cyrilzakka/clinical-trials huggingface dataset:
Geriatric-CO-mAnagement for Cardiology Patients in the Hospital

The primary objective of the evaluation study is to determine if geriatric co-management is superior to standard of care in preventing functional decline in older patients admitted for acute heart disease or Transcatheter Aortic Valve Implementation (TAVI) to the cardiology units of the University Hospitals Leuven.

This study aims to implement and evaluate a geriatric co-management intervention in older patients admitted for acute heart disease or Transcatheter Aortic Valve Implementation (TAVI) to the cardiology units of the University Hospitals Leuven. The study uses a mixed-methods methodology aiming to 1) assess the feasibility and evaluate the effectiveness of geriatric co-management, 2) describe the experiences of intervention participants, and 3) perform a process evaluation. We will first consecutively recruit patients on the cardiology units to measure the standard of care in the control group. The geriatric co-management intervention will then be implemented and piloted on the participating units. Once fully implemented, we will consecutively recruit patients for the intervention group who will receive the geriatric co-management intervention.

Eligibility Criteria:
Inclusion Criteria: Patients will be included if they:

* Are admitted for non-surgical treatment of an acute heart problem (patients may be admitted through the emergency department or the cardiology outpatient services for any heart related acute disease) OR if they are admitted for Transcatheter Aortic Valve Implantation (TAVI);
* Are aged 75 years or older;
* Have an expected length of stay of three days or longer;
* Non-palliative on hospital admission
* Are Dutch speaking and testable;
* Give informed consent or proxy-informed consent;

Exclusion Criteria: Patients will be excluded if they:

* Are admitted from another hospital unit or other hospital;
* Have been admitted to the intensive care unit for three days or longer;
Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of DHP107 (Oral Paclitaxel, Korea brand name: Liporaxel®) compared to IV Paclitaxel in patients with Recurrent or Metastatic Breast Cancer.


Eligibility Criteria:
Key Inclusion Criteria:

1. Subjects with confirmed diagnosis of recurrent or metastatic breast cancer based on histopathology examination
2. Subjects with diagnosis of HER2-negative breast cancer that was confirmed by IHC or in situ hybridization (ISH) assessment of tumor samples
3. Subjects who have received up to 3 lines of therapy for advanced disease, without prior exposure to taxane in the advanced stage setting
4. Subjects who have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.
5. Subjects who have measurable disease according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1).

Key Exclusion Criteria:

1. Subjects who have received prior taxane therapy in the metastatic setting
2. Subjects whose adjuvant or neoadjuvant treatment for early stage breast cancer was completed within 6 months prior to entry into the study.
3. Subjects with neuropathy grade ≥2 based on CTCAE v4.03 at the time of study entry
4. Subjects with symptomatic, untreated metastases to the central nervous system (CNS) at the time of screening.
5. Subjects who have received any investigational drugs or devices within 4 weeks before the first day of study treatment (C1D1).
PRISMA Study (Prospective, Randomized Trial on Intensive Self-Monitoring Blood Glucose Management Added Value in Non-Insulin Treated Type 2 Diabetes Mellitus Patients)

This randomized, parallel study compares 2 groups of type 2 non-insulin treated (NIT) diabetes patients using the Accu-Chek Aviva glucometers. One group (Intensive Group) will perform a 4-point daily glucose monitoring profile 3 times a week Monnier-based. These patients will also receive specific glycemic targets and suggestions on how to reach them following lifestyle recommendations. At the same time, investigators will use SMBG results, downloaded from glucometers, to improve patients' therapy. The second group (Control Group), will follow the SMBG standard care usually adopted in their centers. To be eligible, patients do not to have performed a previous intensive SMBG management (the execution of SMBG measurements used to modify lifestyle, diet or physical activity, in a systematic/structured manner and/or to manage therapeutic approach). The anticipated duration of the trial is 12 months, and the target sample size is 1000 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 35-75 years of age
* Non-insulin treated type 2 diabetes for 1-10 years before enrollment
* Treatment with diet and oral hypoglycemic agents, or with diet only
* HbAlc of 7.0-9.0%

Exclusion Criteria:

* Type 1 diabetes
* Insulin treatment (for \&gt;7 consecutive days)
* Previous intensive SMBG management (the execution of SMBG measurements used to modify lifestyle, diet or physical activity in a systemic/structured manner and/or to manage therapeutic approach)
* impending complications of diabetes;
* serious diseases, including cardiovascular damage or limited life expectancy;
* pregnancy
GBT021601-022: A Study of GBT021601 in Participants With Sickle Cell Disease (SCD)

An Open-label Extension Study of GBT021601 in Participants with Sickle Cell Disease

An Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of GBT021601 Administered to Participants with Sickle Cell Disease Who Have Participated in a GBT021601 Clinical Trial

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 6 months or older with SCD who participated and received study drug or placebo in a previous osivelotor clinical study and completed the end of treatment visit.

   Note: Participants who discontinued study drug in the originating study due to an TEAE, but who remained on study, may be eligible for treatment in this study provided the TEAE does not pose a risk for treatment with osivelotor.
2. Females of childbearing potential are required to have a negative urine pregnancy test prior to dosing on Day 1.

   Note: Females who become of childbearing potential during the study must be willing to have negative urine pregnancy tests to remain in the study.
3. If sexually active, females of childbearing potential must consistently use highly effective methods of contraception consistently throughout the study and for at least 120 days after the last dose of study drug. If sexually active, male participants must use barrier methods of contraception until 84 days after the last dose of study drug. Male participants are eligible to participate if they agree to the following requirements during the study intervention period and for 84 days after the last dose of study intervention:

   * Refrain from donating sperm PLUS either
   * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle OR
   * Must agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person
4. Participant has provided written informed consent/assent. For underage participants, both the consent of the participant's legal representative or legal guardian and the participant's assent (where applicable) must be obtained based on local requirements.

Exclusion Criteria:

* Participant withdrew consent or was noncompliant from the originating osivelotor clinical study
* Current or recent use of voxelotor. Recent use is defined as within 10 days prior to Day 1
* Current or recent use of crizanlizumab. Recent use is defined as within 90 days prior to Day 1
* Participant has any medical, psychological, safety, or behavioral conditions that, in the opinion of the Investigator, may confound safety interpretation, interfere with compliance, or preclude informed consent
* Has received an investigational drug (including investigational vaccines) within 5 times the elimination half-life (if known) or within 30 days (if the elimination half-life- is unknown) prior to study drug administration or is concurrently enrolled in any research judged not to be scientifically or medically compatible with this study
Evaluation of an Active Decision Support System for Hemodynamic Optimization During High Risk Vascular Surgery

Rivers et al. laid the foundation for modern hemodynamic and fluid management by establishing goal directed therapy (GDT) for the treatment of sepsis using fluid and inotropic and vasoactive agents. There have been many subsequent protocols to improve outcome in the operating room or in the ICU. These are mainly passive decision support systems. Active clinical decision support systems using fluid and pharmacologic agents to improve intraoperative hemodynamics are not really found.

The investigators developed an active clinical decision support system based on an institutional GDT-protocol using fluid, vasopressors and inotropes using the LiDCOrapid device.

The goal of the study was to check the feasibility of an active clinical decision support system to optimize hemodynamics during high risk vascular surgery based on the principles of GDT implementing fluid, vasopressors and inotropes.


Eligibility Criteria:
Inclusion Criteria:

* elective major vascular surgery such as peripheral arterial surgery and open abdominal aortic surgery except for carotid artery surgery

Exclusion Criteria:

* patients under 18 years of age
* absence of cardiac sinus rhythm at induction of anesthesia
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-101 Clinical Trial

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial (ALLO-ASC-DFU-101) for 23 months.

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial (ALLO-ASC-DFU-101) for 23 months.

ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Diabetic Foot Ulcer.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are treated with ALLO-ASC-DFU sheet in phase 1 clinical trial of ALLO-ASC-DFU-101.
2. Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Subjects who are considered not suitable for the study by the principal investigator (For example, Subjects requiring surgical procedure on target site).
Mechanisms Defending Fat Mass in Humans After Lipectomy

Liposuction surgery is common, yet animal and limited human data suggest that fat returns when removed. This study was designed as a 1-year randomized-controlled trial of suction lipectomy versus no intervention to determine if adipose tissue is defended, and if so to determine the anatomic pattern of redistribution.

Specific Aims:

1. To determine if suction lipectomy fails to modify regional and/or total body fat over three years.
2. To determine if the expression of candidate genes predicts and/or relates to subcutaneous adipose tissue growth or depletion in subcutaneous adipose tissue after suction lipectomy.
3. To examine adipose tissue before and after suction lipectomy to uncover novel genes where expression predicts and/or relates to subcutaneous adipose tissue growth or depletion after subcutaneous suction lipectomy.

Eligibility Criteria:
Inclusion Criteria:

* Eligible premenopausal women between the ages of 18-50 years;
* BMI of 22-27 kg/m2 at the subjects maximum body weight;
* Weight stable for at least 3 months (defined as a \<5-7% change from the maximum weight over 3-6 months);
* Non-smokers.

Exclusion Criteria:

* Any history of glucose intolerance, dyslipidemia, liver, kidney and cardiac disease, hypertension, cancer or any other chronic debilitating disorder that might have interfered with a 'normal' lifestyle, e.g. nutrition, physical activity;
* Thyroid hormone replacement with abnormal thyroid stimulating hormone (TSH) results;
* Use of oral contraceptives if the subject did/could not remain on therapy throughout study participation.
* Reduced-obese, defined as a history of:

  1. obesity and weight loss \>10% of maximum body weight, or
  2. liposuction or gastric bypass surgery;
* Evidence of body dysmorphic disorder;
* Taking sex steroids, glucocorticoids, or medications affecting carbohydrate and lipid metabolism;
* Hematocrit, hemoglobin, white blood cell count (WBC), platelet count, liver or renal function tests out of the normal range;
* Fasting plasma glucose \>110 mg/dL;
* Triglycerides \>200 mg/dL;
* High density lipoprotein (HDL) cholesterol \<35 mg/dL;
* Low density lipoprotein (LDL) cholesterol \>160 mg/dL;
* Proteinuria;
* Blood pressure \>140/90 mm/Hg;
* Electrocardiogram abnormalities;
* History of claustrophobia;
* Placement of metal implants\*
* History of internal metal fragments\*

\*Were evaluated by the radiologist prior to study determination\*
EARLY IFNb-1a and Atorvastatin Combination Therapy of Isolated Clinical Syndrome Suggestive of Multiple Sclerosis

The primary purpose is to determine the changes in gene expression induced by IFNb-1a (Rebif) and atorvastatin (Lipitor) combination therapy in patients with an isolated clinical syndrome suggestive of multiple sclerosis (MS), to identify markers of therapeutic response, and to predict patients' clinical response based on their in vitro response to this combination therapy measured by the gene expression levels in activated peripheral blood mononuclear cells (PBMCs).

Multiple Sclerosis (MS) is a chronic neurologic disease, characterized pathologically by focal areas of inflammation, demyelination, axonal injury and degeneration in the central nervous system. MS follows several different disease courses. Approximately, 90% of patients have a relapsing form of the disease. We propose that atorvastatin (Lipitor) may enhance the immunomodulatory effects of INFb-1a (Rebif) in patients with clinically isolated neurological syndrome suggestive of MS. This combination may be more effective in preventing development of definitive relapsing-remitting MS if administered early in the course of the disease. The study will identify markers of disease activity that are selectively affected by this combination therapy. Identified markers may be used in future clinical trials to predict patient's clinical response and to monitor the response to treatment as a secondary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* Patients with isolated clinical syndrome suggestive of MS
* At least three out of four magnetic resonance imaging (MRI) findings on the initial scan:

  * One Gd-enhancing lesion or nine T2 hyperintense lesions;
  * At least one infratentorial lesion;
  * At least one juxtacortical lesion; and
  * At least three periventricular lesions.
* Expanded Disability Status Scale (EDSS) 0-5.5
* 18 to 60 years of age
* At least one relapse in previous 12 months

Exclusion Criteria:

* Patients with a diagnosis of clinically definitive relapsing-remitting (RR) MS, secondary progressive, or primary progressive MS.
* Patients who have ever been treated with mitoxantrone, cytoxan, cyclophosphamide, or total lymphoid irradiation (TLI).
* Patients treated with IFNb-1a, IFNb-1b, glatiramer acetate, intravenous immunoglobulins (IVIg), plasma exchange, methotrexate, or azathioprine in the previous 3 months.
* Patients treated with intravenous or oral steroids within 30 days prior to baseline MRI.
* Patients who have been treated with statins in the previous 3 months.
* Pregnant or breast-feeding women.
* Patients with a history of severe cardiac, hepatic, pulmonary, gastrointestinal, or renal disease.
* Abnormal baseline blood tests including alanine transaminase (ALT) or aspartate transaminase (AST) greater than twice the upper limit of normal
Study of Venetoclax and Azacitidine in Advanced BCR-ABL Negative Myeloproliferative Neoplasms

The purpose of this research study is to look at how safe and useful a drug called azacitidine in combination with a drug called venetoclax, is in people with accelerated or blast phase BRC-ABL negative myeloproliferative neoplasms.

All participants in this study will receive azacitidine and venetoclax.

This study will be done in multiple stages:

Safety Run-In Period - 7 participants will receive the study drugs to ensure that the combination is safe and tolerable.

Stage 1 - About 15 participants will receive the study drugs and will be evaluated to see whether they respond to the study drugs.

Stage 2 - If enough participants in Stage 1 respond to the study drugs, then Stage 2 will begin. During this stage, an additional 25 participants will take part in the study to further see if participants respond to the study drugs.

Eligibility Criteria:
Inclusion Criteria:

* Ability to voluntarily provide written informed consent.
* Documented diagnosis per World Health Organization (WHO) 2016 criteria of BCR-ABL negative myeloproliferative neoplasms (MPN).
* Documented MPN transformation to accelerated phase (AP) or blast phase (BP) without prior blast reduction therapy for their AP/BP disease.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Adequate organ function.
* Must practice at least one reliable method of birth-control starting at least on cycle 1 day 1 until at least 90 days after the last dose of study drug.
* Female participants of childbearing potential must have a negative serum pregnancy test within 14 days prior to cycle 1 day 1.

Exclusion Criteria:

* History of allogeneic stem cell transplant for MPN.
* Previous treatment with venetoclax, navitoclax, azacytidine or other hypomethylating agents (HMA).
* White blood cell count \>25 x 10\^9/L.
* Current enrollment in another interventional study.
* Presence of any active uncontrolled infection such as bacterial or fungal infections progressing despite adequate antimicrobial treatment.
* Myocardial infarction in the preceding 3 months.
* Active human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV) infection.
* History of active malignancy in the previous 2 years.
* Any psychiatric illness or social circumstances or significant co-morbid conditions that may compromise study participation.
* Pregnant or breastfeeding women.
* Patients with known central nervous system (CNS) involvement with acute myeloid leukemia (AML) or CNS extramedullary hematopoiesis.
* Patients with t (15;17)
* Patients who have received strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment.
* Active COVID-19 infection.
* History of prior blast-reduction therapy for AP/BP-MPN.
* Preceding history MDS, chronic myelomonocytic leukemia (CMML), and other myelodysplastic syndromes (MDS)/MPN overlap syndromes.
Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms

The primary objective of this study was to demonstrate that Rotigotine improves non-motor symptoms compared to Placebo in subjects with Parkinson's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female, ≥18 years of age
* Subject has idiopathic Parkinson's disease with at least 2 of the following cardinal signs being present: bradykinesia, resting tremor, rigidity or postural instability, and without any other known or suspected cause of Parkinsonism
* Subject has a Hoehn and Yahr stage score ≤4
* Subject has a total Non-Motor Symptoms Scale (NMSS) score ≥40
* If the subject is taking levodopa (L-DOPA), he/she must be on a stable dose of L-DOPA (in combination with benserazide or carbidopa) for at least 28 days prior to the Baseline Visit
* If the subject is receiving anticholinergics, monoamine oxidase (MAO) B inhibitors, or amantadine, he/she must have been on a stable dose for at least 28 days prior to the Baseline Visit and must be maintained on that dose for the duration of the study

Exclusion Criteria:

* Subject discontinued from previous therapy with a dopamine agonist after an adequate length of treatment, at an adequate dose, due to lack of efficacy as assessed by the investigator
* Subject is receiving therapy with 1 of the following drugs, either concurrently or within 28 days prior to the Baseline Visit: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, and quetiapine), monoamine oxidase-A (MAO-A) inhibitors, methylphenidate, amphetamine, or other dopamine agonists (DAs)
* Subject is receiving central nervous system (CNS) therapy (eg, sedatives, hypnotics, selective serotonin reuptake inhibitors \[SSRIs\], anxiolytics, or other sleep-modifying medication) unless dose has been stable daily for at least 28 days prior to the Baseline Visit and is likely to remain stable for the duration of the study
* Subject has evidence of an impulse control disorder according to the modified Minnesota Impulsive Disorders Interview at the Screening Visit (Visit 1), confirmed by a positive structured clinical interview
Trunk Task-oriented Training Combined With Functional Electrical Stimulation in Spinal Cord Injured Individuals

The objectives of the study are to evaluate trunk task-oriented training combined with function electrical stimulation (FES/T-TOT) efficacy on sitting balance and functional independence, and to understand the mechanisms of neuroplasticity that would improve functional independence following FES/T-TOT in individuals with spinal cord injury.

After obtaining their consent, participants will undertake evaluations at different times:

1. Assessment 3 weeks prior to training
2. Assessment 1 week prior to training
3. Training over 12 weeks
4. Assessment 1 week after training
5. Assessment 1 month after training (follow-up)

Each assessment will be divided in 2 sessions and data will be collected over 2 days, at one session per day. The assessment will consist of:

* Session 1 (at Neuro-Concept clinic) will include presentation of the study and the obtention of written consent, clinical (modified Reaching test and muscle strength), quality of life and functional independence assessments.
* Session 2 (at IURDPM in Dr. Barthélemy's laboratory) will include postural control, corticospinal and cortical assessments.

After the initial assessment, the participants with spinal cord injury will realize 36 sessions of trunk task-oriented training alone or combined with function electrical stimulation (3 times a week for 12 weeks).

Eligibility Criteria:
FOR PARTICIPANTS WITH SPINAL CORD INJURY

Inclusion Criteria:

* Level of spinal cord lesion between C6/C7 and T10
* At least, 6 months post-injury
* Be considered as AIS A, B, C or D
* Be able to sit without support for 15 seconds
* Be able to provide informed consent in English or in French

Exclusion Criteria:

* To have cognitive deficits
* To wear a corset
* To have personal or family history of epilepsy
* To have suffered moderate or severe traumatic brain injury
* To have cochlear implant

FOR CONTROL PARTICIPANTS

Exclusion Criteria:

* To have orthopedics problems
* To have cognitive deficits
* To have neurological problems