cyrilzakka/clinical-trials huggingface dataset:
Carboplatin and Gemcitabine in Treating Patients With Advanced Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and gemcitabine in treating patients who have advanced solid tumors.

OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine and carboplatin in patients with advanced solid tumors. II. Determine the dose-limiting toxic effects of this regimen in these patients. III. Evaluate the pharmacokinetics and pharmacodynamics of this regimen in these patients. IV. Determine the observed responses in these patients receiving this regimen.

OUTLINE: This is a dose-escalation study of gemcitabine. Patients are stratified according to prior therapy (no prior chemotherapy and/or prior radiotherapy to less than 20% of bone marrow vs prior chemotherapy and/or prior radiotherapy to at least 20% of bone marrow). Patients receive carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-3 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity. Patients are followed for survival.

PROJECTED ACCRUAL: A maximum of 18 patients (9 per stratum) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor for which no standard therapy exists No untreated brain metastases with evidence of neurologic deterioration or CNS progression

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: More than 3 months Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Other: No serious concurrent infection No other serious concurrent medical illness that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 2 prior systemic chemotherapy regimens for advanced disease Prior adjuvant or induction therapy for initial disease allowed At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or melphalan) No prior combination carboplatin and gemcitabine Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to more than 30% of bone marrow At least 4 weeks since prior radiotherapy Surgery: Not specified
tDCS Effects on Associative Learning in Older Adults of Retirement Age

The aim of this study is to investigate whether a tDCS-accompanied training of audio-visual associative memory leads to a performance improvement in healthy older individuals.


Eligibility Criteria:
Inclusion Criteria:

* Age: old-retired (≥66 years).
* Right handedness
* unobtrusive neuropsychological screening

Exclusion Criteria:

* Mild cognitive impairment (MCI) or other neurological diseases.
* History of severe alcoholism or use of drugs.
* Severe psychiatric disorders such as depression, psychosis (if not in remission) and severe untreated medical problems.
* Contraindication for MRI (claustrophobia, metallic implants, ferromagnetic metals in the body, disorders of thermoregulation, pregnant women)
Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease

Identification of an effective disease-modifying intervention (e.g. pharmaceutical, surgical or behavioral) is an unmet need in Parkinson's disease (PD). Increasing evidence indicates high intensity aerobic exercise is a candidate to alter PD progression. The primary aim of this study is to examine the disease-altering capabilities of a long-term, high-intensity aerobic exercise intervention. A multi-site pragmatic randomized controlled trial design has been selected. Individuals with PD will be randomized into 1) a home-based aerobic exercise program, or 2) a usual and customary care (UCC). Subjects in the home exercise group will receive an indoor stationary bicycle delivered to their home for a 12 month exercise period. Individuals in the UCC group will continue their current level of physical activity. Motor and non-motor assessments will be conducted at the main campus of the Cleveland Clinic or the University of Utah at enrollment, 6 months, and 12 months. Each assessment will last approximately one hour.

Overview of Experimental Design: The study is a randomized controlled clinical trial designed to examine the disease-altering capabilities of a 12 month aerobic exercise program for individuals with PD. A total of 252 individuals with PD will be randomized into 1) a home-based aerobic exercise program, or 2) a usual and customary care (UCC). Subjects in the home exercise group will receive a commercially available Peloton indoor stationary bicycle delivered to their home for a 12 month exercise period. Individuals in the UCC group will continue their current level of physical activity. Both groups will undergo a series of motor and non-motor assessments at enrollment, 6 months, and 12 months to measure disease progression of the 12 month period. Additionally, data will be used to develop a prognostic model to predict 12-month change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale III (MDS-UPDRS III) for patients participating in a home-based high-intensity aerobic exercise program.

Eligibility Criteria:
Inclusion Criteria:

* Adult with a diagnosis of idiopathic PD by a physician or physician extender
* Hoehn and Yahr stage I-III
* Demonstrate the ability to safely mount and dismount the Peloton stationary cycle
* In-home wireless network (WiFi; required for Peloton system exercise data transmission)

Exclusion Criteria:

* Participation in pharmaceutical or behavioral disease modifying PD-related clinical trial or study
* Diagnosis of dementia or any neurocognitive impairment that compromises one's ability to provide informed consent
* Implanted deep brain stimulation electrodes
* If the American College of Sports Medicine (ACSM) screen recommends medical clearance, the subject must obtain medical clearance by their health care provider prior to participation.
* Any musculoskeletal issue that would limit one's ability to engage in exercise
* Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke)
The Resilient Minds Program in Fire Departments

The purpose of the study is to assess the impact of a mental health training program in volunteer and career firefighters.

THE PROBLEM: Firefighters are frequently exposed to distressing events, or critical incidents such as motor vehicle accidents, burnt bodies, failed rescue attempts, threats to one's own life, and completed suicides that can trigger posttraumatic stress reactions. Previous research show that first responders and other public safety personnel report frequent exposure to traumatic events and are at increased risk for mental health illnesses.

THE STUDY OBJECTIVE: To assess the impact of a mental health training program in volunteer and career firefighters.

THE STUDY SAMPLE: 600 firefighters: 300 Prince Edward Island volunteer or career firefighters, 300 Vancouver career firefighters

INTERVENTION: Vancouver Fire \& Rescue Services and the Canadian Mental Health Association-Vancouver Fraser co-developed a new program called, "Resilient Minds-Building the Psychological Health of Fire Fighters." The Resilient Minds training will educate firefighters about the effects of trauma, how to recognize signs of mental health illness and how to access support after critical events. It also trains firefighters to recognize mental health and addictions in co-workers and how to facilitate their help-seeking.

OUTCOMES: The impact of the program will be assessed by pre- and post-program surveys, 3-month, 6-month, 12-month follow-up surveys.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* can read, understand, speak English
* career or volunteer firefighters in PEI participating in Resilient Minds program
Rehabilitation Treatment of Anterior Cruciate Ligament Rupture

The purpose with this present study is to investigate the effect og a non-surgical regime in patients with an Anterior Cruciate ligament injury.

The effect will be measured by patient reported outcome scores, level of function and how many of the patients are converting to operative treatment.


Eligibility Criteria:
Inclusion Criteria:

* Anterior cruciate ligament injury where rehabilitation regime is selected as treatment.

Exclusion Criteria:

* Other knee ligament instability
* Rheumatoid arthritis
* Morbus Bechterews Disease
Mobile MRI for Immediate Radiological Acute Cerebral Lesion Evaluation in Stroke

This prospective observational study will evaluate the potential value of mobile MRI in patients with suspected or proven acute stroke and Transient Ischemic Attack (TIA), undertaking additional imaging in the emergency department, acute stroke unit, or outpatient settings, and comparing diagnostic accuracy, Diffusion-weighted imaging (DWI) lesion volume and detection of complications (brain swelling or haemorrhagic transformation). Information on ease of use, tolerability and image quality will also be gathered.

The study will investigate mobile MRI for immediate radiological acute cerebral lesion evaluation in Stroke. The objectives are:

1. Among patients with possible acute minor stroke or TIA, to compare the detection rate of acute DWI lesions on mobile MRI scan with routine imaging, describe number and distribution of lesions, and describe the intervals between mobile MRI and routine diagnostic scan, and time to final clinical diagnosis
2. Among patients with acute stroke of uncertain onset time, to compare the presence of DWI-Fluid attenuated inversion recovery (FLAIR) mismatch pattern on mobile MRI with CT perfusion (CTP) mismatch.
3. Among patients with confirmed acute ischaemic stroke, to compare the volume of DWI lesion on mobile MRI with the core volume on CTP
4. Among patients with established stroke post-thrombolysis or thrombectomy, to compare the incidence of brain swelling and haemorrhagic transformation on mobile MRI with routine imaging
5. In all groups, to evaluate the tolerability and ease of use of the mobile MRI scanner, and to rate image quality

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female \> or = 18 years of age
* Clinically suspected stroke or transient ischaemic attack, or confirmed clinical diagnosis of stroke or TIA
* Consent of patient or legal representative

Exclusion Criteria:

* Contraindications to MRI brain scan as per standard MRI checklist for NHS Greater Glasgow \& Clyde
Studies of Biomarkers in Different Urodynamic Diagnoses of Female Patients With Lower Urinary Tract Symptoms

Urodynamic study is an objective method to evaluate female patients with lower urinary tract symptoms (LUTS). However, this method includes place a urinary catheter, thus prevents it as a routine method to evaluate and follow up patients with LUTS. Therefore, it is necessary to find a simple and objective method to help in evaluating female patients with LUTS. Several kinds of biomarker had been reported in diagnosing patients with overactive bladder; however, the sensitivity remained poor. The aim of this study is to find a useful biomarker, biomarkers, or combinations, with the aid of urodynamic study, to objectively and precisely in evaluating the female patients with LUTS.


Eligibility Criteria:
Inclusion Criteria:

* All female patients (\> 20 years) with Lower urinary tract syndrome.

Exclusion Criteria:

* Female patients with tumor and stone were excluded.
Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects

This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of anemia in hemodialysis participants.

Following randomization, there will be 2 periods during the study:

* Conversion and Maintenance Period (Weeks 0 to 52): There will be a primary efficacy evaluation period (Weeks 20 to 26) and a secondary efficacy evaluation period (Weeks 46 to 52).
* Safety Follow-up Period (Early Termination \[ET\] and Follow-Up): post-treatment safety follow-up visit (ET/End of Treatment \[EOT\] +4 weeks) either in person or via telephone.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Receiving chronic, outpatient in-center hemodialysis three times weekly (TIW) for end-stage kidney disease for at least 12 weeks prior to Screening Visit 1 (SV1)
* Currently maintained on Mircera® (≤250 μg/month) with at least 2 doses received within 8 weeks prior to Screening Visit 2 (SV2)
* Mean Screening hemoglobin (Hb) between 8.5 and 11.0 grams per deciliter (g/dL) (inclusive), as determined by the average of 2 Hb values measured by the central laboratory at least 4 days apart between SV1 and SV2
* Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening
* Folate and vitamin B12 measurements ≥ lower limit of normal during Screening

Exclusion Criteria:

* Anemia due to a cause other than chronic kidney disease (CKD).
* Clinically meaningful bleeding event within 8 weeks prior to Baseline
* Red blood cell (RBC) transfusion within 8 weeks prior to Baseline
* Having received any doses of darbepoetin alfa (Aranesp®) within 4 weeks prior to Baseline
* Having received any doses of epoetin alfa (Epogen®) within 1 week prior to Baseline.
* Current uncontrolled hypertension.
* Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure (HF) or New York Heart Association Class IV HF, or stroke within 12 weeks prior to or during Screening.
* Known hypersensitivity to vadadustat, Mircera®, or any of their excipients.
Patient Anxiety Associated With Lymphedema Surveillance Method

We propose to study the impact of BIA screening on anxiety and primary prevention strategies for lymphedema development among patients with recent surgery for breast cancer. Currently, professional societies recommend scheduled follow-up visits to screen for lymphedema after recovery from breast cancer (e.g., 6-week, 3-month, 6-month visits with a certified lymphedema therapist). Screening involves a discussion of lymphedema symptoms and risk reduction strategies, measurement of the affected limb with a tape measure, and physical inspection for physical changes consistent with lymphedema. In the proposed study, patients will be randomly assigned to the addition of BIA screening vs. usual care. At each screening visit, all patients will be assessed for their current lymphedema risk behaviors, as outlined by the National Lymphedema Network (7). To evaluate anxiety levels, all patients will be asked to fill out the Beck Anxiety Inventory, a validated screening tool used in prior studies of patients with breast cancer (8,9). This questionnaire will be administered at each follow-up lymphedema screening visit, and the baseline will be administered at the preoperative visit. For patients randomly assigned to BIA screening, this involves the placement of adhesive electrodes on the each wrist and an ankle, followed by connection of the electrodes to the BIA machine, which then uses a painless electrical impulse to measure impedance of flow and thus asymmetry in the extracellular lymphedema volume between the 2 upper limbs (6,10). Statistical analysis will involve comparison of lymphedema risk behaviors and anxiety levels between those patients with vs. without BIA screening.


Eligibility Criteria:
Inclusion Criteria:

* Women recently diagnosed with breast cancer Age 18 and older

Exclusion Criteria:

- Those women with a pacemaker
Sleep, Awake & Move - Part I

Sleep benefit (SB) is a prominent spontaneous, apparently unpredictable, transitory improvement in motor function reported by around 50% of patients affected by Parkinson's Disease (PD) after sleep and before taking their first dose of dopaminergic medications. This study aims at systematically characterizing SB in PD patients in an ecological setting and to explore the relationships between nocturnal and diurnal sleep and subjective and objective measures of motor function. A better understanding of this phenomenon is mandatory for future research on this topic.

The "Sleep \& Move" study is the first part of the Sleep, Awake \& Move project. In this observational study we plan to systematically investigate SB and the day-to-day variation in this phenomenon in PD patients by a prospective, repeated assessment for 14 days of both subjective and objective measures of motor function and sleep at patients' home, by an Android app developed ad hoc by our group and named "SleepFit".

Since is still unknown if a spontaneous, subclinical improvement in motor performance might also occur in healthy subjects or if the SB is a phenomenon only involving subjects with PD, we had the idea to test this hypothesis comparing a subgroup of PD patients with age- and sex-matched healthy volunteers, employing the same assessments as in the Sleep \& Move study.

Eligibility Criteria:
PARKINSON'S DISEASE GROUP:

Inclusion Criteria:

* Diagnostic criteria of idiopathic Parkinson's disease (UKPDBB)
* Mild to moderate disease (Hoehn \& Yahr score ≥ 1 and \<= 3)
* Mentally and physically capable to give informed consent
* Stable antiparkinsonian and psychotropic therapy for the last 30 days

HEALTHY GROUP:

Inclusion Criteria:

* Absence of Parkinson's disease
* Mentally and physically capable to give informed consent

ALL SUBJECTS:

Exclusion Criteria:

* Atypical parkinsonian syndrome
* Cognitive impairment (MMSE ≥ 26)
* History of cerebro-vascular disease, epilepsy, or other disabling neurological diseases
* Psychiatric disorders, excepting mild depression (BDI score \<14)
* Alcohol abuse
* Other clinically significant severe concomitant disease states
* Inability to follow the procedures of the study (e.g. due to language problems, psychological disorders, etc.)
* Participation in another study with investigational drug within the 60 days preceding and during the present project.
Compliance of Thyroid Fine Needle Aspiration Biopsy and Trucut Biopsy Results With TIRADS Score and Surgical Pathology

The investigators retrospectively reviewed the medical records of 760 patients with thyroid nodule biopsy and 88 patients who had thyroid surgery. The investigators evaluated patients' thyroid ultrasonography reports and determined Thyroid Imaging Reporting and Data System scores (TIRADS score: 1-Benign, 2- very low malignant) risk, 3-low risk, 4-medium risk, 5 -malignant high risk). The investigators evaluated patients 'existing thyroid fine needle aspiration biopsy (FNAB) reports and recorded the patients' cytology results (benign, malignant).

Documents of 88 patients who were included in the study and who underwent thyroidectomy were reviewed.Pathology reports of these patients were evaluated and surgical pathology was determined as benign in 58 patients and malignant in 30 patients.

Then, a statistical study was performed between the cor needle biopsy (CNB) results of these participants and the surgical pathology and TI-RADS scores.


Eligibility Criteria:
Inclusion Criteria:

* Having a thyroid nodule
* Being both a thyroid needle and a core biopsy

Exclusion Criteria:

* Child patients
* Pregnant patients
* Patients without a thyroid needle biopsy
Respiratory Variations For Assessing Blood Withdrawal

OBJECTIVES: To investigate whether respiratory variations of the inferior vena cava (ΔIVC) and internal jugular vein (ΔIJV) diameters during standardized breathing (ΔIVCST and ΔIJVST) increase after a therapeutic bleeding in spontaneously breathing and non-obese patients with genetic hemochromatosis.

DESIGN: Prospective, monocentric study in the EFS Nord-de-France blood center.

PATIENTS: Non-obese patients with genetic hemochromatosis undergoing a therapeutic bleeding.

INTERVENTIONS: Ultrasound measures and collected clinical parameters before and after a therapeutic bleeding, during a standardized respiratory maneuver.

MAIN OUTCOME AND MEASURES: The primary endpoint was the ΔIVCST change induced by a 300 to 500ml therapeutic bleeding. It measured the minimal and maximal IVC and IJV diameters during a standardized respiratory maneuver. ΔIVCST and ΔIJVST were calculated as follows: \[(maximal diameter - minimal diameter)/maximal diameter\].100.


Eligibility Criteria:
Inclusion Criteria:

* adult patients of \> or equal 18 years
* genetic hemochromatosis
* undergoing a therapeutic blood withdrawal
* health insured
* non-obese (body mass index \<30Kg/m²)

Exclusion Criteria:

* pregnancy
* transthoracic echogenicity unsuitable for measuring the inferior vena cava diameters
* clinical signs of active exhalation
A Study of ONO-2020 in Patients With Agitation Associated With Alzheimer's Disease Dementia

To evaluate the efficacy and safety of ONO-2020 in patients with agitation associated with Alzheimer's Disease dementia in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable AD according to the diagnostic criteria for AD dementia (NIA-AA 2011)
* Mini-Mental State Examination (MMSE) score ≥ 5 to ≤ 22 at the start of the treatment period
* Symptoms of agitation defined by the IPA from at least 14 days before the start of the screening period
* Neuropsychiatric Inventory-Nursing Home version (NPI-NH) Agitation/Aggression domain (NPI-NH-A/A) score ≥ 4 at the start of the treatment period.
* Patients who can participate in the study under hospitalization from 21 days before the start of the treatment period to throughout the treatment period

Exclusion Criteria:

* Diagnosis of dementia not due to AD or any other disorder with memory impairment, such as mixed dementia, vascular dementia, Lewy body dementia, dementia associated with Parkinson's disease, frontotemporal dementia, drug-induced dementia, dementia associated with human immunodeficiency virus (HIV) infection, traumatic brain injury, normal pressure hydrocephalus, or other non-AD dementia
* Any MRI or CT scan of the brain performed after the onset of dementia with findings consistent with clinically relevant CNS disease other than AD, such as vascular changes (eg, cortical cerebral infarction, multiple cerebral infarctions), space-occupying lesions (eg, tumors), or any other major structural brain disease
* Delirium within 30 days before the start of the screening period or a history of delirium
* At risk of suicide according to the Columbia-Suicide Severity Rating Scale (C-SSRS) (answers "yes" to Question 4 or 5 of the suicidal ideation section of the C-SSRS) or any suicide attempt within 6 months before the start of the screening period, or at serious risk of suicide in the opinion of the investigator or subinvestigator
* Prior or current treatment with anti-amyloid beta antibodies