cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity and Pharmacodynamic of B12019 and Neulasta® in Healthy Subjects

Multiple-doses, randomised, double-blind, three-periods, two-sequences crossover study to assess the immunogenicity and pharmacodynamic comparability of a biosimilar pegfilgrastim (B12019) and the reference product Neulasta® in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects, between 18 and 55 years of age (inclusive).
2. BMI between 20.0 and 30.0 kg/m² (inclusive).
3. Weight between 60 and 100 kg (inclusive).
4. Non-smoker for at least 3 months or mild smokers with a consumption of less than 5 cigarettes (or equivalent) per day prior to study start.
5. Healthy subjects as determined by medical history, physical examination including vital signs, ECG and clinical laboratory testing.
6. Able to comply with protocol requirements, including overnight stays, blood sample collections as defined in the protocol and to participate in the entire trial period.
7. Subjects who are able and willing to give written informed consent.
8. Male subject and his female spouse/partner who is of childbearing potential must be using effective contraception starting at screening and continue throughout the clinical study period.
9. Male subject must not donate sperm starting at screening and throughout the clinical study period and for 3 months after final study drug administration.

Exclusion Criteria:

History of:

1. Evidence in the subject's medical history or in the medical examination of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, haematological, central nervous system diseases or other significant acute or chronic diseases, especially hereditary fructose intolerance, which might influence either the safety of the subject or the absorption, metabolism or excretion of the active agent under investigation.
2. Subjects with clinically relevant neurologic or psychiatric illness.
3. Subjects with clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing).
4. Previous exposure to pegfilgrastim.
5. Known hypersensitivity to Escherichia coli-derived proteins, pegfilgrastim, filgrastim or any other component of B12019 or Neulasta® as listed in section 7.2.
6. History of allergy to any recombinant protein.
7. History of cancer.
8. History of haematological disease, including sickle cell disorder.
9. History of pulmonary infiltrates or pneumonia within 6 months before the first study drug administration.
10. Known anti-drug antibodies to filgrastim or pegfilgrastim, including known antibodies to PEG as a consequence of exposure to PEG other than pegfilgrastim (e.g. cosmetics, etc.).
11. Subjects not willing or able to comply with the food and beverage restrictions (grapefruit/pomelo, starfruit, poppy seeds).
CAM in Hospice Palliative Care in Taiwan

The study aims to explore the effects of silver spike point (SSP) treatment on common symptoms including pain, breathlessness, nausea/vomiting, dry mouth etc. of terminal cancer patients.

The study aims to explore the effects of silver spike point treatment on common symptoms including pain, breathlessness, nausea/vomiting, dry mouth etc. of terminal cancer patients. We will conducted a pilot study to evaluate the effects on different symptoms and then a prospective study will be conducted after validation of major effects.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients
* Competent with clear consciousness
* With symptoms of pain, breathlessness, nause/vomiting, dry mouth, generalized discomfort
* Expected life span of at least 1 week

Exclusion Criteria:

* With implanted devices
* Not having clear consciousness
* Expected life span less than 1 week
* Foreigner
Association Between Laparoscopic Removal of Endometriomas and Anti-mullerian Hormone Levels

Laparoscopic excision of endometriotic cysts is the main stream surgical intervention for treatment of endometriosis. However there is evidence that intervention may effect ovarian reserve by destruction of healthy ovarian tissue during surgery. Available evidence on the topic are contradictory and employed research methodology are diverse. There is need for an adequately powered research with proper methodology to assess actual effects of surgery.


Eligibility Criteria:
Inclusion Criteria:

* Women with endometrioma cyst(s)
* Women of age under 35 years old
* Women without any previous ovarian surgery

Exclusion Criteria:

* Combined oral contraceptive or long term GnRH (gonadotropin-releasing hormone) analog use in the preceding 3 months to enrolment
* Having another cystic lesion besides endometrioma
* Need for extensive bipolar coagulation during surgery
* Any anatomical problem preventing evaluation of ovaries with high-resolution ultrasound
* Postoperative pathology excluding endometrioma
Clinical Evaluation of a Myopia Control Lens in Slowing Myopia Progression.

This is a mono-centre, prospective, one-arm, unmask clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation compared to a single vision spectacle lens from the historical control group of another clinical trial NCT05331378. A total of 40 children will be recruited.

As myopia is a growing worldwide problem, it is important to better understand the range of possible treatments to slow the progression of myopia. Spectacle lenses with aspherical lenslets were shown to be effective in reducing myopia progression and axial length elongation in children in the previous clinical trial (Bao et al. 2022). A dose-dependent effect was demonstrated, with higher lenslet asphericity having greater myopia control efficacy.

This open clinical trial will test the safety and effectiveness of a test lens designed to modify the area and amount of myopic defocus on the retina without compromising vision. The study population includes children in Singapore aged 8 to 13 years (40 subjects) at the time of commencing treatment. Axial length and spherical equivalent refraction will be the primary measure for myopia progression. Visual acuities will also be compared between test lenses and control lenses of the historical control group to determine the quality of vision using test lenses

Eligibility Criteria:
Inclusion Criteria:

* Volunteer subject and guardian, fluent English spoken, willing to follow protocol and able to read, comprehend and sign the informed consent \& assent form.
* Equal to or greater than 8 years and not older than 13 years at time of informed consent and assent.
* Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.75 D in each eye.
* Astigmatism, if present, of not more than 1.50 D.
* Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D.
* Best corrected visual acuity in each eye equal to or better than +0.10 logMAR (≥ 20/25 as Snellen)
* Be in good general health based on his/her and parent's/guardian's knowledge. Absence of ocular disease with full ophthalmic examination. Without any ocular or systemic condition known to affect refractive status.
* Absence of strabismus by cover test at near or distance wearing correction.
* Absence of amblyopia
* Without ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.

Exclusion Criteria:

* Vulnerability of subject
* History of myopia control intervention
* Participation in any clinical study within 30 days of the Baseline visit.
Exercise as a Strategy to Treat Cognitive Dysfunction in Persons With Multiple Sclerosis

Many persons with Multiple Sclerosis ( MS) have problems with memory and thinking.Exercise has been shown to improve memory and thinking in persons with diseases such as Alzheimer's. This study will investigate whether a program of aerobic exercise can improve memory and thinking in persons with MS

Persons with Multiple Sclerosis(MS)will be screened for eligibility and randomized to a protocol with two intervention arms. One group will have aerobic training on a recumbent cross trainer three times a week for 20-30 minutes/session. The other group will participate in stretching exercises at the same frequency and intensity.Total training time will be six months.Outcome measures will include tests of memory and thinking, and fitness measures.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of MS Complaints of cognitive problems Able to ride a recumbent cross trainer

Exclusion Criteria:

* Cardiopulmonary or structural disease that would limit ability to participate in exercise training On treatment with chemotherapy or natalizumab Screening score of \>50 on PASAT
Post ICU Follow up in Patients With Severe SARS-CoV-2 Infection (Covid-19)

Patients affected by new coronavirus infectious disease (COVID) were mostly hospitalized in ICU. This infection seems to cause widespread organ injury (i.e acute renal injury, neurological disorders, pulmonary embolism,...). It is therefore necessary to provide a framework for the follow up of patients. Moreover SARS-CoV-2 infection consequences remain unknow at this time. Study hypothesis is that COVID alters determining factors (physical or psychological) of quality of life after ICU hospitalisation. The aim of the study is to assess quality of life 3 months after ICU hospitalization.

Secondary purposes of the study are 1) assessment of quality of life 6 months and the evolution between the third and the sixth months after ICU hospitalization 2) description patients care after 3 and 6 months ICU left and their clinical status 3) convening and providing a "platform" within several physicians (neurologist, biologist, pneumologist...) will be able to follow up patients and perform complementary investigations according to patients injuries.


Eligibility Criteria:
Inclusion criteria:

* Subject male or female ≥ 18 years old
* Patient hospitalized in the anesthesia-resuscitation department of the NHC for COVID-19 from March 1, 2020.
* Patient (or his legal representative) having given his consent for the use of his data for the purposes of this research.

exclusion criteria:

* Subject not hospitalized in intensive care
* Patient's refusal to participate in the study
* Inability to give informed information to the subject (subject in an emergency, difficulty understanding the subject, etc.)
* Subject under low protection
Assessment Of The Effects Of Short and Long Term Use Of CPAP

We hypothesize that the nocturnal use of continuous positive airway pressure in adults and children with asthma will decrease airway reactivity.

Deep inspirations have been shown to decrease the sensitivity of airways to narrowing (airway reactivity) after inhalation of agents that induce constriction of the bronchi in healthy adults. This response is absent in adult asthmatics; however, there is data demonstrating that use of continuous positive airway pressure (CPAP) for short periods of time may decrease airway reactivity in adult asthmatics. This suggests that although deep inspirations may not result in decreased airway reactivity, sustained lung inflation may lead to changes in asthmatic airway smooth muscle structure that lead to a decrease in airway reactivity. The purpose of our study is to determine whether short and long term use of CPAP in children and adults leads to decreased airway reactivity. If airway reactivity is decreased with CPAP, this may provide a novel therapeutic strategy for patients with asthma.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for children 8-18

* Children 8-18 years of age scheduled to start CPAP for obstructive sleep apnea.
* Subjects can have clinically stable asthma, with no plans by their physician to change asthma therapy over the next month

Inclusion criteria adults 18-60

* Adults 18-60 years of age, seen in adult Pulmonary Clinic for sleep related problems who may require treatment with nocturnal continuous positive pressure (CPAP), which will be determined by polysomnography(PSG) will be approached to participate in the study.

Exclusion Criteria:

Exclusions for Children category age 8-18 include:

1. Cyanotic congenital heart disease.
2. History of acute respiratory symptoms for 3 weeks prior to testing.
3. Inability to perform pulmonary function testing adequately.
4. Escalation in asthma medication at time of recruitment.
5. SaO2 \<93% while awake and breathing room air
6. Baseline FEV1 \<75% predicted

Exclusions for adults 18-60 include:

1. Gastro-Esophageal Reflux requiring Medical management.
2. Chronic Obstructive Pulmonary Disease.
3. Use of Supplemental Oxygen.
4. Ischemic Heart Disease or Hypertension requiring treatment with medications other than diuretics.
5. Use of systemic corticosteroid therapy during the past 6 months.
6. Acute Respiratory Illness in the previous 8 weeks.

Exclusions/Inclusion criteria for adults with asthma include:

1. Juniper Score \<1.5
2. Baseline FEV1 \> or equal to 70%
3. Non-smoking for 6 months
4. Less than 10 pack year smoking history
5. No change in asthma medications for the last 2 months
6. Negative pregnancy test
7. Subject cannot have sleep apnea
Retrospective Chart Review of First-time Opsumit® (Macitentan) Users in the United States

The Opsumit Users registry (OPUS; NCT02126943) was developed to characterize the safety profile of Opsumit and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting. It is expected that the recruitment target of the OPUS registry cannot be achieved within the planned time period (5000 Opsumit new users by October 2018). The OrPHeUS study is designed to supplement the OPUS registry with retrospectively identified first-time Opsumit users in order to achieve the desired sample size.


Eligibility Criteria:
Inclusion Criteria:

* Patients who initiated Opsumit for the first time between 19 October 2013 and 31 December 2016 (inclusive)
* Patients whose medical charts are available for data collection

Exclusion Criteria:

* Patient participation in the OPUS registry
* Patient participation in any clinical trial involving Opsumit treatment or macitentan investigational product
Human Leukocyte Antigen (HLA) - A*2402 Restricted Peptide Vaccine Therapy in Patients With Advanced Esophageal Cancer

The purpose of this study it to evaluate the safety and immune response of peptides (URLC10) emulsified with Montanide ISA51 in treating patients with unresectable, advanced or recurrent esophageal cancer.

URLC10 have been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. In a prior study, it has been shown that URLC10 are upregulated in human esophageal tumors. The investigators identified that peptides derived from these proteins significantly induce the effective tumor specific CTL response in vitro. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of URLC10 peptide. Patients will be vaccinated once in one week to the eighth vaccine and will be vaccinated once in two weeks from the ninth vaccine. On each vaccination day, the URLC10 peptide (1mg) mixed with Montanide ISA 51 will be administered by endodermic injection

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have Advanced or recurrent esophageal cancer, and treatment has failed, or in the situation where effective therapy is not available, or has been refused due to severe adverse effects of chemotherapy
2. WHO performance status of 0 to 2
3. Age ≥ 20 years, ≤80 years
4. The patient does not need to have a measurable disease, but must have a disease that an effect judgment is possible
5. Passing from previous treatment more than two weeks. Passing from radiation therapy more than four weeks.
6. Expected survival of at least 3 months
7. WBC≥ 1,500/mm³ WBC≤ 15,000/mm³ Platelet count ≥ 50,000/mm³ Total bilirubin ≤ 3 x the institutional normal upper limits AST, ALT ≤ 3 x the institutional normal upper limits Creatinine ≤ 3 x the institutional normal upper limits
8. Patients must be HLA-A2402
9. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy, Promise of the pregnancy, Hope of the pregnancy, Breastfeeding
2. Serious infections requiring antibiotics
3. Concurrent treatment with steroids or immunosuppressing agent
4. Disease to the central nervous system
5. Decision of unsuitableness by principal investigator or physician-in-charge
Cyclosporine A in Patients With Small Diameter Abdominal Aortic Aneurysms

Aneurysms of the aorta are dilatations of the main artery in the body that distributes blood to organs. Aneurysms expose patients to aortic rupture. The risk of aortic rupture is high for large aneurysms, and low for small aneurysms. Currently, if the diameter of a small aneurysm grows up to a level at risk for rupture, surgery is indicated to prevent rupture. A drug that would stop growth of small aneurysms would obviate aortic surgery, the current treatment to prevent aortic rupture in patients. The ACA4 study aims at testing the possibility to stop growth of small aortic aneurysms in the abdomen with a drug, cyclosporine A. Patients with small aneurysms will receive cyclosporine A orally, or a placebo (fake liquid), every day during a short period of time. Efficacy of the drug will be evaluated by measuring the diameter of the aneurysm during 2 years after treatment cessation. Drug safety analysis will evaluate the impact of the drug on renal function, blood pressure, and other parameters. In case of adverse event during the drug administration phase, dose of the drug or of the placebo will be decreased or administration stopped.

Abdominal aortic aneurysms (AAAs) expose patients to death caused by aortic rupture. Although screening of AAAs has been shown to decrease AAA-related mortality, translation into medical practice of screening is limited because there is no specific treatment to limit growth of AAAs below diameter thresholds for open surgery or stent graft. We have developed different approaches aimed at inducing healing and thereby stabilizing formed AAAs in animal models. We have identified TGF-beat1 as an inducer of experimental AAA healing. Cyclosporine A is an inducer of tumor growth factor - beta1 (TGF-beta1) in experimental AAAs and in human atherosclerotic AAAs in vitro, causing overgrowth of inflamed tissues. Since AAAs are caused by aortic wall atrophy, we have hypothesised and confirmed in animals, that cyclosporine AAA, when administrated during a short period of time, durably stabilizes small AAA diameter in animals, while inducing aortic wall reconstruction and healing.

The clinical trial ACA4 is a multicentric randomized, placebo controlled, double blind trial that will enrol 360 patients with small AAAs in France. Two doses of cyclosporine A will be tested against a placebo (three arms). Drug administration will be short, and AAA diameter evaluation will be performed for 2 years, by CT-scanner (main outcome) with no contrast, and duplex-scanner.

Eligibility Criteria:
Inclusion Criteria:

* Male patients with asymptomatic AAA ≥ 30 mm, ≤ 49 mm
* Female patients with asymptomatic AAA ≥ 25 mm, ≤ 44 mm

Exclusion Criteria:

* Common iliac aneurysm \> 25 mm
* Saccular aneurysm of the aorta
* Inflammatory aneurysm
* No signature of informed consent
* Renal dysfunction
* Diabetes
Norris ORIEN Total Cancer Care

This research trial collects biological samples and clinical information to create a repository of data from patients with cancer or a predisposition for cancer. Combining genetic information from biological samples and clinical data may lead to more knowledge about why certain cancers respond to treatment and help create more personalized medicine.

PRIMARY OBJECTIVES:

I. To establish a longitudinal study of clinical and related data from patients with or at risk for cancer.

II. To establish a large biospecimen repository that is linked to clinical and related data.

III. To follow patients through their lifetime though passive or active follow-up.

IV. To use clinical data, tissues, other biological samples and derived molecular data in the Total Cancer Care Protocol (TCCP) repositories to match patients in this TCCP study to future studies.

OUTLINE:

Patients undergo collection of blood during a regular care visit or not up to 4 times a year. Extra tissue is collected after removal during standard of care surgery and patients may undergo additional tumor sampling (needle passes) at the time of planned diagnostic biopsies. During bone marrow biopsy, the doctor may reposition the needle up to 3 times, and bone marrow for research will not be collected more than 4 times per year. Patients may undergo additional collection of other biological samples such as saliva, sputum, urine, feces, hair, and surface skin swabs for analysis. Patients also receive surveys or questionnaires to collect demographics, medical, family, and nutritional history, cancer predisposing risk factors, quality of life data, and quality of care data.

After completion of study, patients are followed up periodically.

Eligibility Criteria:
Inclusion Criteria:

* Limited to those patients who are registered for outpatient or inpatient care at University of Southern California (USC) Norris
* Able to understand and sign the TCCP informed consent, California subject's bill of rights, Health Insurance Portability and Accountability Act (HIPAA), and research authorization form directly or through an authorized representative; the informed consent, subject's bill of rights, HIPAA, and research authorization will be available in both English and Spanish languages

Exclusion Criteria:

* Individuals who are not registered as patients for outpatient or inpatient care at USC Norris
* Individuals who are unable to understand or sign the TCCP informed consent, subject's bill of rights, HIPAA, and research authorization in either English or Spanish
Music Imagery for Patients Receiving Chemotherapy for Leukemia or Non-Hodgkin's Lymphoma

The purpose of this study is to explore the effect of music imagery on patients receiving intensive chemotherapy for acute leukemia or high-grade non-Hodgkin's lymphoma.

Standard treatment for acute leukemia and high-grade non-Hodgkin's lymphoma includes intensive chemotherapy that typically requires a 4-week hospital stay in protective isolation. Patients treated in isolation units may experience elevated levels of psychological distress. Both guided imagery and music therapy have been effective in improving the moods of cancer patients, but studies have not been conducted in acute leukemia and non-Hodgkin's lymphoma patients. This study will evaluate the effect of music imagery on these patients.

Participants in this study will be randomly assigned to receive either standard care plus music imagery or standard care alone. Participants assigned to the standard care plus music imagery group will receive a 45-minute weekly music imagery session with a music therapist. All participants will complete questionnaires and self-reports regarding their general anxiety, affect, and fatigue.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to Indiana University Hematologic Malignancy Program for the treatment of newly diagnosed or recurrent acute leukemia or high-grade non-Hodgkin's lymphoma
* Able to read and understand English