cyrilzakka/clinical-trials huggingface dataset:
Immunity to Yellow Fever in HIV-infected Patients 10 Years After a Primary Anti-yellow Fever Vaccination

ANRS 0146s NovaaTen study aims to determine the vaccine responses in the participants of the ANRS EP46 Novaa trial 10 years after a primary anti-yellow fever vaccination

The vaccine responses will be determined with the measurement of the neutralizing antibody titers using the neutralization tests PRNT and Pseudo type ACN 400 to M120 (ten years) in the participants of the ANRS EP 46 NOVAA trial, VIH+ and controls naïve to previous vaccination ten years after a primary anti-yellow fever vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Subjects included in the ANRS EP 46 NOVAA trial:

  * 40 HIV positive subjects from consultations for infectious diseases and travel medicine centers at Saint-Louis, Cochin-Pasteur and Bichat hospitals (on HAART for at least one year and not modified in the 3 months preceding the pre-inclusion visit, CD4 \> 350/mm3 and a viral load \<50 copies / mL for at least 6 months).
  * 20 HIV negative subjects from the consultation of travelers from Saint-Louis, Bichat and Cochin-Pasteur hospitals.
  * Subjects agreeing to be monitored according to the terms of the protocol.
  * Subjects affiliated to a Social Security scheme or beneficiaries of such a scheme.
  * Signature of informed consent.

Exclusion Criteria:

* Non-volunteers for the 10-year follow-up
* Subject under curatorship, guardianship or safeguard of justice.
Study Comparing Regional Anesthetic Blocks and Periarticular Infiltration for the Management of Post-operative Pain After Direct Anterior Total Hip Arthroplasty

To compare two methods of post-operative pain management in patients undergoing total hip arthroplasty. There is a perception that the periarticular injections may not be as effective in controlling post-operative pain.

Both methods are current standard of care. The investigators want to compare the outcomes of each when patients are randomized to one of the methods compared to the other method of post-operative pain control.


Eligibility Criteria:
Inclusion Criteria:

* Subject scheduled for Direct Anterior unilateral total hip replacement
* Weight ≥ 50 and ≤125 kg
* Intact neurological exam
* Cognitively intact with ability to sign consent

Exclusion Criteria:

* Renal insufficiency with creatinine \> 1.5 mg/dl
* Allergic to any of the following : Ropivacaine, Epinephrine, Ketorolac, Morphine sulfate, NSAIDs, Tylenol, Neurontin, Morphine, Oxycodone or Dilaudid.
* Subject taking regular narcotic medications prior to surgery (20mg/day Morphine equivalents for \>7days)
* Subject with prior open hip surgery who received regional anesthesia or periarticular injection for post op pain management.
* Subject with contraindication for spinal anesthesia
Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin to Treat Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to determine whether Endostar pumping into vein with Gemcitabine-Cisplatin are more effective than Endostar with Gemcitabine-Cisplatin regularly in the treatment of Non-Small Cell Lung Cancer (NSCLC).

Endostar have anti-tumor activity by against vascular endothelial growth factor for initial treatment. This study was designed to evaluate the safety and efficacy of Endostar Continued vein-pumping Combining with Gemcitabine-Cisplatin (GP)chemotherapy in patients with NSCLC,and seeking for more effective injection.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically diagnosed NSCLC;
2. primary treatment,inoperable stage IIIB/IV NSCLC;
3. Age of 18-75years; Gender Not Required;
4. Adequate hematologic, renal, and hepatic function ,Specific index as follows:

   liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function: S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow Hemopoietic Function: WBC≥4.0×10\^9/l, ANC≥2.0×10\^9/l platelet count ≥100×10\^9/l, Hb≥100 g/l;
5. ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy;
6. The patients have explicit lung tumor lesions and the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, MRI);
7. No history of serious drug allergy;
8. Informed consent should be obtained before treatment.

Exclusion Criteria:

1. Symptomatic brain metastases with cognitive disorder,bone metastases with complications;
2. Major organ dysfunction and Serious Heart Disease( congestive heart-failure,incontrollable high-risk arrhythmia,unstable angina, valvular disease, myocardial infarct and Resistant hypertension,);
3. Serious complications and investigator consider it is unsuited enrolling;
4. Pregnant or lactating women;
5. Allergic to research drug;
6. participating in other experimental trials and receive the treatment in four weeks;
7. The position that is for observing curative effect have a radiotherapy.
Impact of Perioperative Intravenous Fluid Utilization on Postoperative Outcomes

Subjects undergoing surgery on the small or large bowel will be randomized to one of 2 groups, a normal fluid amount group and a reduced fluid amount group to evaluate the impact of this change on recovery after surgery.

The purpose of this study is to evaluate the impact of reduction in the amount of perioperative fluids on postoperative morbidity, postoperative recovery and the duration of hospitalization. The study will accrue patients undergoing elective open intestinal resection for benign and malignant conditions of the small and large bowel. Patients, who consent to the study, will be randomized at the time of consent, preoperatively. The primary study endpoint will a composite of mortality and major morbidity within the first 30 postoperative days. Secondary endpoints will be return to bowel function (flatus or bowel movement), postoperative hospital stay including the day of surgery and a composite of minor complications. Approximately 186 patients will participate in the study, 93 in each group. Patients will be randomized into one of two groups: the Restricted Fluid Regimen group and the Normal Fluid Administration Regimen group. A very specific flow chart for each group will be followed to distinguish the group. A research nurse will collect the data needed for the study on a daily basis. The patient will be managed by the primary surgeon and his team and the study group flow chart will be followed. If for medical reasons, the patient's care needs to be varied from the study, this is allowed, and will be documented for the study purposes.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older
* ASA I-III
* Ability to provide informed consent
* Creatinine less than or equal to 1.3 mg/mL)

Exclusion Criteria:

Patients younger than 18 years old

* ASA IV or higher
* Urgent or emergent surgery
* Mental disease or addictive disorders impairing ability to provide informed consent
* Renal insufficiency (Cr greater than 1.3 mg/mL)
* Significant language barriers
* Cirrhosis causing ascites
* NYHA III or IV, EF less than 25%
* Use of intraoperative epidural anesthesia
* Uncontrolled diabetes
* Uncontrolled hypertension in the opinion of the enrolling surgeon
* ETOH consumption greater than 35 drinks weekly
* Cachexia or absolute neutrophil count of less than 1,200/mm3
* Existing uncontrolled coagulopathy or platelet count of less than 100,000/mm3
Risk of Asthma in Infants With Atopic Dermatitis

Infants will be enrolled in this study if they have never been diagnosed with asthma or wheezing and have been diagnosed with atopic dermatitis or eczema. Infants with some types of skin rashes are at high risk for developing asthma by 6 years of age. The purpose of this study is to determine whether we can identify infants who will develop asthma.

Asthma is a disease characterized by recurrent episodes of wheezing, inflammation of the airways, and airways that are very sensitive to stimulation (hyper-responsiveness). Symptoms of asthma frequently begin in early childhood; however, it has been difficult to identify pre-symptomatic, at-risk infants and toddlers. Family history of asthma and allergy is strongly associated with the early onset and persistence of asthma symptoms, and children with early onset persistent asthma are more likely to demonstrate allergies. The development of allergic disease results from complex interactions between genetic susceptibility and environmental factors; however, infants with atopic dermatitis have a 50% chance of developing asthma by 6 years of age. Airway inflammation and airway hyper-responsiveness are characteristics of asthmatic children. We plan to evaluate whether infants with allergic dermatitis have evidence of airway inflammation and hyper-responsiveness, and whether cells from the blood and the nose are also hyper-responsive to stimulation prior to the onset of clinical symptoms of asthma. In addition we will evaluate whether certain genetic profiles are associated with allergic disease in infants.

Eligibility Criteria:
Inclusion criteria-

1. Full term infants born greater than 37 weeks
2. History of atopic dermatitis or eczema

Exclusion criteria

1. Heart disease
2. asthma
3. Respiratory illness such as RSV, bronchiolitis or croup
4. Hospitalization for respiratory illness
5. History of wheezing
New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) in Patients With Asthma

The purpose of this study is to evaluate the long-term safety of the fixed combination asthma drug FlutiForm HFA MDI (containing fluticasone propionate and formoterol fumarate) in adult and adolescent patients with mild to moderate-severe asthma.


Eligibility Criteria:
Ages eligible for study: 12 years and above; genders eligible for study: both; prior steroid use: steroid-requiring.

Inclusion Criteria:

* History of asthma for at least 12 months.
* Documented use of inhaled corticosteriod for at least 4 weeks prior to Screening Visit Demonstrate FEV-1 of 40-80% of predicted normal values at Screening and Baseline Visit.
* Documented reversibility of 15% within 6 months of Screening Visit or at Screening Visit (15% increase from pre-FEV-1 levels following albuterol inhalation).
* Symptoms of Asthma during Run-in.
* Females of childbearing potential must have a negative urine pregnancy test at Screening and Baseline Visits. Females are eligible only if they are not pregnant or lactating and are either sterile or using acceptable methods of contraception.
* Must otherwise be healthy.
* Provide written informed consent. Wishes of minors must be respected.

Exclusion Criteria:

* Life-threatening asthma within past year or during Run-in Period.
* History of systemic corticosteroid medication within 3 months before Screening Visit.
* History of omalizumab use within the past 6 months.
* History of leukotriene receptor antagonist use, e.g., montelukast, within the past week.
* Current evidence of history of any clinically significant disease or abnormality including uncontrolled hypertension, uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia.
* Upper or lower respiratory infection within 4 weeks prior to Screening Visit or during Run-in Period.
* Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease \[COPD\], cystic fibrosis, bronchiectasis).
* Known Human Immunodeficiency Virus (HIV)-positive status.
* Smoking history equivalent to "10 pack years".
* Current smoking history within 12 months prior to Screening Visit.
Gynecological Symptoms and Health-related Quality of Life in Egyptian Women With SLE

The purpose of our study was to Recognize gynecological symptoms and health-related quality of life in Egyptian women with systemic lupus erythematosus and evaluate the impact of duration of remission on QOL in SLE patients.

Despite significant advances in recent decades, systemic lupus erythematosus (SLE) is still burdened by irreversible organ damage and a notable impact on health-related quality of life (HRQoL). Improving the quality of life is a pivotal goal in the management of SLE. According to the Treat to Target (T2T) recommendations for SLE management, particular attention needs to be paid to the factors that negatively influence HRQoL such as fatigue, pain and depression.

Recent epidemiological studies demonstrate that prolonged remission is an achievable target in SLE patients and is clearly associated with better outcomes in terms of damage accrual. Such findings also raise questions about the possible impact of remission on HRQoL. In a retrospective study, Patients in prolonged remission reported significantly better HRQoL as assessed by the 36-Item Short-Form Health Survey (SF36) and Lupus PRO questionnaire.

Methodology in details L:

70 women with SLE will be included in this study from the outpatient clinic. in Fayoum University hospital It will be conducted in the Department of Obstetrics and Gynecology, Fayoum University Maternity Hospital, Egypt.

Full history taking (Age, Duration of marriage, Parity, Occupation, Mode of delivery, History of abortion, Medical and Surgical history).

Menstrual histories obtained from participants included: age at menarche, duration of heavy bleeding, duration of menses and menstrual cycle, and other gynecological symptoms as Questionnaire form.

Patients' blood pressure, height, weight, body mass index (BMI), and other clinical parameters were reviewed by the attending doctors.

The patient's medications, which included immunosuppressive therapy such as steroids, cyclophosphamide, azathioprine, and cyclosporine A, where noted, and the use of other adjunctive medications were also recorded.

Definition of remission Definition of remission was in line with European Consensus Criteria . Clinical remission (CLR) was present when clinical SLEDAI score=0 and physician global score less than 0.5

Eligibility Criteria:
Inclusion Criteria:

1. Patients fulfilling the American College of Rheumatology (ACR) 1982 revised criteria for SLE,
2. age between 15 and 55 years
3. and consented to the interview.

Exclusion Criteria:

1. Patients with active malignancy
2. and end-stage lupus nephritis
3. Patients who had been treated with Belimumab in the last 7 years, due to the reported effects of Belimumab on HRQoL.
Acute Pancreatitis and Thrombosis (PATHRO)

Severe acute pancreatitis (AP) is a pathology with high morbidity and mortality. Portosplenomesenteric vein thrombosis is a well-known local complication of AP with a variable incidence, which can reach up to 50% in case of severe AP. However, there is no specific recommendation regarding the management of Portosplenomesenteric vein thrombosis. By analogy to all venous thrombosis, the European Society of Gastroenterology recommends curative anticoagulation. However, the efficacy of curative anticoagulation has never been evaluated by prospective studies. In addition, bleeding complications during AP occur in approximately 10% of patients and are associated with a poor prognosis.

The investigators wish to conduct an observational multi-center study with epidemiologic aims, including all patients admitted for AP and with a diagnosis of portosplenomesenteric vein thrombosis. The aim of this study is to evaluate the therapeutic management of these patients, the efficacy and safety of anticoagulant treatment for the treatment of Portosplenomesenteric vein thrombosis, and their outcomes.

The investigators will include prospectively all patients admitted for AP with a computed tomography diagnosis of portosplenomesenteric vein thrombosis.

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients (age \> 18 years) with acute pancreatitis
* AND a diagnosis on CT injected with portal time of portosplenomesenteric vein thrombosis or laminated veins (without passage of blood flow through the vessel but without visible intraluminal thrombus) will be included.

Exclusion Criteria:

* Patient under guardianship
* Refusal to participate in research
* Pregnancy
A Confirmatory Study for Evaluation of the Treatment by the Celluma3 of Periorbital Wrinkles

The primary objective of this study is to confirm the safe and effective use of the Celluma3 for the reduction in the appearance of periorbital wrinkles.

This clinical study is an open label investigation into the use of the Celluma3 for the effective treatment of periorbital wrinkles.

Test subjects will visit a study center for thirty minute treatments, three times per week, for a period of four weeks, and a twelve week post-treatment follow up after the final treatment. Test subjects will have photos taken at the start, at the end of the four week treatment, and at the final twelve week post-treatment follow up visit.

One of the three Clinical Investigators, will act as the Principal Investigator and all three Clinical Investigators will evaluate the test subjects for inclusion and final results. The Clinical Research Associate (CRA) will monitor the study for conformance to the test protocol.

There will be seven estheticians participating in the study and there will be fifty test subjects recruited.

Eligibility Criteria:
Inclusion Criteria:

1. 30-75 years of age
2. Fitzpatrick Skin Color Type I-IV
3. Clinical evidence of mild to moderate facial wrinkles as specified by the Fitzpatrick Classification of Facial Wrinkling (Perioral and Periorbital) for the degree of wrinkling and elastosis.
4. Willingness and ability to comply with the protocol requirements, including returning for follow up visits and abstaining from excluded behaviors for the duration of the study.
5. Willingness and ability to provide written consent for use of photographic record and adherence to photographic procedures (i.e., removal of makeup and jewelry).
6. Willingness and ability to provide written informed consent prior to any study-related procedure.
7. Absence of any of the exclusionary criteria

Exclusion Criteria:

1. Subject who is pregnant, nursing, or planning to become pregnant during the course of the study.
2. Subjects who have any history of diabetes.
3. Subjects who, in the preceding 12 months prior to the study start, have:

   1. Been exposed to hyaluronic acid, or
   2. any other filler, or
   3. injection for cosmetic purposes related to the face, or
   4. undergone any cosmetic procedure for the face, or
   5. had an active cut, wound or infection of the face, or
   6. had oral isotretinon.
4. Subjects who, in the preceding six months prior to the study start, have:

   1. Had any botulinum toxin ("Botox"), or
   2. had ablative skin resurfacing on the glabellar area.
5. Subjects who, in the preceding three months prior to the study start, have:

   1. Had retinoid, microdermabrasion or prescription level glycolic acid treatments, or
   2. had any compromising procedure in the opinion of any clinical evaluator.
6. Any other diagnosis of any contraindication in the current User Manual.
The Study on Effects of Acute Exposure to High Altitude Hypoxia on Cognitive Function in Lowlanders

The purpose of this study is to investigate the impact of rapid elevation to 3,800 meters on the cognitive function of low-altitude residents through a plateau field and plain control study, and explore the objective indicators related to the impaired cognitive function.

This study intends to recruit 60 healthy young people residing in plain area to 3000 m. Participants were divided into two groups: the plateau group (N=30) and the plain group (N=30).

Firstly, we collected baseline data one week before the plateau group rushed to the plateau, and then repeated the above data collection at the same time on day 1 (3-5 hours after arrival), day 2, day 3, day 5, and day 7 after entering the plateau. The plain group was studied in the plain according to the same test plan.

Finally, analyze and find out the main types of cognitive impairment, and explore the physiological prediction index, including exploring the characteristics of EEG changes before and after entering the plateau.

Eligibility Criteria:
Inclusion Criteria:

* Lived in plain, never entered the plateau

Exclusion Criteria:

* patients with epilepsy, migraine, brain injury, stroke and other neuropsychiatric diseases;
* central nervous system drugs;
* history of heart or head surgery;
* MMSE score \< 25;
* patients suffering from pulmonary heart disease, chronic obstructive pulmonary disease, emphysema, pulmonary embolism and other serious respiratory diseases;
* patients with negative resistance to the study and poor compliance.
Remote Assessment of Physical Function

The primary objective is to evaluate the validity and reliability of using videoconferencing to assess physical performance tests self-administered by older cancer survivors in their own homes. This remote assessment will be compared to the traditional face-to-face (i.e., in-person) assessment and to accelerometer data.

The ultimate goal of this research study is to develop a test protocol to allow older cancer survivors to self-administer physical performance tests in the survivor's own home, while an investigator remotely assesses the tests via videoconferencing. The test protocol includes written and video instructions and the test kit. To achieve this objective, the study will proceed with a series of phases. A similar concept of "saturation" will be applied, as is done in qualitative studies. In qualitative studies, the number of focus groups or interviews is based on the saturation point, i.e., the point at which no new information is learned. For the current study, each study phase will include a range in the number of participants enrolled. At the point at which no new information is being learned, i.e., no further adjustments are needed to the test protocol, the study will proceed to the next phase.

Eligibility Criteria:
Inclusion Criteria:

* Residence in New Mexico
* Previous diagnosis of cancer, completed primary treatment (surgery, radiation, chemotherapy), and not currently being treated for a recurrence.
* Mild-to-moderate physical functional impairment (≥2 functions limited a lot or limited a little on the Short Form 36-item Physical Function Subscale)
* Able to speak, read, \& understand English
* Participating in less than 120 minutes per week of moderate-to-vigorous intensity physical activity
* Living independently and capable of walking 3 blocks without stopping to rest.
* Availability of a family member or friend to be present (for safety) during remote assessment of performance tests (Phases III and IV only)
* No severe impairments or pre-existing medical limitations for engaging in daily light-intensity physical activity (e.g., severe orthopedic conditions, pending hip/knee replacement, chronic vertigo, dementia)
* No severe hearing or vision deficits that would inhibit communication with the research team via videoconferencing and tablet use.
* Willing to use a tablet computer and videoconferencing software to communicate with a study team member during the assessment.
* Enough space (14 feet by 3 feet) to safely conduct the physical function tests.
* Not at high risk for falls
Clinical Outcomes of Cyclosporine Eye Drops in Management of Herpetic Keratitis

Objective: To compare the additive effect of topical cyclosporine A 0.05% eye drops to prednisolone eye drops, with topical prednisolone acetate 1% eye drops alone in treatment of herpetic stromal keratitis.

Methods: Patients diagnosed with herpetic stromal keratitis are randomly divided into 2 groups; Group A: receive cyclosporine eye drops together with prednisolone eye drops.

Group B: receive topical prednisolone with placebo eye drops (tear replacement).

The 2 groups receive systemic acyclovir therapeutic dose 400 mg five times daily, which then tapered to twice daily prophylactic dose after one month of treatment. Follow up for patients is scheduled as a weekly visit for a duration of 2 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with herpetic stromal keratitis

Exclusion Criteria:

* associated ocular diseases, DM, renal disease, pregnancy, breast feeding.