cyrilzakka/clinical-trials huggingface dataset:
Detection of CSF Next Generation Sequencing in the Application of Brain Metastases From Lung Adenocarcinoma or Meningeal Metastasis

This study aimed to detect cell free DNA (cfDNA) in the cerebrospinal fluid and plasma, and to determine whether cfDNA can be used for concomitant diagnosis to improve the treatment efficacy and prognosis of patients with brain (meningeal) metastasis by monitoring tumor-related genetic mutations in cfDNA in the plasma and cerebrospinal fluid.

This study planned to enroll 50 patients with lung cancer diagnosed with brain (meningeal) metastases, and all cases were slated to receive radiotherapy and targeted therapy. Patients' clinical data were collected (including but not limited to: age at diagnosis with brain (meningeal) metastases, KPS score, smoking history, stage of disease at diagnosis, time to progress to brain metastases, number of brain metastases, extracranial metastases (ECM), and systemic disease at the time of brain metastases. Anticoagulated whole blood and anticoagulated cerebrospinal fluid were collected before local treatment (samples of primary cancer tissue and metastatic carcinoma of some patients were preserved) and at 7 days, 1 month, 3 months, as well as 6 months after the treatment (time of sample retention was to be determined, Figure 2). DNA was extracted from tumor tissues, genomic DNA was extracted from leukocytes, and cfDNA was extracted from plasma and cerebrospinal fluid, for complete quantitative detection of DNA, DNA library construction, as well as targeted capture sequencing. Tumor-related genes were analyzed, and changes in the tumor burden during the treatment process were evaluated. The clinical significance of cfDNA in the plasma and cerebrospinal fluid for treatment efficacy and prognosis was evaluated, and compared with that of clinical indicators of treatment efficacy.

This study involved two stages. The first stage was a pre-experiment: samples were retained from 3-5 cases, and mutations in tumor-related genes in the cfDNA in plasma and cerebrospinal fluid were compared. The investigators analyzed, combined with clinical indicators, whether mutations of cfDNA in plasma accord with that of the cerebrospinal fluid and whether mutations of cfDNA in cerebrospinal can reflect the mutational status of tumor cells. The second phase was conducted by expanding the number of cases, based on the first stage.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with confirmed diagnosis of lung adenocarcinoma with brain (meningeal) metastasis.
2. Samples collection should be allowed.

Exclusion Criteria:

1. Pregnant women
2. Minors (subjects less than 18 years of age)
D-dimer In Patients With atRial Fibrillation rEceiving antiCoagulation Therapy

This is a sigle-center, prospective study to evaluate the role of D-Dimer testing in patients with atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy.

Patients with atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy was screened and signed to two group: Dabigatran group and Warfarin group. D-dimer test was analyzed before and 3 months after anticoagulation starting specificly. Patients were followed-up for at least 12 months,and clinical outcomes, including thrombotic events major bleeding events and all-cause deaths were recorded during follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Non-valvular atrial fibrillation
* Receiving oral anticoagulation therapy and have good compliance

Exclusion Criteria:

* Life expectancy less than 1 year
* Thrombosis or major bleeding history within 3 months
* Refusal to Participate
In Vivo Study of THC-induced Immune-genome Changes At Single Cell Solution in HIV-infected Humans

In this study, the investigators hypothesize that THC alters the immunogenome in a cell type-specific fashion and alters cytokine production via epigenetic regulatory mechanisms and that these alterations differ between HIV-infected and HIV-uninfected host genomes.

In this study, the investigators hypothesize that THC alters the immunogenome in a cell type-specific fashion and alters cytokine production via epigenetic regulatory mechanisms and that these alterations differ between HIV-infected and HIV-uninfected host genomes. To test these hypotheses, the investigators propose defining the epigenomic and transcriptomic alterations at single cell resolution in peripheral blood mononuclear cells by administering THC to humans with and without HIV infection. The THC-associated epigenomic/transcriptomic alterations will be linked to genomic variants to understand the causal effects of THC response in immune cells.

Eligibility Criteria:
Inclusion Criteria (HIV-infected group):

* HIV-positive
* Good medication adherence
* Negative urine toxicology for drugs of abuse (including cannabis)
* Good mental and physical health (other than HIV) as determined by history, psychiatric interview, collateral information, physical and laboratory examinations, ECG, and vital signs.

Inclusion Criteria (HIV-uninfected group):

* HIV-negative
* Negative urine toxicology for drugs of abuse (including cannabis)
* Good mental and physical health as determined by history, psychiatric interview, collateral information, physical and laboratory examinations, ECG, and vital signs.

Exclusion Criteria (common to both groups):

* Major medical conditions, e.g., myocardial infarction, hypertension, etc.
* Positive pregnancy test and lactation;
* Weight greater than 166 kg (365 lbs)
Oral Nifedipine Versus Oral Labetalol

This study's aim is to determine whether oral extended release nifedipine is superior to oral labetolol for the management of postpartum severe hypertension, specifically time to achieve goal blood pressure, and shortening hospital stay. Our hypothesis is that oral extended release nifedipine is superior to oral labetolol for achieving goal blood pressure in the postpartum period.

Hypertension complicating pregnancy is common and, when uncontrolled, can have devastating consequences. While the true incidence of postpartum hypertension is unknown, blood pressure (BP) is known to initially decrease 48 hours following delivery then peak on postpartum days 3-6, likely 45 from the mobilization of interstitial fluids following parturition.

The American College of Obstetricians and Gynecologists (ACOG) recommends medical treatment of persistent postpartum hypertension, defined as systolic BP (SBP) ≥150 mmHg or diastolic BP (DBP) ≥100 mmHg, on two or more occasions 4-6 hours apart. Prior studies compared intravenous medications to intramuscular and immediate-release oral 50 medications in the treatment of postpartum hypertension. However, oral labetalol and oral extended release nifedipine are the most commonly used medications for post- partum hypertension, and their efficacy has not been directly compared.

Our aim was to determine whether oral labetalol is associated with a shorter time to BP control compared to oral extended release nifedipine for management of persistent 55 postpartum hypertension. Our primary outcome was time to sustained BP control defined as the absence of severe hypertension (SBP ≥160 mmHg or DBP ≥105 mmHg) for at least 12 hours. Secondary outcomes included postpartum length of stay, need for increased dosing, need for additional oral antihypertensive agents, and patient-reported side effects.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years with the abililty to give informed consent
* Intrauterine pregnancy ≥ 32 weeks
* Postpartum
* Persistent postpartum blood pressures ≥ 160/105 on two or more occasions
* Primary obstetrician amenable to starting either study medication in the postpartum period

Exclusion Criteria:

* Use of other oral antihypertensives concomitantly
* Known AV heart block
* HR \<60 or \>120
* Absolute contraindication to nifedipine or labetolol such as allergy
* Significant renal disease (Cr \>1.5 mg/dL)
* Heart failure
* Moderate persistent or severe asthma
* Preexisting diagnosis of chronic hypertension with medical treatment before delivery
* Chronic hypertension
Validation of Quantitative Ventricular Function Imaging Single Photon Emission Tomography (Spect)Using the D-SPECT Cardiac Camera

The purpose of this study is to validate the use of DSPECT camera for the performance of quantitative spect ventricular function imaging by comparison to a validated procedure performed on standard nuclear cameras.


Eligibility Criteria:
Inclusion Criteria:

* patients who have been referred by their physician to the nuclear medicine department for the quantitative SPECT ventricular function study
* voluntarily participate in the study

Exclusion Criteria:

* voluntarily to the study without being referred to the nuclear medicine department for the quantitative SPECT ventricular function study
Factors Influencing Pediatric Asthma

Asthma is a chronic lung disease with serious morbidity and potential mortality. Multiple physiologic, environmental and social conditions impact the prevalence and severity of asthma. Even when diagnosed, effective control can be impeded by improper use of medication, not understanding or being unable to avoid environmental triggers, lack of continuity in follow-up care, and lack of an asthma action plan. American Indians are especially at-risk for health problems related to asthma. American Indians have the highest asthma rate among single-race groups; 18.5% of American Indians are diagnosed with asthma, while only 11% are diagnosed with asthma in the general population but little is known about why this is true. Asthma is a prototypic example of the interaction of biologic, environmental and psychosocial influences on disease and this study investigated the possible improvement in asthma control from an intensive educational intervention.

The primary aim of this study was to test the hypothesis that intensive patient education regarding self-directed, stepped care will result in reduced morbidity and medical care utilization, while increasing quality of life.

One half (54) of the identified cases will be randomized to receive the previously established "BREATHE" study educational program, emphasizing patient-centered, self management of asthma. Periodic follow-up through personal contact and surveillance of IHS RPMS or other medical provider records was conducted.

Eligibility Criteria:
Inclusion Criteria:

* Cases must be "American Indian" (eligibile for care within the Indian Health Service); and at least 2 of the following 3 criteria:

  1. a diagnosis of asthma on at least 2 occasions by more than one provider during the past 2 years.
  2. refills of asthma treatment medications on at least 2 occasions during the past 2 years.
  3. Improvement of spirometry FEV1 of 20% with use of albuterol MDI or nebulizer.
* Controls meet the same demographic criteria as cases, but must also meet all of the following criteria.

  1. No diagnosis of asthma by any provider during the past 2 years.
  2. No prescriptions of any asthma meds during the past 2 years.
  3. FEV1 on spirometry greater than 80% of predicted value Exclusion Criteria:

Exclusion Criteria:

1. Birthweight less than 2500 grams
2. Neonatal ventilator treatment
3. Hospitalization at birth greater than 15 days.
4. Congenital heart anomaly requiring surgery
5. Diagnosis of cystic fibrosis
6. Congenital lung, diaphragm, chest wall, or airway anomaly
7. Diagnosis of pneumonia, pertussis, or tuberculosis within the past year
8. Congenital muscular disorder
The Use of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer

The purpose of this study is to evaluate the safety and optimal dose of RAD001 and docetaxel plus prednisone in men with hormone refractory, metastatic prostate cancer (Phase I).

Once an appropriate dose is reached, the purpose then will be to determine the response rate of docetaxel plus RAD001 (Phase II).

* Patients will be designated into one of two groups based upon the results of a FDG-PET scan.
* A patient with a baseline positive scan will have serum drawn for baseline serum proteomics assessment then be treated with RAD001 daily for two weeks. On day 10-14, another FDG-PET scan and serum assessment will be performed. An optional bone marrow biopsy may also be done. On day 15, patients will enter the Phase I portion of the trial at the current enrolling dosage or if Phase I is completed patients will enter Phase II.
* A patient that does not have a positive scan will enter directly into the Phase I trial or Phase II depending on which trial is currently enrolling.
* Phase I trial patients will have weekly laboratory evaluations and clinical evaluation every three weeks.
* Phase II trial patients will have laboratory evaluations on day one and day eight and clinical evaluation every three weeks.
* The maximum duration of the trial is one year of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of the prostate with radiographic evidence of metastatic disease.
* Willingness to undergo a baseline tumor biopsy.
* Castrate levels of testosterone (testosterone \< 50 ng/dL) on androgen deprivation therapy (ADT) with evidence of progression on ADT. GnRH therapy will be continued for those on it at baseline
* Patient must have suspected tumor in an area that is safe to biopsy.
* Other prior hormonal interventions or experimental approaches are allowed. These therapies must have been discontinued for a minimum of 28 days with cancer progression.
* Prior or concurrent use of bisphosphonates is allowed.
* One prior non-taxane chemotherapy allowed
* ≥ 3 weeks since major surgery; ≥ 4 weeks since radiotherapy; ≥ 8 weeks since prior strontium-89 or samarium 153
* Performance Status: ECOG 0 or 1
* ANC \> 1,500/_l; platelets \> 100,000/_l; total Bilirubin \< upper limit of normal; AST and ALT \< 3 x upper limits of normal; creatinine \< 1.5 x upper limits of normal; total fasting cholesterol \< 350 mg/dl; total triglycerides \< 300 mg/dl

Exclusion Criteria:

* Ongoing oral steroid use. Patients with a history of oral steroid use are eligible as long as the steroids have been discontinued prior to study entry. Ongoing topical and/or inhaled steroid use is allowed.
* Prior taxane chemotherapy
* Prior mTOR inhibitors (RAD001, rapamycin, CCI-779)
* Currently active second malignancy other than non-melanoma skin cancer.
* Ongoing peripheral neuropathy of Grade 2
Assessment of Effectiveness of Belatacept Patient Alert Card in Patients Following Renal Transplantation in a Sample of EU Countries

The purpose of the study is to determine a) if the implementation of belatacept patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes.

3 sub studies: 2 Cross-Sectional and 1 retrospective chart review

Eligibility Criteria:
Inclusion Criteria:

* Patient survey (cohort 1):
* Patients has taken belatacept within the previous 3 months for renal transplantation
* Patient is over 18 years of age
* HCP survey (cohort 2):
* Physician or nurses working in nephrology centers, with at least 1 patient taking belatacept in the previous 6 months for renal transplantation (by prescribing, administering or by follow up)
* Retrospective chart review study (cohort 3):
* Patient survey questionnaire received, Informed Consent Form (ICF) signed (if required)

Exclusion Criteria:

* Patient survey:
* Patient has participated in a clinical trial for their renal condition in the previous 12 months
* Currently an employee of BMS
* HCP survey:
* Physicians or nurse who have recruited patients for the Patient survey
* Currently an employee of BMS
Exploration of Molecular Biomarkers for Lu-177 DOTATATE Therapy in Midgut Neuroendocrine Tumor

Midgut neuroendocrine tumours present an increasing incidence and poor survival at 5 years with limited therapeutic options for metastatic, non-operable cases. Lu-177 Dotatate, targeting somatostatin receptors, is an internal vectorized radiotherapy using Lu-177, an ideal radionuclide for peptide radionuclide therapy. In NETTER-1 phase III randomized clinical trial, Lu-177 Dotatate proved its superiority in increasing progression free survival for midgut neuroendocrine tumors. This study hypothesize that finding biomarkers of individual radio sensitivity for this type of internal vectorized therapy would allow treatment personalization. The protocol aim at studying transcript variations induced by this therapy.

Internal vectorized therapy using Lu-177 Dotatate (abbreviated peptide receptor radionuclide therapy) was recently shown to improve progression free survival and response in metastatic progressive midgut neuroendocrine tumors (NETTER-1 phase III trial).

Lu-177 Dotatate is administered as a series of four consecutive intra veinous injections of an activity of 7.4 gigabequerel every 8 weeks.

In order to identify potential biomarkers of radio sensitivity to Lu-177 Dotatate, investigators aim to study the stability of gene/miRNA transcripts in the absence of Lu-177 Dotatate or at 6 months after treatment as well as the variations in transcript analysis after 2 Lu-177 Dotatate injections and at the end of the treatment.

Transcript variation analysis will be confronted and correlated with peripheral blood pharmacokinetic studies aimed at calculating time activity curves and provide biodosimetry information; other correlations with imaging modalities assessment of dosimetry or disease response to treatment or toxicity effects induced by Lu-177 Dotatate will also be studied.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old; histopathologically confirmed grade 1-2 midgut neuroendocrine tumor with documented progression during the year preceding inclusion upon RECIST criteria on computerized tomography, Octreoscan or Ga-68 positron emission tomography/computerized tomography
* Patients having an indication for Lu-177 Dotatate treatment validated during multidisciplinary meeting coordinated by Pr Rosine Guimbaud under RENATEN coordination;
* Measurable target lesions upon RECIST criteria
* Patients on somatostatin analogues treatment. Every somatostatin analogue injection should be organized to be administered 24 to 48 hours after each injection of Lu-177 Dotatate.
* All patients should be in a clinical state allowing them to continue treatment.
* Social security affiliation is mandatory.

Exclusion Criteria:

* Patients on chemotherapy or other targeted therapy within the 4 months preceding peptide receptor radionuclide therapy
* Fertile patients refusing active contraception ; pregnancy.
* Patients with prior chemotherapy or peptide receptor radionuclide therapy administration
* Patients with uncontrollable psychotic disorders
* Renal hepatic and medullary insufficiency
MRI Based Active Selection for Treatment Trial

The main purpose of this study is to determine if Magnetic Resonance Imaging (MRI), along with MRI targeted biopsy of suspicious lesions, is of value in detecting patients who would be likely to require treatment earlier.


Eligibility Criteria:
Inclusion Criteria:

1. Biopsy confirmed adenocarcinoma of the prostate within 18 months prior to enrollment;
2. Pre-enrollment prostate biopsy must consist of at least 8 cores;
3. Biopsy reviewed by a University of Miami Pathologist;
4. Serum Prostate-Specific Antigen (PSA) ≤ 20 ng/ml within 3 months of study enrollment;
5. Age ≥ 35 and ≤ 85 years;
6. Ability to understand and willingness to sign a written informed consent document;
7. Patients must agree to undergo serial multiparametric MRI and MRI-guided biopsy;
8. Patients must agree to fill out the longitudinal psychosocial questionnaires assessing health related quality of life.

Exclusion Criteria:

1. Greater than 4 cores positive, of any Gleason score, on the University of Miami (UM) review,
2. Greater than 2 cores positive for Gleason 3+4 cancer,
3. Gleason 4+3 or higher cancer in any single biopsy core.
4. Extracapsular extension suspected on digital rectal exam with confirmation on MRI. Suspicion of extracapsular extension on MRI alone is not an exclusion for study enrollment.
5. Subject is not a candidate for multiparametric MRI with contrast. Some reasons may include (but are not limited to): renal insufficiency, foreign body or pacemakers.
6. No prior pelvic radiotherapy.
7. No prior surgery to the prostate, other than transurethral procedures for benign prostatic hyperplasia (e.g., transurethral resection, green light laser treatment).
8. No concurrent, active malignancy, other than non-metastatic skin cancer of any type, superficial bladder cancer, or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma) or \<stage IV follicular lymphoma. If a prior malignancy is in remission for ≥ 3 years then the patient is eligible.
9. Bilateral hip replacement.
Conventional and Experimental Chemotherapy With Allogeneic Transplant in Young Patients With Acute Myeloid Leukaemia

The purpose of this study is evaluate patients with acute myeloid leukemia (\<=66 years), treated with conventional and experimental chemotherapy following allogeneic transplantation. THis patients have been enrolled from 2000 to 2011 at the Division of Hematology, Molinette University Hospital. The purpose of data collection is to assess, with retrospective analysis, the clinical outcome divided by risk class and evaluated in patients who achieve complete remission after induction therapy and consolidation.


Eligibility Criteria:
Patients with acute myeloid leukemia (\<=66 years), treated with conventional and experimental chemotherapy following allogeneic transplantation. THis patients have been enrolled from 2000 to 2011 at the Division of Hematology, Molinette University Hospital.
A Phase II Study of Doxorubicin, Cyclophosphamide and Vindesine With Valproic Acid in Patients With Refractory or Relapsing Small Cell Lung Cancer After Platinum Derivatives and Etoposide

The primary aim of this study is to determine if the addition of valproic acid to a combination of adriamycin, cyclophosphamide and vindesine could increase progression-free survival in patients relapsing after first-line chemotherapy including platinum derivatives, cisplatin or carboplatin, and etoposide.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of small-cell lung cancer (SCLC)
* SCLC refractory to prior chemotherapy regimen including platinum derivatives (cisplatin or carboplatin) and etoposide, either primary refractory (immediate progression or recurrence less than 3 months after the end of previous chemotherapy) or secondary refractory (sensitive patients to platinum plus etoposide in first-line, progressing or recurring less than 3 months after reintroduction of the same chemotherapy).
* At least one evaluable or measurable lesion
* Availability for participating in the detailed follow-up of the protocol
* Signed informed consent.

Exclusion Criteria:

* Patient who were previously treated with anthracyclin or vinca-alcaloid derivatives or cyclophosphamide
* Performance status \< 60 on the Karnofsky scale
* A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder or cured malignant tumour (more than 5-year disease free interval)
* A history of prior HIV infection
* Polynuclear cells \< 2,000/mm³
* Platelet cells \< 100,000/mm³
* Abnormal coagulation tests (aPTT, PTT, prothrombin time) and/or decreased fibrinogen
* Serum bilirubin \>1.5 mg/100 ml
* Transaminases more than twice the normal range
* Serum creatinine \> 1.5 mg/100 ml
* Recent myocardial infarction (less than 3 months prior to date of diagnosis)
* Congestive cardiac failure (ejection fraction of the left ventricle \< 50%) or uncontrolled cardiac arrhythmia
* Uncontrolled infectious disease
* Active epilepsy needing a specific treatment
* Concomitant treatment with IMAO, carbamazepine, mefloquine, phenobarbital, primidone, phenytoïn, lamotrigine, zidovudine
* Pregnancy or refusal to use active contraception
* A known allergy to valproic acid and/or doxorubicin, cyclophosphamide, vindesine
* Serious medical or psychological factors which may prevent adherence to the treatment schedule.