cyrilzakka/clinical-trials huggingface dataset:
An Expanded Access Program for AM0010 (Pegilodecakin)

This is an Expanded Access Program (EAP) available to patients who have advanced cancers, who have failed or progressed on standard of care systemic therapy and do not qualify for ongoing clinical trials.


Eligibility Criteria:
* Patient is NOT eligible for other AM0010 clinical trials currently open in the region
* Patient is in urgent need of therapy who fail to meet eligibility criteria for other clinical trials related to AM0010 (PEG-IL-10) can be considered for enrollment into this Expanded Access Program.
* Patient has advanced cancer in indications where preliminary anti-tumor efficacy of AM0010 has been demonstrated or where AM0010 mediated immune activation is likely to benefit the patient.
* Patient has failed or progressed on standard of care (SOC) systemic therapy
* Patient is refusing SOC therapy
Ferumoxytol for Iron-Deficiency Anemia in Chronic Kidney Disease and Peritoneal Dialysis Patients

The purpose of this study is to investigate the efficacy of ferumoxytol for the repletion of iron stores and correction of iron deficiency anaemia in patients with severe chronic kidney disease or end-stage chronic kidney disease on peritoneal dialysis, and to assess the impact of the administration of a ferumoxytol dose on various markers for iron stores, as well as on various markers for inflammation and oxidative stress.


Eligibility Criteria:
Inclusion Criteria:

* For women of childbearing age, negative serum pregnancy test at screening.
* Severe chronic kidney disease (TFGe lower than 30 ml/min) OR end-stage kidney disease on peritoneal dialysis.
* Anaemia, as defined by haemoglobin (Hb) \< 120 g/L, within 14 days prior to screening, in a patient with or without an Erythropoiesis-stimulating agent (ESA).
* Iron depletion, as defined by transferrin saturation (TSAT) \< 20% and/or a ferritin assay (FERR) \< 200, within 14 days prior to screening.
* If an ESA is used, stable dose over the past 60 days.

Exclusion Criteria:

* Allergy to ferumoxytol or another intravenous iron formulation.
* Administration of ferumoxytol or any other intravenous, intramuscular or oral iron formulation within 30 days of enrolment.
* Patient who have received a blood transfusion within 2 weeks prior to enrolment, or are planned to receive a blood transfusion over the duration of the study.
* Patient currently participating in a clinical trial with another investigational drug or device or who have received an investigational drug or device within 30 days of enrolment in this study.
* Hb \< 90 g/L at the time of screening.
* Existing or clinically suspected bleeding of digestive, gynaecological or other origin.
* Patient who have another cause of anemia, other than iron deficiency (for example, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, multiple myeloma, myelodysplastic disorder, etc.).
* Patients who are not responding to ESA or who are receiving in excess of 30000 units/week of erythropoietin (EPO), or 150 mcg/week of darbepoietin alfa.
* Major surgery within one month prior to enrolment in the study or planned surgery, other than vascular access creation, while the patient is in on the study.
* Patient who have had a malignancy (except for non-melanoma cancer of the skin) unless the patient has received curative treatment and has been disease-free for \> 2 years.
* Patient who are considered by the Investigator to have a medical status that would preclude the patient's participation in this protocol.
* Patient due to have a magnetic resonance imaging examination or in whom such an examination is planned, in the next three months.
* Woman who plans to become pregnant in the next three months.
* Woman that is breastfeeding.
* Ongoing or recent (\< 2 weeks) bacterial infection requiring treatment.
* Patient unable to give informed consent.
* Patient refuses to give informed consent.
Efficacy of Biosimilar Filgrastim on the Mobilization of Hematopoietic Stem Cell CD34+ (Cluster of Differentiation 34) and on the Kinetic Engraftment

The endogenous growth factor granulocyte (G-CSF) stimulates the proliferation and differentiation of hematopoietic progenitors commissioned to mature as neutrophils and activated granulocytes mature neutrophils. In the field of hematology oncology G-CSF it is used to reduce the duration and complications of chemotherapy-induced neutropenia and to stimulate the mobilization and subsequent collection of circulating hematopoietic stem cells in order to use them for autologous transplantation procedure.

Filgrastim and Lenograstim originator are marketed for many years and are considered the reference molecules for the production of biosimilar.

For several years it is available and entered into common clinical practice the use of filgrastim biosimilar (Bio-GCSF) in treating the patient oncohematologic.

Aim of the study is to analyze retrospectively a large series of patients and assess the impacts of the Bio-GCSF on the collection of hematopoietic stem cells and recovery of blood counts post autologous transplantation; the data will be compared with a historical cohort of reference that has been treated with G-CSF originator.

The study results will not generate any diagnostic or therapeutic intervention in patients still alive.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years with history of autologous transplant
* hematological diseases including:
* Multiple Myeloma
* Hodgkin's Lymphoma
* Non-Hodgkin lymphoma B and T
* Lymphocytic leukemia
* Acute myeloid leukemia

Exclusion Criteria:

* N.A.
The Co-Op @ HeartWorks

This protocol is a research study involving human subjects diagnosed with Congenital Heart Defects/Disease (CHD). The Co-Op @ HeartWorks is a cooperative between the research platform at HeartWorks and members of the CHD community. Individuals choosing to participate will be referred to as 'members' of the co-op. This study aims to create a database of members medical journey data to inform future clinical innovation and design of clinical trials which address the needs of the members. The knowledge generated from this study will help advance the care of CHD patients through the deliberate action of The Co-Op @ HeartWorks members. Unlike a traditional disease registry, the members of The Co-Op @ HeartWorks will actively inform and contribute to the future studies affecting their health.


Eligibility Criteria:
Inclusion Criteria:

* Adult with a congenital heart defects/disease
* Caregiver of a minor with a congenital heart defect/disease
* Authorized family member of a now deceased person with congenital heart defect/disease

Exclusion Criteria:

- Not having a congenital heart defect/disease
Preoperative Regional Nerve Block for Acute and Chronic Post-Operative Pain Following Mastectomy

The purpose of this study is to see if pre-operative regional nerve blocks compared to a placebo nerve block can decrease chronic post mastectomy pain, immediate postoperative pain and postoperative narcotic consumption.

Surgical intervention of breast cancer is vital to breast cancer treatment or prevention and patient outcomes. However, surgical therapy can lead to chronic pain that may affect quality of life for breast cancer survivors including the potential for long-term disability. Chronic pain after breast cancer surgery is common, occurring in about 25-50% of patients. This chronic pain commonly affects women following a mastectomy and is referred to as Post Mastectomy Pain Syndrome (PMPS). Regional anesthesia utilizing single dose nerve blocks is frequently utilized in the preoperative period for many surgical procedures and decreases postoperative pain. Regional anesthesia also frequently results in decreased narcotic use in the post-operative period. The use of regional fascial plane blocks or Pectoralis (PECs) blocks has increased in the setting of mastectomy. The regional block utilizes ultrasound guidance to inject local anesthesia into the fascial planes of muscles thereby infiltrate the surrounding nerves. One example is the pectoral I block which deposits local anesthetic between the pectoralis major and minor muscles and pectoral II above the serratus anterior muscle with an intended blockade for intercostals III, IV, V, VI and long thoracic nerves. These techniques have shown a decrease in postoperative pain and postoperative narcotic consumption. The investigators seek to evaluate if preoperative regional nerve blocks decrease post mastectomy chronic pain, improving the quality of life of breast cancer survivors. Therefore, the aim of this study is to determine whether regional nerve blocks affect chronic post-mastectomy pain and whether the regional block is associated with perioperative pain and postoperative narcotic consumption.

Eligibility Criteria:
Inclusion Criteria:

1. Women at least 19 years old who are able to provide written and informed consent
2. Women undergoing unilateral or bilateral, simple, skin-sparing, or nipple sparing mastectomy for breast cancer (Stage 0-III) or breast cancer prevention
3. Patients with ASA class of I-III will be included

Exclusion Criteria:

1. Stage IV breast cancer, morbid obesity with BMI \>45kg/m2
2. Renal insufficiency (Creatinine \>1.5 mg/dL)
3. Current chronic analgesic use (daily use for \> or equal to 4 weeks)
4. History of opioid abuse or dependence
5. Presence of chronic pain with a self-reported average pain score of 4 or greater on a pain scale of 0-10 prior to any surgical intervention
6. Incarceration
7. Pregnancy
8. Immediate autologous tissue reconstruction.
A Pilot Study to Determine Nutrition Status in Glioblastoma Multiforme Patients

The study is designed to evaluate how the composition of a participant's body, diagnosed with a brain tumor (glioblastoma multiforme) as determined by bioelectrical impedance analysis can predict the progression and outcomes of disease.

The purpose of this study is to monitor the nutritional status of (Glioblastoma Multiforme)GBM patients for one year. We will look at the relationships between phase angle determined by Bioelectrical Impedance Analysis (BIA), nutrition assessment by Subjective Global Assessment and serum albumin, the type of microbes present in the gut, the participant's DNA information, and tumor progression. We will also compare estimated caloric needs determined by BIA and Harris Benedict Equation to Resting Energy Expenditure from Indirect Calorimetry of the people with GBM and the people without.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 19 years of age.
* Subjects must have a histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme).
* Women of childbearing potential must have a negative pregnancy test.

Exclusion Criteria:

* Subjects with implanted pacemakers or defibrillators.
* Subjects who are pregnant.
* Subjects with edema.
* Subjects with an amputated extremity.
An Efficacy and Safety Study for the Treatment of Mild to Moderate Acute Pain Associated With Ankle Strain or Sprain.

This is a randomized, double blind, placebo controlled, parallel group study to assess the efficacy and safety of K-103-IP compared with placebo patch for treatment of mild to moderate acute pain associated with ankle strain or sprain.


Eligibility Criteria:
Inclusion Criteria:

* Subject must provide informed consent before any study specific evaluation is performed.
* Subject is male or female aged 18 to 70 years, inclusive.
* Subject has a grade 1 (mild functional impairment) or grade 2 (moderate functional impairment) ankle strain or sprain that occurred within 48 hours before the Screening visit.
* Subject has pain intensity upon monopodal weight bearing of 5 to 8, inclusive, measured by an 11 point nominal rating scale (NRS), plus pain intensity score at rest that is less than upon monopodal weight bearing.

Exclusion Criteria:

* Subject has a grade 3 (severe functional impairment) strain or sprain, bilateral strain or sprain, or concomitant fracture or wound at the site of the strain or sprain.
* Subject has had an ankle strain or sprain to the same foot within 6 months before the Screening visit.
* Subject has received topical analgesic medication within 24 hours before the Screening visit.
* Subject has applied ice or compression to the injured area within 2 hours before the Screening visit.
Belgian Cross-sectional Allogeneic Transplant Survivor Study

With the increasing successful use of allogeneic hematopoietic stem cell transplantation (HSCT) to cure advanced hematological disease, it becomes essential to evaluate the long-term effects of such a drastic treatment.

This study investigates the prevalence of several demographic, psychosocial and behavioral aspects of survivorship after an allogeneic transplantation. Income, return to work, social isolation, pain, medication adherence, influenza vaccination status, alcohol use, smoking habits, drug use, healthy diet, prevention of UV exposure, physical activity, functional status/Quality of life (QoL), couple life/sexual function, depression, anxiety, spirituality and resilience will be studied.

This is a cross sectional study, where participants are interviewed and fill in a self reported survey. The interview and survey are only taken once. It is non interventional because the patients only give us extra information, which is not usually recorded in our medical records.

Eligibility Criteria:
Inclusion Criteria:

* Ability to read and write in Dutch
* Age above 18 years at time of transplant
* Transplanted in UZ Leuven between 1992 and 2012 with an allogeneic donor (i.e. being at least 2 years post-Tx)
* Presenting for a periodic health check in UZLEUVEN from November 15th, 2014 to November 15th 2016
* Willing to provide oral and written consent

Exclusion Criteria:

* Unable to communicate fluently in Dutch
* Presenting with major visual, hearing, cognitive or psychiatric conditions precluding participation
* Presenting with relapse or other major illness, with less than 6 months expected survival
* Hospitalized for a life-threatening condition
Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD)

The purpose of this study is to determine whether prazosin will:

* reduce the incidence of nightmares and sleep disturbance
* increase functioning and sense of well being in combat-trauma exposed Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) Veterans.

This is a 15-week randomized parallel design, double-blind, placebo-controlled augmentation trial of prazosin to evaluate the efficacy and tolerability of prazosin augmentation in the treatment of PTSD trauma-related nightmares, sleep disturbance, global function and sense of well-being, and other clinical features and comorbidities of PTSD. Participants will be 210 OIF/OEF soldiers and veterans who have suffered war zone trauma. Participants will be randomized 1:1 to prazosin or placebo and all previous psychotropic medications and/or psychotherapy will be maintained constant. Randomization will be stratified by site and use of an antidepressant.

Eligibility Criteria:
Inclusion Criteria

* Age \>18 years;
* Clear evidence of exposure to one or more war zone trauma events sufficient to satisfy DSM-IV criterion A1 for diagnosis of PTSD;
* DSM-IV diagnosis of PTSD derived from the CAPS; CAPS total score \>50;
* CAPS Recurrent Distressing Dreams item score \>5 (of maximum score of 8);
* stable dose of non-exclusionary medications and psychotherapeutic treatment for at least 4 weeks prior to randomization;
* good general medical health.
* Female participants must agree to use a reliable form of birth control during the study.

Exclusion Criteria

* Psychiatric/Behavioral - meets DSM-IV criteria for current schizophrenia, schizoaffective disorder, psychotic disorder, delirium, or any DSM-IV cognitive disorder; substance dependence disorder within 3 months or any current substance dependence; current cocaine or stimulant abuse; severe psychiatric instability or severe situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to patient or others.
* Medical - acute or unstable chronic medical illness, including unstable angina, recent myocardial infarction (within 6 months), congestive heart failure, preexisting hypotension or orthostatic hypotension, chronic renal or hepatic failure, pancreatitis, Meniere's disease, benign positional vertigo; narcolepsy, or diagnosed sleep apnea; allergy or previous adverse reaction to prazosin or other alpha-1 antagonist.
Cardiac Rehabilitation and Sedentary Behavior

This trial randomizes patients who plan to attend cardiac rehabilitation to either a behavioral intervention to specifically reduce sedentary behavior or to usual care which exclusively focuses on increasing exercise.

Cardiac rehabilitation after a cardiac event or procedure is of key importance to physical and psychological recovery. Cardiac rehabilitation comprises a standardized stepwise approach to exercise in a supervised setting and is proven to reduce morbidity and mortality after a cardiac event. However, cardiac rehabilitation does not necessarily change behavior in the long-term and many do not attend cardiac rehabilitation due to lack of motivation, difficulty accessing programs, and cost. These individuals loose an important opportunity to improve their health, sense of well-being and outcomes. The investigators propose to test the effect of a patient-centered approach to reduce sedentary behavior for aging adults added to usual cardiac rehabilitation. In this study, the investigators will identify patients at their introductory visit to cardiac rehabilitation and randomize to either a program to decrease in-home sedentary behavior vs. a standard program to increase in-home exercise. Both groups will receive additional support and encouragement to attend cardiac rehabilitation. Using motivational interviewing techniques in both groups the investigators will assist the patients in recognizing their potential and goal-setting. Patients will be monitored using the ActivPAL monitor, a new technology that quantifies sedentary time and steps/day. Patients will be monitored four times as they proceed through cardiac rehabilitation for a total of 13 weeks and receive 3 educational and goal setting sessions. Those in the intervention group will have sedentary behavior change emphasized with feedback from the ActivPAL monitor. The control group will focus on standard exercise recommendations and feedback from his/her exercise diary. Outcomes include change in sedentary time and steps/day. Anticipated results include a significant change in the intervention group vs. the control: a decrease in in-home sedentary time, an increase in steps/day. The results of this study will provide the basis for designing a larger randomized controlled trial to investigate the effects of an intervention to reduce sedentary behavior as an adjunct to cardiac rehabilitation especially for older adults. Additional investigation will be warranted for those who do not attend cardiac rehabilitation but are able to follow a post-cardiac event program to reduce in-home sedentary behavior.

Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled in Cardiac Rehabilitation
* Age 50 years old or greater
* Short Physical Performance Battery (SPPB) score equal or less than 10

Exclusion Criteria:

* Hypoxia
* Orthopedic Disease that limits mobility
* Neurologic Disease that limits mobility
* Metastatic Cancer
* Life expectancy of \<6 months
* Depression
* Montreal Cognitive Assessment less than 24
* Left Ventricular Assist Device (LVAD)
* Cardiac Transplant
* Patient Health Questionnaire-9 (PHQ-9) of 15 or greater
Outpatient Medical Abortion With Mifepristone and Misoprostol Through 77 Days of Gestation

To demonstrate non-inferiority of the efficacy of 200 mg mifepristone followed in 24 to 48 hours by 800 µg buccal misoprostol in outpatient medical abortion services among women 71-77 days' compared to women 64-70 days' LMP.


Eligibility Criteria:
Inclusion Criteria:

* intrauterine pregnancy between 64 days and 77 days' LMP
* eligible for medical abortion according to study doctor assessment
* willing and able to sign consent form
* speak english or spanish (in US sites); speak the local language(s) (in international sites)
* agree to comply with the study procedures and visit schedule

Exclusion Criteria:

* Have known allergies or present other contraindications to mifepristone or misoprostol
The Optimization of Iron Bioavailability of Supplements Using Hepcidin Levels in Humans

Background: Oral iron supplementation (OIS) is a widely-used strategy to treat iron deficiency anemia. However, absorption of OIS is often low and response is variable. To overcome this, large doses are given but this may reduce compliance due to gastric irritation. Thus, OIS doses should be low, while maximizing absorption. The prevailing serum hepcidin concentration (SHep) is the major determinant of iron absorption and erythrocyte iron utilization. Based on limited data in humans, SHep can be increased by a single OIS dose but the duration of the increase is uncertain: In a recent study conducted in our laboratory it has been found to last approx. 24 h. Also, there are few data on how the increase in SHep determines the absorption of further doses of oral iron. Is there a threshold SHep at which subsequent iron absorption is sharply reduced? Better understanding of this relationship would be valuable to design more effective and safer OIS regimens.

Objectives: 1) Determine whether two consecutive dosages of 60 mg Fe differently affect hepcidin response and iron bioavailability (Study 1) 2) Compare the bioavailability of iron supplement dosages given at different times of the day (Study 2).

Methods/Subjects: Healthy female subjects will be screened for low iron status. Anemic subjects will be excluded from the study. Thirty two subjects will be included with serum ferritin \<20 µg/L, C-reactive protein \<5 mg/L and Hemoglobin \>117 g/L. Subjects will be randomized in two groups and their Hepcidin (sHep) and iron status markers monitored at day 1 (baseline). Subjects will receive iron supplement dosages of 60 mg with stable iron isotopes 54Fe, 57Fe, 58Fe in form of 4 mg of FeSO4. Prior administration blood samples will be collected to monitor sHep and iron status markers.

Outcome: The combined use of stable iron isotopes and a sensitive SHep assay will allow for better understanding of the iron-hepcidin relationship and this may enable design of more effective OIS regimens.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, no blood donation in the last 4 months, not pregnant, not lactating, not taking vitamin and mineral supplements 2 weeks prior the study, non smoker, weight \<65 Kg, BMI between 18 and 25.
* No anemia (defined as 11.7 g/dl, Serum ferritin level \< 20 microgram/L).