cyrilzakka/clinical-trials huggingface dataset:
Metabolic Syndrome in Young Patients With Acute Lymphoblastic Leukemia in Remission

RATIONALE: Gathering information about metabolic syndrome from young patients with acute lymphoblastic leukemia may help doctors learn more about the disease.

PURPOSE: This phase I trial is studying the metabolic syndrome in young patients with acute lymphoblastic leukemia in remission.

OBJECTIVES:

Primary

* To determine the incidence and prevalence of the components of metabolic syndrome (e.g., obesity, hypertension, dyslipidemia, and insulin resistance) in pediatric patients with acute lymphoblastic leukemia in remission.
* To determine the trajectory of the onset of these components over a 1-year period in patients undergoing maintenance therapy.

Secondary

* To identify potential associations between components of metabolic syndrome and fatigue, health-related quality of life, family history, nutrition, and physical activity.
* To identify potential biomarkers that are associated with clinical features of metabolic syndrome.
* To evaluate whether patients will show a decrease in IGF-1 levels.

OUTLINE: This is a two-part study. Patients are enrolled in either part 1 or part 2.

* Part 1: Patients undergo physical exam measurements (e.g., body mass index, waist circumference, and blood pressure) at baseline (during maintenance course 1) and at 12 months (during maintenance course 5). Patients also undergo blood sample collection at baseline and at 12 months to measure laboratory markers (e.g., fasting lipid profile, fasting insulin and glucose, IGF-1, leptin, and adiponectin levels). Patients or their parents complete a family history questionnaire at baseline and questionnaires to assess physical activity, quality of life, nutritional intake, and fatigue at baseline and at 6 and 12 months.
* Part 2: Patients or their parents complete a family history questionnaire at baseline.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Part 1

* Diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL)

  * In first remission
  * In first 3 months of maintenance therapy
* No T-cell ALL, very high-risk ALL, or infant ALL (\< 1 year old at diagnosis)

Part 2

* Diagnosis of precursor B-cell or T-cell ALL

  * In first remission
* Must have been diagnosed and treated (at least to the maintenance phase) at the Division of Pediatric Oncology at the Vanderbilt-Ingram Cancer Center within the past 7 years
* No very high-risk ALL or infant ALL (\< 1 year old at diagnosis)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior or concurrent cranial radiotherapy (Part 1)
A Study of the Safety and Pharmacology of GDC-0980 in Combination With Either Paclitaxel and Carboplatin (With or Without Bevacizumab) or Pemetrexed and Cisplatin in Patients With Solid Tumors

This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0980 administered with either paclitaxel and carboplatin (with or without bevacizumab) or pemetrexed and cisplatin to patients with locally advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented, incurable, locally advanced, or metastatic solid malignancy
* Adequate hematologic and end organ function
* For female patients of childbearing potential and male patients with partners of childbearing potential, agreement to use an effective form of contraception and to continue its use for the duration of the study
* Measurable disease per RECIST (Response Evaluable Criteria in Solid Tumors), with the exception of prostate cancer (two rising PSA Levels that meet the criteria of progression per PSA Working Group) and ovarian cancer (two rising CA-125 levels greater than the ULN)

Exclusion Criteria:

* Current dyspnea at rest due to complications of advanced malignancy, or other conditions requiring continuous supplemental oxygen
* Uncontrolled hypomagnesemia or hypokalemia
* History of Grade \>= 3 fasting hyperglycemia
* Any condition requiring full-dose anticoagulants
* Known HIV infection
* Known untreated or active central nervous system (CNS) metastases
* Pregnancy, lactation, or breastfeeding
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the first dose of study treatment or anticipation of need for major surgical procedure during the course of the study
* For Arm B: Conditions that preclude the use of bevacizumab
* For Arm C: Conditions that preclude the use of pemetrexed or cisplatin
Comparison of the Efficacy of a Biological Implant to Reinforce Overlapping Sphincter Repair Versus Overlapping Sphincter Repair Alone

The aim of this study is to compare the efficacy of Biodesign™ Surgisis® Tissue Graft to reinforce an overlapping sphincter repair versus the standard overlapping sphincter repair in controlling episodes of incontinence in patients who have fecal incontinence and a defect in the anal sphincter.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18 years or older
* fecal incontinence due to an anterior defect in the external anal sphincter or both external and internal anal sphincter muscles
* Fecal incontinence severity score of 10 or more
* Fecal incontinence episodes of 4 or more over a 2 week period

Exclusion Criteria:

* History of diabetes
* History of allergy to porcine derivatives
* History of infection in the anal area (abscess, fistula)
* History of inflammatory bowel disease
* History of hidradenitis suppurativa
* History of immunosuppression
* History of HIV positivity
* History of radiation to the study site within the last 12 months
* Patients who cannot travel to keep follow up appointments
* Patients who are prisoners
* Patients who are mentally handicapped
* Patients who are pregnant or plan to become pregnant during the study period, or who are currently breastfeeding
* Patients with significant posterior pelvic organ prolapse and who would be candidates for concomitant treatment.
* Patients with a FIQL baseline score of ≤ 4
* Patients participating in another clinical trial for the same indication
* Patients unwilling to give informed consent
A Study of Single and Multiple Doses of KHK6640 in Subjects With Prodromal or Mild to Moderate Alzheimer's Disease

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a single dose and as multiple doses in patients with Prodromal Alzheimer's Disease (AD) or Mild to Moderate AD.


Eligibility Criteria:
Inclusion Criteria:

* Patients with prodromal AD or mild to moderate AD
* Clinical Dementia Rating (CDR) score of 0.5, 1.0, or 2.0
* Have a cognitive impairment
* Low Aβ and high Tau in Cerebrospinal fluid (CSF)
* Mini Mental State Examination (MMSE) score \> 16 at Screening

Exclusion Criteria:

* Previous active treatment with an AD immunotherapy in an investigational study
* Use of another investigational drug within 30 days of screening
* History or presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease
* Presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's AD
* Evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than AD
Clinical Outcomes of Tiotropium Plus Fluticasone Propionate/Salmeterol Compared With Tiotropium for Chronic Obstructive Pulmonary Disease (COPD) in Korea

Study title

* A randomized, open label, multicenter, phase 4 study for the comparison of efficacy of tiotropium plus salmeterol/ fluticasone propionate compared with tiotropium alone in COPD patients

Study objectives

* To investigate clinical outcomes of combining tiotropium with fluticasone propionate/salmeterol (FSC) 250/50μg bid compared with tiotropium alone in patients with moderate or severe COPD in Korea

Study Design

* Randomized, open-label, multicenter, parallel-group, two group study

Study assessment

* FEV1
* Inspiratory capacity (IC)
* History of COPD exacerbation
* History of hospitalization for COPD exacerbation and all causes
* QoL (SGRQ-C)


Eligibility Criteria:
Inclusion Criteria:

* Subjects Aged 40 to 80 years.
* Subjects diagnosed with COPD.
* Tobacco smoking 10 pack-years or more.
* Subjects with post-bronchodilator FEV1/FVC \< 0.7 and FEV1 \< 65% predicted.

Exclusion Criteria:

* Subjects with a history of physician-diagnosed asthma or a respiratory disorder other than COPD which is clinically significant such as diffuse bilateral bronchiectasis.
* Subjects suffering from serious diseases likely to interfere with the study such as chronic congestive heart failure.
* Subjects who used systemic corticosteroids within 4 weeks prior to study entry.
* Subjects with any malignant disease.
* Subjects with a history of severe glaucoma, urinary tract obstruction.
* Previous lung volume reduction surgery.
* Subjects who are pregnant or breastfeeding.
* Subjects with a known hypersensitivity or intolerance to tiotropium or fluticasone-salmeterol.
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Male and female ≥50 to \<80 years of age
* Lp(a) ≥175 nmol/L at the screening visit, measured at the Central laboratory
* Mild or moderate calcific aortic valve stenosis
* At the randomization visit, participant must be optimally treated for existing CV risk factors

Exclusion Criteria:

* Severe calcific aortic valve stenosis
* Uncontrolled hypertension
* History of malignancy of any organ system
* History of hemorrhagic stroke or other major bleeding
* Platelet count ≤ LLN
* Active liver disease or hepatic dysfunction
* Significant kidney disease
* Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply
PDL1 in Ovarian High Grade Serous Carcinoma

the main purpose is to study the prognostic effect of PDL1 in ovarian cancer especially HGSC. Therefore, in the present study the investigators analyzed the expression of PDL1in HGSC by immunohistochemistry, and results were correlated to prognosis.

this cross-sectional study on 54 specimens of primary ovarian high grade serous carcinoma cases who attended to Oncology Centre, Mansoura University, Mansoura, Egypt in the period from 2012 till 2019. The cases were chosen randomly. All clinicopathological data including tumor stage (T), L.N metastases (N), metastasis (M), (FIGO) staging system, ascites, recurrence, residual tumor, CEA level, CA125 level, and peritoneal deposits analyzed. The investigator followed the clinical outcomes in the form of disease free survival (DFS) and overall survival (OS). The mean duration of follow up will be 43.4 months. The OS were calculated from the time of diagnosis to death. DFS is the time from the end of therapy to first recurrence or metastases. the specimens were stained with PDL1 marker in pathology department Port Said university.

Statistical analysis: Data was analyzed using SPSS software V.16. Continuous data was presented in the form of mean (SD) or Median (min-max) according to the results of Shapiro-Wilk testing for the assumptions of normal distributions of data. Categorical data will be presented in the form of frequencies and percentages. Statistical significance will be tested by Welch's t-test, or Mann-Whitney U for continuous data (with respect to presence or absence of normal distribution of data). Also, chi square test or Fisher's Exact Test will be performed for categorical data (with respect to the minimal expected values in the contingencies tables). Correlations of different tumour markers will be calculated using Spearman's rho Coefficient. Kaplan-Meier test was used to test for overall survival and disease free survival of patients with respect to tumour expression of PDL1. Comparisons will be done using Log Rank (Mantel-Cox). Significance level is set at 0.05.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with primary ovarian cancer

Exclusion Criteria:

* patients with metastatic ovarian cancer
Use of Testicular Spermatozoa in Non-azoospermic Patients

Use of testicular spermatozoa in non-azoospermic patients.

The aim of the study is to evaluate the characteristics of couples whose male partner is offered TESE after the failure of previous ICSI technique performed with ejaculated semen. All couples in a third-level University affiliated centre, between January 2010 and January 2020, whose male partner were diagnosed with any type of oligospermia and underwent TESE after ICSI from ejaculated semen, were included in the analysis.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergone testiscular sperm extraction (TESE) after failure of ICSI with the use of ejaculated sperm

Exclusion Criteria:

* Female age \>40 yo
Effect of Probiotic Lactobacillus Reuteri in the Treatment of Mucositis and Periimplantitis

Evaluate clinically and microbiologically the effect of the oral probiotic Lactobacillus reuteri Prodentis (PerioBalance®, Sunstar, Switzerland) on implants with mucositis or periimplantitis, as a coadjuvant treatment of mechanical therapy.

A total of 44 patients, 22 with mucositis and 22 with periimplantitis, were randomly assigned to either the control or the test group, so that 11 patients received placebo and 11 probiotic treatment. After the baseline clinical, radiological and microbiological examination, and once the study group was randomly assigned (probiotic or placebo), supragingival prophylaxis was performed in the mucositis group and subgingival mechanical therapy in the periimplantitis group. Then they get a container with 30 probiotic or placebo tablets and instructions on how and when to take them. At 30 and 90 days after beginning the treatment, a clinical, radiological and microbiological examination was performed.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with general good health,
* non-smokers,
* history of mild or moderate chronic periodontitis
* at least one dental implant with probing pocket depth ≥4mm together with bleeding on probing and/or suppuration, and a fixed prosthetic restoration in function for at least 12 months,
* compliance with the periodontal maintenance program,
* accessibility during all the study period and receptiveness and ability to fulfill with the protocol.

Exclusion Criteria:

* pregnant or lactating women,
* patients who required prophylaxis of bacterial endocarditis or had taken local or systemic antibiotic, anti-inflammatory, antiseptic or probiotic therapy in the previous 3 months,
* subjects who had received surgical periodontal treatment in the last 6 months,
* uncontrolled periodontal disease,
* previous or current history of alcoholism or smoking,
* treatment with bisphosphonates, neurologic deficiencies, systemic diseases such as immunodeficiencies or uncontrolled diabetes, rheumatoid, hepatic, renal, cardiovascular or infectious pathologies, radiotherapy, chemotherapy, use of any medication which can affect at periodontal level,
* lack of patient cooperation (failure to follow the treatment instructions and/or failure to attend visits),
* implants with mobility and/or radiographic bone loss ≥ 5mm and/or ≥ 50% of implant length.
Prediction of Chronic Pain in Cardiac Surgery: Evaluation by Algocartography Predict-ALGOCARTE

Sternotomy results in chronic postoperative pain in 30-55% of subjects. Few studies have been published on chronic pain in cardiac surgery, but there appears to be a relationship between the area of peri-scar hyperalgesia, which is indicative of postoperative hyperalgesia, and the occurrence of persistent pain 6 months after surgery. The aim of this study was therefore to assess whether the area of the postoperative hyperalgesia zone predicts chronic pain at 3 months post-surgery in cardiac surgery. To define the area of hyperalgesia at Day 2, pain mapping (algocartography) will be performed in patients who have had a sternotomy in cardiac surgery, together with pain assessment using the Simple Digital Pain Scale. Von Frey filaments of different sizes will be used for mapping. At Day 90, additional quality-of-life questionnaires will be carried out to check whether chronic pain is still present. A simple numerical scale (ENS) assessment at rest and during activity, and a record of pain-relieving treatments related to the surgery will also be carried out during this call.

The investigators hypothesize that the area of the zone of hyperalgesia assessed at Day 2 predicts the occurrence of chronic pain at 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled surgery
* Conventional cardiac surgery by sternotomy: valve repair or replacement, coronary, thoracic aortic or combined surgery
* Age over 18
* No opposition from patient
* Patient affiliated to a social security

Exclusion Criteria:

* Emergency surgery
* Patient refusal
* Redux surgery
* Patients under guardianship
* History of drug addiction
* Preoperative opioid treatment
* Morbid obesity (body mass index \>30kg/m2)
* Pregnant or breast-feeding women
* Patients taking part in another clinical study likely to interfere with the results of the present study.
Genomic and Dietary Aspects in Gastric Cancer Risk

Gastric Cancer (GC) ranks fourth in the number of deaths worldwide and it is sixth in Italy with almost 9,000 deaths in 2020. Survival of GC is one of the lowest reported amongst major cancers, thus making prevention a central priority for its control. However there is currently a lack of evidence on gastric cancer determinants.

Our study will pursue the following specific objectives:

* analyze dietary and lifestyle habits for GC, also infrequent ones (WP1);
* analyze major risk factors in rare patient subgroups (WP2);
* develop a Genome-wide Modelling of polygenic risk score (PRS) in GC (WP3)

The Stomach cancer Pooling project (StoP) Consortium dataset has grown to the current number of 35 studies from Europe, America, Middle East and Eastern Asia. It will be used as the cornerstone upon which the investigation on the dietary and lifestyle determinants of gastric cancer (GC) will be built. It will allow the analyses of relatively infrequent habits or exposures, genetic factors as well as to perform sufficiently powered analyses of interactions and subgroups that may present relevant heterogeneity in the etiological correlates of GC.

The potential of genomics to personalize and thereby improve diagnosis, treatment, and prognosis of individuals has long been recognized, but so far evidence of the opportunity for genomics to drive prevention remains limited. Recent advances in research on Polygenic Risk Score (PRS) have created new interest about the use of genetic information in prevention of common diseases and its application to risk stratification. A long-lasting open question is whether common genetic variants used to build PRS are able to predict the risk of developing complex diseases with enough power to be used in a clinical setting.

The lack of large enough dataset able to allow an unbiased PRS validation, hampered this question to be answered for many years. This study builds upon the StoP project (a consortium collecting data from about 13,500 GC cases and 32,000 controls) and the UK Biobank (480 GC cases and 338,000 controls) to develop a Polygenic Risk Score for gastric cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients participating in studies that collaborate with the StoP Project
* Patient enrolled by the UK Biobank

Exclusion Criteria:

* Age \<18 years old
* Studies with less than 80 cases of histologically confirmed Gastric Cancer
Genistein in Treatment of Metastatic Colorectal Cancer

Colorectal neoplasms are the third most common malignancies in the United States. Patients with metastatic (stage IV) colorectal cancer have a median life expectancy of 2 years. The response rates to chemotherapy range from 35-40%.

Epidemiologic evidence suggests that soy compounds may reduce the incidence of colorectal cancers. Laboratory analyses demonstrate that genistein, a soy-derived compound, may inhibit Wnt signaling, a pathway activated in majority of colorectal cancers. Laboratory observations also demonstrate that genistein may augment growth inhibition when combined with chemotherapeutic agents of 5-Fluorouracil and platinum compounds.

Based on pre-clinical data the investigators hypothesize that combining genistein with the standard of care chemotherapeutic regimens will reduce chemotherapy resistance and improve response rates in patients. The aim of the study is to add genistein to the regimens of FOLFOX or FOLFOX-Avastin in patients with newly diagnosed stage IV colon or rectal neoplasms.

OBJECTIVES:

Primary

* Evaluate the tolerability of genistein when combined with chemotherapy

Secondary:

* Evaluate Response Rate (RR) as measured by the radiologic RECIST criteria
* Evaluate Progression Free Survival (PFS)

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female patients ≥18 years old
* Have pathologically confirmed colon or rectal carcinoma
* Have metastatic (stage IV) disease
* Have a plan by treating physician to receive FOLFOX or FOLFOX-Avastin
* Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* Have adequate hematopoietic, hepatic and renal function

  1. Hematopoietic function

     * Hemoglobin ≥10g/dL
     * Absolute Neutrophil Count(ANC) ≥1,500cells/mm2
     * Platelet Count ≥100,000/µL
  2. Hepatic Function

     * Total bilirubin ≤ 1.5x the upper limit of normal
     * ALT and AST must each be ≤2,5x the upper limits of normal
  3. Renal Function

     * Estimated creatinine clearance (Clcr) ≥30 mL/minute
* Are not pregnant and do not plan to become pregnant

Exclusion Criteria:

* Prior systemic chemotherapy for metastatic disease
* History of breast cancer, endometrial cancer or ovarian cancer or taking aromatase inhibitors or selective estrogen receptor modulators
* Patients taking MAO-inhibitors
* History of myocardial infarctions or cardiac stent placement less than 1 year before recruitment into the study
* Unable to give informed consent or comply with clinical trial requirements
* Uncontrolled hypertension
* History of clinically significant GI bleeding within prior 2 months prior to enrollment
* Presence of GI fistula
* Prior history of bowel perforation
* History of CNS thrombotic/embolic or ischemic events
* Have past or current, acute or chronic concurrent medical condition/illness or therapy that, in the opinion of the investigator, would make the subject unsuitable for the clinical trial or unable to comply with the follow up visits.