cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy

The purpose of this study is to evaluate the pharmacokinetic (PK) profile of a fixed dose of SPI-2012 in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) chemotherapy, as measured by the serum concentration of SPI-2012 on specific days following drug administration.

This is a Phase 1, single-arm multicenter study to evaluate the PK and safety of SPI-2012 (a long acting myeloid growth factor) in breast cancer patients treated with TC chemotherapy.

Approximately 25 patients will be enrolled.

Each cycle will be 21 days and patients will receive 4 cycles of treatment with 2 additional cycles based on the investigator's discretion. On Day 1 of each cycle, patients will receive TC chemotherapy and on Day 2 of each cycle, patients will receive SPI-2012.

Pharmacokinetics will be evaluated only in Cycles 1 and 3.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, histologically confirmed early-stage breast cancer, defined as operable Stage I to Stage IIIA breast cancer.
* Candidate to receive adjuvant or neoadjuvant TC chemotherapy.
* ANC ≥1.5x10\^9/L
* Platelet count ≥100x10\^9/L
* Hemoglobin \>9 g/dL
* Calculated creatinine clearance \>50 mL/min
* Total bilirubin ≤1.5 mg/dL
* AST and ALT ≤2.5xULN
* Alkaline phosphatase ≤2.0xULN
* ECOG ≤2

Exclusion Criteria:

* Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of cervix) or life-threatening disease. If history of prior malignancies or contralateral breast cancer, must be disease free for at least 5 years.
* Known sensitivity to E. coli derived products or known sensitivity to any of the products to be administered during dosing.
* Concurrent adjuvant cancer therapy.
* Locally recurrent/metastatic breast cancer.
* 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 antibiotics or any serious underlying medical condition which would impair the ability of the patient to receive protocol-specified treatment.
* Prior bone marrow or hematopoietic 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.
* Prior radiation therapy within 30 days prior to enrollment.
* Major surgery within 30 days prior to enrollment.
A Study To Observe Safety And Concentrations Of PF-05297909 And Proteins In Both Blood And Cerebrospinal Fluid After A Single Dose Of PF-05297909 In Healthy Adults

This study is designed to observe the safety and concentrations of PF-05297909 and proteins in both blood and cerebrospinal fluid after a single dose of PF-05297909 in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* For Healthy adult volunteers: healthy male and/or female subjects of non child bearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.)

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Applicability of PDOX in Patients With Primary Liver Cancer: A Randomized Controlled Trial

This Randomized Controlled Trial was to clarity the clinical feasibility of PDOX results in guiding the drug use of interventional chemotherapy after primary liver cancer surgery.

Data of Patients who received PDOX after primary liver cancer radical reaction and received Transarterial Chemoembolization #will be collected

#excluding incomplete data. The primary endpoint was the one-year disease-free survival(DFS) rate #Secondary endpoint was the adverse event.

Eligibility Criteria:
Inclusion Criteria:

1. Undergone radical surgical resection.
2. Aged 18-75.
3. Patients voluntarily cooperated with the study and signed an informed consent form.
4. Histopathologically diagnosed hepatocellular carcinoma.
5. Patients with R0 resection confirmed by imaging and pathology (no residual lesions and complete tumor resection after radical surgery).
6. Child-Pugh score of 5-7 (A or B), patients with a score of 7 must be free of ascites.
7. ECOG physical fitness status score of 0-1.
8. No serious heart, lung, or renal dysfunction

Exclusion Criteria:

1. Unable to provide specimens for PDOX testing.
2. Patients with recurrent liver cancer.
3. Developing two or more types of tumors simultaneously.
4. Patients with existing extrahepatic distant metastases.
5. Treatment with other experimental drugs or other interventions after radical resection.
6. Patients with other malignant tumors that have not been cured within 5 years.
7. Patients with non-radical resections (R1 and R2 resections).
8. Patients with residual or recurrent lesions detected on imaging within 1-2 months after surgery.
9. Died within 1 month after surgery.
Evaluation of Splinting in Tetraplegia

This study compared pre-fabricated and custom resting hand splints among people who were in inpatient rehabilitation after a cervical spinal cord injury.

This was randomized parallel group controlled clinical trial where arms, not patients were the unit of randomization. This trial was funded by the Craig H. Neilsen Allied Health Professional Development Award of the American Spinal Injury Association (ASIA). This research was conducted at a 32-bed spinal cord injury and multi-trauma rehabilitation unit in an urban center. Participants were recruited from an inpatient spinal cord injury rehabilitation unit. Eligible participants were 18 years or older and undergoing acute rehabilitation after a cervical spinal cord injury with hand function impairment, and the primary occupational therapist deemed splinting intervention was required. Each eligible extremity was randomized to receive a custom or pre-fabricated resting hand splint for night use.

Eligibility Criteria:
Inclusion Criteria:

* Spinal Cord Injury
* Inpatient Rehabilitation
* Limited hand function

Exclusion Criteria:

* Under 18
* Full hand function
* Orthopedic injury to hand
Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma ?

Background:

It seems that in the infants and the young children, the increase of the Exhaled Nitric Oxide (eNO) is in connection with: (1) the risk of developing respiratory symptoms; (2) the risk of family and personal atopy; (3) the intensity of the respiratory symptoms; (4) the risk of passage of recurrent wheezing to asthma; (5) and contrary to the fact that the investigators noticed at the child's a positive relation with the environmental tobacco smoke

Objective: the investigators objective is to bring to light that the rise of the eNO, a non invasive biomarker of the bronchial inflammation, would be a risk factor expected from passage of recurrent wheezing of the infant and the young child (of less than 36 months old) towards the asthma of the child.Methods: Once the diagnosis of recurrent wheezing established, the investigators estimate by questionnaire the severity of the asthma, the personal and familial atopy, the collection of the environmental data. After allergic exploration (skin tests and assay of serum total and specific IgE, complete blood count), the eNO is measured by an off-line tidal breathing method using a chemiluminescence NO analyzer. Annually, a questionnaire will be send to families to appreciate the persistence or the remission of the asthma. After a simple descriptive analysis of the population and a multifactorial descriptive analysis, the investigators shall look for the connections between the rise of the eNO and the various clinical, biological and environmental parameters known to influence the variations of this marker. Then the investigators shall select a set of explanatory variables for a multivariate analysis by a logistic regression step by step.

This study is a epidemiological observation study

Eligibility Criteria:
Inclusion Criteria:

* Infant between 6 and 36 months
* More than 3 wheezing episodes
* Questionary and biological assessment for recurrent wheeze
* Signature of the consent by 2 parents or by the only one of 2 parents (if this last one is the only present in the inclusion of the child)

Exclusion Criteria:

* Infant with respiratory disease in neonatal period
* Infant with other obstructive pathology (cystic fibrosis, Primary Ciliary Dyskinesia,...)
* Infant who have a respiratory infection less than 4 weeks
* Infant with asthma exacerbation or who still have corticosteroid treatment
* Infant without social security from their parents
A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme

This Phase 4 study will evaluate the safety and tolerability of Fabrazyme at current approved dose with increases in the infusion rate and reduced infusion volume. This study aims to generate data to provide the guidance on how infusion rate can be safely increased and minimize the burden of the life-long treatment with Fabrazyme.

The total duration will be up to 7 months

Eligibility Criteria:
Inclusion Criteria:

- Participants with confirmed diagnosis of FD who are ≥2 and ≤65 years of age at the time of signing the informed consent form (ICF) or assent, if applicable.

* Cohort 1: female participants with body weight ≥30 kg who have been treated with Fabrazyme for at least 3 months without IARs during the most recent 3 infusions.
* Cohort 2: non-classic male participants with body weight ≥30 kg who have been treated with Fabrazyme for at least 3 months without IARs during the most recent 3 infusions.
* Cohort 3: classic male participants with body weight ≥30 kg who have been treated with Fabrazyme for at least 3 months without IARs during the most recent 3 infusions.
* Cohort 4: participants with body weight \<30 kg who have been treated with Fabrazyme for at least 3 months without IARs during the most recent 3 infusions.

Women of childbearing potential must use a highly effective method of contraception through the study.

Exclusion Criteria:

* Female participants who are pregnant or breastfeeding.
* History of significant allergic disease or hypersensitivity to Fabrazyme or other medicinal products.
* Contraindication to Fabrazyme or any of the premedications or rescue medications (diphenhydramine, loratadine, cetirizine, fexofenadine, acetaminophen, montelukast, dexamethasone).
* Any other medical condition considered to make the increased infusion rate not tolerable at the Investigator's discretion.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer

The purpose of this study is to compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks) with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of the treatments are similar or better.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed prostate adenocarcinoma within 365 days prior to randomization.
* History/physical examination with digital rectal examination of the prostate and baseline toxicity assessment within 90 days prior to randomization.
* Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material;Gleason score must be in the range of 2-6. \> 6 cores are strongly recommended.
* PSA values \< 10 ng/ml within 90 days prior to randomization. Either done prior to biopsy or at least 21 days after prostate biopsy.
* Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.). Staging must be done by treating investigator.
* No pelvic lymph nodes \> 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
* Patients must be at least 18 years old.
* ECOG performance status 0-1 (appendix I) documented within 90 days prior to randomization.
* IPSS score \<= 16.
* Patients must give IRB approved, study specific, informed consent.
* Patients must complete all mandatory tests listed in section 4.0 within the specified time frames.
* Patients must be able to start treatment within 56 days of randomization.

Exclusion Criteria:

* Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.
* Previous pelvic radiation for prostate cancer.
* Androgen deprivation therapy prior to radiation is allowed. However, it is not acceptable if continued during radiation or as adjuvant therapy.
* Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis.
* Prior systemic chemotherapy for prostate cancer.
* History of proximal urethral stricture requiring dilatation.
* Current and continuing anticoagulation with warfarin sodium (Coumadin, heparin, low-molecular weight heparin, Clopidogrel bisulfate (Plavix),or equivalent. (Unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or for marker placement).
* Any major medical, addictive or psychiatric illnesses which would affect the consent process, completion of treatment and/or interfere with follow-up. Consent by legal authorized representative is not permitted in this study.
* Evidence of any other cancer within the past 5 years and \< 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed).
Advanced MR Imaging as Predictor of Treatment Response in Newly Diagnosed Glioblastomas

This clinical trial studies advanced MR imaging techniques in measuring early response of standard treatment may become predictors of long-term treatment response in patients with newly diagnosed glioblastomas.

The standard care of patients with glioblastoma is concomitant chemoradiation and adjuvant temozolomide. Allowing for assessment of tumor therapy prior to treatment completion is important to select patients most likely to benefit from alternative treatment option. Multimodal advanced MR imaging- contrast-enhanced T1 weighted imaging, diffusion-weighted imaging, chemical exchange saturation transfer imaging, and perfusion imaging on 3T enables quantitative assessment of treatment response. Quantifying changes in advanced MR imaging techniques would allow predict outcome for early and long-term treatment response and survival in glioblastomas.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have radiologically and histologically confirmed diagnosis of newly diagnosed glioblastoma
* Patients must have measurable disease, defined as evident tumors with gadolinium enhancement on MRI that is measurable in at least one diameter
* Life expectancy of greater than 3 months
* Patients scheduled for standard therapy (6 weeks radiation treatment (RT) \~ 60 Gy, plus temozolomide 75 mg/m\^2 during 6 week RT, and followed routine monthly temozolomide therapy)
* Ability to understand and the willingness to sign a written informed consent document; all patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines

Exclusion Criteria:

* Patients who underwent complete resection
* Patients with no evidence of measurable disease after surgery
* Patients who have had chemotherapy or radiotherapy
* Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, electronic infusion pumps, etc), because such devices may be displaced or malfunction
* Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
* For patients who have undergone surgical resection prior to joining the study, in whom baseline magnetic resonance (MR) images exhibit enough signal degradation (due to susceptibility artifact in the region of the surgical bed) such that the data are uninterpretable will be excluded
One Heart to Care for

This is an open randomized clinical trial with two study arms. One group, receiving usual care for heart failure, will be compared to another group, receiving usual care plus active telemonitoring interference.

When leaving the hospital, the usual care arm receives a document with a predefined medication scheme and advice for the general practitioner (like it is currently done in usual care). Besides the normal consultations at 2 and 5 weeks, no active interactions take place between the study nurse and the patient.

The telemonitoring interference in the other study arm consists of an automatic blood pressure device and medication dispenser that transmit data to a central platform. During the first 12 weeks, the nurse of the call center will give incentive for medication up titration on the basis of the available data. Before up titration can be done, the patient needs to take blood pressure measurements 3 times in the morning and 3 times in the evening and at least 6 measurements a week.


Eligibility Criteria:
Inclusion Criteria:

* - Age ≥ 50
* Patient has to be followed in Ziekenhuis Oost-Limburg or Jessa Ziekenhuis Hasselt
* The patient has to be able to live independently or in a service flat
* The diagnosis of heart failure or severe myocardial infarction has to be done after September 1, 2013 according to:

  * Left ventricular ejection fraction (LVEF) \<40%
  * eGFR\>30ml/min/kg
  * Treatment minimally with ACE-I and BB
* The general practitioner had to give his approval for the installation of telemonitoring On the basis of an interview between the heart failure nurse and patient, one will decide if the patient is eligibil to join the study. The patient also needs to speak sufficient Dutch to be communicative about his/her medical condition.

Exclusion Criteria:

* Reversible form of heart failure
* Heart failure due to severe aortic stenosis
* eGFR less than 30ml/min/kg
* Presence of a cardiac resynchronization therapy (CRT) device
* Palliative status following the RIZIV guidelines or according to the assessment of the cardiologist (\<1 year)
* Patients staying in a nursing or retirement home
* Active treatment with either ACE-I/ARB or BB
Study of Efficacy and Safety of WELT-ED for Eating Disorder (WCTP-ED-B-01)

The purpose of this clinical trial is to evaluate the safety and efficacy of a digital therapeutic device (WELT-ED) based on Cognitive Behavioral Therapy (CBT) for the treatment of eating disorders.

The main questions it aims to answer are:

* Is WELT-ED as effective as standard treatment in reducing the symptoms of eating disorders?
* Is the WELT-ED safe for use in the target population without causing adverse effects?

Participants will:

* Undergo assessments to determine their baseline health status and severity of eating disorder symptoms.
* Use WELT-ED or receive standard treatment as directed for the duration of the study period (8 weeks).
* Participate in assessments to monitor changes in their eating disorder symptoms and any potential side effects.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 19 and 65 years
* Diagnosed with an eating disorder according to ICD-10.

F50.0 Anorexia nervosa F50.1 Atypical anorexia nervosa F50.2 Bulimia nervosa F50.3 Atypical bulimia nervosa F50.4 Overeating associated with other psychological disturbances F50.5 Vomiting associated with other psychological disturbances F50.8 Other eating disorders F50.9 Eating disorder, unspecified)

* Have a binge eating frequency (as per item 14 of the EDE-Q) of 4 or more times over the past 4 weeks (28 days) at the time of screening.
* Able to use a mobile application (app) on a smartphone without difficulty.
* After receiving and understanding sufficient information about this clinical trial, voluntarily decides to participate and provides written consent.

Exclusion Criteria:

* Previously received Cognitive Behavioral Therapy for the treatment of an eating disorder.
* Have a history of bariatric surgery (e.g., adjustable gastric band, sleeve gastrectomy, biliopancreatic diversion, Roux-en-Y gastric bypass).
* Have a BMI less than 17 kg/m\^2 or more than 40 kg/m\^2 at the time of screening.
* Diagnosed with a major psychiatric disorder according to the MINI.
* Have a past or current diagnosis of schizophrenia or bipolar disorder.
* At risk of suicide (C-SSRS score of 4 or higher) or have attempted suicide in the past 2 weeks.
* Have active and progressive physical illnesses (e.g., congestive heart failure, chronic obstructive pulmonary disease, acute pain), neurological disorders (e.g., cerebrovascular disease), neurodegenerative diseases (e.g., dementia, multiple sclerosis), unstable medical conditions, or a life expectancy of less than 6 months.
* Pregnant or planning to become pregnant during the trial period.
* Participated in another clinical trial within 4 weeks prior to screening.
* Have a history of alcohol or substance abuse.
* Considered by the investigator to be unsuitable for participation in this clinical trial for any other reason.
Studying Genes in Samples From Younger Patients With Ovarian or Testicular Sex Cord Stromal Tumors

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.

PURPOSE: This research trial is studying genes in tumor samples from younger patients with ovarian or testicular sex cord stromal tumors.

OBJECTIVES:

* To assess the role of DICER1 mutations and miRNA pathways in the etiology and progression of ovarian or testicular sex cord stromal tumors.

OUTLINE: Archived tumor tissue samples are analyzed for D1CER1 mutation and mRNA expression by reverse-transcriptase polymerase chain reaction (RT-PCR) and laser micro dissector. Results are then correlated with medical data, including age at diagnosis, diagnosis, pathology report, presenting symptoms, family history, treatment, outcome, and length of follow-up, when available.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Fixed and frozen tissue samples from the ATBR01 B1 tissue bank and from the International Pleuropulmonary Blastoma Registry, Children's Hospital of Boston, and Massachusetts General Hospital
* Tissue samples from patients diagnosed with:

  * Ovarian

    * Sertoli-Leydig cell tumor
    * Juvenile granulosa cell tumor
    * Adult granulosa cell tumor
    * Gynandroblastoma
    * Sex cord stromal tumor with annular tubules
    * Sex cord stromal tumor, undifferentiated
    * Sertoli tumor
    * Leydig tumor
  * Testicular:

    * Granulosa cell tumor
    * Sertoli tumor
    * Leydig tumor
    * Sertoli-Leydig
    * Undifferentiated stromal tumor

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified