cyrilzakka/clinical-trials huggingface dataset:
Fibrin Glue or Tranexamic Acid for Total Knee Arthroplasty

Objectives:

a) Principal: To assess if the fibrin glue or the tranexamic acid reduce less than 20% the blood losses with respect to the habitual haemostasia in patients with arthroplasty total of knee.

Secondaries: To assess the treatment safety. To perform a cost- analyses.

Methods: Randomized, unicentric, and parallel clinical trial with four comparative groups: Tissucol® (fibrin glue), fibrin glue manufactured by the Cryoseal® system (Banc de Sang i Teixits de Catalunya), tranexamic acid and habitual haemostasia.

Nº of participant centres: 1. Random allocation will be centralised.

Main outcome: Blood losses (ml) in the post-operatory period collected by the habitual drain system.

Secondary outcomes: Proportion of patients with blood transfusion, complications of surgery wound, pre and post-operative haemoglobin, units of blood transfused, post-operative mortality, days of hospital stay, safety of interventions assessed.

Size sample calculation: The number needed of patients is 172 (43 per group) to demonstrate a 20% difference in the post-operative blood losses between the treatments assessed and the habitual haemostasia, with a statistical power of 80% and a 0.05 bilateral alpha, and a 20% of withdrawals.

Statistical analysis: The investigators will perform a comparison of outcomes through the "t" test, the Mann-Whitney test of chi square, depending of the evaluated outcomes, quantitative or ordinals or qualitative, respectively. The software used will be Statistical Package for the Social Sciences (SPSS) version 17.


Eligibility Criteria:
Inclusion Criteria:

* Total knee arthroplasty
* The patient consent to participate

Exclusion Criteria:

* Intolerance drugs to the study or to bovine protein (aprotinin)
* Antecedent of thromboembolic disease
* Patient with cardiac alterations of the rhythm
* Patients with valvular cardiac prosthesis
* Patients with pro-thrombotic alterations of coagulation
* Treatment with anticonceptive drugs
Study of Pain Processing in Subjects Suffering From Obstructive Sleep Apnea

We would like to test the effect of opioid medication on pain sensitivity in subjects who have been diagnosed with a sleep disorder called Obstructive Sleep Apnea (OSA) compared to other subjects without OSA. Patients with OSA may have an altered sensitivity to the sedative, analgesic, and respiratory depressant effects of opioids.

The purpose of the study is to test the hypothesis that patients who suffer from moderate-to-severe OSA have increased pain thresholds and are more sensitive to the analgesic effects of opioids compared to patients with normal sleep-related breathing physiology. We will evaluate the effect of remifentanil, a short acting mu-opioid receptor agonist, on pain using an experimental heat and cold-induced pain tests, and compare it between volunteers with and without a polysomnography (PSG)-based diagnosis of obstructive sleep apnea.

Eligibility Criteria:
Inclusion Criteria:1. Male 2 .18 - 55 years of age 3. Body mass index (BMI) lower or equal to 30 kg/m2 4. Absence of severe systemic disease that results in functional limitations (i.e. poorly controlled hypertension, angina pectoris, prior myocardial infarction, pulmonary disease that limits activity) 5.Subjects must be able to comprehend spoken and written English

Exclusion Criteria:1. Major psychiatric, neurological, or neuromuscular disorder 2. Known diabetes mellitus or thyroid disease 3. Allergy to study medication (remifentanil) 4. History of addiction 5. Alcohol consumption which exceeds 2 drinks per day and /or drug abuse. 6. Chronic or acute use of opioids, or other medications affecting the CNS.
Study to Evaluate Efficacy and Tolerability of Micardis®/Micardis® Plus in Patients With Hypertension

Study to evaluate efficacy and tolerability of Micardis®/Micardis® Plus under usual daily-practice prescribing conditions in hypertensive patients


Eligibility Criteria:
Inclusion Criteria:

* Males and females for whom a medical antihypertensive therapy is indicated
* Age \>= 18 years

Exclusion Criteria:

* Age \< 18 years
Contribution of MUltiparametric Analysis in Bone Scintigraphy for the Characterisation of Solitary Bone Lesions

The hypothesis of the study is that non-invasive Single photon emission computed tomography (SPECT-CT) bone scintigraphy makes it possible to better characterize solitary bone lesions, in particular the exclusion of their malignancy in order to avoid unnecessary biopsy and possible complications for the patient.

Bone scintigraphy includes 3 stages: study of perfusion then of early tissue uptake and finally of late bone fixation.

Hyperactivity of malignant bone lesions at the 3 stages of bone scintigraphy has been reported, but on planar scintigraphic images not allowing precise anatomical localization of the lesions.

Currently, the generalization of SPECT-CT (Single Photon Emission Computed Tomography) combined with Tomodensitometry) acquisition thanks to the deployment of semiconductor cameras, makes it possible to carry out a multiparametric analysis of bone lesions with quantification of the intensity of the signal expressed in SUVmax (Standard Uptake Value maximum) at the 3 times of the scintigraphy

Eligibility Criteria:
Inclusion Criteria:

* Person, having received complete information on the organization of the research and having signed the informed consent and:

  * Age ≥ 18 years old.
  * Having read and understood the information document.
  * Affiliated to a social security scheme.
* Patient with an indeterminate solitary bone lesion on conventional imaging, for which an indication for biopsy +/- excision is planned.

Exclusion Criteria:

* Pregnant woman or woman of childbearing age and without contraceptive means or nursing mother.
* Unstable medical condition and/or inability to remain still during recordings.
* Known allergy to one of the components of the radiopharmaceutical technetium-99m-Technescan HDP (product required to perform the bone scan).
* Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code.
* Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under articles L. 3212-1, L. 3213-1
A Cohort Study Comparing IFX to CS for Moderate to Severe UC

The first-line treatment strategy of moderate to severe UC was a important question at issue. The biological agents had potentiality to alter the disease course of UC. The AGA clinical guidelines had conditional recommend that IFX and other biological agene migtht be first-line therapy for high-risk UC patints but only had low grade evidence.We launched this multicenter prospective cohort trial to compare the efficacy and safety of infliximab (IFX) and corticosteroids(CS) when they was used as first-line therapy in UC patients.


Eligibility Criteria:
Inclusion Criteria:

* moderately to severely active ulcerative colitis, defined as a total score of 6 to 12 on the Mayo scale (scores range from 0 to 12, with higher scores indicating more severe disease) and a subscore of at least 2 on the endoscopic component of the Mayo scale (subscores on each of the four components of the Mayo scale range from 0 to 3)
* Patients who had colonic involvement of at least 15 cm
* Patients who had a confirmed diagnosis of ulcerative colitis at least 3 months before screening and confirmed by Pathology

Exclusion Criteria:

* Patients who had previously used any TNF inhibitor
* Patients who were steroid-dependent or steriod-resistant
* Patients who had undergone subtotal colectomy or total colectomy
* Patients who had stoma
An Observational Study of Patients With Coronavirus Disease 2019

This is an observational study of patients with COVID-19 designed to specifically address important clinical questions that remain incompletely answered for coronavirus disease 2019.

Data from up to 5,000 adult patients in the US will be captured from eligible patients enrolled following admission to the hospital. Participants will have de-identified medical records collected from hospital admission to discharge, including but not limited to critical care monitoring, details on mechanical ventilation, laboratory data, imaging reports, medications, and all procedures. Diagnosis and patient management will follow each hospital's standard of care and no specific treatments, procedures or laboratory tests will be dictated by enrollment in TARGET-COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age ≥18 years) who are or have been hospitalized and diagnosed with Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection.
* SARS-CoV-2 confirmed diagnosis (e.g. polymerase chain reaction \[PCR\] or other clinically utilized test).

Exclusion Criteria:

N/A
Tear Ferning Test for Dry Eye Diagnosis

Application of tear ferning test for clinical dry eye diagnosis

Comparing dry eye patients' tear ferning structure with non-dry eye patients' to develop a protocol for easy and costless diagnosis in ophthalmology.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 20 and 65 years
* For dry eye disease group:
* Schirmer's test results between 5 - 10 mm
* Tear Film Break Up Time less than 10 seconds
* Ocular Surface Disease Index of more than 25

Exclusion Criteria:

* Those have diabetes, hypertension or other chronic diseases
* No evident ocular diseases such as cornea disease, cataracts, vitreous degeneration, glaucoma, and retinopathy.
* Belong to vulnerable groups(pregnancy woman, prisoner, ethical minorities, economic or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminal ill individuals)
The Influence of Eccentric Training on the Volume and Vascularisation of the Rotator Cuff in Patients With Rotator Cuff Tendinopathy and Healthy Subjects

Patients with rotator cuff tendinopathy make up a large part of the population in physiotherapy practice. The rotator cuff, a shoulder muscle group, plays an important role in causing pain. Tendons suffer large compression and friction, which can lead to degeneration of these tendons. Rehabilitation often leads to unsatisfying results.

In Achilles and patella tendinopathy, a new training program called eccentric training has shown very good results. Eccentric training contains exercises during which a force has to be resisted while the muscle lengthens instead of shortens. This would have a larger influence on tendon tissue. Some small studies also show promising results of eccentric training in patients with rotator cuff tendinopathy but the mechanisms behind these results remain unclear.

To investigate this, 30 patients with rotator cuff tendinopathy and 30 healthy subjects will be evaluated before and immediately after performing the exercise. Three measurements will be done: ultrasonographic measurement of tendon thickness, power Doppler imaging and measurement of microcirculation around the tendon with Oxygen to see. All measurements are non-invasive, pain free and without risks for the human body.


Eligibility Criteria:
Inclusion Criteria Patients:

* Male/ Female
* 18-40 years old
* Unilateral shoulder pain for at least 3 months
* Pain of at least 3/10 on a visual analogue scale
* Painful arc or pain at end range abduction
* 2/3 impingement tests positive
* 2/4 resistance tests positive
* Pain at insertion rotator cuff

Exclusion Criteria Patients:

* Spurling test positive
* Shoulder surgery in the past
* Osteoarthritis shoulder
* Full thickness ruptures

Inclusion Criteria Healthy subjects:

* Male/ Female
* 18-40 years old

Exclusion Criteria Healthy subjects:

* Shoulder pain during the last 3 months
* Shoulder surgery in the past
* Neck pain or disability
* Systemic disease (e.g. Marfan, Ehlers Danlos,...)
Populational Program of Physical Activity and Healthy Eating Promotion: the "Life of Health" Study

This is a population-based "natural experiment" study aimed to examine the effect of a multi-approach intervention focused on physical activity and healthy eating promotion to individuals living in Jaguariuna city (São Paulo, Brazil).


Eligibility Criteria:
Inclusion Criteria:

* citizens from Jaguariuna city (Sao Paulo, Brazil)

Exclusion Criteria:

* citizens not from Jaguariuna city (Sao Paulo, Brazil)
* children below 8 years of age.
A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.

This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in adult patients with type 2 diabetes mellitus. Patients that are on stable metformin therapy are eligible to enter the study. There will be a 5-weeks exenatide run in period and a 5-weeks period when co-administered with the study drug. RO5095932 will be administered subcutaneously as a single dose or as escalating doses. Patients will be randomized to receive either active drug or placebo in weeks 1 to 4. Active drug or placebo will be administered once weekly for 4 weeks. Patients who received active drug in weeks 1 to 4 will receive placebo in week 5. Patients who received a single dose of placebo in weeks 1 to 4, will receive a single dose of active drug in week 5. The anticipated time of study treatment is \<6 months. The target sample size is \<100 patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18-65 years of age
* Diabetes mellitus, type 2 for at least 6 months before screening
* On treatment with stable doses of metformin for at least 3 months before screening
* BMI between \>/=25 and \</=39

Exclusion Criteria:

* Type 1 diabetes
* Pancreatitis
* Treatment with insulin for more than one week within 3 months prior to study start
Quality of Life Questionnaire Validation for Patients With Changed Tacrolimus Dosing After Kidney Transplantation

The purpose of this study is to develop and validate a questionnaire to assess the quality of life when the recipients of kidney transplantation switched their medication from tacrolimus twice daily (BID regimen) to Advagraf (once daily (QD) regimen of modified release tacrolimus).

This study will develop and validate a questionnaire to assess the health-related quality of life when switching from tacrolimus twice daily (b.i.d) regimen to once daily (q.d) regimen after kidney transplantation.

In-depth interviews are conducted to develop questionnaire items, and the interviewees are as follows: participants who have received tacrolimus b.i.d for a minimum of 6 months to a maximum of 12 months, and who are within 1 month of switching to Advagraf (q.d regimen of modified release tacrolimus).

The time required for the in-depth interview is approximately 30 minutes to one hour.

After questionnaire items are developed, survey participants for validation are as follows: the first survey is conducted on participants who have received tacrolimus b.i.d for a minimum of 6 months to a maximum of 12 months during the period. The second survey is conducted within one month after switching to Advagraf (q.d regimen of modified release tacrolimus).

At the validation stage, the survey using the developed questionnaire is conducted twice, once during the b.i.d. regimen and once after switching to the q.d. regimen.

Eligibility Criteria:
Inclusion Criteria

Selection criteria for in-depth interview subjects:

* One male or female aged 30 or over but below 40 years old.
* One male or female aged 60 or over but below 70 years old.
* One male or female with an occupation.
* One male or female without an occupation.
* Two subjects, depending on the number of medications (more or less medications) that the subject is taking.
* Participation available Period: subjects who have received tacrolimus twice daily (b.i.d) for a minimum of 6 months to a maximum of 12 months after surgery and who are within 1 month of switching to Advagraf (once daily (q.d) regimen of modified release tacrolimus).
* Subjects who understood the purpose and risks of the questionnaire development and who were well-acquainted with the contents and submitted the written consent to participate in the interview for the questionnaire development.

Selection criteria for validation stage subjects:

1. Males and females aged 19 to 65 years old.
2. Participation Available Period: the first survey is conducted on the subjects who have received tacrolimus twice daily (b.i.d) for a minimum of 6 months to a maximum of 12 months during the period. The second survey is conducted within one month after switching to Advagraf (once daily (q.d) regimen of modified release tacrolimus).
3. Subjects who understood the purpose and risks of the questionnaire development and who were well-acquainted with the contents and submitted the written consent to participate in the interview for the questionnaire development.

Exclusion Criteria:

* None.
StayOK - an Innovative Measuring Instrument for the Early Identification and Treatment of Psychosocial Risks

The validity and the sensitivity of different measures implemented in the web application StayOk are investigated. The measures are used primarily for the assessment and the early identification of psychosocial risks. Secondarily, the results of the assessment are applied to generate health-promoting advices for the user of the web application.


Eligibility Criteria:
Inclusion Criteria:

* at 16 years of age
* mild to moderate psychological distress

Exclusion Criteria:

* serious cognitive impairment due to dementia or cerebrovascular insult
* Insufficient knowledge of one of the following languages: German, French, Italian or English
Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA NSCLC With EGFR-mutation

Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage II-IIIA non-small cell lung cancer patients with EGFR mutation. The primary endpoint is disease-free survival.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed non-small cell lung cancer after surgical resection
* Stage II-IIIA disease according to 7th edition of TNM staging
* Positive EGFR gene mutation (19/21)
* ECOG 0-1
* At least 1-year life expectancy
* Adequate organ function

Exclusion Criteria:

* Previous systemic anti-tumor therapy, including chemotherapy or targeted therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc
* Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* Pneumonectomy of right lung
* Any unresolved chronic toxicity from previous anticancer therapy
* Allergic to study drug
Spanish Survey on Third Wave of COVID-19

Due to the pandemic situation, a rapid online survey may be the best method to assess and track people's pandemic cooping. Regarding the huge media influence and the government's restrictions to control the spread of covid-19; it is needed to know more about people's perception and situation to conduct future contentions plans. This study aims to apply a rapid online survey to determine the Spanish situation in this third wave of the pandemic. The survey will be delivered to 1000 participants to obtain a representative sample. It would be divided into six sections (general information, demography data, social and consuming habits, Covi-19 question, questions for Covid-19 positive, and questions for Covid-19 negative).


Eligibility Criteria:
Inclusion Criteria:

* Owning online connection
* Ability to answer and complete the survey

Exclusion Criteria:

* None
A Study to Evaluate Transplantation of Astrocytes Derived From Human Embryonic Stem Cells, in Patients With Amyotrophic Lateral Sclerosis (ALS)

This is a study of transplantation of Astrocytes derived from human embryonic stem cells, in patients with Amyotrophic Lateral Sclerosis (ALS).

There will be no change in the routine ALS treatment of the patients enrolled into the study. Treatment will be administered in addition to the appropriate standard of care treatment.

The study hypothesis is that transplantation of Astrocyte(AstroRx) cells can compensate for the malfunctioning of patients' own astrocytes by restoring physiological capabilities like the reuptake of excessive glutamate, reducing oxidative stress, reducing other toxic compounds, as well as by secreting different neuroprotective factors


Eligibility Criteria:
Main Inclusion Criteria:

1. El Escorial criteria for probable or definite ALS
2. Males and and non pregnant females between 18 and 70 years of age
3. Patients with an ALS-FRS-R score of at least 30 with an ALS diagnosis of two years or less
4. No history of active psychiatric disorder. Patients receiving antidepressants as a preventive treatment, with no history of active psychiatric disorder may be included.
5. Patient has a good understanding of the study and nature of the procedure
6. Patient provides written informed consent prior to any study procedure
7. Patients should either be on a stable dose of Riluzole and/or Radicava® (if applicable) for at least 30 days, or not be treated with Riluzole and/or Radicava®
8. Patient is medically able to tolerate immunosuppression regimen
9. Presence of a willing and able caregiver who understands the need to attend all follow-up visits, even if mobility declines

Main Exclusion Criteria:

1. Patient has a past infection or a positive test for HBV,HCV or HIV
2. Patient is in need of respiratory support
3. Patient has a lower than 10/12 in ALS-FRS-R respiratory parameters or below 70% of predicted slow vital capacity (SVC)
4. Patient has renal failure
5. Patient has impaired hepatic function
6. Patient has a Body Mass Index (BMI) of \<18.5 or \> 30
7. Patient suffers from significant cardiac disease, diabetes, autoimmune diseases, chronic severe infection, malignant disease or any other disease or condition that may risk the patient or interfere with the ability to interpret the study results
8. Patient has systemic inflammation or active infections
9. Patient has been treated previously with any stem cell therapy
10. Current use of immunosuppressant medication or use of such medication within 6 weeks of Screening visit (Visit 0)
11. Patient has participated in another clinical treatment trial or received other experimental medications outside of a clinical trial within 1 month prior to start of this study
12. Any known immunodeficiency syndrome
13. Any concomitant disease or condition limiting patient safety to participate