cyrilzakka/clinical-trials huggingface dataset:
A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies

CP-MGD024-01 is a Phase 1, open-label, multi-center study of MGD024 as a single agent in participants with select blood cancers that have not responded to treatment with standard therapies or who have relapsed after treatment. The study is designed to determine the safety, tolerability, pharmacokinetics (affect of the body on the drug), pharmacodynamic (affect of the drug on the body), immunogenicity (development of antibodies against the drug), and preliminary anti-cancer effect of MGD024.

Participants will receive treatment with MGD024 in consecutive 28-day cycles for a study treatment period of up to 12 cycles (approximately 1 year) or until treatment or study discontinuation criteria are met. Response assessments will be performed after Cycle 1 and then after every even numbered cycle starting with Cycle 2 until progression or study treatment discontinuation. Participants will be checked for side effects throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients at least 18 years of age, able to provide informed consent and willing to comply with all study procedures.
* Participants with

  * primary or secondary acute myeloid leukemia (AML) except acute promyelocytic leukemia,
  * primary or secondary myelodysplastic syndrome (MDS) with prognostic score of \>3 and \<20% bone marrow blasts,
  * classical Hodgkin lymphoma (cHL),
  * chronic myelogenous leukemia (CML),
  * b-cell acute lymphocytic leukemia (B-ALL),
  * hariy cell leukemia (HCL),
  * advanced systemic mastocytosis (ASM), or
  * blastic plasmacytoid dendritic cell neoplasm (BPDCM)
* Relapsed after or refractory to at least one prior line of therapy and with no available potentially curative treatment option.
* Evidence of CD123 expression
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
* Life expectancy of at least 12 weeks.
* Acceptable laboratory values, and heart function.
* Continuing side effects of prior treatment are mild
* Women and men of childbearing potential must agree to use highly effective forms of contraception throughout the study through 4 months after the last dose of MGD024.

Exclusion Criteria:

* Prior treatment with an anti-CD123-directed agent (except patients with BPDCN, who are allowed to have received prior tagraxofusp).
* Known involvement of central nervous system (CNS) by the disease under investigation.
* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient.
* Systemic anti-cancer therapy, investigational therapy, corticosteroids or other immune suppressive drugs within 14 days of first dose
* Vaccination with any live virus vaccine within 4 weeks prior to first dose. Inactivated annual influenza and SARS-CoV-2 vaccination are allowed.
Study of Flavocoxid (Limbrel) vs Naproxen in Subjects With Mod-Severe Osteoarthritis of the Knee

Randomized, double-blind, placebo controlled parallel group, multi center study in subjects with moderate-severe osteoarthritis.

This will be a randomized, double blind, placebo controlled, parallel group, multi-center study in subjects with moderate-severe OA. Subjects will be randomized to receive flavocoxid 250 mg bid, flavocoxid 500 mg bid, naproxen 500 mg bid or placebo in a 2:2:2:1 ratio. Subjects will take study materials twice daily for twelve (12) weeks. After the 12 week visit subjects in the placebo arm will be re-randomized to the two flavocoxid arms. All subjects will then continue on the study for an additional 12 weeks.

Subjects will keep a diary noting date of onset of symptom change (better or worse), adverse events and cost of all aspects of medical care related directly or indirectly to osteoarthritis.

Laboratory studies for inflammatory markers will be drawn and archived at baseline and at the 12 week visit. In addition, a subgroup of subjects will have arthrocenteses performed at baseline and the 12 week visit and the synovial fluid archived for study of intra-articular inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* OA of the Knee
* K-L Grade 2-3
* Positive response to NSAIDS

Exclusion Criteria:

* K-L grade 1 0r 4 OA of the knee
* History of GI Bleed within past 5 years
* Chronic bleeding disorder
Ga-68-NODAGA-MJ9 Compared to F-18-FCH PET/CT for Prostate Cancer Patients

Prostate cancer patients for whom a F-18-FCH PET/CT is indicated. Ga-68-NODAGA-MJ9 is a new PET/CT radiotracer aiming at giving complementary information : more precise images and early localisation of recurrence to standard imaging

Patient with primary or relapsing prostate cancer for whom F-18-FCH PET/CT is indicated will be proposed to participate to the present study. After signing the patient informed consent, both F-18-FCH and Ga-68-NODAGA-MJ9 PET/CT will be scheduled with a maximum 10 day-interval.

No adverse events are expected.

Eligibility Criteria:
Inclusion Criteria:

* Age : adult patients
* Karnofsky : ≥ 80%
* Patients with histologically proven prostate cancer for whom 18F-fluocholine PET/CT is indicated for primary cancer staging, or for recurrence with increase of blood PSA. In order to provide a detection probability of 30% or more, a blood PSA 0.5 ng / ml or more in post initial curative intent surgery will be required.
* Signed informed consent.

Exclusion Criteria:

* Lack of discernment to sign the consent form
* Age \<18 years
* Patient under hormonal treatment
MR-BIO: a Study to Evaluate Changes in MR Imaging and Biological Parameters

The MR BIO study aims to understand the changes in the tumour and normal tissues during a course of radiotherapy. This is accomplished by studying the MR images taken during each treatment session on the MR Linear accelerator (MR Linac). The overarching hypothesis is that changes in MR imaging and biological parameters from blood, tissue, or urine biomarkers can be measured during radiotherapy and associated with clinical outcome.

The MR Linac is a new radiotherapy machine with an on board MR scanner. This enables us to take images with high resolution and target the tumours more precisely and also reduce the dose to normal tissues. All patients undergoing treatment in the MR Linac at the Christie hospital will be considered for enrolment regardless of tumour site being treated.

The study participants will receive the standard of care treatment for their disease condition. In addition, they will be requested to give weekly blood and urine samples during the course of radiotherapy and at first follow up. On completion of radiotherapy treatment, the participants will continue to be on standard of care follow up protocol with the treating oncologist.

A small cohort of ten healthy volunteers will also be recruited to the study to develop and select some of the MR sequences only; they will not provide blood or urine samples. The healthy volunteers will be scanned for no more than one hour per session for a maximum of two sessions in total. These optimised sequences can then be used in the patient cohort.


Eligibility Criteria:
Inclusion Criteria:

Be willing and able to provide written consent. Over 18 years of age. Undergo and satisfy MRI Safety Screening Patient volunteers must be under the care of a clinical oncologist at The Christie NHS Foundation Trust and be planned to receive radiotherapy to the target site to be imaged.

Patient volunteers must be able to give blood and/or urine sample as required through the treatment period.

Non-patient (healthy) volunteers must have no known or suspected significant medical condition.

Exclusion Criteria:

The following apply to both patients and healthy volunteers:

Any conditions that would be a contra-indication to MRI including:

* Failure to satisfy MRI Safety Screening Form
* Implanted pacemakers and/or pacing wires
* Cochlear implants
* Programmable hydrocephalus shunts
* Ferromagnetic implants
* Unable to tolerate MR scans
* Known HIV or active HepB or C
* Pregnancy Healthy volunteers must not be a member of the study team.
The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors

The microbiome has the potential to serve as a robust biomarker of clinical response to immunotherapy. Additionally, microbial manipulation, through diet, exercise, prebiotics, probiotics, or microbially-derived metabolites, may prove to be beneficial in promoting anti-tumor immune responses. However, large prospective studies in humans with longitudinal sample collection and standardized methods are needed to understand how microbiota and their byproducts affect cancer therapies, particularly among patients undergoing identical therapy but experiencing different outcomes. The proposed observational study builds upon these hypotheses by proposing a large cohort design to further assess the associations between the gut microbiota (composition and function), host immune system, and ICI treatment efficacy across multiple cancer types.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women ≥18 years of age
2. Screened negative for COVID-19 symptoms at time of consent, as per institutional policy and as applicable for the duration of the COVID-19 pandemic
3. Diagnosed with stages I-IV primary NSCLC, MM, TNBC or RCC
4. Plan to be treated at a partner cancer site with a checkpoint inhibitor (anti-PD-1, anti-PD-L1, or anti-CTLA-4) as a single agent or in combination with another checkpoint inhibitor or other treatment agent or modality (e.g., targeted therapy, chemotherapy, surgery, radiation, etc.) in accordance with FDA-labeled use of the agent
5. Able to provide informed consent and answer study questionnaires in either English or Spanish
6. Able to provide stool specimens for research purposes

Exclusion Criteria:

1. Mental incapacity
2. Incarcerated individuals
3. Pregnancy (by self-report of pregnancy status)
4. Experiencing active brain metastasis/metastases
5. Treatment with checkpoint inhibitor in off-label capacity or through a clinical/interventional trial
6. Active participation in an immuno-oncology clinical/interventional trial or pharma-sponsored observational study
SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide

The purpose of this study is to compare the efficacy of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) as measured by the duration of severe neutropenia (DSN).

This is a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer treated with TC chemotherapy as measured by the duration of severe neutropenia (DSN).

Each cycle was 21 days. Four cycles were evaluated for this study. On Day 1 of each cycle, participants received TC chemotherapy. On Day 2 of each cycle, participants received study drug (SPI-2012 or pegfilgrastim).

After cycle 1, as applicable, participants who received at least one dose of study drug will be followed for safety for 12 months after the last dose of study treatment.

Eligibility Criteria:
Key Inclusion Criteria:

* New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer
* Candidate for adjuvant or neo-adjuvant TC chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status \<= 2
* Absolute neutrophil count (ANC) \>=1.5×10\^9/L
* Platelet count \>=100×10\^9/L
* Hemoglobin \>9 g/dL
* Calculated creatinine clearance \> 50 mL/min
* Total bilirubin \<=1.5 mg/dL
* Aspartate aminotransferase (AST) / Serum glutamic oxaloacetic transaminase (SGOT) and Alanine aminotransferase (ALT)/Serum glutamic pyruvic transaminase (SGPT) \<=2.5×ULN (upper limit of normal)
* Alkaline phosphatase \<=2.0×ULN

Key Exclusion Criteria:

* Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease
* Locally recurrent/metastatic breast cancer
* Known sensitivity to E. coli-derived products
* Concurrent adjuvant cancer therapy
* Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug
* Active infection, receiving anti-infectives, or any underlying medical condition that would impair ability to receive protocol treatment
* Prior bone marrow or stem cell transplant
* Used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study• Radiation therapy within 30 days prior to enrollment
* Major surgery within 30 days prior to enrollment
A Study in Healthy Men to Test How Different Doses of BI 3000202 Are Tolerated and How Food Influences the Amount of BI 3000202 in the Blood

The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of BI 3000202.

The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3000202 formulation.


Eligibility Criteria:
Inclusion criteria

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests without any clinically significant abnormalities
2. Age of 18 to 45 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
4. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

Exclusion criteria

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.
Drug Use Investigation Of Gabapentin

The objective of the this surveillance is to collect information about 1)adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.

All the patients whom an investigator prescribes the first Gabapentin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

Patients need to be taking Gabapentin in order to be enrolled in the surveillance

Exclusion Criteria:

Patients not taking Gabapentin
Cardiac and Vascular Late Sequelae in Long-term Survivors of Childhood Cancer (CVSS)

Due to remarkable advances in childhood cancer therapy the 10-year survival rate increased to over 80% and late sequelae come to the fore. Childhood cancer survivors (CCS) suffer from significant excess in mortality risk associated with treatment-related complications at least for 25 years after the initial cancer diagnosis. In particular, the prevalence of cardiovascular disease seems to be elevated compared to the general population. The CVSS study is a multi-disciplinary cooperation project between the Institute for Medical Biostatistics, Epidemiology and Informatics (IMBEI) and the German Childhood Cancer Registry (GCCR), the Preventive Cardiology and Preventive Medicine and the Pediatric Hematology and Oncology all at the University Medical Center of the Johannes Gutenberg University Mainz. The central element is a thorough clinical cardiovascular examination of all patients, which permits detecting subclinical disease. Therapy data will be extracted retrospectively from various sources. The study intends to describe the current situation of a cohort of approximately 1000 CCS in Germany aged 24 to 49 years with respect to cardiovascular health. The role of risk factors (treatment related and classic cardiovascular risk factors), as well as related predisposing genetic factors is investigated. The results will contribute to recommendations to improve follow-up care.


Eligibility Criteria:
Inclusion Criteria:

1. Survivors of oncological disease according to ICCC-3 aged \<15 years at diagnosis, diagnosed 1980-1990 while resident in Germany
2. Declaration of consent for storage of personal data at GCCR

Exclusion Criteria:

1. Patient has refused contact with GCCR
2. Current address not available
3. Second malignant neoplasm
4. Diagnosis Morbus Hodgkin
5. Diagnosis WILMS tumor in 1990
6. Former treating center recommends exclusion
7. Insufficient knowledge of German language
8. Inability to travel to the study center and participate in the examinations
Study of the Effect of the Cognitive Orientation to Daily Occupational Performance (CO-OP) on Cognitive Impairment in Parkinson's Disease

The purpose of the study will be to determine the effects of the Cognitive Orientation to daily Occupational Performance (CO-OP) as a treatment program for individuals with Parkinson's disease-related cognitive impairment. The potential effects of the CO-OP on successful engagement in meaningful activities will be examined from participants' and live-in caregivers' perspectives. Effects of the CO-OP on participant-perceived health-related quality of life and caregiver burden will also be evaluated.

Hypotheses:

1. Training with the CO-OP will have an effect or multiple effects on participation in meaningful activities and health-related quality of life for individuals with Parkinson's-related cognitive impairment.
2. Training with the CO-OP will have an effect or multiple effects on caregiver burden and health-related quality of life for caregivers of individuals with Parkinson's-related cognitive impairment.


Eligibility Criteria:
Inclusion Criteria for Participants with Parkinson's disease:

* Clinical diagnosis of Idiopathic Parkinson's Disease
* Presence of a live-in caregiver or significant other who is willing to participate in the study
* Montreal Cognitive Assessment (MoCA) score above 16/30 and below 26/30
* Schwab and England Activities of Daily Living Scale scores between 60% and 90%
* Hoehn and Yahr Scale scores between Stage 1 and Stage 3
* Self-reported difficulty completing routine functional activities that may be related to new cognitive changes since PD diagnosis

Exclusion Criteria for Participants with Parkinson's disease:

* Clinical diagnosis of atypical parkinsonism
* Clinical diagnosis of young-onset Parkinson's disease
* Co-morbidities associated with cognitive impairment
* Poorly controlled depression
* Clinical diagnosis of dementia
* Residence outside boundaries of the city of Winnipeg, Manitoba, Canada

Inclusion Criteria for Caregiver Participants:

* Live in the same residence as participant with Parkinson's
* Be willing to participate

Exclusion Criteria for Caregiver Participants:

* Scores at or below 16/30 on Montreal Cognitive Assessment (MoCA)
The Efficacy Study of Sodium Hyaluronate to Treat Symptomatic Hip Osteoarthritis

To demonstrate the difference in terms of symptomatic efficacy between ADANT® sodium hyaluronate and placebo following an intra-articular injection in patients with symptomatic osteoarthritis of the hip.

Each patient will receive an injection of sodium hyaluronate or placebo in the symptomatic hip and will be followed up for three months.

At the third month, if the score for overall pain is still \> 40 mm on the VAS, a second injection of ADANT® can be given irrespective of which treatment was received previously. The patient will be followed up for a further 3 months in an open-label fashion (monthly visits).


Eligibility Criteria:
Inclusion Criteria:

* 1. Primary osteoarthritis of the hip defined according to the ACR criteria; symptomatic, 2. Osteoarthritis of radiological grade II to III according to the Kellgren-Lawrence classification, using X-rays performed during the last three months, 3. Overall pain intensity between 40 and 80 mm on a VAS of 100 mm at the pre-screening examination, 4. The patients experienced pain at least one in two days during the last 30 days, it was resistant to paracetamol treatment at a dose of 4 g/day and a step 2 analgesic or a NSAID taken for at least 10 days, 5. A prosthesis is not planned in the next six months.

Exclusion Criteria:

* Women who are pregnant or breastfeeding or women who could become pregnant and are not using effective contraception,
* Major dysplasia (defined using Lequesne's criteria as dislocation of the hip),
* Treatment by intra-articular injection of hyaluronic acid in the symptomatic hip during the 6 months prior to pre-screening,
* Patients with a history of hypersensitivity to any of the ingredients in the hyaluronan,
* The presence of inflammatory arthropathy or another disorder or condition that could affect the joint (e.g., rheumatoid arthritis, metabolic bone disease, femoral head necrosis, psoriasis, gout, infection),
* Another muscular or skeletal condition that could interfere with the evaluation of the efficacy of the treatment on the hip in question (evaluation of pain or functional handicap),
* Systemic corticosteroid therapy or intra-articular injection of corticosteroids into the ipsilateral hip or knee within the last month,
* Intermittent claudication or vascular disease,
* Previous surgery on the hip in question,
* Septic arthritis at any site,
* Any surgical procedure, including arthroplasty or arthroscopy, to the hip during the six months prior to pre-screening or surgery scheduled during the trial,
* Any chronic skin condition that could affect the site of the injection,
* Use of the investigational treatment or material during the last three months,
* Oral or injectable anticoagulant treatment,
* Antiaggregant platelet treatment, particularly low-dose aspirin,
* Symptomatic chondrocalcinosis in the painful hip