cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Tinoridine in Treating Pain and Inflammation in Adults

The purpose of this study is to confirm the efficacy of tinoridine hydrochloride (HCL), three times daily (TID), in the treatment of pain and inflammation in patients with acute tonsillitis and/or acute pharyngitis of nonbacterial origin versus placebo.

Tonsillitis and pharyngitis are the most common upper respiratory tract infections. The signs and symptoms are sore throat, difficulty with swallowing and/or inflamed tonsils and/or pharynx. In most cases these infections are viral in origin.

Tinoridine is a nonsteroid anti-inflammatory drug with a different mechanism of action than common nonsteroidal anti-inflammatory drugs (NSAIDs), which act by inhibiting the cyclooxygenase enzyme and thereby inhibit the synthesis of prostaglandins.

The purpose of this study is to confirm the efficacy of tinoridine in the treatment of pain and inflammation in patients with acute tonsillitis and/or acute pharyngitis of nonbacterial origin versus placebo.

Eligibility Criteria:
Inclusion Criteria:

* Participants with the following signs \& symptoms: sore throat, difficulty with swallowing, and inflamed of pharynx and/or tonsils.
* Onset within 2 days

Exclusion Criteria:

* Pregnant or lactating women
* Participants hypersensitive to tinoridine
* Participants with fever, peptic ulcer, serious blood abnormality, serious hepatic impairment, serious kidney impairment
* Participants with aspirin-induced asthma
* Drug or alcohol abuse
* Participants receiving analgesic antiinflammatory drug, antibiotic and/or antiviral within 2 days before entering this study
Impact of Socio-economic Vulnerability on Initial Severity and Prognosis in Patients Admitted to an ICU.

A gravity admission largest resuscitation and a poorer prognosis are expected for patients experiencing socio-economic vulnerability. This is the first study in France and investigating the field of resuscitation which will allow us to have a vision of the French health system and its consequences. The frequency of PTSD is expected to be more important in this vulnerable population itself with quality of life at discharge worse. The results of this study are a prerequisite for the implementation of preventive measures targeted and more suitable for those patients experiencing socio-economic vulnerability remediation.


Eligibility Criteria:
Inclusion Criteria:

* Patient who have been informed about the study (directly or via a person of trust) and have given their consent
* Patients admitted to intensive care in accordance with the criteria defined by decree n° 2002-465 of the law of 05th April 2002 relative to the rights of patients and the quality of the healthcare system. It concerns patients who present or are likely to present life-threatening acute multi-organ failure requiring support care involving at least one of the following procedures: invasive or non-invasive mechanical ventilation, continuous or discontinuous hemofiltration, dobutamine, adrenaline, noradrenaline, ECMO

Exclusion Criteria:

* - Refusal to take part,
* Age \< 18 years
* Adult under guardianship (or ward of court),
* Patients impossible to follow for 3 months (concomitant disease not related to the admission to the ICU that may cause death within 3 months....),
* Patients presenting major cognitive impairment that precludes a reliable interview,
* Patients and/or close relatives/friends who cannot be questioned or cannot provide information,
* Absence of a family and/or close friends
Improving Weight Loss Maintenance Through Alternative Schedules of Treatment

This project examines the effects of differing schedules of extended care contact following weight loss treatment in order to prevent weight regain following treatment.


Eligibility Criteria:
Inclusion Criteria:

* At least 21 years-old
* body mass index (BMI) = 28.0 - 45.0 kg/m2
* willing to provide informed consent and accept randomization

Exclusion Criteria:

* BMI \>45 kg/m2
* Illnesses requiring medical attention and/or conditions for which weight loss and moderate physical activity would be inadvisable: diabetes not under active treatment, myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; congestive heart failure; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); serious infectious diseases (e.g., self-reported HIV); chronic hepatitis; cirrhosis; chronic malabsorption syndrome; chronic pancreatitis; chronic lung diseases that limit physical activity; orthopedic injuries or conditions that significantly limit physical activity.
* Conditions or behaviors likely to affect the conduct of the trial: unwilling or unable to give informed consent; unable to read English at the 5th grade level; unwilling to accept random assignment; unwilling or unable to travel to attend intervention (due to distance from clinic, work schedule or other scheduling conflicts); likely to relocate out of the service area in next 18 months.
Efavirenz and Ritonavir on Human Brain P-Glycoprotein

To determine the effects of ritonavir and efavirenz on the activity of P-glycoprotein in human brain.

Sequential crossover using tracer 11C-desmethylloperamide, a substrate for brain P-glycoprotein, and positron emission tomography (PET), administered after nothing (control), oral ritonavir (3d), and oral efavirenz (14d) with washout in between

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female, 18-40 yr old
* Good general health with no remarkable medical conditions
* BMI \< 33
* Provide informed consent

Exclusion Criteria:

* Known history of liver or kidney disease
* History of major medical conditions
* HIV seropositive
* Fasting blood glucose \> 110 mg/dl
* Family history of type 2 diabetes
* Use of prescription or non prescription medications, herbals or foods known to be metabolized by or altering P-glycoprotein or CYP3A activity (hormonal birth control medications are acceptable if alternative means of contraception are used)
* Females who are pregnant or nursing
* Females taking hormonal contraceptives who are unwilling to use alternative means of contraception
* Contraindications to MRI
* Contraindications to PET scanning
Proteomic and Metabolomic Lacrimal Fingerprint in Diverse Pathologies of the Ocular Surface

This study aims to obtain the lacrimal fingerprint for frequent pathologies of the ocular surface and establish a normative base for each of them.

This is an exploratory study. The investigators aim to:

* Test and perfect a tear sample analysis technique by mass spectrometry with samples collected by Schirmer strips;
* Obtain the lacrimal fingerprint for various pathologies of the ocular surface, notably different forms of dry eye syndrome, infectious keratitis/conjunctivitis, mucous membrane pemphigoid and allergic conjunctivitis, and establish a normative base for each of them.

During regular clinics at the cornea service of the ophthalmology department of the CHUM (Centre Hospitalier de l'Université de Montréal), the investigators aim to recruit a few hundred patients with various pathologies of the ocular surface, notably different forms of dry eye syndrome, infectious keratitis/conjunctivitis, mucous membrane pemphigoid and allergic conjunctivitis, and collect a sample of their tears via Schirmer strip. A case report form will be completed for each patient, noting known ocular diagnoses and active topical ophthalmic medication. Schirmer strips will be sent in sterile tubes to UQAM (Université du Québec à Montréal)'s department of chemistry for analysis by mass spectrometry.

Eligibility Criteria:
Inclusion Criteria:

* Patients with healthy corneas or suffering from one of these pathologies:

Dry eye syndrome; Infectious keratitis and/or conjunctivitis; Mucous membrane pemphigoid; Allergic conjunctivitis.

Exclusion Criteria:

* Patients younger than 18 years old;
* Patients incapable of giving informed consent.
Sequential Radiotherapy With CAR-T Cells in the Treatment of Relapsed and Refractory Hematological Malignancies With Extramedullary Lesions

Clinical trial for the safety and efficacy of sequential radiotherapy with CAR-T cells in the treatment of relapsed and refractory hematological malignancies with extramedullary lesions

This is a prospective, single arm study. To evaluate the safety and efficacy of sequential radiotherapy with CAR-T cells in the treatment of relapsed and refractory hematological malignancies with extramedullary lesions. The main endpoints were dose limiting toxicity (DLT) and incidence of adverse events (TEAEs).

Eligibility Criteria:
Inclusion Criteria:

Age≥15 years old; Relapsed and refractory hematological malignancies with extramedullary lesions, mainly including B-cell non Hodgkin's lymphoma, multiple myeloma, acute lymphoblastic leukemia, etc; Flow cytometry or pathological biopsy confirmed that tumor cells have potential therapeutic targets for Car-T cells; PET-CT confirmed that the extramedullary lesions were located in a single radiotherapy region; Anticipated survival time more than 12 weeks; Those who voluntarily participated in this trial and provided informed consent.

Exclusion Criteria:

History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; Pregnant (or lactating) women; Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); Active infection of hepatitis B virus or hepatitis C virus; Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids; Previously treated with any CAR-T cell product or other genetically-modified T cell therapies; Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl; Other uncontrolled diseases that were not suitable for this trial; Patients with HIV infection; Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors

Background: Retroperitoneal tumors are typically large and inhomogeneous, with a variable amount of necrosis within the tumor mass which decreases the diagnostic yield of biopsy (false negative or inadequate).

Rationale: Real-time contrast enhancement can highlight the viable tumoral tissue and avoid the necrotic area.

Aims: To compare contrast-enhanced ultrasound (CEUS) guidance and conventional (B-mode) ultrasound (US) guidance in terms of diagnostic yield, need for repeat biopsy, and rate of adverse events.

Methods: A consecutive series of patients with previously documented retroperitoneal tumors and indications for percutaneous biopsy were randomly assigned to benefit from the standard of practice B-mode US-guided biopsy or CEUS-guided biopsy.

The diagnostic accuracy, need for repeat biopsy, and adverse events were noted.


Eligibility Criteria:
Inclusion Criteria:

* All patients with retroperitoneal tumors with indication for percutaneous biopsy

Exclusion Criteria:

* Tumors inaccessible for ultrasound guided biopsy
* Standard contraindications for biopsy (altered coagulation tests, poor performance status)
* Lack of written informed consent
Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation

This study is for a new marketing authorization application for the seasonal vaccine strains in compliance with the Note for Guidance (NfG) on harmonization requirements for influenza vaccine from the Committee for Human Medicinal Products (CHMP)

Objectives:

* To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine NH 2008-2009 formulation with the requirements of the CHMP NfG CPMP/BWP/214/96.
* To describe the safety of the inactivated, split-virion influenza vaccine, NH 2008-2009 formulation.


Eligibility Criteria:
Inclusion Criteria :

* Aged 18 to 60 years or 61 years and older on the day of inclusion
* Provision of a signed informed consent
* Able to attend all scheduled visits and comply with all trial procedures
* For a woman of child-bearing potential: avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 21 days after vaccination

Exclusion Criteria :

* For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test at visit 01
* Febrile illness (temperature ≥ 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
* Breast-feeding woman
* Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
* Planned participation in another clinical trial during the present trial period
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
* Known systemic hypersensitivity to egg proteins, chick proteins, neomycin, formaldehyde and octoxinol 9, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing any of the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
* Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
* Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
* Receipt of any vaccine in the 4 weeks preceding the trial vaccination
* Planned receipt of any vaccine in the 3 weeks following the trial vaccination
* Previous vaccination against influenza in the previous 6 months
* Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
* Known Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen or Hepatitis C seropositivity
* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Mood Management Effects of Brief Unsupported Internet Interventions II

The main goal of this study was to compare the effect of a one-session unsupported Internet intervention on participants' clinical symptoms (depressive and anxiety symptoms) and related variables (mood, confidence and motivation).

The main goal of this study was to compare the effect of a one-session unsupported Internet intervention on participants' clinical symptoms (depressive and anxiety symptoms) and related variables (mood, confidence and motivation).

Method: A total of 275 adults residing in the United States will take part in a randomized controlled trial. Participants were randomly assigned to an experimental condition based on Behavioral activation or a one week wait list condition. They will be follow-up one week after consenting.

Eligibility Criteria:
Inclusion Criteria:

* most be U.S. citizens

Exclusion Criteria:

* non-U.S. residents
Frailty Study of Older Adults Getting Chemotherapy and Radiation Therapy

The investigators hypothesize that frailty assessment prior to concurrent chemotherapy and radiation therapy in the elderly will predict treatment-related toxicity and morbidity and that such assessment at serial time points will help improve treatment and outcomes for these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have one of the following histologically or cytologically confirmed cancers: lung cancer, head and neck cancer, gastric cancer, anal cancer, rectal cancer, cervix cancer, or bladder cancer, and must have appropriate indications for the use of standard concurrent chemotherapy plus radiation therapy as defined in the NCCN (National Comprehensive Cancer Network) Guidelines for each of these specific organ-sites.
* Age \>70 years.
* ECOG (Easter Cooperative Oncology Group) performance status of 0, 1 or 2.
* Life expectancy Tables showing upper, middle, and lower quartiles of life expectancy for women and men age 70 and older should be used and life expectancy should be estimated to be of sufficient to justify the use of concurrent chemotherapy plus radiation for each organ site and indication.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered to baseline from adverse events due to agents administered more than 4 weeks earlier.
* Patients who are receiving any investigational agents.
* Patients with known distant site metastases (M1 disease) or brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Patients who have a history of one or more other concurrent cancers besides the cancer for which concurrent chemotherapy plus radiation therapy is considered are ineligible only if the other cancer or cancers are being considered for treatment or are actively being treated.
* Patients carrying a pre-existing diagnosis of HIV/AIDS and are on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with chemotherapy. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
* Patients with any standard contraindication to chemotherapy or radiation therapy are ineligible.
* Transplant recipient patients on immune-suppressant agents are ineligible due to increased risk of infection.
Myths About Bipolar Affective Disorder: The Role of Structured Group Psychoeducation Therapy

This study will examine:

1) The impact of psycho education group therapy sessions relating to beliefs/myths associated with bipolar affective disorder (BAD) on the emotional wellbeing, clinical course and cognition of individuals diagnosed with BAD 2) Will examine the existence of those same beliefs among the various caregivers - psychiatrists, general practitioners, social workers, and psychiatric nurses.

The investigators hypothesize that psychoeducation group therapy will be effective in refuting the myths and will lead to better treatment adherence, longer remissions, fewer hospitalizations, improved self esteem, increased optimism, and better control over the disease process. The investigators also believe that they will identify some beliefs/myths or preconceived notions that are common to both caregivers and individuals with BAD.

Methods:

Effect psychoeducation:

Study population - 30 patients diagnosed with BAD treated in the outpatient clinic, in a state of remission will be evaluated with the Hamilton Rating Scale for Depression, Young Mania Rating Scale, and will then participate in 7 weekly sessions of brief structured psycho education therapy Control group - 30 patients diagnosed with BAD treated in the outpatient clinic, in a state of remission will be evaluated with the Hamilton Rating Scale for Depression, Young Mania Rating Scale. In addition both groups will complete the Snyder Hope Scale, Accepting the Mental Illness Label Scale and a questionnaire regarding Myths in BAD prior to the study, and when the study group finishes their group therapy sessions. (Controls will not participate in the psychoeducation group therapy).

Caregivers beliefs:

50 caregivers from various professions will complete the questionnaire regarding the myths, once only.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of BAD
* State of remission

Exclusion Criteria:

* HAM-D score \< 10
* YMRS score \< 12
* Has a guardian for either self or property
Safety and Performance Study of the CardioGard Cannula

The objective of the study is to collect additional information related to the safety and performance of the CardioGard Cannula during bypass procedures.


Eligibility Criteria:
Inclusion Criteria:

* AVR (Aortic Valve Replacement), AVR+CABG (Coronary Artery Bypass Surgery)
* Non pregnant female

Exclusion Criteria:

* Contraindication for open heart surgery under bypass machine
* Emergency Operation
Thoracic Epidural Analgesia and Bilateral Erector Spinae Plane Block on Postoperative Pain in Open Heart Surgeries

Postoperative pain negatively effects respiratory functions in open heart surgeries. The aim of the study is to compare the effects of thoracic epidural analgesia (TEA) and erector spinae plane block (ESPB) on postoperative pain and respiratory functions in patients undergoing open heart surgery with sternotomy

Thoracic epidural catheter was inserted to patients in Group T at the T4-T5 vertebra level before induction of general anesthesia. And then local anesthetic infusion was started until postoperative 48. hours.

Bilateral erector spinae plan block was applied with total 40 ml of local anesthetic solution to patients in Group E at the T4-T5 vertebra level before induction of general anesthesia.

The control group was infused with 1 mcg/kg/min fentanyl during the surgery. In the postoperative period, 1 g paracetamol was infused 4 times a day.

All patients underwent general anesthesia with the same method and medications.

Tramadol/diclofenac was administered to patients with a pain score (NRS) above 4. NRS and tidal volumes (TV) of the patients were measured at 0, 2, 6, 12, 24, 36 and 48. hours after extubation. Postoperative mechanical ventilation durations, intensive care unit and hospital stays, additional analgesic needs and respiratory complications of the patients were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Has ASA II-IV score
* Having open heart surgery

Exclusion Criteria:

* Having a psychiatric illness
* Using analgesic medication due to chronic pain
* Uncooperative
Use of Ultrasound to Evaluate Clavicle Fractures in Pediatric Patients

This studies investigates the hypothesis that bedside ultrasound is as accurate as plain x-rays for diagnosing clavicle fractures in children in a pediatric emergency department. Children with shoulder injuries are enrolled and receive both an ultrasound imaging (experimental) and x-rays (standard-of-care) to see if ultrasound has the same (or better)accuracy, with less cost, time, and radiation.


Eligibility Criteria:
Inclusion Criteria:

* Age 1-18 years
* Pain from recent shoulder/clavicle injury
* Intact neurovascular exam
* Radiographs performed as part of normal ED evaluation

Exclusion Criteria:

* Hemodynamic instability
* Multisystem trauma
* Altered mental status
* Open wounds to injured shoulder
* Developmental delay
* Prior radiographs at another clinic/hospital for this injury
* Previous clavicle fracture on the affected side
* Ultrasound gel allergy
* Non-English-speaking parents/child (unable to give informed consent)