cyrilzakka/clinical-trials huggingface dataset:
BAY2586116 Nasal Spray and OSA Severity

This investigator-initiated study aims to determine the effects of BAY2586116 (a novel TASK channel blocker nasal spray) on sleep apnoea severity and the potential influence of route of breathing.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged 18 years or older at screening
* Must have completed Part A of the KOALA study (NCT04236440)
* Must be willing to sleep three nights in the sleep lab without OSA therapy (This includes continuous positive airway pressure therapy (CPAP) and/or a mandibular advancement device (MAD))
* Must be willing to refrain from drinking alcohol on the study days.
* Must be willing to limit consumption of tobacco to four cigarettes or one cigar a day and not smoke while at the sleep laboratory. This might be up to 12 hours.
* Must be willing to limit caffeinated beverage intake (coffee, tea, cola, and other soft drinks) to 400 mg / day or less of caffeine and not to be used within 4 hours of bedtime on study days.
* Contraceptive use required by men or women according to the methods of contraception for those participating in clinical studies

Exclusion Criteria:

* Any medications or herbal supplements that may interfere or be contraindicated with the study drug as determined by the investigator
* Severely impaired breathing within two days prior to randomization (e.g., acute nasal congestion during upper airway infection).
* known allergies or hypersensitivities to the study drugs (active substances or excipients of the preparations).
* Any other condition which at the discretion of the investigator would make the participant unsuitable for participation in the study and will not allow participation for the full planned study period (e.g., active malignancy or other condition limiting life expectancy to less than 12 months)
A Modified Sinus Floor Elevation Technique - a Pilot Study on 12 Patients

The aim of the present study is to establish a modified minimally invasive surgical technique for sinus floor augmentation with a residual bone height of 3-6mm.

Hypothesis: The investigators expect that the present surgical technique allows to achieve an adequate implant bed of at least 10mm height after a healing period of 3-5 months. Further the modification of the technique enables a reduced patient stress level.


Eligibility Criteria:
Inclusion Criteria:

* residual bone height of 3-6mm
* residual bone width of \>4mm

Exclusion Criteria:

* not treated periodontal disease
* smoker (\>5cig/day)
* acute or chronic sinusitis
Prospective Observational Study Based on a Cohort of Geriatric Patients With Hip Fracture Treated in the Centers Belonging to the GIOG Group

The study aims to collect the clinical activity and management data of the Orthogeriatrics and Orthopedics Units participating in the study on a continuous and long-term basis. By collecting clinical data and comparing the performance of the various centers, the study aims to guide the participating centers towards the principles of good clinical practice in orthogeriatrics.

Multicenter prospective cohort observational study. The enrollment period will be 5 years. An additional 4 months will be required to allow the last enrolled patients to complete the 120-day follow-up. It is estimated to enroll a total of 7,000 patients. To facilitate the participation in the study of non-university or IRCCS assistance departments, two methods of data collection will be possible:

* High intensity: continuous data collection for the whole period of the study on all the incident cases
* Low intensity: data collection once a year on incident cases over a continuous period of 1 month, with a reduced number of variables.

The choice of the level of intensity with regard to the data collection method will take place on a voluntary basis (each OU will actually choose the type of speed with which it intends to collaborate in the project, after communicating to the steering committee and to the biostatisticians of the study)

Eligibility Criteria:
Inclusion Criteria:

* Fracture of the femur, regardless of the cause
* Age ≥ 65 years
* Willingness to participate in the study by the patient or a relative / caregiver, if the patient is unable to understand and is not "competent" at the time of the evaluation.
* Able to speak the Italian language

Exclusion Criteria:

* none
Cohort of HIV Associated Lymphomas

The incidence of lymphomas is increased among HIV infected patients. In 70 % of cases, those are Non Hodgkin's lymphomas (NHL) and Hodgkin lymphomas (HL) in 30% of cases. In France, their incidence is estimated to 100 cases per year (data from the "Base de données Hospitalière Française sur l'Infection à VIH" (FHDH)). The main mechanisms involved in lymphomagenesis are immune dysfunction, involvement of oncogenic viruses (Epstein-Barr (EBV) and HHV8) and molecular oncogenic events. A better understanding of these different pathways, give the possibility to design specific treatments. The treatment of these lymphomas is not standardized. A prospective study of patients with HIV associated lymphoid malignancies is an innovating tool to answer epidemiological, physiopathological and therapeutic questions. We propose a prospective multicentric study of these patients.

The main objectives of this prospective study are to:

* evaluate the incidence, characterise clinically and histologically NHL and HL cases associated to HIV
* perform an observational study of the treatment and outcome of these patients out of the context of clinical trials,
* study the differentiation and activation of B-cell populations,
* better understand the role of specific T cell responses in the control of EBV infection,
* allow other biological studies from the ANRS group " Lymphome et VIH ".

The recruitment of 40 cases per year is expected. The length of inclusions is 7 years. The follow-up will be of 2 years. Clinical, pathological and biological data at diagnosis and during follow-up will be collected. This will allow characterizing the lymphoma, the HIV infection, the antitumoral treatments and the outcome of lymphoma. Biological samples will be centralized to collect cell, DNA, RNA, plasma, serum and tumour collections (Y.Taoufik, S Prevot\* ). To better understand the EBV infection and lymphomagenesis in HIV infection, we propose to follow the viral load and the molecular characteristics of EBV in PBMC, plasma and tumour (P.Morand\* , V.Boyer\* ), to investigate the EBV-T cell responses (G.Carcelain) and the presence and reactivation of EBV in peripheral B cells (C.Amiel\* , JC Nicolas) and in tumoral samples (M.Raphael\* , I.Joab\* ). The other mechanisms of lymphomagenesis in HIV infection will be studied by the analysis of the sub-populations of B-cells in terms of activation and differentiation (Y.Taoufik) and by the characterization of MSI tumours (A.Duval).


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients over 18 years of age
* patients with HIV-1 or 2 infection
* with Non Hodgkin's lymphomas (NHL) or Hodgkin lymphomas (HL) in the diagnosis or in relapse
* sign an informed consent

Exclusion Criteria:

* patients who suffered from acute leukemia
* patients treated for lymphoïd blood disease
* Patients whose lymphomas treatment was stopped for less than 3 months
* unaffiliated to the social healthy security french system
Cryotherapy in the Treatment of Desmoid Tumors

Desmoid tumor is a benign neoplasm with an unpredictable course and a high rate of local recurrence if treated surgically. Therefore, over time the surgical approach has become conservative, preferring simple observation or medical therapy in case of disease progression through the use of hormonal therapy and low-dose chemotherapy. Since this neoplasm remains benign, our study aims to avoid chemotherapy in patients usually young through the use of a minimally invasive treatment such as cryotherapy.


Eligibility Criteria:
Inclusion Criteria:

* histologic diagnosis of desmoid tumors
* age \> 18 years
* abdominal and extra-abdominal desmoid tumors

Exclusion Criteria:

* contraindication to the procedure by the interventional radiologist in terms of tumor proximity to neurologic/vascular structures
* retroperitoneal desmoid tumors
* age \< 18 years
Does Testosterone Therapy Improve Patient-Reported Outcomes in Age-Related Testosterone Deficient Patients Undergoing Total Hip Replacement: A Randomized-Controlled Trial

This randomized-controlled trial will study on the effect of testosterone therapy on patients undergoing total hip replacement. Subjects will be male patients \> 50 years with testosterone deficiency undergoing total hip replacement due to severe degenerative joint disease. All participants will receive a total hip replacement and will be randomized to either testosterone therapy or placebo. A total of 80 subjects will be recruited randomized into 2 groups of 40 subjects. Testosterone therapy will be administered once to each patient at 2 weeks before surgery. The long-term follow up will be the same as all patients with patient-reported outcomes after total hip replacement, VAS for pain and satisfaction at regular intervals.


Eligibility Criteria:
Inclusion Criteria:

* Male patients
* 50 years of age and older
* Individuals who have degenerative joint disease requiring total hip replacement after failure of conservative measures.

Exclusion Criteria:

* History of prostate cancer less than 5 years ago or those men whom are not considered to be cancer free
* History of breast cancer less than 5 years ago or those men whom are not considered to be cancer free
* History of deep vein thrombosis (DVT)
* Presence of Factor V Leiden (as seen in labs)
* Presence of Protein S Deficiency (as seen in labs)
* History of atherosclerotic artery disease - by history having had a diagnosis made of CAD, MI, or stroke
* Liver disease (as viewed by liver function tests)
* Testosterone free level greater than 10pg/mL
* Hematocrit \>51%; PSA \>= 3ng/mL.
Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics

Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics

The study aims to study the Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics

Eligibility Criteria:
Inclusion Criteria:

* Children with traumatic brain injury: Moderate and Severe.

Exclusion Criteria:

* Underlying CNS disorders,
A CHW Intervention to Identify and Decrease Barriers to COVID 19 Testing & Vaccination

The objective of this study is to compare the results of a COVID-19 specific curriculum led by LACDHS Community Health Workers (CHWs) from these same communities of safety-net patients to effectively increase COVID-19 testing and vaccination for individual patients, and to facilitate needed healthcare in a timely manner for the safety net health system, and to develop a sustained public health presence in these communities to build trust and preparedness for critical COVID-19 related future needs.

This study represents the third aim of a grant with three aims. The study used unsupervised machine learning and qualitative interviews to develop a CHW intervention for this aim. The aim will compare and evaluate a Community Health Worker-led curriculum aimed to identify and address barriers to COVID-19 testing and vaccination among LACDHS safety-net patients.

For the study, the investigators will recruit 66 eligible safety-net patients for a COVID-19 specific curriculum, provided by Community Health Workers at Los Angeles County Department of Health Services. The study will take place remotely over the course of 6-weeks. Utilizing a randomized control design among African American and Latinx safety net patients, will assess the effect of the CHW hypothesis-driven intervention on trust, self-efficacy, and intent to participate in COVID-19 testing and vaccination.

The remote CHW intervention that the study participants will participate in and be compensated for is a pilot program intended to provide additional CHW training. Monthly calls from LACDHS to remind them of COVID-19 vaccination are standard of care for all empaneled LACDHS patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 16 years and older
* Self-identify as African American or Latinx
* English Speaking
* Receives primary or specialty care treatment at an LACDHS facility
* Has either not completed lab orders for COVID-19 testing and/or vaccination at an LACDHS facility
* Have reliable internet access

Exclusion Criteria:

* Not meeting the inclusion criteria listed above
Spirulina Platensis for PPI Withdrawal

Background: Rebound acid hypersecretion after proton pump inhibitors (PPIs) discontinuation may be accompanied by dyspepsia.

Aim: To assess whether Spirulina platensis, by its anti-inflammatory properties, could minimize rebound symptoms after PPIs withdrawal.

Forty-five regular users of PPIs entered in a 28-day run-in phase of pantoprazole 40 mg/day, followed by clinical and endoscopic evaluation. In the absence of large hiatal hernia, peptic ulcer, or moderate to severe reflux esophagitis, patients stopped PPIs and were randomly assigned to receive Spirulina (1.6 g/day) or placebo for 2 months, when evaluation was repeated. Primary outcomes were dyspepsia and typical reflux symptoms (either appearance or maintenance of symptoms \> 50% from baseline). Intention-to-treat analysis was applied.

Eligibility Criteria:
Inclusion Criteria:

* Chronic use of any PPIs, either original brand or generic
* Absence of conditions that contraindicate the cessation of PPIs, such as active or recent peptic ulcer, active or recent upper digestive bleeding, regular use of salicylates or non-steroidal anti-inflammatory drugs, moderate to severe reflux esophagitis, and sliding hiatal hernia greater than 3 cm
* Formal agreement to participate

Exclusion Criteria:

* Uncompensated acute and chronic morbidities
* Gastroesophageal surgery
* Cognitive deficit
Implications of MEDIcal Low Dose RADiation Exposure - BReast Cancer Acute Coronary Events

MEDIRAD-BRACE aims to determine the relationship between 3D dose distributions in cardiac structures and the risk of acute coronary events (ACE) and other cardiac complications in breast cancer (BC) patients to develop and externally validate multivariable Normal Tissue Complication Probability (NTCP) models to assess the risk of ACE in individual patients based on cardiac dose metrics in the first 10 years after BC radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Female breast cancer patients;
* Treated with primary surgery for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS);
* Age between 40-75 years at time of start RT;
* WHO performance status 0-1;
* Planned for RT alone to the breast, the chest wall and/or the lymph node areas;
* Start of RT is between 01-01-2015 and 31-12-2013;
* Available planning CT scan and dose distribution;
* Adjuvant systemic treatment, including hormonal therapy or chemotherapy is allowed;
* Medical history of coronary artery disease and/or myocardial infarction is not an exclusion criterion;
* Written informed consent.

Exclusion Criteria:

* Male breast cancer patients;
* Women with metastatic breast cancer (M1 disease);
* Any prior malignancy other than non-melanoma skin cancer;
* Previous thoracic or mediastinal radiation;
* Women treated with neoadjuvant chemotherapy.
Comparative Study of 0.5% Carboxymethylcellulose With 0.005% Stabilized Oxychlorocomplex (PURITE™) Versus 0.5% Carboxymethylcellulose in the Treatment of Dry Eye

To compare if 0.5% carboxymethylcellulose with 0.005% SOC (Stabilized oxychloro complex) have the same effectiveness and safety as 0.5% carboxymethylcellulose on dry eye patients.

Dry eye is the very common disorder of tear film. There are millions of people who have dry eye around the world. Dry eye patients may suffer from redness, sandy sensation, itching, excessive watering, burning sensation, excessive mucous discharge, blurred vision, contact lens intolerance, and increased risk of ocular surface damage and ocular infection. Currently, there is no curative treatment for dry eye. The mainstay of treatment is still artificial tear supplement or punctual occlusion. In moderate to severe dry eye patients, the standard replacement is using non-preservative artificial tear more than 4 times a day. However, non-preservative artificial tear has some limitation such as inconvenience to carry, expensive, ocular surface trauma due to sharp plastic tip.

Recently, there is improvement in using new disappearing preservatives in artificial tears. One of the new preservative is stabilized Oxychlorocomplex (SOC, Purite™) which can dissipate into water and sodium chloride, components of natural tears when exposed to light. It also has bactericidal and viricidal activities. Scanning electron microscopy also reveals that, carboxymethylcellulose (CMC) with SOC has a very low toxicity to corneal epithelium than other preservative.

The past study had documented that 0.5% CMC preserved with SOC was safe, comfortable and well tolerated for mild to moderate dry eye patients when applying 4-8 times daily.

The objective of this study was comparing efficacy, tolerability, and safety of 0.5% carboxymethylcellulose(CMC) with Stabilized Oxychlorocomplex(SOC) and 0.5% carboxymethylcellulose alone in patients with moderate to severe dry eye symptoms and/or signs.

Eligibility Criteria:
Inclusion Criteria:

* Out patients of Ophthalmology department, King Chulalongkorn Memorial Hospital, who have symptoms and/or signs of dry eye
* Bilateral dry eye symptoms and/or signs with equal severity between both eyes
* Age \> 18 years, capable of following the study protocol, and considered be able to return for all scheduled visit

Exclusion Criteria:

* Different severity of dryness between both eyes
* Current or recent use of topical ophthalmic medications that could affect dry eye condition
* History of any systemic or ocular disorder or condition that could possibly interfere with the interpretation of study result
* Recent contact lens wear (within one month)
* Known hypersensitivity to 0.005% SOC or carboxymethylcellulose
* Pregnancy or planned pregnancy
* Having received permanent punctal occlusion
Low Literacy Intervention for Colorectal Cancer Screening

Of 17 performance measures of hospital quality regularly reported for the Veterans Administration (VA) health care system, rates of colorectal cancer screening are the lowest.

Background:

Of 17 performance measures of hospital quality regularly reported for the Veterans Administration (VA) health care system, rates of colorectal cancer screening are the lowest.

Objectives:

The objectives of this study were to 1) test whether a health care provider-directed intervention increased colorectal cancer screening rates in an urban VA medical center and 2) evaluate the cost-effectiveness of the intervention.

Methods:

The study was a randomized controlled trial, conducted at two clinic firms at a VA Medical Center in Chicago. Eligible patients were men, age 50 and older, had no personal or family history of colorectal cancer or polyps, had not received colorectal cancer screening, and had at least one visit to the clinic during the study period. Health care providers in the intervention firm attended a workshop on colorectal cancer screening. Every 4-6 months they attended quality improvement workshops where they received group screening rates, individualized confidential feedback, and training on improving communication with patients with limited literacy skills. Medical records were reviewed for colorectal cancer screening recommendations and completion. Literacy level was assessed in a subset of patients. In the cost-effectiveness analysis, resource and cost estimates were derived.

Status:

The project is complete.

Eligibility Criteria:
Inclusion Criteria:

Patients over 50 with average risk for colorectal cancer. Patients with family history and/or personal history excluded, as well as those up to date on colorectal cancer screening.

Exclusion Criteria:
Hunger, Satiety, and Metabolic Responses to High-fat Meals of Varying Fatty Acid Composition

This study evaluates the effects of dietary fatty acid composition from high fat meals on markers of hunger, satiety and metabolism.


Eligibility Criteria:
Inclusion Criteria:

* BMI of \>18.5-24.9kg/m2
* Woman
* 18-40yrs of age

Exclusion Criteria:

* Evidence of weight loss or gain exceeding 5% of their body weight within the past 3 months.
* Plans to lose weight or begin a weight loss program between initiation of study and final testing.
* Plans to begin an exercise program or change current exercise routines between initiation of study and final testing.
* Is on a medically prescribed diet
* Does not consume breakfast regularly
* Rate less than 80% of foods offered in the buffet at 50mm or more on the 100mm VAS as palatable
* Medications that could influence appetite or sensory function
* Reports of metabolic or endocrine disease, gastrointestinal disorders, or history of medical or surgical events that could affect fat digestion and hormone signaling.
* Any chronic disease including type II diabetes, hypothyroidism, hyperthyroidism, cardiovascular disease, and cancer
* Any supplements that a subject begins taking between initiation of study and final testing.
* Anyone who is currently pregnant, lactating, or planning on becoming pregnant before the conclusion of this study.
* Anyone who has allergies to any of the components of the liquid meals
* Anyone who has donated blood in the last 20 days
Study of the Breast Milk Microbiota and Its Influence on the Development of Early and Late Neonatal Bacterial Sepsis Under Three Months of Age.

Breast milk contains many microorganisms including bacteria that are beneficial to health (probiotics), but also bacteria that are generally considered pathogenic.

Several studies have described an increased risk of infections due to pathogenic germs in breast milk in premature newborns whose digestive system is immature and whose digestive flora is modified by repeated antibiotic treatments.

However, a breastfed baby is better protected against infectious diseases than a bottle-fed baby. The objective of this study is to define the breast milk microbiota of infants with confirmed early or late neonatal bacterial infection compared to the breast milk microbiota of infants with no evidence of bacterial infection. For that purpose, an exploration will be performed using the principle of "Microbial Culturomics" and targeted metagenomics (16S ribosomal RNA gene sequencing).


Eligibility Criteria:
Inclusion Criteria:

Breastfeeding mothers of infants:

* Aged 1 to 89 days consulting in hospitals in the Marseille area (Assistance Publique des Hôpitaux de Marseille: Hôpital de la Timone-enfants and Hôpital Nord),
* Suspected neonatal bacterial infection due to the presence of fever (rectal or axillary temperature \> 38°C),
* In whom bacteriological samples have been taken (cerebrospinal fluid, joint fluid, blood cultures, urine),
* Patients affiliated or benefiting from a social security system.

Exclusion Criteria:

* Exclusive formula milk feeding
* Opposition of legal guardians
* No bacteriological sample to prove infant infection
* No confirmation of fever by standardized method
* Opposition to participating in the study
* Neonatal hospitalization \> 48 hours for management of prematurity.
* Severe congenital malformations in the infant.
* Antibiotic treatment for a concomitant bacterial infection in the infant.