antibiotics in the last three months, previous hospital admissions, previous isolation of MDR germs, sensitivity profile of the isolated germs, severity of disease (measured by SAPS 3), presence of sepsis diagnosis at admission, length of stay in the ICU, and 28-day mortality

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the ICU with an infectious disease initiated within 48 hours of hospital admission and a microbiological positive result for bacteria

Exclusion Criteria:

* Patients with results considered as contamination according to the institutional protocol.
* Surgical wound and bloodstream infections.
* Microbiological isolation of only fungi.
* Vigilance cultures, such as anal, rectal, nasal, and axillary swabs.