cyrilzakka/clinical-trials huggingface dataset:
Immunotherapy in Subjects With HPV-6 Associated Aerodigestive Precancerous Lesions and Malignancies

This is a Phase I, open-label study to evaluate the safety, tolerability, and immunogenicity of INO-3106 alone or in combination with INO-9012 DNA vaccines delivered by Electroporation to subjects with HPV6 associated aerodigestive precancerous lesions and malignancies.

This is a Phase I, open-label, study to evaluate the safety, tolerability, and immunogenicity of 3 mg or 6 mg INO-3106 alone or in combination with 1 mg of INO-9012 (DNA plasmid encoding human interleukin 12) delivered by electroporation (EP) in subjects with HPV6 associated aerodigestive precancerous lesions and malignancies. Subjects will be enrolled in 2 cohorts (3 subjects in each cohort):

Cohort I: First 3 subjects will be enrolled sequentially and will receive INO-3106 alone or in combination with INO-9012.

Cohort II: The next 3 subjects will be treated with 6 mg of INO-3106 and 1 mg of INO-9012, or at the MTD (Maximum Tolerated Dose) determined in Cohort I.

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated written Ethics Committee approved informed consent
* Age ≥18 years
* Histologically documented HPV-6 positive aerodigestive invasive malignancy (mucosal squamous cell head and neck cancer or lung cancer) who have completed therapies such as radiation/chemoradiation/chemotherapy; or
* Histologically documented HPV-6 positive papilloma or HPV-6 related premalignant lesion (i.e., carcinoma in situ) in aerodigestive or head and neck regions.
* Prior to study entry, subjects will have exhausted all treatments that are/have been used in these indications which may include any combination of surgery, anti-viral therapy, chemotherapy and/or radiation therapy.
* Core biopsy must be obtained prior to enrollment to confirm invasive cancer. Archival material is allowed.
* Adequate bone marrow, hepatic, and renal function. ANC (Absolute Neutrophil Count) ≥ 1.5x109 cell/ml, platelets ≥75,000 cells/mm3, hemoglobin ≥ 9.0 g/dL, concentrations of total serum bilirubin within 1.5 x upper limit of normal (ULN), AST, ALT within 2.5x ULN, CPK within 2.5 x ULN, serum creatinine ≤ 1.5x ULN
* ECOG (Eastern Cooperative Oncology Group) performance status of 0-2

Exclusion Criteria:

* Participation in a clinical trial within 30 days before entry
* Any cardiac pre-excitation syndromes, e.g. Wolff-Parkinson-White syndrome
* Presence of metal implants within 5 cm of the planned site(s) of injection
* Anticipated concomitant immunosuppressive therapy (excluding non-systemic inhaled, topical skin and/or eye drop-containing corticosteroids)
* Administration of any vaccine within 6 weeks of enrollment
Stepped Care for Youth at Risk of Psychosis

The study will recruit 60 young people who meet established criteria for being at clinical high risk for psychosis. They will be offered a range of psychological interventions starting with the most benign treatments in different steps. At step 1 they will be offered individual or group support and if there is no improvement they will be offered more intensive CBT individual therapy or CBSST group therapy. Assessments will occur at baseline, 6,12 and 18 months

In treating youth at clinical high risk of developing psychosis we have not been able to address what treatment to offer first and when to offer more intense and, ultimately, more costly treatments. The goals of achieving Precision Health objectives require that these questions be addressed through research.

The overall aim is to determine the most effective and efficient way to offer active and maintenance treatment resources for CHR youth. The first step would be to offer a range of treatments starting with the most benign as advocated in the McGorry and Hickie stage model. We will use this project to test whether clinical staging will improve prediction of prognosis and result in improved matching of treatment. The specific objectives of this project are: (1) to determine which and what proportion of participants would remit (i) within the first 1-2 months of treatment, (ii) after a brief supportive therapy, (iii) after longer term, focused psychological interventions such as CBT, CBSST and family intervention and (iv) how many make use of medications; (2) to determine adherence of CHR individuals to different treatments; and (3) to determine the need for maintenance treatment. To assess these objectives the following outcomes will be determined:

1. Improvement of Attenuated Psychotic Symptoms
2. Improved social functioning as rated by Global: Social Functioning
3. Percentage of the sample that demonstrate either symptomatic or functional improvement after Step 1 treatments and do not require to move to Step 2 treatments.
4. Percentage of sample that move to Step 2 Treatments and the percentage that achieve improvement in either symptoms or functioning.
5. Percentage of participants allocated to a given treatment that adhere to the treatment.

Participants will be between ages 12 and 30. We will recruit 60 participants who meet well-established criteria for clinical high risk for psychosis based on the Structured Interview for Psychosis-Risk Syndromes (SIPS).

Assessments will be conducted at baseline and 2, 6, 12, and 18 months after baseline. Assessments consist of clinical assessments. Clinical raters will be experienced raters and will be trained on all clinical measures and routine reliability checks will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Meeting SIPS criteria for clinical high risk for psychosis

Exclusion Criteria:

* meeting criteria for any current or past axis I psychotic disorder, IQ less than 70, or past or current history of a clinically significant central nervous system disorder.
Prehabilitative Exercise Prior to Immobilization

This is a 10-week human study involving 24 younger (20-35 y) and 24 older (65-85 y) healthy individuals. All participants will undergo unilateral immobilization of a knee for 7-10 days, followed by 4 weeks of heavy resistance exercise training (HReT). Half of the participants (12 younger and 12 older) will also undergo 4 weeks HReT prior to the immobilization. Prehabilitative exercise may confer protective effects on subsequent immobilization, and the various underlying mechanisms involved


Eligibility Criteria:
Inclusion Criteria:

* Age: Between 20-35 years old or between 65-85 years old.
* BMI: Between 18.5 and 35 kg/m2.
* Healthy and well, with normal dietary habits (not vegan).

Exclusion Criteria:

* More than one muscle biopsy previously taken from both vastus lateralis muscles.
* Smoking.
* Pregnancy.
* Past or present substance or alcohol abuse.
* Medical/surgical conditions that are assessed to affect protein synthesis or the participant's involvement in the trial.
* Knee pain that could affect the completion of the training intervention.
* High intake of supplements that increase the risk of bleeding during muscle biopsy (such as fish oil and ginger).
* Participation in regular strength training within the past year.
* Regular participation in structured sports.
* Current use of blood-thinning medication.
* Previous participation in trials involving oral intake of heavy water.
* Metal in the body preventing MRI scanning.
* For the older group, not having gone through menopause, and for the younger group, not having a regular menstrual cycle.
Lactoferrin Use in (SARS-CoV-2) Management

Background: Preventive, adjunctive and curative properties of lactoferrin have been evaluated since the first wave of severe acute respiratory syndrome coronavirus (SARS-CoV), viral respiratory disease, emerged 18 years ago. Despite the discovery of new vaccine candidates, there is currently no widely approved treatment for SARS-CoV-2 (COVID-19). Strict adherence to infection prevention and control procedures, as well as vaccines, can, however, prevent the spread of SARS-CoV-2. Objective: Hence, this study evaluated the efficacy of lactoferrin treatment in improving clinical symptoms and laboratory indices among individuals with mild to moderate coronavirus disease-19 (COVID-19). Design and Participants: A randomized, prospective, interventional pilot study conducted between July 8 and September 18, 2020 used a hospital-based sample of 54 laboratory confirmed participants with mild to moderate symptoms of COVID-19. Randomization into a control and two treatment groups ensured all groups received the approved Egyptian COVID-19 management protocol; only treatment group participants received lactoferrin at different doses for seven days. Clinical symptoms and laboratory indices were assessed on Days 0, 2 and 7 after starting treatments. Mean values with standard deviation and one-way analysis of variance with least significant difference post hoc of demographic and laboratory data between control and treatment groups were calculated. Key Results: Our study showed no stastically significant difference among studied groups regarding recovery of symptoms or laboratory improvement. Conclusion: Further research into therapeutic properties particularly related to dosage, duration and follow-up after treatment with lactoferrin in individuals with COVID-19 is required.


Eligibility Criteria:
Inclusion Criteria:

1. participants over 20 years of age
2. positive for nasopharyngeal swab reverse transcriptase polymerase chain reaction (RT-PCR) for COVID-19
3. blood oxygen saturation (SpO2) \> 93%.

Exclusion criteria:

1. pregnant and breastfeeding women
2. individuals confirmed to be allergic to milk protein
3. those with a medical history of bronchial hyperactivity or pre-existing respiratory diseases
4. ICU inpatients with COVID-19.
Respiratory Pattern During Neurally Adjusted Ventilator Assist (NAVA) in Preterm Infants

This study is to investigate the effect of a wide range of assistance levels on respiratory pattern, breathing variability including tidal volume and peak inspiratory pressure during neurally adjusted ventilatory assist (NAVA) in preterm infants. The investigators also aim to explore whether the effects of NAVA on the electrical activity of diaphragm (Edi) signal amplitude, work of breathing and comfort of preterm infants.


Eligibility Criteria:
Inclusion Criteria:

* preterm infants born before 36 weeks of gestational age
* who received mechanical ventilatory care through the endotracheal tube at least 24 hours for respiratory distress
* no use of anesthetics or analgetics

Exclusion Criteria:

* with major congenital anomalies (facial, gastrointestinal tract, cardiac, etc)
* with phrenic nerve palsy or injuries
Long-term Oncologic Outcome of Breast-conserving Surgery in Breast Cancer Patients With BRCA1/2 Mutations

The investigators matched BCS and mastectomy group using propensity scores and analyzed the recurrence and survival among the evenly matched patients in breast cancer patients with BRCA 1/2 mutations.

The purpose of study is to assess the oncologic safety of BCS in patients carrying BRCA1/2 mutations by comparing long-term outcomes with mastectomy. The investigators matched BCS and mastectomy group using propensity scores and analyzed the recurrence and survival among the evenly matched patients. By providing insights into the feasibility of BCS for patients with BRCA1/2 mutations, the investigators aim to present evidence to aid in surgical decision-making for the care of these patients.

Eligibility Criteria:
Inclusion Criteria:

* Primary invasive breast cancer who underwent BCS or mastectomy
* Received a BRCA1/2 mutation test

Exclusion Criteria:

* Patients with de novo metastasis
* Pregnancy-associated breast cancer
Prospective Evaluation of Single Cell Mutations in a Panel of Known Oncogenes in NSCLC Surgical Specimens

The goal of this observational study is to evaluate the feasibility of a single cell mutation research method in a panel of known oncogenes, using the Tapestri method. Tissue samples will be obtained after surgical treatment in patients with I-II-III stage NSCLC.

NSCLC is a particularly heterogeneous disease with different genetic alterations in oncogenes 'drivers', responsible for the development and progression of the disease. In most cases all these anomalies represent clonal mutations in all neoplastic cells. However, several sub-clonal genetic alterations were identified in some multi-regional sequencing studies, demonstrating an intra-tumor heterogeneity. Tracing the clonal architecture of the disease and also the temporal order of the various mutations appearance, would bring two benefits:

1. prioritize the molecular targets
2. identify evolutionary trajectories associated with the outcome of therapies and survival, useful to stratify patients considering the likelihood and the duration of response For the bioinformatic data analyses will be used the Tapestri MissionBio pipeline.

Given the limited number of patients that can be included in the study (10 patients), no statistical analyzes will be performed. Results will be presented thorugh narrative reports for each patients.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years old.
* histological diagnosis of NSCLC technically operable following multidisciplinary discussion
* informed consent freely granted and obtained before the start of the study

Exclusion Criteria:

* age under 18 years old
* unconfirmed NSCLC histological diagnosis
* medical treatment with neoadjuvant purposes
* absence of informed consent
Novel Internet-Based Interventions to Reduce Sexual Risk Among Men Who Have Sex With Men

The purpose of this study is to develop and test the efficacy of online HIV risk reduction interventions among men who have sex with men.

This is an Internet-based, five-branch randomized controlled intervention, enrolling 3,000 adult MSM. The five branches include 1) a control condition receiving no intervention content, 2) a standard text-based prevention webpage, 3) an 8 minute dramatic video addressing sexual risk reduction within the context of alcohol use, 4) a 5 minute documentary video addressing HIV disclosure, HIV testing, and condom use with the sub-context of drug use, and 5) both videos. After completing the baseline survey, eligible participants who consent to participate in the intervention will be randomly assigned to the control condition or one of the four intervention conditions. The control condition will not include the delivery of any intervention content. All participants (branches 1-5) will be asked to complete a brief post-intervention survey (to measure intentions). All intervention participants will be invited to complete a final 60-day follow-up survey.

Eligibility Criteria:
Inclusion Criteria:

* Male;
* Age 18 and over;
* Ability to read and respond in English;
* Reside within the United States;
* Report oral or anal sex with any male (new partner or not) in the past 60 days AND report oral, anal or vaginal sex for the first time with any partner (male or female) in the past 60 days;
* Complete baseline survey
* Provide an email address;

Exclusion Criteria:

* Women and transgender persons
Influence of Posture and Gas Insufflation on Perioperative Lung Function

Perioperative airway resistance and lung function are evaluated perioperatively in patients, who undergo surgical procedures in different postures and with or without gas insufflation into the peritoneal cavity.

Lung function, upper and lower airway resistance measurements are performed in patients in prone horizontal or head tilted down (40°) position. Half of the patients with head down position will have surgery in laparoscopic technique (including gas insufflation to achieve a pneumoperitoneum). Measurements are performed on the day prior to surgery, on the morning of surgery, 30 - 45 minutes, 2 hours, and 24 hours after extubation.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age.
* Patients with normal lung function with respect to age, gender and weight. -Patients scheduled for Prostatectomies, robotic Prostatectomies, and open hemicolectomies.

Exclusion Criteria:

* Patients younger than 18 years.
* Patients with pathological lung function.
* Patients with with major cardiac disease.
Stimulus Intensity in Left Ventricular Leads

Cardiac resynchronization therapy (CRT) is a device implanted to improve the function of some people's hearts. CRT involves the placement of 3 wires in the heart through a vein near the front of your left or right shoulder into three pumping chambers of the heart, the most important being the left lower chamber, left ventricle (LV).

The purpose of Cardiac resynchronization therapy (CRT) is to send small amounts of energy (called pacing) through the wires to both the left and right lower chambers of your heart at (or near) the same time. This helps the heart pump in a more coordinated way and send more blood to your body with each beat. How much energy is used for pacing is called the stimulus intensity. Increasing the pacing stimulus intensity of the left ventricular wire can lead to an increase in the volume of heart muscle directly stimulated. This has previously been shown to produce beneficial effects on the heart function, like strength of contraction and increased volume of blood pumped. The purpose of this study is to determine if pacing the wires in the left ventricular chamber of the heart using higher stimulus intensity improves the strength of the heart's contraction.

Eligibility Criteria:
Inclusion Criteria:

* Adults who fulfill approved criteria to receive a cardiac resynchronization device.

Exclusion Criteria:

-Adults who are unable to give informed consent.
Effect on Cognitive Performance and Safety/Tolerability of SSR180711C in Mild Alzheimer's Disease

The primary objective of the study is to assess the effect of 3 doses of SSR180711C on cognitive performance in patients with mild Alzheimer's Disease (AD). Other objectives are to assess the safety/tolerability of SSR180711C in patients with mild AD.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with diagnosis of mild AD

Exclusion Criteria:

* Concomitant or previous treatment by acetylcholinesterase inhibitors and/or memantine
* Medical condition which may interfere with the study
* History of epileptic seizures
* Lens opacity
* Lack of reliable caregiver

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Low Dose Prasugrel vs Clopidogrel for Stenting or Flow Diverter for Unruptured Aneurysm

Low clopidogrel response has been reported in about 5-44% of the total population, which is associated with an increase in thromboembolism.

Recently prasugrel drug widely accepted as a good option for these patients. The purpose of this study is to compare the safety and usefulness of prasugrel versus clopidogrel in patients who are scheduled to undergo stent or diverter treatment for non-ruptured cerebral aneurysms.

Unruptured intracranial aneurysm (UIA) is a relatively common disease with a prevalence of about 1% of the total population. Widely accepted techniques of neuro-interventional therapy are coil embolization with or without stent deployment and flow diverter insertion. However, these two techniques inevitably had the risk of thromboembolism. For prevention and decrease, dual antiplatelet therapy is commonly used in the clinical field. However, clopidogrel does not produce normal metabolites due to various internal and external factors in the metabolic process in the liver and eventually fails to perform its original role of platelet activity suppression in many situations, called "clopidogrel hyporesponsive". Low clopidogrel response has been reported in about 5-44% of the total population, which is associated with an increase in thromboembolism.

Recently prasugrel drug widely accepted as a good option for these patients. The purpose of this study is to compare the safety and usefulness of prasugrel versus clopidogrel in patients who are scheduled to undergo stent or diverter treatment for non-ruptured cerebral aneurysms.

Eligibility Criteria:
Inclusion Criteria:

* UIAs without any evidence of rupture in intracranial imaging study within the last 6 months
* Planned treatment with coil embolization with stent insertion or flow diverter insertion
* If the patient himself/herself consented to this study

Exclusion Criteria:

* ∙ History of acute ischemic stroke or transient ischemic attack

  * Any intracranial hemorrhage except subarachnoid hemorrhage due to aneurysm rupture within the last 3 months
  * Concurrent treatment other than endovascular procedure (e.g. open craniotomy and microsurgical clipping)
  * Contraindications to iodine contrast agents
  * Already taking antiplatelet drugs or antithrombotic drugs other than aspirin
  * Hypersensitivity to aspirin, prasugrel or clopidogrel
  * Cardiac arrhythmia that should be needed to take anticoagulants
  * Pregnancy or lactating
  * Chronic kidney disease (\< GFR 60)
  * Patients with chronic liver disease who have at least over 100 IU/L of either AST/ALT in the liver function test
  * Patients with pathological active bleeding, such as peptic ulcer
  * Patients with genetic problems, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption because they contain lactose
  * Patients continuously taking non-steroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase-2 inhibitors
  * Patients requiring concomitant administration of methotrexate 15 mg or more for one week
  * If it is judged difficult to follow up after treatment
Nutrition Support in Pediatric Stem Cell Transplantation

The purpose of this study is to determine which method of providing parenteral nutrition (complete intravenous nutrition) will provide the best nutritional and clinical results to children undergoing hematopoietic stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

* First myeloablative allogeneic SCT using either TBI (1400 cGy) or busulfan in addition to other chemotherapeutic agents
* GVHD prophylaxis with a calcineurin-inhibitor and methotrexate +/- corticosteroids
* Matched, related or 6/6 HLA-matched unrelated SCT donor
* Age 6 years and older

Exclusion Criteria:

* Age less than 6 years, or otherwise unable to comply with study procedures
* Underweight (body mass index (BMI) z-score \<2 for age and sex) at baseline
* Overweight (BMI z-score \>2 for age and sex) at baseline
* Unable or unwilling to return for day + 100 studies
* Previous stem cell transplant
* Unmatched SCT donor
* Current treatment for hypo- or hyperthyroidism
* Current insulin dependent diabetes
* Current use of parenteral nutrition
* Allergy to egg or soy products
* Other contraindication to parenteral nutrition at baseline