cyrilzakka/clinical-trials huggingface dataset:
The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention

Based on data regarding the effect of colchicine on the inflammasome NLP3 and microtubule formation and associations thereof with the pathogenetic cycle of SARS-COV-2, the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect the patients' clinical course by limiting the myocardial necrosis and pneumonia development in the context of COVID-19. If present, this effect would be attributed to its potential to inhibit inflammasome and (less probably) to the process of SARS-CoV-2 endocytosis in myocardial and endothelial respiratory cells.


Eligibility Criteria:
Inclusion Criteria:

Patients \>18 years old with laboratory confirmed SARS-CoV-2 infection (RT PCR) AND body temperature \>37.5 degrees centigrade AND at least two of: i. sustained coughing, ii. sustained throat pain, iii. anosmia and/or ageusia, iv. fatigue/tiredness, v. PaO2\<95 mmHg.

Exclusion Criteria:

* pregnancy, lactation;
* known hypersensitivity to colchicine
* known hepatic failure
* eGFR\<20 ml/min
* clinical estimation that the patient will require mechanical respiratory support in less than 24 hours
* any clinical estimation of the attending physician under which the patient shall be excluded
* QTc \> 450 msec (colchicine is not known to significantly prolong QTc, but may interact with other medications which prolong QTc).
* participation in another clinical trial
* under colchicine treatment for other indications
* patient who is not likely to comply to study procedures
PRELOAD-TAVI Trial

The aim is to assess the response of cardiac output and stroke volume to volume preload optimization in patients with severe aortic stenosis treated with aortic prosthesis implantation.

Patients with severe aortic stenosis present a maintained overload pressure of the left ventricle that can lead to a progressive hypertrophy. This results in elevated left-sided filling pressures and impaired diastolic function.In this context, paradoxical changes in left ventricular function after aortic valve replacement have been described, with acute decrease of the afterload condition that can result in the development of a dynamic intraventricular gradient, especially in the presence of small ventricles with severe hypertrophy, resulting in hemodynamic collapse.

In this setting, it is particularly important to ensure accurate left ventricular preload to optimize myocardial contractility and guarantee an adequate hemodynamic response to valve implantation.

Patients with severe aortic stenosis submitted for transfemoral TAVI on spontaneous breathing will be randomly assigned 1:1 to standard care vs volume preload optimization. Non-invasive continuous monitoring (Clear Sight System, Edwards Lifesciences) will be used to evaluate the cardiac output and the stroke volume in both groups, comparing the hemodynamics before and after valve implant.

Eligibility Criteria:
Inclusion Criteria:

* Aortic valve stenosis with echocardiographic derived criteria: mean gradient \>40 mmHg or jet velocity greater than 4.0 m/s or an initial aortic valve area of \< 0.8 cm2

Exclusion Criteria:

* Cardiogenic shock.
* Life expectancy \< 1 year.
* Need of mechanic ventilation.
Prevention of Sequelae Pain After Breast Cancer Surgery by Self-massages and Self Stretching. Impact of Learning Workshops.

Myofascial pain syndrome is a common cause of chronic pain characterized by myofascial pain and trigger points. Recommendations regarding management of pain after breast cancer don't mention myofascial syndrome despite a study suggests possible myofascial syndrome with roughly 75% of patients in pain.

144 patients having a local breast cancer requiring surgery will be randomized in this study, ratio 1:1 standard and experimental groups.

Every patients (standard and experimental groups) will attend 4 specific consultations during which standard recommendations will be given, pain, quality of life, shoulder range of motion, global upper limbs force will be assessed.

In addition, patient randomized in experimental group will attend self massages and self stretching workshops, one before surgery and one after surgery. Patients will be encouraged to performed daily self massages and self stretching.

The aim of the study is to assess impact of self massages and self stretching workshops on sequelae pain further surgery for breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Woman
* Local development of breast cancer, every stages except stage IV
* Indication of surgery whatever surgery type except breast reconstruction
* More than18 years
* Life expectancy \> 12 months assessed by surgeon or pain specialist
* Informed and written consent
* Affiliated to a social security system

Exclusion Criteria:

* History of chronic pain
* History of shoulder pain
* Any illness or severe disease, medical or psychiatric, that could prevent the patient to follow study procedures or to give her informed consent, according investigators,
* History of breast surgery
* Pregnant or lactating woman
* Protected adult or deprived of her liberty
Individualized Prophylaxis for Severe Hemophilia A Children

A multi centre two year long term escalating dose tertiary prophylaxis study on the efficacy and cost saving of individualized low dose prophylaxis regimens for boys with severe hemophilia A in China staring with a low dose regimen in step I, an escalated low dose regimen in step II and a tailored dose regimen based on individual PK profiles in step III. The dose escalation criteria are adjusted according to patterns and frequencies of joint bleeding and assessed in each subject every 3 months. Efficacy of the 3 different dose regimens are measured by the Annualized Joint Bleeding rate (AJBR) as a primary end point and the Hemophilia Joint Health Score (HJHS ) and QoL scores (CHO-KLAT and PedsQoL) , image studies of target joints by Ultrasound, X-ray and MRI examinations, consumption of factor VIII and inhibitor rates as secondary end points.


Eligibility Criteria:
Inclusion Criteria:

1. Severe hemophilia A with FVIII \<1 %
2. Age from 6 to 10 years
3. Patients with more than 50 exposure day (ED)
4. Patients with one or more target joints (a target joint is defined as a joint with 3 or more bleeds in a consecutive 3 months) or disease joints (defined as presence of visible joint swelling and /or limitation of movements and/or joint deformities in the absent of an acute joint bleed )
5. on-demand treatment more than 12months before the study

Exclusion Criteria:

1. A history of FVIII inhibitor (titer greater than 0.6 BU) and detectable FVIII inhibitor at screening (titer greater than 0.6 BU)
2. Chronic renal failure (serum creatinine greater than 2.0 mg /dL)
3. Chronic Liver disease (ALT greater than 200 U/L))
4. Patients with clinically documented immunodeficiencies
5. Patients anticipated to require Major surgery
6. Patients with competing high risks such as symptomatic HIV infection, Juvenile rheumatoid arthritis, metabolic bone diseases, or other diseases known to mimic or cause joint diseases
7. Patients live too far from the comprehensive care centre at BCH and had demonstrated previous non compliance to therapies or clinical studies
Lidocaine Infusion for Pain After Herniotomy

This study seeks to investigate lidocaine infusion to reduce occurrence of chronic postoperative pain at 3-month after inguinal herniotomy

Inguinal hernia repair is associated with a 5%-30% incidence of chronic pain; however, the pathogenesis remains unknown, and few studies have assessed chronic pain as the primary aim of the study. Lidocaine infusion could be a possible approach to reducing the prevalence of chronic pain after herniotomy. Recently, a meta-analysis concluded a modest but statistically significant reduction of pain severity in the first four postoperative hours measured by the visual analogue scale (mean difference, -0.84; 95% CI, -1.10 to -0.59). However, a more recent meta-analysis found that only limited clinical data and biological plausibility support lidocaine infusions for the prevention of postoperative persistent pain (odds ratio, 0.29; 95% CI, 0.18 to 0.48). This study was designed to investigate whether lidocaine infusion after inguinal herniotomy would lower the incidence of chronic postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo unilateral inguino herniotomy

Exclusion Criteria:

* (1)ASA classification status III or above
* (2)Body weight\<35kg
* (3)Liver cirrhosis
* (4)A history of previous herniotomy
* (5)Pregnancy
* (6)Severe arrhythmia
* (7)Congestive heart failure
* (8)Opioid or steroid use 6 months before surgery
* (9)Allergy to lidocaine
* (10)Chronic pain syndrome (any type)
* (11)Emergency surgery
* (12)Incapacity to give an informed consent, Visual dysfunction or severe mental disorders
Non-invasive Neurally Adjusted Ventilatory Assist Versus Nasal Intermittent Positive Pressure Ventilation for Preterm Infants After Extubation

Non-invasive respiratory support has been emerging in the management of respiratory distress syndrome (RDS) in preterm infants to minimise the risk of lung injury. Intermittent positive pressure ventilation (NIPPV) provides a method of augmenting continuous positive airway pressure (CPAP) by delivering ventilator breaths via nasal prongs.It may increase tidal volume, improve gas exchange and reduce work of breathing. However, NIPPV may associate with patient-ventilator asynchrony that can cause poor tolerance and risk of intubation. It may also in increased risk of pneumothorax and bowel perforation because of increase in intrathoracic pressure.

On the other hand, neurally adjusted ventilatory assist (NAVA) is a newer mode of ventilation, which has the potential to overcome these challenges. It uses the electrical activity of the diaphragm (EAdi) as a signal to synchronise the mechanical ventilatory breaths and deliver an inspiratory pressure based on this electrical activity. Comparing NI-NAVA and NIPPV in preterm infants, has shown that NI-NAVA improved the synchronization between patient and ventilator and decreased diaphragm work of breathing .

There is lack of data on the use of NI-NAVA in neonates post extubation in the literature. To date, no study has focused on short-term impacts. Therefore, it is important to evaluate the need of additional ventilatory support post extubation of NI-NAVA and NIPPV and also the risk of developing adverse outcomes.

Aim:

The aim is to compare NI-NAVA \& NIPPV in terms of extubation failure in infants\< 32 weeks gestation.

Hypothesis:

Investigators hypothesized that infants born prematurely \< 32 weeks gestation who extubated to NI-NAVA have a lower risk of extubation failure and need of additional ventilatory support.

Study Design: Randomised controlled trial

Study Setting: single center NICU level III, KFAFH tertiary care center , Jeddah Saudi Arabia

Eligibility Criteria:
Inclusion Criteria:

1. Born less than 32 weeks gestation with respiratory distress syndrome (RDS) and requiring endotracheal tube and mechanical ventilation.
2. Less than two weeks old
3. First extubation attempt
4. CRIB score 0-5
5. Written-informed parental consent for the study

Exclusion Criteria:

1. Major congenital malformations or respiratory abnormalities
2. Neuromuscular disease
3. phrenic nerve palsy
4. Intraventricular hemorrhage (IVH) grade III or IV
5. Absence of informed consent
6. Out born infants
Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Parietaria Judaica

The objective of this trial is to assess the clinical efficacy of the modified extract (depigmented and polymerized with glutaraldehyde) of the subcutaneous injection of Parietaria Judaica pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis ( with or without episodic asthma) induced by hypersensitivity to grass pollen, evaluating the score regarding symptoms and consumption of the medication.

Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with two arms of treatment: placebo and active.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent, signed by the subject
* Positive clinical history of rhinitis/rhinoconjunctivitis allergy to Parietaria pollen
* Patient of both gender aged from 18 up to 55
* Diagnosed Sensitivity to Parietaria pollen base on:

Positive Nasal provocation test Positive prick test to P. Judaica Specific IgE to P.Judaica \>0,7KU/L

- Patients who are able to comply with the dose regime

Exclusion Criteria:

* Relevant sensitivity to another perenne allergen
* Patient with asthma
* Use of immunotherapy during the last four years
* Treatment with B. Blocking agents
* Patient suffering from some pathology in which adrenaline was contraindicated
* Subject suffers from a serious medical condition, which would interference the treatment and follow up of the subject in the study
* Subject suffers from autoimmune disease(thyroiditis, lupus, etc.)
* Conditions in which the patient can not offer full co-operation nad significant psychiatric disturbance.
* Intolerance to aspirin
* Pregnant women or with pregnancy risk and brest-feeding
Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer Patients

Many women with breast cancer who are treated with aromatase inhibitor medications develop difficulty sleeping and fatigue during treatment. Some examples of aromatase inhibitor medications include anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara). Frequently, sleeping pills do not work very well to improve sleep. Cyclobenzaprine (Flexeril) is a medication that was originally developed to treat muscle spasms. It may also improve sleep in patients with chronic pain disorders, such as fibromyalgia. In this study we are testing to see if cyclobenzaprine at bedtime will help improve sleep in women treated with aromatase inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Female gender, age ≥ 18, postmenopausal.
* Histologically proven stage 0-III invasive carcinoma of the breast
* Initiating or have been receiving a standard dose of aromatase inhibitor therapy (letrozole 2.5mg once daily or exemestane 25mg once daily or anastrozole 1mg once daily) for up to a total of 48 months of AI therapy.
* Trouble sleeping during the past week. (After signing the informed consent document, subjects must also have a global PSQI score of ≥5)
* ECOG performance status 0-2 (see Appendix A).

Exclusion Criteria:

* Known hypersensitivity to cyclobenzaprine or any of the inactive ingredients
* Diagnosis of sleep apnea that is currently interfering with sleep or requiring CPAP, restless leg syndrome that is currently interfering with sleep or requiring medication, or Epworth sleepiness scale \>10.
* Subjects with a history of hypothyroidism must have been on a stable dose of thyroid replacement medicine for at least 3 months prior to enrollment
* Treatment with steroids within 1 month
* Treatment with monoamine oxidase inhibitors (MAO-I) within 14 days of enrollment.
* Concurrent treatment with bupropion, MAO inhibitors, phenothiazines (including thioridazine), selegiline, tramadol, or medications known to prolong the QT interval (www.azcert.org/medical-pros/drug-lists/drug-lists.cfm)
* Currently primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder
* Known moderate or severe hepatic impairment
* History of congestive heart failure or cardiac arrhythmia (other than atrial fibrillation); myocardial infarction within the past 6 months
* Uncontrolled narrow-angle glaucoma
* Pregnant or breast feeding
* Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation
KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors

The primary objective of the trial was to characterize the safety, tolerability, and maximum tolerated dose (MTD)/recommended dose (RD) for expansion of single agent KAZ954 and KAZ954 in combination with PDR001, NIR178 and NZV930.

The purpose of this trial was to explore the clinical utility of several therapies in patients with advanced cancer.

This is a multi-center, open-label Phase I/Ib study. The study consisted of a dose escalation part and a dose expansion part testing KAZ954 as a single agent or KAZ954 in combination with PDR001, NZV930 and NIR178.

The dose escalation part estimated the MTD and/or RD and tested different dosing schedules. The dose escalation arm KAZ954 + NZV930 was not opened.

The dose expansion part of the study was planned to use the MTD/RDE determined in the dose escalation part to assess the activity, safety and tolerability of the investigational products in patients with specific types of cancer. The dose expansion part of the study was not started.

Eligibility Criteria:
Inclusion Criteria:

Patients with metastatic and/or advanced malignancies not amenable to curative treatment by surgery.

Must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. Patient must be willing to undergo a new tumor biopsy at screening and during the study.

ECOG Performance Status of \<2.

Exclusion Criteria:

Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require concurrent treatment - including surgery, radiation and/or corticosteroids.

History of severe hypersensitivity reaction to any ingredient of study drug(s) and other mAbs and/or their excipients.

Impaired cardiac function HIV Known history of tuberculosis Systemic chronic steroid therapy

Other protocol-defined inclusion/exclusion criteria may apply.
Fish Oil and Asthma in House Dust Mite Allergy

Native populations consuming high amounts of fish suffer less from allergic diseases. The purpose of this study is to determine whether polyunsaturated fatty acids (fish oil) might have a disease modifying influence on asthmatics sensitized to house dust mite.

Most asthmatics suffer from mild disease and non pharmacologic intervention would be beneficial for the majority of these subjects. We investigated the anti-inflammatory potential of polyunsaturated fatty acids (PUFA) in allergic asthma.

In our parallel, double-blinded study, 23 patients allergic to house dust mite were randomly assigned to dietary supplementation with a PUFA enriched fat blend or placebo for five weeks. The verum contained eicosapentaenoic acid (EPA) 450 mg/day, docosahexaenoic acid 180 mg/day, stearidonic acid 60mg/day, and gamma-linolenic acid 60 mg/day; the placebo consisted of mainly unsaturated and monosaturated fatty acids. After three weeks, the patients were challenged with low doses of inhalative house dust mite allergen for two weeks.

Following parameters were determined during low-dose allergen exposure in both groups: exhaled NO (eNO) as a marker of bronchial inflammation, clinical symptoms, FEV1, beta-agonist usage, and bronchial hyperreactivity, sputum eosinophils and sulfoleucotrienes. Compliance with the study protocol was controlled by the determination of PUFAs in plasma and erythrocytes.

Eligibility Criteria:
Inclusion Criteria:

* allergic sensitization to house dust mite as proven by skin test and specific IgE
* normal lung function, episodic asthma

Exclusion Criteria:

* history of hypersensitization towards fish oil, chronic illness, pregnancy
Open Versus Closed Reduction of Mandibular Sub-Condylar Fractures

Patients with mandibular sub-condylar fractures underwent either either open reduction with internal fixation (ORIF) or closed reduction with external fixation (CREF) and were followed up for 6 months to assess treatment adequacy with the hypothesis that ORIF is superior to CREF.


Eligibility Criteria:
Inclusion Criteria:

* Age 16-60 years
* Displaced Mandibular Subcondylar Fractures(MCFs) irrespective of multiple mandibular fractures.

Exclusion Criteria:

* Bilateral MCFs
* MCF with mid-facial fractures
* Insufficient bilateral dentition
* Medically unfit for surgery
* Old healed mandibular fractures
* History of previous mandibular surgery for the same indication
Effect of Esmolol on Perioperative Stress Reaction

The goal of this clinical trial is to observe the effect of low dose continuous infusion of esmolol on perioperative stress response in patients undergoing airway intervention .

Airway intervention is known to activate stress response and release catecholamines resulting in severe hemodynamic instability. Various techniques which are recommended to prevent the stress response include increasing the depth of anesthesia, improving surgical procedures and the use of various pharmacological agents. Esmolol blocks the action of the endogenous catecholamines, we plan low dose esmolol infusion decrease stress response and hemodynamic fluctuation during airway intervention.

46 patients scheduled airway intervention under general anesthesia were randomly divided into esmolol group and control group. esmolol 50μg/kg/min or saline 50μg/kg/min were iv administered before Operation beginning. If HR（heart rate）is greater than 90 beats/min, esmolol or saline 50μg/kg/min is added each time, with interval more than 5 min and the peak value is 200 μg/kg/min. If the heart rate is lower than 60 times/minute, Stop medication. Plasma level of Norepinephrine, epinephrine, and cortisol before induction of anesthesia and 30 minutes after beginning of operation were determined by high-performance liquid chromatography. Perioperative hemodynamics changes, extubation time, incidence of severe sinus bradycardia and bronchospasm were recorded.

Eligibility Criteria:
Inclusion criteria

1. American Society of Anesthesiologists (ASA) Physical Status I to III.;
2. Body mass index (BMI): 20-30 kg/m2;
3. Elective airway intervention under general anesthesia with jet ventilation，duration of operation less than 2hs;
4. Sign informed consent for clinical trial

Exclusion criteria

1. The patient and his or her family refused to participate in the study;
2. Severe respiratory or/cardiovascular or/ neurological disease, or/ hepatic or/renal dysfunction
3. Those who are allergic to the drugs used in this study;
4. Psychiatric history or with unstable mental state;
5. Patients with atrioventricular block
6. Patients with history of asthma
7. Patients now treated with β-adrenergic receptor blockers
8. Patients participating in other clinical trial
Quality Control of Colposcopy Application

Colposcopy has become an important link and tool in the prevention and treatment of cervical cancer. The quality and pathological assessment of colposcopy is a key point in follow-up and treatment.The main purpose of this study was to analyze the correlation between colposcopy indications and pathological findings.

1. inclusion/exclusion criteria inclusion：(1) at least 18 years of age; (2) Complete colposcopy report; (3) Clear pathological diagnosis was reported after colposcopic biopsy.

   exclusion：Not all of the above criteria are met
2. study purpose Main purpose

1）analyze the correlation between colposcopy indications and pathological findings Secondary purpose

1. Influence of colposcopic transformation area type on pathological evaluation
2. Colposcopic follow-up results
3. The differences and causes of colposcopic biopsy pathology and histology
4. Quality of colposcopy in our hospital （3）Retrospective study Data of out-patient population in our hospital from 2005 were included

Eligibility Criteria:
Inclusion Criteria:

1. at least 18 years of age;
2. Complete colposcopy report;
3. Clear pathological diagnosis was reported after colposcopic biopsy.

Exclusion Criteria:

1. Under 18 years of age;
2. Lack of colposcopic reports;
3. Lack of cervical biopsy pathology results;
4. Other conditions deemed inappropriate by the investigator to participate in this study.