cyrilzakka/clinical-trials huggingface dataset:
The Effects of a Zeaxanthin Intervention on Visuomotor Function

This study was designed to test whether two zeaxanthin formulations (supplements containing different nutritional compounds with zeaxanthin and omega fatty acids being the primary ingredients of interest) influenced visual motor function. Visual motor function refers to the processing speed of the visual system and how individuals respond behavioral to visual stimuli (e.g., reaction time).

This study was designed to test whether two zeaxanthin formulations (supplements containing different nutritional compounds with zeaxanthin and omega fatty acids being the primary ingredients of interest) influenced visual motor function. Visual motor function refers to the processing speed of the visual system and how individuals respond behavioral to visual stimuli (e.g., reaction time).

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥18 and ≤ 40 years
* BMI: ≥ 20 and ≤ 30 kg/m2
* No anticipated changes in dieting habits (as relevant to the intake of xanthophylls and fats/oils).
* No anticipated surgical procedures.
* Willingness and ability to give written informed consent and willingness and ability to comply with the study requirements.
* Corrected visual acuity (ETDRS): better than 20/60 in the eye selected for the study

Exclusion Criteria:

* Smokers
* Current or history of relevant ocular diseases (such as AMD) or other conditions e.g., lipid disorders.
* Inability to reliably perform macular pigment optical density measurements by "Heterochromatic Flicker Photometry" or any of the other ophthalmic tests of the study.
* Any condition likely to interfere with normal gastro-intestinal absorption of xanthophylls (e.g., digestive disorders: inflammatory bowel disease, ulcerative colitis, Crohn's, irritable bowel, etc. or lipid disorders including conditions such as hypercholesterolemia)
* Current use of xanthophyll containing supplements or use of xanthophyll containing supplements in the past 6 months (but excluding multivitamins containing lutein or zeaxanthin at low potency).
* Participation in any other study during last 1 month before study initiation.
* Known hypersensitivity or allergy to xanthophylls.
* Regular intake of medications or supplements, which the principal investigator deems likely to confound the study outcomes. These include diabetes medication and statins or any other drug/supplement to modulate cholesterol or fat digestion/absorption.
Paclitaxel in Treating Patients With Locally Advanced or Metastatic Soft Tissue Angiosarcoma or Lymphangiosarcoma That Cannot Be Removed By Surgery

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with locally advanced or metastatic soft tissue angiosarcoma or lymphangiosarcoma that cannot be removed by surgery.

OBJECTIVES:

Primary

* Determine the 2-month objective response rate in patients with locally advanced or metastatic, unresectable soft tissue angiosarcoma or lymphangiosarcoma treated with paclitaxel.

Secondary

* Determine the 4- and 6-month response rate in patients treated with this drug.
* Determine tolerability of this drug in these patients.
* Determine the time to disease progression and overall survival of patients treated with this drug.
* Determine the clinical criteria predicting response in patients treated with this drug.
* Correlate the efficacy of this drug with the expression of genes involved in angiogenesis regulation in these patients.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed soft tissue angiosarcoma or lymphangiosarcoma

  * Locally advanced or metastatic disease
  * Unresectable disease
* Angiosarcomas in previously irradiated areas allowed provided disease is clearly progressive
* Measurable disease
* No Kaposi's sarcoma

PATIENT CHARACTERISTICS:

Age

* 18 to 70

Performance status

* WHO 0-2

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3

Hepatic

* Bilirubin \< 3 times upper limit of normal (ULN)
* SGOT and SGPT \< 2.5 times ULN
* No severe liver failure

Renal

* Creatinine clearance \> 60 mL/min
* No severe kidney failure

Cardiovascular

* LVEF ≥ 50%

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No weight loss ≥ 20% of body weight prior to illness
* Patient must be amenable to receiving care during the day
* No HIV positivity
* No clinical neuropathy
* No known allergy to study drug or to any of its components (e.g., Cremophor EL)
* No other progressive malignant tumor
* No chronic illness (somatic or psychiatric) that would preclude study compliance and follow-up
* No psychological, geographical, or social reason that would preclude study follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No more than 2 prior courses of chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics

Surgery

* Not specified

Other

* No other concurrent anticancer therapy
* No concurrent participation in another therapeutic investigational study
Congenital Hypothyroidism in Children With Eutopic Gland or Thyroid Hemiagenesis: Predictive Factors for Transient vs Permanent Hypothyroidism.

In France, the incidence of congenital hypothyroidism has increased significantly since the newborn screening program was introduced in 1978. The largest increase is seen in children with eutopic thyroid gland. More than one-third of children with eutopic gland have transient hypothyroidism. Clinical practice guidelines recommend to re-evaluate thyroid function in children with eutopic gland around the age of 3 years to determine whether hypothyroidism is transient or permanent. Up until today it is still difficult to determine early on whether hypothyroidism is transient or permanent in children with eutopic gland. Our aim is to identify one or more predictive factors for transient congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis.


Eligibility Criteria:
Inclusion Criteria:

* Children with congenital hypothyroidism
* Eutopic thyroid gland or thyroid hemiagenesis
* Born between 1996 and 2017
* Treated at the Nancy Regional and University Hospital
* Follow-up of at least 3,5 years.

Exclusion Criteria:

* Polymalformative syndrome
* Thyroid dysgenesis except for thyroid hemiagenesis
Factors Associated With Mortality, Morbidity and Prognosis in Dementia Patients

Dementia; It is a chronic syndrome characterized by a general and progressive deterioration in cognition, including memory, orientation, language, and comprehension. The prognosis of this progressive and neurodegenerative disease after diagnosis may differ between individuals. In its broadest sense, the prognosis after a diagnosis of dementia; can be defined by shortening of life span, high level of cognitive and functional loss, decrease in quality of life and increased need for care. However, the prognosis of different types of dementia is highly variable. Because it is the most common type of dementia, studies are usually on Alzheimer's disease. It constitutes 50-75% of total dementia cases. Vascular dementia is the second most common cause of dementia and accounts for approximately 15% of dementia cases. Dementia with Lewy bodies constitutes 10-20% of the total dementia patients and ranks second among degenerative dementia types. Frontotemporal dementia, which mimics psychiatric disorders and has prominent behavioural problems, and Parkinson's disease-associated dementia, which is characterized by cognitive impairment that can be added to the existing picture in Parkinson's patients, are also counted among other types of dementia. Prognosis-related data on dementia types other than Alzheimer's disease are limited in the literature. Determining the prognosis is important to support patients, anticipate long-term health problems, plan physician and healthcare provision, and support patients with dementia.In view of the lack of sufficient data on dementia types other than Alzheimer's disease, it is aimed to contribute to the literature on this subject and to determine the factors that may affect prognosis, morbidity and mortality in patients belonging to all dementia types.


Eligibility Criteria:
Inclusion Criteria:

Having applied to the Gulhane Training and Research Hospital Geriatrics Polyclinic Being diagnosed with Alzheimer or Lewy Body Dementia or Vascular Dementia or Fronto-Temporal Dementia or Parkinson Disease Dementia Being at the age of 60 years or older

Exclusion Criteria:

Being under the age of 60 Patients with insufficient recorded data and follow-up for the study Patients who either have diagnosis or follow-up in another center. Patients who have severe dementia that prevents applying for outpatient clinic
Double-dose Rabeprazole Accelerates and Sustains the Control of Symptoms in Patients With NERD

To the best of our knowledge, there has been no randomized controlled trial to compare double dose PPI therapy with standard one dose PPI therapy for NERD patients. Thus, we hypothesize that a double dose PPI would accelerate and sustain the control of symptom in NERD patients.

In Asian, the majority of GERD cases are cases of nonerosive reflux esophagitis(NERD). NERD is a difficult -to-treat acid reflux condition even with PPI compared to reflux esophagitis(RE). In addition, the quality of life of NERD patients is quite low, NERD patients need quicker and more effective treatment options. At present, PPI-based step-down treatment is recommended for GERD patients. Doubling th PPI dose has become a commonly practiced therapeutic strategy in patients with GERD who failed PPI once daily. In patients with symptomatic GERD who failed the one dose PPI can increase the rate of overall symptom improvement by 22-26%. There are various mechanisms for standard dose PPI failure in GERD patients. Esophageal hypersensitivity is likely the underlying mechanism in a significant number of patients. Patients with the sensitive esophagus (normal endoscopy and pH test but positive symptom index) were more likely to respond to PPI twice a day. It is thus of clinical interest to determine whether an increased dosage of PPI can achieve rapidly the control of symptoms for patient with NERD patients.

Eligibility Criteria:
Inclusion Criteria:

* heartburn and/or reflux at least twice weekly in the absence of visible esophageal mucosal breaks at endoscopy

Exclusion Criteria:

* pregnancy
* lactation
* Hx of gastric surgery
* Hx of gastric cancer or peptic ulcer
* major medical problems (including CHF, renal failure, COPD, asthma, liver cirrhosis)
* severe systemic illness
* Hx of malignancy, allergy Hx to rabeprazole
* patients who had taken antibiotics
* antisecretory agents including H2-blocker
* PPI within 4 weeks before endoscopy
* current usage of steroids, NSAIDs, aspirin, anticoagulant medication
A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than \[\>\] 1 millimeter \[mm\] in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed melanoma of cutaneous origin
* Participants with BRAFV600 mutation-positive, cutaneous melanoma (either pathologic Stage IIC or Stage III according to AJCC Staging Criteria version 7 that has been completely resected
* BRAF V600 mutation status of the current primary tumor or involved lymph node determined to be positive using the cobas BRAF V600 mutation test
* Surgically rendered free of disease within 90 days of randomization
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy of at least 5 years
* Fully recovered from the effects of any major surgery or significant traumatic injury prior to the first dose of study treatment
* Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

* History of any systemic or local therapy (e.g., chemotherapy, biologic or targeted therapy, hormonal therapy, or photodynamic therapy) for the treatment or prevention of melanoma, including interferon alpha-2b and pegylated interferon alpha-2b
* History of limb perfusion therapy
* History of radiotherapy for the treatment of melanoma
* Invasive malignancy other than melanoma at the time of enrollment or within 5 years prior to first dose of study treatment
* Family history of inherited colon cancer syndromes
* Known personal history of \>3 adenomatous colorectal polyps or a personal history of adenomatous colorectal polyp(s) \>2 centimeters (cm) in size
* History of or current clinical, radiographic, or pathologic evidence of in-transit metastases, satellite, or microsatellite lesions
* History of or current clinical, radiographic, or pathologic evidence of recurrent lymph node involvement after resection of a primary melanoma with lymph node involvement at any time in the past
* History of local and/or regional and/or distant melanoma recurrence
* History or current radiographic or pathologic evidence of distant metastases
* History of clinically significant cardiac or pulmonary dysfunction
* Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study treatment
* Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus
Lavage and Suction of the Right Upper Quadrant to Reduce Post Laparoscopic Shoulder Pain

The use of laparoscopy in gynecologic surgery has been well established to decrease morbidity, blood loss, hospital stay, and post-operative pain when compared to traditional open abdominal surgery. However, the laparoscopic technique is associated with post-operative shoulder pain.

We hypothesize that a combination of intraperitoneal saline lavage and active suction removal of carbon dioxide gas from the right upper quadrant of the abdomen will decrease incidence of post-laparoscopic shoulder pain when compared to passive exsufflation of carbon dioxide gas.


Eligibility Criteria:
Inclusion Criteria:

* English speaking patient
* Female
* Age 18-75
* must undergo laparoscopic surgery
* willing to participate in the study

Exclusion Criteria:

* Male patients
* Under 18 or older than 75
* Laparoscopic procedures that get converted to laparotomy
* Intraoperative hemorrhage more than 500 cc
* Patients with active joint disease
* History of shoulder surgery
* Intraoperative laceration to the liver
* Malignancy
* Long term daily narcotic use
* Chronic right upper quadrant/ shoulder pain
* Pregnancy
* History of dementia, Alzheimers, stroke or other condition causing altered mental status
Validation of a Questionnaire Assessing Quality of Life in Children With Amblyopia and Strabismus

The validation of a French questionnaire is very important to assess rigorously and objectively the impact of the treatments of strabismus and amblyopia on children quality of life.


Eligibility Criteria:
Inclusion Criteria:

* children with a status of strabismus or not strabismus made by a specialized ophthalmologist
* children with a status of amblyopia or not amblyopia made by a specialized ophthalmologist
* signed consent of parents

Exclusion Criteria:

* ocular pathology (except for isolated ametropia)
* evolutive paralytic strabismus
* antecedent of surgery for strabismus
* strabismus surgery in the past 6 months
* disease with possible impact on the child's answers, such as severe neurologic troubles)
* poor knowledge of French language
Part II: Granulocyte-Colony Stimulating Factor Adjunct Therapy for Biliary Atresia

The Investigators propose to test the hypothesis that GCSF enhances the clinical outcome of biliary atresia in a multi-institutional Phase 2 trial to prospectively evaluate the safety and efficacy of GCSF in each of the 2 groups of newly diagnosed BA patients: KBA (i.e., Kasai-operated) or NoK (i.e., patients who did not undergo Kasai surgery). Subjects who participate in the trial will be followed for 2 years.

This is a prospective, randomized, multi-institutional trial in KBA and NoK subjects to be conducted under a Food and Drug Administration approved Investigational New Drug application.

The KBA group is composed of just operated Kasai patients with intraoperative liver biopsy-confirmed BA. Their clinical characteristics have been described in the previously completed Phase 1 study under CR00005169 (ie. inclusion and exclusion criteria as described below)

The NoK group will be composed of newly diagnosed BA patients, including the following:

* surgical patients in whom the Kasai was not performed for intraoperative technical reasons or due to advanced liver disease, who also have no option for rescue liver transplantation.
* Unoperated patients whose family refuses surgery or who are not operative candidates

Having met the same inclusion and exclusion criteria as the Kasai KBS group,

* eligible KBA subjects will be randomized to GCSF vs. no-GCSF at the 10 ug/kg/d dose to be given subcutaneously for 3 consecutive daily doses on the third day following the Kasai procedure.
* eligible NoK subjects will be randomized to GCSF vs. no-GCSF at the 10 ug/kg/d dose to be given subcutaneously for 3 consecutive daily doses on the third day following diagnostic liver biopsy.

Eligibility Criteria:
Inclusion criteria

1. preliminary work up for cholestasis suspected or inconclusive diagnosis of BA.
2. Serum Direct bilirubin \> 2 mg/dl,GGT\> 100 U/L
3. Male or female infants with a gestational age\> 36 weeks
4. Admission weight \> 2 kg
5. Age \> 14 days - 180 days at diagnosis
6. For Kasai operated subjects, Type 3 or 4 anatomy of BA
7. For Kasai operated subjects, cholangiogram (if performed) diagnostic of BA
8. Liver biopsy supporting BA diagnosis

Exclusion criteria

1. Patients having access to liver transplantation for immediate liver failure
2. Prior Kasai patients
3. Major cardiac, renal, central nervous system (CNS) malformations
4. Intracranial hemorrhage
5. History of recent total parenteral nutrition (TPN) use within the last 2 weeks
6. Gl tract obstruction

   For Kasai-operated subjects: Type 1 or 2 biliary atresia anatomy
7. Current systemic infection
8. WBC \> 20,000 cells/uL
9. Platelet count \< 20,000 cells/uL or \>1 million cells/uL
10. Concurrent respiratory, metabolic, neurological, cardiovascular, metabolic, and renal illness
11. Elevated serum creatinine \> 1 mg/dL
12. Purpura fulminans or unexplained vascular thrombosis
Screening for Heart Failure in General Medicine Consultations

Heart failure poses a significant public health challenge due to its high prevalence and the substantial human and financial costs it generates. Furthermore, the lack of clear screening guidelines and challenges in accessing care and multi-professional coordination, contribute to diagnostic delays, leading more patients to seek care in more severe clinical states and requiring direct admission to emergency departments. There is therefore also a major organizational challenge in better managing the entry of patients into the healthcare system. This necessitates the development of structured heart failure screening strategies.

The 2021 European Society of Cardiology (ESC 2021) guidelines on heart failure screening prioritize the identification of at-risk individuals and the early detection of disease manifestations. They suggest that, in high-risk groups, tests such as echocardiography and biomarker measurement (NT-proBNP) should be used to detect heart failure at an early stage, even in the absence of symptoms. The guidelines also delineate specific biomarker thresholds and propose organizational frameworks with defined timelines to facilitate systematic screening.

The implementation of a heart failure screening pathway within primary care involving multi-professional cooperation is therefore warranted.

Stratifying screening based on risk factors and symptomatology is expected to enhance the positive predictive value of the screening process. Furthermore, evaluating the efficacy of this pathway is crucial for establishing a standardized, reproducible clinical protocol suitable for routine primary care practice.

This study is a prospective, multicenter, observational study conducted within the context of routine clinical care.


Eligibility Criteria:
Inclusion Criteria:

1. Patient consulting in general practice.
2. Aged 65 years or older

Exclusion Criteria:

1. Known heart failure.
2. Patient who has already consulted a cardiologist within the last 12 months.
3. Patient opposition to participate in the study
Efficacy/Safety Study to Explore a New Revised Topical Formulation in Atopic Dermatitis

The study shall explore whether treatment of atopic dermatitis is equally effective with respect to a marketed medical device and a new medical device.


Eligibility Criteria:
Inclusion Criteria:

* Male or female Caucasians aged between 18 and 60 years
* Patients with mild to moderate AD (Atopic Dermatitis) presenting a scoring AD (SCORAD) rating below 50
* Skin type I - IV according to Fitzpatrick
* Acute AD symptoms on each assessment areas (local SCORAD ≥ 3 and \</= 12) at Baseline
* Acute symptom of pruritus at Baseline

Exclusion Criteria:

* Any other skin disease at the test area that would interfere the clinical assessment in the opinion of the investigator
* Moles, tattoos, strong pigmentation, or scars at the test area that would interfere the clinical assessment
* Regular intake of antiphlogistic drugs (for example, nonsteroidal anti-inflammatory drug \[NSAIDs\])
* Any condition or treatment which might influence the trial (e.g. any treatment with topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as well as during the trial (exception: topical treatment of AD lesions other than the test areas (for example, face) with low potency steroids restricted to small areas)
* UV-therapy or the use of solarium within 30 days before screening as well as during the trial
* Any alternative treatment of AD (e.g. acupuncture, kinesiology, and homoeopathy) within 30 days before screening as well as during the trial
Management of Ventilation Acquired Pneumonia Caused by Pseudomonas and Acinetobacter Organisms in a Pediatric Center

The goal of this clinical trial is to determine the most effective empirical therapy of antibiotics for better ventilator-associated pneumonia control. The main question it aims to answer is:

• Which is better for clinical response single or combination empiric antibiotic therapies ?


Eligibility Criteria:
Inclusion criteria:

-Patients ranging from one month to twelve years old, who had been undergoing mechanical ventilation for over 48 hours and were diagnosed with Ventillator Associated Pneumonia.

2.1.3. Exclusion criteria:

* Patients with pneumonia prior to mechanical ventilation initiation.
* Patients who had been intubated for more than 24 hours before admission to the PICU, or those transferred from other PICUs and were already receiving antibiotic therapy.