cyrilzakka/clinical-trials huggingface dataset:
Long-term Extension Study of Ligelizumab in Food Allergy

This is an extension study to evaluate the long-term safety and efficacy of ligelizumab in participants who have completed a ligelizumab Phase III study in food allergy.

Participants will receive up to 3 years treatment with ligelizumab after which they will enter a follow-up period for 16 weeks. During the study, participants will undergo allergy testing by a Skin Prick Test and Oral Food challenge to test if the treatment is working or not. Accordingly, this study will generate data that should provide guidance relative to the long-term (chronic) use of ligelizumab in food allergic patients in terms of safety, efficacy, pharmaco-dynamics, biomarkers and Qualify of Life, and potential discontinuation from treatment.

During the study, treatment will be administered every 4 weeks and while this can take place in the hospital clinic, some participants will be trained to administer study treatment at home by either the participant or parent/caregiver. Participants at home will record administration of the study treatment on a dosing log and return this to the clinic for review.

Eligibility Criteria:
Key Inclusion Criteria:

* Signed informed consent form (ICF) and assent form (where applicable) obtained from the participant/legal representative before study participation. If a minor participant reaches the age of legal majority (as defined by local law), they must be re-consented at the next study visit
* Participants have completed the treatment period in any ligelizumab Phase III studies in food allergy
* Participants who are willing to adhere to the study visits and procedures, including receiving injections (study treatment) and participating in the OL-OFC (open label oral food challenge)
* Participants who agree to continue avoiding exposure to allergens (per core study) and any other foods they are allergic to throughout this study
* Participants who are able to safely continue into the study as judged by the investigator

Key Exclusion Criteria:

* Development of a severe or life-threatening episode of an allergic reaction that required intubation and/or ICU admission during the core studies
* Development of a serious adverse event which is suspected to be related to the study treatment judged by the investigator during the core study
* Development of uncontrolled asthma during the core study that could compromise the safety of the participants judged by the investigator
* Development of clinically significant cardiovascular, neurological, and or psychiatric conditions during the core study that could interfere with or compromise the safety of the participants, interfere with evaluation or interpretation of the study results or preclude completion of the study judged by the investigator
* Participants who failed to comply with the protocol requirements and procedures during the core study, and in the Investigator's opinion they should not participate in this extension study
* Platelets \<75,000/ul at end of treatment of the core study

Other protocol defined inclusion/exclusion criteria may apply
Incorporating Avocados in Meals

The purpose of this study is to examine the effect of incorporating avocados in meals on post-ingestion glycemic index, insulin response, sensations of satiety and on appetite-related gastrointestinal peptide and hormone release. Also the effect of consuming avocado containing meals on the caloric intake of participants in subsequent eating episodes will be explored.

Each subject will participate in one intervention for one day, wait one or two weeks, come for another intervention, wait one or two weeks and come for a final intervention- three in total. Participants will be randomly assigned to one of six treatment sequences. Postprandial response to the control and two avocado-containing test meals will be assessed and compared using a 3 x 3 single blind cross-over design. The Subjects will be between 25 and 60 years old, female or male, with a BMI of 23 to 32, stable weight, no sports involvement, non-smoking and not dependent on caffeine. Thirty subjects will be recruited.


Eligibility Criteria:
Inclusion Criteria:

* 23-60 years old
* BMI 23-32
* Stable weight for 6 months
* Live or work near Loma Linda University

Exclusion Criteria:

* Smoker
* Heavy involvement in sports
* Dependent on caffeine
Effectiveness of Low Volume and Low Pressure in Severe Hypoxemic Patients

The present study set up to answer two questions: (a) "how low tidal volume must be to provide protective ventilatory settings able to minimize the risk of death due to Ventilator-Induced Lung Injury (VILI)?"; (b) "if protection from VILI is better achieved by targeting the driving pressure instead of the tidal volume, what is the optimal target for the driving pressure?". Solving these questions is pivotal for clinicians to personalized and precise mechanical ventilation practices to reduce the risk of VILI and avoid unnecessary risks associated to protective ventilatory settings.

Two multicenter emulated target trials will be performed using data collected with the Electronic Health Record MargheritaTre, to investigate the effect of low tidal volumes (6.0 to 8.0 ml/kg PBW vs 8.0 to 10.0 ml/kg PBW) and low driving pressures (7.0-12.0 cmH2O vs 12.0-18.0 cmH2O), respectively. Data will be used to obtain the dose-response curve of lower VT and lower ∆P in mechanically ventilated patients with acute severe hypoxemia.


Eligibility Criteria:
Inclusion Criteria:

all the following conditions present continuously for 24 hours commencing within 36 hours of ICU admission, while the patient is undergoing invasive mechanical ventilation in either flow or pressure- regulated assist/controlled modes:

1. arterial oxygen tension (PaO2) to inspiratory oxygen fraction (FiO2) ratio P/F ≤ 300 mmHg
2. hypoxemia developed within one week of a known clinical insult
3. hypoxemia not fully explained by cardiac failure or fluid overload\*

Exclusion Criteria:

1. pregnancy
2. expected duration of mechanical ventilation \< 48h
3. severe or moderate COPD
4. chronic liver disease
5. acute brain injury
6. patient admitted for palliative sedation
7. tumor with metastases
8. prior cardiac arrest
9. New York Heart Association Class IV
10. acute coronary syndrome
11. patients transferred from other ICUs
12. patients transferred to the ICU from the Emergency Department after a duration exceeding 24 hours in the Emergency Department
13. patients on Pressure Support Ventilation and/or patients in whom end-inspiratory plateau pressure was not measured
A Pilot Randomized Controlled Trial of the Effects of Daily Skin-to-skin Contact (PRCTS2S)

Late preterm infants are at risk of experiencing inadequate glycogen stores with immature glucose metabolism and increased adenosine triphosphate (ATP) degradation, which indicates cellular increased and stress. Processes mediating infant acute/chronic stress symptoms and their biochemical effects have not been adequately investigated. Skin-to-skin contact (SSC), also known as Kangaroo Mother Care (KMC), is as an intervention that activates mechanisms of energy preservation that decrease stress in preterm infants. SSC has been shown in numerous clinical trials to reduce mortality and morbidity by stabilization of breathing, thermal regulation, oxygen saturation, and heart rate. SSC also reduces behavioral distress during painful and stressful procedures and improves breast-feeding parent bonding. However, little is known about how SSC affects biomarkers of stress and energy expenditure in late preterm infants in the first week of life.

The aim of this pilot randomized controlled trial is to evaluate changes in biomarkers of stress, stress modulation and energy expenditure in late preterm infants who receive two hours of continuous SSC care or two hours of lying undisturbed in an incubator administered daily for 3 consecutive days in the first week of life, and to provide preliminary data for future research comparing the effects of usual incubator care with prolonged SSC on stress biomarkers in preterm infants.


Eligibility Criteria:
Inclusion Criteria:

* Infants between 34 weeks and 0/7 days through 35 weeks and 6/7 days gestational age
* Medically stable as determined by a Neonatal Acute Physiology- Perinatal Extension SNAPPE -II (SNAPPE-II) score of less than 9
* Mothers able to read and write English
* Mothers have no medical contraindications to holding their infant in SSC for up to 2 hours

Exclusion Criteria:

* Surgery in the first week of life
* Intraventricular hemorrhage (IVH) of grade 3 or 4
* Opioids, benzodiazepines, muscle relaxants, phenobarbital, and/or dilantin
* Plasma creatinine of \>1 mg/dl
* Severe cyanotic heart disease or severe respiratory distress
* Abdominal wall or intestinal anomaly or injury (NEC)
* Facial anomaly or other known chromosomal anomaly
* Life-threatening congenital anomaly or are so critically ill that they are unlikely to survive or are receiving palliative care
PAN-EU Utilization, Effectiveness and Safety of Ipilimumab Administered in EAP Patients With Advanced Melanoma

Observational study to evaluate the effectiveness and safety of ipilimumab, administered during the European expanded access programme (EAP) in pretreated patients with advanced (unresectable or metastatic) melanoma.

Minimum age: 18 years old (at time of inclusion in the CA184-367- but 16 for the EAP)

Eligibility Criteria:
Inclusion Criteria:

* Patients have been enrolled in the EAPs
* Patients still alive must provide informed consent if required by local regulations
* Deceased patients are eligible per local regulations, their legal representatives must provide informed consent if required by local regulations

Exclusion Criteria:

* There are no specific exclusion criteria in this observational study other than the exclusion criteria of the EAP
Comparative Clinical Efficacy Between Multi-layer Bandage Pressure Therapy and Gradient Pressure Elastic Stocking Treatment After Endovenous Radiofrequency Ablation

Objective: To assess the clinical efficacy of different compression methods within 48 hours after endovenous radiofrequency ablation (RFA) in terms of great saphenous vein closure rate, postoperative complications, quality of life, time to return to normal work, and patient satisfaction.

Postoperative compression of varicose veins can achieve compression hemostasis, early getting out of bed, reducing edema, preventing phlebitis, ensuring closure effect, reducing soreness and pain, and preventing thrombosis. Compression therapy is a continuation of minimally invasive treatment of varicose veins, and postoperative compression therapy is continued for at least 1 month, and grade II compression therapy may be considered.The application of postoperative compression to the treated limb after radiofrequency ablation of the great saphenous vein has been a topic of controversy. The basic principle of using postoperative compression is to reduce the risk of bleeding, hematoma formation, pain, swelling, and thrombus formation. However, many patients find wearing gradient pressure elastic stockings cumbersome and uncomfortable, as the silicone grips around the stockings can cause skin itching and discomfort. Moreover, there is a lack of strong evidence supporting this treatment. The purpose of this study was to investigate the effectiveness of continuous 48-hour use of gradient pressure elastic stockings for compression of the affected limb after endovenous radiofrequency ablation.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years and \<80 years, and able to understand the requirements of the study and provide informed consent and accept the exams and follow-up.
* C2 - C5 varicose veins / CVI Symptomatic primary GSV, SSV, or AASV incompetence, with reflux \>0.5 seconds on color duplex, eligible for patients undergoing radiofrequency ablation.
* Color replica ultrasound or venography of the lower extremity veins shows saphenous varicose veins without evidence of deep venous stenosis, filling defects, or ultrasound abnormalities.
* No contraindications to the wearing of compression stockings (e.g., arterial insufficiency, skin allergies)

Exclusion Criteria:

* Severe deep vein valve insufficiency or acute deep vein thrombosis of the lower extremities
* Previous history of high ligation and dissection of the saphenous vein, recurrence of collateral branches of the deep vein
* Superficial vein thrombosis is present at the treatment site, with local redness, swelling, warmth, pain, and significant signs of inflammation
Data Collection - Of Syncope Tilt Table Testing Study

To characterize the impact of orthostatic hypotension (OH) and reflex syncope on signals measured using a wearable cardiac monitor prototype device.

To evaluate the relationship of signals measured from the wearable cardiac monitor prototype device with reported symptom severity of orthostatic intolerance per standard data collection, analysis, and questionnaires.

This is a non-randomized feasibility study that will enroll up to 50 participants that have undergone a previous autonomic reflect screen (ARS) assessment and were either diagnosed with OH or reflex syncope, or considered to be control subjects for this study.

A maximum of 20 subjects diagnosed with reflex syncope, a maximum of 10 subjects diagnosed with OH and a maximum of 10 control subjects will be enrolled. There will be one study visit per subject.

Eligibility Criteria:
Inclusion Criteria:

* Willing and capable to provide informed consent
* Age 18 or above
* No contraindications to undergo tilt table test, Valsalva maneuver test, and deep breathing test (Components of the ARS assessment)
* Previously underwent a clinically indicated ARS assessment without complications (including deep breathing, Valsalva maneuver, and tilt table testing). Previously diagnosed with OH, reflex syncope, OR control subjects assessed as normal, based on the ARS assessment. Patient enrollment shall be based on the type of diagnosis.
* Willing to participate in one additional tilt table test, Valsalva maneuver test, and deep breathing test (components of the ARS assessment)

Exclusion Criteria:

* Currently enrolled in another clinical trial that might interfere with data collection.
* Subject is pregnant or planning to become pregnant during the study
* Active Implantable Medical Device, e.g. cardiac implantable electronic devices, bladder stimulators, diaphragm stimulators, implantable neuro stimulator, implantable active monitoring devices, implantable active drug administration devices, etc.
* Have a prosthetic cardiac valve or previously underwent cardiac valve surgery.
* Known allergy to materials used in the study (adhesive, ECG electrodes)
* Diagnosed with syncope due to cardiologic causes.
* Have had a myocardial infarction in the previous 90 days
* Have been diagnosed with tachycardia that requires medical treatment
* Experienced complications during previous clinically indicated ARS assessment
* Are on medications that could affect autonomic function, if considered not safe or unwilling to hold such medications for at least four half-lives prior to testing (judged by the study Principal Investigator)
* Have any contraindication for tilt test, Valsalva maneuver test or deep breathing test
Precision Care for Major Depressive Disorder

This study aims to assess whether phenotyping-guided intervention selection is superior to intervention selection without phenotyping guidance (i.e., routine clinician and patient judgment regarding treatment selection) for depression.

This study will classify patients seen in the Depression Clinic of the UCSF Department of Psychiatry and Behavioral Sciences into one of five phenotypes (subtypes), including: 1) Anhedonia, 2) Cognitive deficits, 3) Stress sensitivity, 4) Anxious distress, and 5) Grief.

After phenotyping, participants will be randomized to receive phenotype-specific intervention (PSI) or care as usual (CAU).

Eligibility Criteria:
Inclusion Criteria:

* Participant is able to provide informed consent
* English speaker
* 18 years of age or older at time of consent
* Meets DSM-5 criteria for Major Depressive Disorder
* The subject meets eligibility criteria for at least one study phenotype as determined by assessments, imaging and/or clinical judgment.
* PHQ-8 score at baseline of \>= 10
* Scheduled for or completed intake in UCSF outpatient psychiatry

Exclusion Criteria:

* Unstable or untreated medical or psychiatric condition based on clinical assessment by investigator(s)
* Significant risk of suicidal or violent behavior as determined by clinical judgement
* In the Investigators' opinion, the subject is not capable of adhering to the protocol requirements, or the subject has a history of poor or suspected poor compliance in clinical research studies, or the subject has a history of poor or suspected poor compliance to antidepressant medication or that study participation is not in their best interest (e.g., different treatment is indicated given their clinical presentation)
* Pregnant or breastfeeding or planning to become pregnant during the study
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection

This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.


Eligibility Criteria:
Inclusion Criteria:

* HCV RNA ≥ 10\^4 IU/mL at screening
* Chronic genotype 4 or 5 HCV Infection
* Individuals may be treatment naive or treatment experienced
* Presence or absence of cirrhosis, a liver biopsy may be required
* Healthy according to medical history and physical examination with the exception of HCV diagnosis
* Agree to use two forms of highly effective contraception for the duration of the study

Exclusion Criteria:

* History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the individual's participation for the full duration of the study or not be in the best interest of the individual in the opinion of the investigator
* Prior exposure to approved or experimental HCV specific direct acting antiviral(s) (DAA) other than NS3/4A protease inhibitors
* History of any other clinically significant chronic liver disease
* Evidence of or history of decompensated liver disease
* HIV or chronic hepatitis B (HBV) infection
* Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
* Chronic use of immunosuppressive agents or immunomodulatory agents
Effect of Gelsectan® in the Treatment of Low Anterior Resection Syndrome

Low Anterior Resection Syndrome (LARS) is an intestinal disorder affecting patients undergoing rectal resection for rectal cancer. A possible therapeutic option may be Gelsectan®, a class II device used in Irritable Bowel Syndrome (IBS). The aim of this study is to evaluate the efficacy of Gelsectan® in improving the symptoms of LARS.

Low Anterior Resection Syndrome (LARS) affects almost 70% of patients after rectal resection for rectal cancer and is characterized by intestinal symptoms including urgency, fractioned defecation, and fecal incontinence. LARS is clinically diagnosed using the LARS score: a score higher than 21 indicates the presence of LARS and a score higher than 30 indicates severe LARS. The treatment opportunities for LARS are limited and failure rates are high. Gelsectan® is a class II device containing xyloglucans, xylo-oligosaccharides, pea proteins, and tannins from grape seeds extract, resulting effective in improving intestinal symptoms in patients with diarrheic Irritable Bowel Syndrome (IBS). Given the symptomatic similarities between LARS and IBS, Gelsectan® may represent a valid first line treatment for LARS patients.

The objective of this study is to provide preliminary data to determine whether the administration of Gelsectan® may ameliorate the symptoms of LARS.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged more than 18 years old.
* Patients who underwent low rectal resection for rectal cancer and who closed the ileostomy at least three months before the screening visit.
* Patients with a LARS score ≥21 and/or clinically relevant symptoms of urgency, increased stool frequency, or fecal incontinence.
* Patients indicated to treatment with Gelsectan® according to the clinical judgment.
* Oncological chemotherapy or radiotherapy completed at least four weeks before the screening visit.
* Presence of a functional, intact anastomosis.
* Female patients of childbearing potential must agree to use a reliable method of contraception.

Exclusion Criteria:

* Known hypersensitivity to the investigational medicinal product (IMP).
* Any condition that, in the opinion of the investigator, may interfere with the study procedures.
* Significant anastomotic complications (e.g., strictures, fistula), which may impair the treatment efficacy.
* Pregnant or breastfeeding women.
* Inability to comply with the study procedures.
HFNC vs. NIV in Acute COPD Exacerbations

The investigators investigated the efficacy and safety of High Flow Nasal Cannula (HFNC) at different flow rates compared to non-invasive ventilation (NIV) in patients presenting to the emergency department (ED) with acute exacerbations of Chronic obstructive pulmonary disease (COPD) who did not respond adequately to bronchodilator therapy and continued to exhibit hypercapnic respiratory failure. Specifically, the investigators tested the hypothesis that HFNC would be more effective at reducing partial pressure of carbon dioxide (PaCO2) levels and hospital stay duration and would be associated with greater patient comfort than NIV.

The patients were divided randomly into one of three study groups: NIV, HFNC-30, and HFNC-50. The investigators collected patient data, including demographic characteristics (age and sex), vital signs upon admission (systolic blood pressure \[SBP\], respiratory rate \[RR\], and heart rate \[HR\]), complaints and symptoms upon admission, initial arterial blood gas parameters (e.g., pH, PaCO2, lactate, and bicarbonate), length of stay, ED revisits, patient satisfaction, intubation status, and clinical outcomes (hospitalization, admission to the intensive care unit \[ICU\], or 28-day mortality). Changes in arterial blood gas parameters (e.g., ΔpH, ΔPaCO2, Δlactate, and Δbicarbonate) before treatment vs. 30, 60, and 120 minutes after treatment were recorded using a pre-prepared case data form.

Eligibility Criteria:
Inclusion Criteria:

- patients age ≥18 years with a confirmed diagnosis of COPD who presented to the ED with exacerbations that did not respond to bronchodilator therapy

Exclusion Criteria:

* patients aged younger than 18 years
* patients had an arterial pH ≤ 7.25;
* patients were in cardiopulmonary arrest;
* patients had unstable cardiac arrhythmias or hemodynamic instability;
* patients showed persistent hypoxemia despite supplemental oxygen therapy;
* patients were unconscious or uncooperative;
* patients could not protect their airway or manage secretions;
* patients had cardiogenic pulmonary edema, active hemoptysis, pneumothorax, recent upper respiratory tract/esophagus surgery, significant airway obstruction (e.g., laryngeal mass or tracheal tumor), active upper gastrointestinal bleeding, or facial trauma or deformities