cyrilzakka/clinical-trials huggingface dataset:
Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDS

The purpose of this study is to evaluate whether escitalopram is safe, well tolerated, and effective in the treatment of HIV-infected patients with generalized anxiety disorder.

Anxiety disorders are twice as prevalent among HIV-infected patients as they are in the general population. Approximately 25%-40% of HIV-infected patients have anxiety disorders; Generalized Anxiety Disorder, Panic disorder and post-traumatic Stress Disorder being the most frequent. Non-adherence to anti-retroviral medications is commonly seen in patients with HIV with GAD.The role of specific selective serotonin reuptake (SSRIs) in the treatment of HIV-patients with GAD is unclear. Escitalopram has been used in the treatment of GAD in the general population. It has been shown to be safe in HIV-patients with a tolerable side-effect profile. However, whether it can improve GAD in HIV-infected patients has not yet been investigated.

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 65 years,
* DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria for Generalized Anxiety Disorder
* confirmed stable HIV disease and attending a HIV treatment program
* stable dose of highly active anti-retroviral therapy for a minimum of 4 weeks
* ability to give informed consent

Exclusion Criteria:

* bipolar disorders, any psychotic disorder
* current major depression
* substance dependence (except nicotine dependence) in the previous 3 months
* currently suicidal or high suicide risk, serious or unstable medical disorders (e.g. uncontrolled hypertension or diabetes)
* any hospitalization for HIV-related illness in the previous 3 months
* any active CNS (central nervous system) CNS opportunistic infection or CNS malignancies related to HIV
* current active treatment for opportunistic infections related to HIV
* any psychotropic drug treatment in the previous 2 weeks before screening
* history of hypersensitivity to escitalopram and/or citalopram
* admission BDI 23
* seizure disorder, traumatic brain injury
* pregnant, nursing mother or planning to get pregnant.
* Concomitant mediations: At least 2-week washout of antidepressant (4 weeks for fluoxetine) or antipsychotic or anti-anxiety medications.
* In the opinion of the investigator the clinical condition precludes participation in the trial.
ESj- Powder Complete T&A Study

The goal of this study is to gather data on the tolerance and acceptability of a new ONS (ESj-powder complete) in children currently taking ONS.

The goal of this study is to demonstrate the tolerance and acceptability of the test product when consumed by children who are currently prescribed (a similar) ONS. The data generated from this study will be submitted to the ACBS, who will consider it for reimbursement as a Food for Special Medical Purpose (FSMP) in the UK.

Eligibility Criteria:
Inclusion Criteria:

* \>1-18 years of age
* Children currently prescribed and consuming Oral Nutritional Supplements (ONS)
* Willingness to take part in the study, and consent to the study protocol signed by parent/guardian or older child (when appropriate)

Exclusion Criteria:

Participants requiring exclusive enteral tube feeding

* Participants on parenteral nutrition
* Participants with cow's milk or soy allergy or lactose intolerance
* Participants with galactosaemia
* Participants with a chronic renal or liver disease
* Participants who are acutely unwell
Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome

Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) is a common and serious neurological complication associated with the use of CAR-T cells. The mechanisms involved are still poorly understood but studies suggest that inflammation during treatment leads to an increase in the permeability of the barrier between the brain and the blood vessels and the emission of extracellular vesicles (EVs) circulating between the brain and the blood vessels. EVs are biological particles that play an important role in cellular communication and the modulation of several physiological processes. The VESICANS study aims to characterize the EVs released before and during CAR-T cells treatment and upon the occurrence of ICANS, using flow cytometry, electron microscopy, Nanoparticle Tracking Analysis associated with MRI assessment of the barrier between the brain and blood. This study will ultimately contribute to facilitating the prevention and treatment of this toxicity which affects the prognosis of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged over 18,
* Patient for whom CAR-T treatment is indicated,
* Patient affiliated to a social security system
* Patient who give his consent to participate in the study.

Exclusion Criteria:

* Pregnant or breastfeeding woman,
* Patient unable to understand informed consent,
* Patient under legal protection.
RADIOSO MILAN I (RADar Reflector localisatiOn-SCOUT for carcinOma Mammae, the MILAN IEO Experience I)

This is a monocentric prospective observational study for patients with clinical undetectable breast lesions and indications to breast conserving surgery for histological characterization.

The SCOUT® Radar occult breast lesion Localization (SRL) consists of an implantable reflector, a detector handpiece and a console and it uses non-radioactive micro-impulses to guide surgical excision in real time.

The study describes the experience with 300 patients at the European Institute of Oncology.

The primary endpoints of the study are the rates of successful positioning, localization and recovery of the reflector SRL.

It has been estimated that 31,8% of breast cancer patients undergo pre-operational lesion localization. Of them, 19% have been previously administered neoadjuvant chemotherapy (NACT). Based on retrospective data, NACT administration is believed to steadily increase by 1,3%, each year.

The IEO Breast Division Program aims at improving the treatment and planning options available to patients referred for radio guided breast surgery.

At IEO, ROLL remains the standard of care. From its inception 25 year ago to the present day,the investigators have gained significant expertise and now perform more than 1000 procedures per year.

The investigators believe that SRL (SCOUT® Radar occult breast lesion Localization) could be added to the procedure of reference in the following cases, still under investigation, where it seems to present some advantages when compared to ROLL:

1. Long-term positioning of the reflector, as in the case of patients undergoing neoadjuvant treatment
2. Reflector placement in malignant lymphadenopathy prior to neoadjuvant chemotherapy
3. Placement of multiple reflectors, or use of both SRL and ROLL in patients with multifocal or multicentric neoplasia referred for conservative surgery
4. BI-RADS 5 patients suspected for ductal carcinoma in situ (DCIS) and eligible for conservative surgery, could undergo reflector placement after vacuum-assisted breast biopsy (VABB) and also be scheduled for Monday morning surgery
5. Placement of the reflector using MR-compatible introducer needles

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of nonpalpable breast or lymph nodes
* Patients referred to IEO for breast surgery
* Patients between 18 and 90 years old
* Female patients
* Conservative surgery
* Patients willing and able to follow the study procedures and available for follow-up over the entire duration of the study

Exclusion Criteria:

* Patients known or suspected to be allergic to materials similar to those in the SAVI SCOUT components (nickel)
* Any condition that may expose the individual to a higher risk or preclude the study from achieving full compliance or completion.
Influence of Epidural Analgesia on Natural Killer Cell (NK) Activity After Colonic Cancer Surgery

Regional anesthesia may decrease the release of endogenous opioids, increase Natural Killer cell (NK) function and decrease development of metastasis. The recent analysis of the Cancer Registry has noted an improved 5-year survival in patients who received epidural analgesia during surgery for colorectal carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing colonic cancer surgery

Exclusion Criteria:

* Patients with poor physical status Patients needed emergency surgery Coagulopathic disorders with international normalized ratio (INR) level more than 1.4 Thrombocytopenia with platelets count less 100000 per mcl Allergic reaction to local anesthetics in patient history Failure to performing the epidural analgesia from another cause Preoperative immunomodulating treatment Recent history of chemotherapy or radiation therapy
Inflammatory Markers in Exhaled Breath (Condensate) in Childhood Asthma

Background:

Exhaled nitric oxide and inflammatory biomarkers in exhaled breath condensate may be useful to diagnose and monitor childhood asthma. Their ability to indicate an asthma diagnosis, and to assess asthma severity and control, is largely unknown.

Objective:

To study 1) the ability of exhaled nitric oxide and inflammatory markers in exhaled breath condensate (nitrite, nitrate, hydrogen peroxide, 8-isoprostane, interferon-γ, tumor necrosis factor-α, interleukin-2,-4,-5,-10, acidity) to discriminate between childhood asthma and controls. 2) the ability of these biomarkers to indicate asthma severity and control.

Methods:

114 Children were included: 64 asthmatics (10.7±3.0 years, 67.2% atopic) and 50 controls (10.0±0.4 years). Condensate was collected using a glass condenser


Eligibility Criteria:
Inclusion Criteria:

* Asthmatic and control children, aged 5 to 16 years
* Children with doctor-diagnosed asthma, known at the department of Paediatric Pulmonology, University Hospital Maastricht

Exclusion Criteria:

* Presence of a disease that might interfere with the results of this study (e.g. recent upper airway infection, heart disease, anatomic abnormalities of the airways and other chronic inflammatory diseases such as Crohns disease and rheumatoid arthritis)
* Mental retardation
* Inability to perform the EBC procedure properly
* Active smoking
* The use of one of the following medication: Papaverin, Sodium nitroprusside, ACE inhibitors, Oxymetazoline, L-arginine, or NOS inhibitors
Analysis of Effects and Side Effects in Patients Undergoing Radiation Therapy

To collect and analyze effects and side effects in patients undergoing radiotherapy.

This study investigates how analysis of effects and side effects will influence outcome of patients. These retrospectively collected data allow to adapt and improve radiotherapy treatment regimens .

Effects and side effects in patients undergoing radiotherapy will be collected over the next five years (2015-2020). It is planned to include 600 to 650 new patients referred for radiotherapy per calender year. It is estimated that 3000 patients will be included at the end of the study after five years. Patient Information on diseae and treatment will be collected and analyzed. Common statistical algorithms will be performed for outcome analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing radiotherapy at the Kantonsspital Graubuenden

Exclusion Criteria:

* No radiotherapy at Kantonsspital Graubuenden
* Age: \< 20 years, \> 105 years
Frailty Prevalence in Surgical European Patients. European Prospective Cohort Stufy of the Prevalence of Frailty in Surgical Patients.

European prospective one day cohort study. Analysis of the prevalence of frailty and predefined 30-day postoperative complications in adult patients undergoing emergency or elective surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 who will undergo emergency or elective surgery with an intended hospital stay of more than 24 hours and any type of anesthesia.

Exclusion Criteria:

* Outpatient (ie. day case) surgery, obstetric analgesia or anesthesia, organ transplant surgery, cardiac surgery, neurosurgery.
Intraoperative Radiation Therapy for Resectable Pancreatic Cancer

This phase II study is designed to investigate the efficacy of IORT for patients with resectable pancreatic adenocarcinoma. The purpose of the study is to show the local recurrence rate after surgical resection and IORT is superior to that of surgical resection alone from the historical control. A total of 42 patients will be enrolled, and these patients will receive IORT of 10 Gy at 5 millimeter depth of the tumor bed, followed by 6 cycles of adjuvant gemcitabine chemotherapy.

Treatment outcomes of pancreatic cancer are poor even after surgical resection, thus patients may receive adjuvant chemotherapy or chemoradiotherapy. Intraoperative radiotherapy (IORT) with low energy (50 kV) x-ray allows delivery of a high dose radiation to the tumor bed during surgery while effectively sparing adjacent critical organs. Another advantage of IORT is that delivery of IORT does not interfere with the scheduled administration of adjuvant chemotherapy or chemoradiotherapy. Here we investigate the efficacy of IORT for patients with resectable pancreatic adenocarcinoma by comparing the local recurrence rate after surical resection and IORT with that of surgical resection alone from the historical control. A total of 42 patients will be enrolled in this phase II trial, and these patients will receive IORT of 10 Gy at 5 millimeter depth of the tumor bed, followed by 6 cycles of adjuvant gemcitabine chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* 1. Pathologically confirmed pancreatic adenocarcinoma 2. Age ≥20 years 3. Performance status ECOG 0-2 4. Patients must have resectable disease. In order to be resectable the following criteria must be met:
* Absence of distant metastases
* Clear fat planes around the celiac axis, hepatic artery, and superior mesenteric artery
* Absence of direct involvement of inferior vena cava or aorta
* Stage I-III disease per AJCC 7th edition 5. Laboratory data obtained ≤14 days prior to registration on study, with adequate bone marrow and renal function defined as follows:
* Hemoglobin \>10 g/dL, Absolute Neutrophil Count (ANC) \>1,500/mm3, Platelets \>100,000/mm3
* Serum Cr \<1.4 mg/dL, BUN \<20 mg/dL 6. Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* 1. Patients who have received external beam radiotherapy in the abdominal area 2. Defined treatment area which cannot be adequately covered by the radiation field as defined by the radiation oncology treatment team 3. Patients who have received neoadjuvant chemotherapy 4. Stage IV disease 5. Patients with distant metastases 6. Current pregnancy or currently nursing
Effect of Botulinum Toxin Injection Into Upper Esophageal Sphincter in Patients With Medullary Infarction

Dysphagia is an important complication in patients with medullary infarction, the incidence rate is 57%-69%. Compared with other brain infarctions, the medulla oblongata involves multiple swallowing-related nerve nuclei, and the possibility of brain remodeling after injury is small. Dysphagia has become a prominent clinical problem in patients with medullary infarction, which can lead to malnutrition, decrease the quality of life of patients and affect the prognosis of the disease. Solving this clinical problem is particularly important for patients with medullary infarction. The incidence of UES opening disorder in patients with medullary infarction is as high as 80%, and the clinical problem of UES opening disorder is enthusiastically studied at home and abroad. At present, the intervention measures include balloon dilatation, surgical incision and botulinum toxin injection. Balloon dilatation is easy to cause mucosal edema and damage, and cricopharyngeal myotomy often has complications such as local infection, massive hemorrhage and local nerve injury. There is no significant difference between the success rate of UES botulinum toxin injection and surgical incision. Among the above measures, UES botulinum toxin injection has a good clinical application prospect, but the drug dosage and injection method are still not unified in clinic. In particular, how to accurately locate has become a hot topic in current research. On this basis, this study uses ultrasound combined with balloon localization to inject UES botulinum toxin and make clinical observation.

Under the ultrasound combined with balloon fixation, two injection sites were selected from the left upper esophageal sphincter, and 30U was injected respectively, and one injection site was selected from the right side, and 30U was injected. In addition, the patient also received routine swallowing training once a day for 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* MRI examination of the head confirmed the medullary infarction.
* Those who have not significantly improved swallowing function after standardized rehabilitation treatment for more than 2 weeks (FOIS remains unchanged or decreases)
* Video-fluroscopic swallowing study (VFSS) indicated incomplete/non-opening of the cricopharyngeal muscle
* Based on Fiberoptic endoscopic evaluation of swallowing, the hyoid bone moves upward more than half the height of the C3 cone
* Vital signs are stable
* The patient himself or his family voluntarily signed a written informed consent form.

Exclusion Criteria:

* Brain MRI showed that there were lesions in other areas outside the medulla oblongata
* People who have suffered from stroke in the past
* Patients with severe cognitive impairment, mental illness and severe cardiopulmonary disease
* Abnormal throat structure
* Malignant tumor patient
* Patients with other neuromuscular diseases
* Infection or wound at the injection site
* Botulinum toxin allergic person
* Hemorrhagic tendency and coagulation dysfunction
Study Evaluating Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis

B7451013 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* 12 years of age or older with a minimum body weight of 40 kg
* Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (\>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4)
* Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control

Exclusion Criteria:

* Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
* Prior treatment with JAK inhibitors
* Other active nonAD inflammatory skin diseases or conditions affecting skin
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
* Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception
Dermacyd Tina Gel Sweet Flower - Photo Evaluation

The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Tina Gel Sweet Flower.


Eligibility Criteria:
Inclusion Criteria:

* Phototype Skin II and III
* Integral skin test in the region

Exclusion Criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection
* Diseases which can cause immunity decrease, such as HIV, diabetes
* Use of drug photosensitizer
* History of sensitivity or irritation for topic products
* Active cutaneous disease which can change the study results
* History or photodermatosis active
* Family or personal antecedent of cutaneous photoinduced neoplasias
* Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium
* Intense solar exposure in the study area
* Use of new drugs or cosmetics during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Cook Enforcer Post-Market Study

The purpose of this study is to evaluate the performance of the Cook Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter (or Enforcer balloon) in treating narrowed blood vessels compared to treatment with a conventional angioplasty balloon.


Eligibility Criteria:
Inclusion Criteria:

* Clinical or physiological abnormalities which indicate dialysis access dysfunction (e.g., decreased access blood flow, elevated venous pressure, decreased dialysis dose, abnormal physical exam)

Exclusion Criteria:

* Less than 18 years old
* Pregnant, lactating, or planning to become pregnant in the 3 months following enrollment
* Underwent any surgical or interventional procedure of the access circuit less than or equal to 30 days prior to enrollment
* Scheduled for a kidney transplant
* Stent or stent graft in the arteriovenous (AV) dialysis access circuit
Evaluation of an Oral Nutrition Supplement

The objective of this study is to capture gastrointestinal tolerance (GI) information on a nutrient dense oral nutritional supplement (ONS) in healthy elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

Subjects will be eligible for the study if they meet all of the following inclusion criteria:

* Male or female ≥ 60 and ≤ 90 years of age.
* Body Mass Index (BMI) \> 20 but \< 35.

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following criteria:

* History of diabetes
* Antibiotic use within 1 week prior to enrollment
* Undergone major surgery less than 3 months prior to enrollment.
* Current active malignant disease or was treated within the last 6 months for cancer.
* Immunodeficiency disorder.
* Myocardial infarction within the last 3 months.
* Chronic obstructive pulmonary disease (COPD).
* Allergy to any of the ingredients in the study product.
* Obstruction of the gastrointestinal tract or other major gastrointestinal disease.
* Dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder.
* Unintentional weight loss or weight gain ≥ 5% in last 4 weeks.
* Taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect GI motility.