cyrilzakka/clinical-trials huggingface dataset:
Erector Spinae Plane Block in Spine Surgeries

Aim of this study was to assess the efficacy of erector spinae plane block (ESB) for postoperative pain management in lumbar spine surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients American Society of Anesthesiologists physical status (ASA) I and II.
* Both sexes.
* Age between 20 to 60 years old.
* Scheduled for lumbar spine surgeries.

Exclusion Criteria:

* Patients who received long acting opioids preoperatively.
* Patients with bleeding disorders and coagulopathy.
* Infection at the injection site.
* Allergy to local anesthetics.
* Patients with significant cognitive dysfunction.
* Patients with diabetic neuropathy.
* Patients with uncontrolled hypertension or diabetes.
* Patients with advanced cardiac, respiratory, hepatic or renal disease.
* Patients with viral hepatitis or HIV.
The Predictive Value of Complement C3 in Patients With Advanced Gastric Cancer

This study is designed to investigate whether complement C3 depletion is associated with poor short-term outcomes in postoperative patients with gastric cancer.

The complement system plays an important role in the development of digestive malignancies. The complement C3 is the point of convergence for the three complement activation pathways. However, the concrete effect of C3 in the development of gastric cancer is still obscured. This study is designed to explore whether complement C3 can be regarded as a predictive factor of postoperative outcomes for postoperative patients with gastric cancer.

This study is designed as a prospective cohort study and included consecutively treated patients. The perioperative plasma value of complement components, such as C3, C4, and CH50, are detected to explore the incidence rate of complement depletion. All enrolled patients are divided into two groups mainly according to the levels of preoperative C3 levels (C3 depletion and Non-C3 depletion groups). The primary endpoints are the 1-year overall survival and disease-free survival, while the secondary endpoints are postoperative complications, length of hospital stay, and hospital charges.

This study would be helpful to confirm the role of complement depletion in anticipated outcomes of postoperative patients with gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of gastric adenocarcinoma
* Radical operation and adjuvant chemotherapy endurable
* Informed consent approved

Exclusion Criteria:

* Age \<18 or \>75 years old
* Pregnancy or lactating woman
* Any primary diagnosis other than gastric cancer
* Confirmed complement deficiency due to immunity dysfunction or other disease
* Required blood transfusion, plasmapheresis, or emergent operation
Effect of Injectable Platelet-rich Fibrin on Disc Displacement Without Reduction

This randomized clinical study was conducted on patients with disc displacement without reduction. Patient was selected one of the two study groups: control group received only arthrocentesis or test group received arthrocentesis + injectable platelet-rich fibrin (i-PRF). As primary outcome variable, pain was recorded at preoperatively and at postoperatively 1, 2, 3, 6 and 12 months. Maximum mouth opening, lateral and protrusive movements were formed as secondary outcome variables.

This randomized clinical study was conducted on patients with disc displacement without reduction. Patient was selected one of the two study groups: control group received only arthrocentesis or test group received arthrocentesis + i-PRF. Arthrocentesis procedure was performed for all groups with two needle technique. For test group, intra-articular i-PRF was made. As a primary outcome variable, pain was recorded at preoperatively and at postoperatively 1, 2, 3, 6 and 12 months. Maximum mouth opening, lateral and protrusive movements were formed as secondary outcome variables.

Eligibility Criteria:
Inclusion Criteria:

* unilateral or bilateral disc displacement without reduction
* localized pain on temporomandibular joint
* decreased mouth opening, lateral and protrusive movements

Exclusion Criteria:

* Malignant or inflammatory disorders
* prior surgical history of temporomandibular joint
A Study of PHST001 in Advanced Solid Tumors

PHST001-101 is a multicenter, open-label, Phase 1 study of PHST001 in patients with advanced solid tumors. The study design includes a Dose Escalation Phase and a Dose Expansion Phase, and will enroll patients with advanced relapsed and/or refractory solid tumors. The study's primary object is to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically or cytologically confirmed advanced solid tumor which has relapsed from or been refractory to all locally available standard therapies.
* Adequate hepatic function:
* AST and ALT ≤ 2.5 × times ULN (≤ 5 × ULN if liver metastases)
* Total bilirubin ≤ 1.5 × ULN (\<3 ×ULN for patients with elevations due to Gilbert syndrome)
* Lipase and amylase ≤ 2×ULN
* Adequate renal function: calculated creatinine clearance of ≥ 30 mL/min calculated per institutional standard
* Adequate bone marrow function without packed RBC transfusion within the prior 2 weeks. Patients can be on a stable dose of erythropoietin (approximately ≥ 3 months). Criteria must be met without platelet transfusion within 7 days of screening blood draw:
* Absolute neutrophil count (ANC) ≥1,500/µL
* Platelet count ≥100,000/µL
* Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La

Key Exclusion Criteria:

* History of a previous additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. Patients with basal cell carcinoma of the skin, Stage I melanoma, melanoma in situ, squamous cell carcinoma of the skin, early-stage prostate cancer, or carcinoma in situ, excluding carcinoma in situ of the bladder, who have undergone potentially curative therapy are not excluded and can be enrolled regardless of disease-free period following completion of potentially curative therapy. Patients with early-stage breast cancer who have undergone curative intent treatment and with no disease recurrence for 2 years after treatment are not excluded.
* Active known CNS metastases and/or carcinomatous meningitis. Patients with previously treated CNS metastases may participate provided they are radiologically stable (ie, without evidence of progression for at least 2 weeks by repeat imaging \[note that the repeat imaging should be performed during study screening\]), clinically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of study treatment.
* Received prior systemic anticancer therapy including investigational agents within 21 days or, if shorter, within 5 half-lives prior to the first dose of study treatment. Patients must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Patients with Grade ≤2 neuropathy may be eligible. Patients with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.
* Prior autologous or allogeneic hematopoietic stem cell transplant or solid organ transplant.
* Received previous treatment with another agent targeting CD24.
Assessing Tenapanor As a Treatment of CF-related Constipation.

Tenapanor is the newest FDA-approved drug for IBS with constipation (IBS-C). This study seeks to understand tenapanor as a treatment for cystic fibrosis-related constipation (CFrC) in CF patients. Participants will ingest one 50 mg tablet of tenapanor, twice daily, for a 4-week treatment period. They will also complete three questionnaires, the PAC-SYM, PAC-QoL, and IBS-SSS, and daily diaries to characterize GI symptom burden and spontaneous bowel movement (SBM) frequency.


Eligibility Criteria:
Inclusion Criteria:

1. Having confirmed cystic fibrosis (either by sweat chloride or genetic testing)
2. Meeting criteria for CFrC

   Must include 2 of the following, with or without abdominal pain for at least 3 months, with symptom onset at least 6-months prior:
   * Straining in at least 25% of defecations
   * Bristol Stool Scale 1-2 more than 25% of defecations (change in stool form)
   * Sensation of incomplete evacuation more than 25% of defecations
   * Sensation of anorectal obstruction/blockage more than 25% of defecations
   * Manual disimpaction/manipulation of pelvic floor to facilitate more than 25% of defecations
   * Fewer than 3 spontaneous bowel movements weekly (change in stool frequency)
   * Loose stools rarely present without the use of laxatives
3. Willingness to avoid major dietary or lifestyle changes during study.

Exclusion Criteria:

1. Use of any antibiotic to treat infection within the 4-weeks prior to study initiation (stable azithromycin dosed 3-times weekly for lung function is to be allowed)
2. Inability to discontinue standing bowel regimen (including fiber, stool softener, as well as either osmotic or stimulant laxative, pro-kinetic serotonergic agents, or other therapy) 2-weeks prior to study drug initiation (with ability to use osmotic laxative therapy as rescue therapy only).
3. Severe CFrC as determined by study team
4. Prior tenapanor usage
5. Hospitalization within 4-weeks prior to study initiation.
6. DIOS within 4-weeks prior to study initiation.
7. Other known/suspected mechanical obstruction
Optimized Glycemic Control in Heart Failure Patients With DM2:"Effect on Left Ventricular Function and Skeletal Muscle"

The investigators wish to investigate wether a more strict diabetic control improves cardiac function, muscle strength, exercise capacity and decreases symptoms.

The investigators hypothesis is that improving the glycemic control in suboptimized diabetics with heart failure will improve cardiac performance, muscle strength, exercise capacity and decrease symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Ejection fraction =\<45%
* Diabetes
* Hba1c =\>7,5%
* In anticongestive treatment
* NYHA class 2-4

Exclusion Criteria:

* Severe angina (CCS 3-4)
* Hemodynamic significant heart valve disease
* Congenital heart disease
* Pregnancy
Alternative in Beta Blocker Intolerance: The ABBI Trial

In this study the investigators will assess the tolerance of Nebivolol (Bystolic) in cardiovascular patients who are not able to tolerate conventional beta blockers. A side effect profile will be tracked and compared with previous beta blocker use.

The investigators hypothesize that Bystolic will be tolerated by many patients who are intolerant of conventional blockers.

Patients who have been prescribed standard beta blockers but were unable to tolerate them due to side effects will be studied. They will take a new beta blocker, Nebivolol (Bystolic) for 30 days, if tolerated. Side effects will be tracked and compared to previous.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 21
* Male or female who is post-menopausal or not pregnant and using an approved contraceptive regimen
* Previous beta blocker use and intolerant of beta blocker

Exclusion Criteria:

* Systolic blood pressure \< 100 mmHg unless another blood pressure medication is stopped at the time of study entry
* Hospitalized for heart failure within the past 4 weeks
* Bradycardia with a heart rate \< 60
* Heart block greater than first degree
* History of sick sinus syndrome (unless a permanent pacemaker is in place)
* History of severe hepatic or renal dysfunction; serum Creatinine \> 2.0 or Amylase \> 3x normal
* Use of CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.)
* Ingestion of investigational drug within the past 30 days
Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance

Ischemic stroke is a major health burden globally and in Australia. Treatment for ischemic stroke is time critical and is significantly more effective if administered within the first 90 minutes of symptom onset. This clinical trial will identify if early administration of oral thrombolytic agent, tenecteplase prior to hospital can improve outcomes from stroke, and reduce costs compared to standard care of IV alteplase in hospital

Currently, alteplase is the standard clot-dissolving therapy for ischemic stroke, however this treatment is only effective in 30-45% of patients. Importantly, treatment of ischemic stroke is more effective when given within 90 minutes of stroke onset. Means of treating patients earlier with more effective therapies are needed.

Ischemic stroke is a major public health problem, for which effective and accessible drug therapies remain limited. Current management of acute ischemic stroke includes treatment with a solution called alteplase, which dissolves clots in a cerebral artery. The treatment effect of alteplase is much greater if given within 90 minutes of stroke onset.

As a result, there has been a significant push to take stroke care to the patient in the form of the Mobile Stroke Unit (MSU). The MSU is the first designed as a CT-capable ambulance that allows assessment and treatment of stroke patients in the pre-hospital setting. In the proposed research project, we will undertake a clinical trail investigating the effectiveness of a new thrombolytic agent in the MSU, tenecteplase.

Tenecteplase has been shown to be significantly more effective at improving stroke survivor's recovery and opening blocked blood vessels than alteplase in the hospital setting. However, it is unknown if earlier administration of tenecteplase is more effective than early administration of alteplase.

The tested agent, tenecteplase, is cheaper, easier to administer (no time-consuming infusions required) and more practical for an ambulance delivered therapy than the current standard of care alteplase. If tenecteplase results in better clinical outcomes in addition to these practical advantages, there is significant scope for improved patient outcomes and cost savings.

Eligibility Criteria:
Inclusion Criteria:

1. Patients being attended by the mobile stroke unit with an acute ischemic stroke eligible for thrombolysis using standard clinical and CT criteria.
2. Patient's age is ≥18 years
3. Premorbid mRS \<4

Exclusion Criteria:

1. Intracranial hemorrhage (ICH) or other diagnosis (e.g. tumor) identified by CT on the MSU
2. Hypodensity in \>1/3 MCA territory or equivalent proportion of ACA or PCA territory on non-contrast CT on MSU
3. Pre-stroke mRS score of \> 3 (indicating significant previous disability)
4. Any terminal illness such that patient would not be expected to survive more than 1 year
5. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
6. Pregnant women.
7. Rapidly improving symptoms.
Cardiac Resynchronization in Atrial Fibrillation Trial - a Pilot Study

The purpose of this prospective randomized study is to determine whether patients on cardiac resynchronization therapy with concomitant long-standing persistent or permanent atrial fibrillation would benefit from a strategy to restore and maintain sinus rhythm (rhythm control strategy) in comparison to a rate control strategy in terms of higher biventricular paced beats percentage.

Due to a lack of sufficient data the present guidelines on treatment of patients with atrial fibrillation (AF) and cardiac resynchronization therapy (CRT) devices are of low scientific evidence. The efficacy of CRT in AF patients is limited by the percentage of the effective biventricular paced beats (BiVp%), which should exceed 95%-98% - a goal which is seldom obtained by means of pharmacological rate control strategy. The only treatment strategy which effect is scientifically established is an atrioventricular junction ablation (AVJA) but the use of this method is limited.

On the other hand, about 10% of patients with persistent forms of AF experience a spontaneous sinus rhythm (SR) resumption after CRT implantation. Moreover, SR resumption and it's maintenance by means of single external electrical cardioversion in AF patients has been proven feasible. A strategy of rhythm control in AF patients on CRT could provide high BiVp% and improve the efficacy of CRT in this group of patients.

To show superiority of the rhythm control strategy over the rate control strategy a sample size of 60 patients was calculated based on following assumptions: two-tailed test, a type I error of 0.05, a power of 80%, efficacy (mean BiVp%) of rate control strategy 90%, efficacy (mean BiVp%)of rhythm control strategy 98% and 8% drop-out rate to fulfill the criteria of intention-to-treat analysis. Due to presumed lack of statistical power the secondary end points and safety endpoints will be considered exploratory.

Eligibility Criteria:
Inclusion Criteria:

* Permanent or long-standing persistent atrial fibrillation (definitions according to the latest European Society of Cardiology guidelines on AF)
* At least 3 months after a procedure of a CRT device implantation
* A CRT device with a presence of a right atrial electrode
* Age: ≥18 years old
* Effectively biventricular paced captured beats \<95%
* Effective therapy with oral anticoagulants for at least 3 months
* Written informed consent

Exclusion Criteria:

* Reversible causes of AF
* Significant valve disease
* Advanced A-V block (including: AVJA)
* Contraindications to amiodarone (hyperthyroidism, not compensated hypothyroidism, drug intolerance, QT\>460ms for men, QT\>450 for women)
* Long-QT syndrome
* Decompensation of the heart failure within 48 hours before the qualification
* Cardiac transplantation in 6 months
* Life expectancy less than 1 year
* Chronic dialysis
* LA diameter \>6cm
* Alcohol abuse
* Pregnancy/lack of effective contraceptive therapy (in case of females in the reproductive age)
* Participation in other clinical trial
What is the Future of Vulnerable New-borns

The aim of this data base is to know exactly the future of a "vulnerable newborns" cared in Pontoise Hospital (In the neonatology service) and compare the information with the national data of preterm birth.

The aim of this data base is to know exactly the future of a "vulnerable newborns" cared in Pontoise Hospital (In the neonatology service), it means, newborns who are in these following risk categories:

* Birth before 33 weeks of amenorrhea
* Birth between 33 and 36 weeks of amenorrhea and fetal growth retardation lower to the 3rd for the gestation age
* Perinatal anoxic-ischemia
* Other children whose birth, perinatal history or the existence of a pathology classified them in a category at risk of developmental psychomotor disorders, the co-twin of a child of the preceding groups.
* A regular follow-up is made in Pontoise hospital till the age of 7 to 8 year sold. It tries to screen growth anomalies (neuromotor, sensorial, behavioral, and cognitive or growth development) or health status. The data collect allow us to monitor these parameters and do a statistical study with them.

These information may be used to inform the parents about the future of the premature children cared at Pontoise. They also may be used to compare these children's future with the national data (EPIPAGE 2)

Eligibility Criteria:
Inclusion Criteria:

* Birth before 33 weeks of amenorrhea
* Birth between 33 and 36 weeks of amenorrhea and fetal growth retardation lower to the 3rd percentile for the gestational age.
* Perinatal anoxic-ischemia

Other children whose birth, perinatal history or the existence of a pathology classifies them in a category at risk of developmental psychomotor disorders, the co-twin of a child of the preceding groups.

Exclusion Criteria:

* Children born in normal conditions.
Supra High-intensity Interval Training for Police Officers

Police work is extreme in terms of the physical activity and physical exertion spectrum as it is composed of a mixture of enforced sitting and sudden physical exertion. Police officers remain sitting for the majority of their working hours. In theory, regular physical activity exerts a number of health and fitness benefits that could act on most issues that police officers suffer from. Supra high-intensity interval training (supra HIIT) appears to be a perfect solution for police officers as the training modality can be accomplished in less than 5 minutes. The primary purpose of this proposal is to create and assess supra HIIT program that is suitable for police officers and then to assess feasibility of such exercise program in a small pilot study.


Eligibility Criteria:
Inclusion Criteria:

• Police officers in the local Police Department who are capable of performing physical exercise

Exclusion Criteria:

* Being pregnant
* Having had a recent illness
* History of diabetes, heart disease, or other cardiovascular problems
* Recent surgery, orthopedic, or musculoskeletal injuries
Study of Antidepressant Efficacy of a Selective, High Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder (AMDD)

This study will determine if a highly selective enkephalinergic receptor modulator is effective in the treatment of anxious major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures
* Diagnosis of major depressive disorder without psychotic features (MDD)

Exclusion Criteria:

* A history of substance or alcohol abuse within the past 6 months or dependence within 1 year of enrollment as defined by DSM-IV criteria.
* Women that are pregnant or lactating
* History of pancreatitis
Prevention of PNX and Haemorrhagic Complications in Diagnostic Percutaneous Lung Biopsy Using the MIPP-Kit Device

The study will assess the safety and feasibility of a new medical device, MIPP-Kit, for the prevention of complications during diagnostic, CT guided ,percutaneous lung needle biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Clinical indication for diagnostic percutaneous lung biopsy

Exclusion Criteria:

* Pregnant, or breastfeeding patient (Female)
* actively participating in other clinical trials in the previous 30 days
* known allergies to the investigational device components
* comorbidities that preclude undergoing percutaneous lung biopsy procedure
* concomitant treatments that preclude undergoing percutaneous lung biopsy procedure
Test of a Preventive Effect of a Deodorant Device Against Respiratory Infections

This study is to test whether a chlorine dioxide gas-generating device, which releases a low concentration gas of chlorine dioxide in a sustained manner, can protect against respiratory infections in elderly individuals living in nursing homes. Such a device is used as a deodorant for normal domestic purposes. The investigators reasoned that the antiviral and antibacterial properties of chlorine dioxide might lead to a lowering in the incidence of respiratory infectious diseases. The study is designed as a randomized placebo-controlled double-blind crossover multicentre trial involving approximately 1500 subjects.

Chlorine dioxide (ClO2), which is used as household deodorant, is a volatile gas that displays very strong oxidative activity. Indeed, the powerful oxidative activity of chlorine dioxide (Ogata, N., Biochemistry 46, 4898-4911, 2007) is responsible for its antimicrobial activity against bacteria (Benarde, M. A., et al. Appl. Mircrobiol. 15, 257-265, 1967), fungi (Morino, H., et al. Yakugaku Zasshi 127, 773-777, 2007) and viruses (Ogata, N. and Shibata, T. J. Gen. Virol. 89, 60-67, 2008). Recently, we found that the rate of absenteeism due to illness in a school was lower in classrooms where a chlorine dioxide gas-generating device was placed than in classrooms with no such device. Based upon this unexpected observation we hypothesize that chlorine dioxide gas, at a concentration low enough not to harm humans, may lower the incidence of respiratory infections by inactivating airborne microorganism within an enclosed space.

Eligibility Criteria:
Inclusion Criteria:

* Those who who agrees with the aim of the study

Exclusion Criteria:

* Those who do not agree with the aim of the study