cyrilzakka/clinical-trials huggingface dataset:
Lung Ultrasound and Alveolar Recruitment in Mechanically Ventilated Infants

Investigators hypothesized that lung ultrasound-assisted recruitment maneuver would be beneficial in mechanically ventilated infants compared to those who did not receive lung ultrasound and alveolar recruitment maneuver.


Eligibility Criteria:
Inclusion Criteria:

* Minor surgery less than 2 hours under general anesthesia
* Mechanically ventilated after endotracheal intubation

Exclusion Criteria:

* History of surgery on the lungs
* Laparoscopic surgery
* Abnormal preoperative chest radiograph findings including atelectasis, pneumothorax, pleural effusion, and pneumonia
* Considered inappropriate by the investigator
Effect of Weight Loss on Breast Density Using Digital Mammography and MRI in Women Who Are At Increased Risk For Breast Cancer

Diagnostic procedures, such as digital mammography and MRI, may help measure how weight loss affects breast density in women who are at increased risk for breast cancer.

OBJECTIVES: I. To determine if weight loss in patients undergoing Roux en Y gastric bypass procedures has any effect on breast density as measured by mammography and breast MRI. OUTLINE: GROUP I: Participants undergo mammography and MRI at baseline and 1 year. Participants also undergo gastric bypass surgery. GROUP II: Participants undergo mammography and MRI at baseline and 1 year. After completion of study treatment, patients are followed up at 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Women eligible for gastric bypass surgery
* Pre-menopausal women
* All women will have signed an informed consent form prior to participating in study procedures

Exclusion Criteria:

* Women with a history of breast cancer
* Women currently taking exogenous hormone replacement therapy
* Women currently taking a SERM
* Women currently taking an aromatase inhibitor
* Pregnant or lactating women
* Women who have been pregnant or lactating in the past 2 years
* Women who have metallic or other surgical implants
* All subjects will have a determination of their estimated glomerular filtration rate (eGFR) within 24 hours of undergoing any study where gadolinium based contrast agents will be administered
* Subjects should not have a known history of recent onset acute renal dysfunction
* Subjects with a history of stable chronic renal dysfunction may participate in studies using GBCA based on their eGFR, as outlined below
* Subjects should not have severe liver dysfunction, particularly when associated with kidney disease
* Subjects should receive GBCAs in the perioperative period (i.e. within 4 weeks) after renal or liver transplantation
Itraconazole Pharmacokinetic With and Without Efavirenz Using the Capsule Formulation as Part of Talaromycosis Treatment in HIV-infected Adults

Talaromycosis continues to be a common opportunistic fungal infection among people living with HIV/AIDS (PLWHA) in Southeast Asia and remains a leading cause of death among this population. Itraconazole (ITZ) is an important component of talaromycosis treatment. In Thailand, the capsule formulation of ITZ is primarily used to treat talaromycosis but it is known to have lower bioavailability than the more expensive solution formulation. Limited data on the drug exposure of ITZ with the capsule formulation are available in adults PLWHA in Thailand. Moreover, the effect of efavirenz (EFV), which has been recommended as the first line antiretroviral therapy in Thailand, to ITZ level is not well understood. Thus, our aim is to assess ITZ pharmacokinetics with and without EFV in adult PLWHA receiving talaromycosis treatment with the capsule formulation. An understanding of the relationship between ITZ drug exposure and its active metabolite (hydroxyl-itraconazole) and treatment response is also planned to help optimize therapy.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Available documentation of HIV infection
3. ITZ capsule therapy is indicated for talaromycosis infection with the anticipation to start on EFV-based ART
4. Willing to consent and compliance to the study protocol

Exclusion Criteria:

1. History of ITZ allergy
2. Pregnancy or lactation
3. Use concurrent medication that could interfere with ITZ level
4. Creatinine clearance less than 30 mL/min
5. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) value is more than 5 times of upper normal limit and total bilirubin is more than 3 times above upper normal limit
6. Hemoglobin less than 7 mg/dL
7. History of ITZ exposure within 35 days (only applicable to intense PK group)
Fitness and Exercise for People With Arthritis

The purpose of this study is to develop and evaluate a progressive, land-based exercise program, that includes muscular and aerobic conditioning, resistance and stabilization exercises and balance training, for persons with arthritis.

There is evidence that people with arthritis who participate in appropriate types of physical activity can improve physical function and pain management. Most existing programs focus on improving flexibility and balance. Less attention has been paid to conditioning and overall functional fitness. To address some of these concerns, this study will develop, evaluate, and implement a non-aquatic physical activity program to increase health-related functional fitness in community-dwelling adults with arthritis. Specific goals are:

1. To develop a systematic and progressive program (FEPA: Functional Exercise for Persons with Arthritis) that integrates muscular and aerobic conditioning, balance and trunk/pelvic stabilization exercises emphasizing joint-protective, multi-plane movement patterns that mimic those used in everyday activities.
2. Implement the FEPA program in an ethnically diverse, low SES community sample of older adults with arthritis.
3. Conduct process, outcomes and impact evaluations to assess the effectiveness of the FEPA program for increasing short- and immediate-term health and functional fitness outcomes.
4. Evaluate the sustainability of the FEPA program through a program logic model process and identify inputs, activities and outputs that contribute to successful program implementation and the building of community capacity to support long-term program maintenance.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported doctor-diagnosed arthritis
* No physical limitations precluding exercise participation
* Negative screen for CVD (PAR-Q)
* Age 20+
* English or Spanish speaking

Exclusion Criteria:

* Presence of any condition for which exercise is contraindicated
* Physical inability to complete exercise program
Adult Bipolar Mania

The purpose of this study is to determine if lithium 600-1800 mg/day is effective when added to quetiapine fumarate extended release (quetiapine XR or SEROQUEL® XR) 400-800 mg/day in treating acute mania and if so, how it compares with placebo (a non-active capsule, like a sugar pill, that looks like lithium).


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent before any study procedures are performed.
* The patient must have a documented clinical diagnosis for bipolar I disorder, including recent episode manic or mixed, and being male of females age 18-65 years, inclusive.
* Patients may be outpatients or inpatients at enrollment visit, but all patients must be inpatients when randomized and remain inpatients until discharged at the discretion of the investigator.

Exclusion Criteria:

* The patient can not have had up to 8 mood episodes during the past 12 months and not been continuously hospitalized for acute bipolar for up to 3 weeks immediately before participating in the study.
* The patient can not have a past diagnosis of stroke or medically documented transient ischemic attacks (TIA) or a history of seizure disorder, except for febrile convulsions.
* The patient must not have received electroconvulsive treatment (ECT) within 90 days before participating in the study and in the doctors judgement pose a current suicidal or homicidal risk.
Determine the Efficacy of TT-173. Reducing the the Total Blood Loss Associated With Total Knee Arthroplasty (HESTAT)

The purpose of this study is to determine the haemostatic efficacy of TT-173, reducing the total blood loss associated with the total knee arthroplasty.

As the TT-173 has been cleared for use as a topical hemostatic agent, the proposed study will further investigate the safety and efficacy of TT-173 in the knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who signed the informed consent.
2. Patients affected of degenerative osteoarthritis of the knee that have to undergo a primary total knee replacement.
3. Patients of both sexes older than 18 years.
4. Female patients in childbearing age\* that are not permanently sterile, should present a negative pregnancy test and should agree to use a medically accepted anti contraceptive method during its participation in the study. This includes oral, intravaginal, transdermal, injectable or implantable hormonal contraceptives, sexual abstinence, bilateral tubal occlusion, intrauterine hormone-releasing system or dispositive and vasectomy of the partner.

   \* Includes the period between menarche and until becoming post-menopausal. A woman is considered post-menopausal when she has gone without a period for 12 consecutive months.
5. Patients must have a haemoglobin concentration ≥ to 12.5 g/dL at the selection visit.

Exclusion Criteria:

1. Patients affected of any kind of congenital or acquired coagulopathies or with personal history of abnormal haemorrhagic episodes.
2. Patients subjected to knee replacement due to rheumatoid or seronegative arthritis, infection or other autoimmune inflammatory causes of join degeneration.
3. Patients subjected to revision procedures of the knee, hemiarthroplasty or that will receive non-cemented knee prosthesis.
4. Subjects affected of a serious medical condition that would compromise their clinical outcome such as hepatic, respiratory, cardiac or renal insufficiency, acute infectious disease and active cancer.
5. Subjects with known history of haematological alterations which are causative of thrombophilia.
6. Subjects with personal history of deep vein thrombosis, pulmonary thromboembolism, retinal vascular occlusion or multiple abortions.
7. Subjects with known hypersensitivity or allergy to any component of the drug.
8. Subjects that are currently under treatment with anticoagulant, antiplatelet or antifibrinolytic drugs. These subjects may be eligible if the treatment is stopped preoperatively according with the conditions indicated in section 9.2.
9. Subjects who have received treatment (erythropoietin, iron, folate) to improve preoperative anaemia.
10. Subjects who are not free to give informed consent or who are mentally incapacitated to the discretion of investigators.
11. Subjects who participate or have participated in the past three months in another clinical trial with drug treatment.
12. Subjects that are the investigators, collaborators, nurses, centre employees or any other person directly related to the development of the protocol.
13. Subjects who are pregnant or lactating.
A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates

The purpose of this study is to evaluate the impact of a new Amino-acid based formula on allergic symptoms and growth of infants with cow's milk protein allergy and intolerant to extensively hydrolysed formulas;


Eligibility Criteria:
Inclusion Criteria:

* less than 18 months old
* with a proven cow's milk protein allergy by a double blind placebo controlled food challenge or a positive Skin prick test (\>=6mm) or specific immunoglobulin E \>= 5 kilo-unit/L or combination
* still symptomatic while fed an extensively hydrolysed formula

Exclusion Criteria:

* Exclusively breast fed infants
* non allergic digestive enteropathy
Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome

Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent
* Male or female aged from ≥ 18 years old.
* Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study selection.

Exclusion Criteria:

* Best far corrected visual acuity \< 1/10
* Severe blepharitis
* Severe Dry Eye
* Eyelid malposition
* Known hypersensitivity to one of the components of the study medications or test products.
* Pregnant or breast-feeding woman.
* Woman of childbearing age (neither menopausal, nor hysterectomised, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms).
* Inability of patient to understand the study procedures and thus inability to give informed consent.
* Non compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance).
* Already included once in this study.
* Patient under guardianship.
Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age

The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age.

Primary Objective:

To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of one dose of Menomune® when administered to children aged 3 years to \<6 years of age.

This is a Phase II, open-label, parallel, exploratory, multi-center study in healthy toddlers.

Eligibility Criteria:
Inclusion Criteria :

* Aged either 9, 12, 15 or 18 months of age or 3 to \< 6 years of age on the day of inclusion.
* Informed consent form that has been approved by the site's Institutional Review Board (IRB) and signed by the parent or legal guardian
* Able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria :

* History of a serious chronic disease that could interfere with trial conduct or completion.
* Known or suspected impairment of immunologic function.
* Acute medical illness with or without fever within the last 72 hours, or rectal temperature ≥ 100.4°F (≥ 38.0°C) or axillary temperature ≥ 99.4°F (≥ 37.4°C) on the day of inclusion.
* History of invasive meningococcal disease (confirmed either clinically, serologically or microbiologically) or previous meningococcal vaccination.
* Administration of immune globulin or other blood products within 3 months, or oral or parenteral corticosteroids or other immunosuppressive therapy within the last 6 weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
* Antibiotic therapy within the 72 hours prior to having any blood sample drawn.
* Received or scheduled to receive any vaccine in the 28-day period prior to receipt of either dose of the study vaccine, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 28-day period after receipt of either dose of the study vaccine. Hyposensitization therapy and influenza vaccination may be received up to two weeks before or after receiving the trial vaccine.
* Suspected or known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
* Unable to attend one or more of the scheduled visits or to comply with the study procedures.
* Participation in another clinical trial in the 4 weeks preceding enrollment.
* Planned participation in another clinical trial during the present trial period.
* Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Treating Depressed Mood With a Smartphone-delivered Positive Word Stimulation for Subthreshold Depression

Major depressive disorder (MDD) is an important public health problem. Thus, preventive interventions against subthreshold depression (StD), which is one of the key risk factors for the development of MDD, are important. The study developed a smartphone application (SPSRS) that improves depressive symptoms in people with StD by automatically presenting positive word stimuli during videos. The SPSRS application has the potential to improve depressive symptoms in people with StDs. However, whether it can immediately improve depressed moods in people with StD is unclear. The study aims to investigate the immediate effects of SPSRS applications on depressed mood in people with StD.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female
2. 20 to 39 years old
3. Beck Depression Inventory-II (BDI-II) score of 10 points or more
4. Persons with written informed consent prior to participation

Exclusion Criteria:

1. History of mental illness
2. Currently receiving treatment from a professional for mental health issues
3. Vision or hearing problems that interfere with daily life.
4. With a major depressive episode in the last two weeks according to the Mini-International Neuropsychiatric Interview
Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome

This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with fibromyalgia syndrome. The study is being conducted in 2 parts. Part A enrolled 211 pts dosed with either 3, 20, 60 mg BID AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 440 pts and dose with either 20, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of fibromyalgia syndrome
* Moderate or severe pain associated with fibromyalgia

Exclusion Criteria:

* Any other uncontrolled disease
* Pregnant or nursing females
Evaluation of the Results of Simultaneous Pancreatic and Hepatic Resections for Metastatic Neuroendocrine Tumors.

The indications for synchronous liver resection for metastatic neuroendocrine tumors of pancreatic origin remain debated and poorly described in the literature.

The reported mortality of this type of simultaneous resection remains very high, especially when a cephalic duodenopancreatectomy is associated with a hepatic resection (up to 40%). The benefit in terms of survival remains to be evaluated. The ReSiPaTNE study proposes to create a retrospective cohort of simultaneous pancreatic and hepatic resections for metastatic neuroendocrine tumors in order to evaluate the short and long term results of this type of resection. The evaluation of the results of this type of resection may be useful for the selection of patients for treatment.


Eligibility Criteria:
Inclusion criteria:

* Major subjects (≥18 years old)
* Subject having had a first pancreatic resection for NET with resections of synchronous metastases
* Subject having had a first pancreatic resection for NET followed by a delayed resection of synchronous metastases
* Subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research

Exclusion criteria:

* Subject who expressed their opposition to participating in the study
* Pregnant women
* Subject under safeguard of justice
* Subjects under guardianship or curatorship
PEP and OPEP Devices in Cystic Fibrosis

Cystic fibrosis (CF) is the most common severe autosomal recessive genetic disease in Caucasians. The CFTR (cystic fibrosis transmembrane regulator) gene, which encodes the chloride channel of the epithelial cell membrane, is responsible for the development of the disease. Respiratory physiotherapy, especially bronchial drainage is one of the basic elements of comprehensive management in patients with CF. Among the many procedures used in CF drainage physiotherapy, the most commonly include these using positive expiratory pressure (PEP) and oscillating positive expiratory pressure (OPEP). The aim of the study is to assess the efficacy of the usage of selected PEP and OPEP devices in bronchial drainage in cystic fibrosis patients during exacerbation of the disease.

The aim of the study is to assess the efficacy of the short-term (4-days) use of selected devices generating positive expiratory pressure (PEP device: PARI PEP® S System) and oscillating positive expiratory pressure (OPEP devices: Aerobika\* OPEP Device and PARI O-PEP Device commonly called: Flutter) in bronchial drainage in cystic fibrosis patients during exacerbation of the disease. Patients will perform bronchial drainage in three different groups using different devices in each of them. The main questions study aims to answer are: 1. Whether the devices used are effective in bronchial drainage in patients with cystic fibrosis, 2. Are there differences in efficiency between the devices used.

Eligibility Criteria:
Inclusion Criteria:

* written consent of the patient and/or guardian, age over 12, no disease complications (within the last 2 months) in the form of: active haemoptysis, pneumothorax, chest surgeries, surgical procedures in the area of the esophagus (esophageal varices), otitis media,
* the ability to perform correctly lung function tests and FEV1 value above 20% predicted,
* the presence of respiratory symptoms indicating exacerbation of the disease, i.e. increasing of cough, increasing of dyspnoea, decrease in FEV1 by 10% or more from a previously recorded value.

Exclusion Criteria:

* lack of written consent of the patient and/or guardian, age below 12, occurrence of disease complications (within the last 2 months) in the form of: active hemoptysis, pneumothorax, chest surgeries, surgical procedures in the area of the esophagus (esophageal varices), otitis media,
* inability to perform lung function tests, FEV1 value below 20% of predicted value,
* PEP, OPEP device intolerance,
* no symptoms of the respiratory system indicating exacerbation of the disease, i.e. increasing of cough, increasing of dyspnoea, decrease in in FEV1 less than 10% from a previously recorded value.