cyrilzakka/clinical-trials huggingface dataset:
Collecting and Storing Samples of Blood and Tumor Tissue From Patients With Osteosarcoma

The purpose of this study is to collect and store samples of blood and tumor tissue from patients with osteosarcoma. Collecting and storing samples of tumor tissue and blood from patients to test in the laboratory may help the study of cancer in the future.

OBJECTIVES:

I. To collect biological specimens from patients with osteosarcoma at Children?s Oncology Group (COG) institutions.

II. To provide a repository for long-term storage of osteosarcoma-related biological materials.

III. To make these specimens available to qualified researchers to understand the biology of osteosarcoma and correlate these results with the patients' clinical data.

OUTLINE:

After the initial submission of blood samples, patients may undergo open or closed biopsy in order to obtain fresh and frozen tissue samples as well as paraffin embedded material. Patients who are enrolled at the time of initial diagnosis but then have a definitive surgery or develop recurrent disease may submit additional samples (paraffin block, frozen and fresh tumor tissue, or slides together with blood samples). Autopsy tumor samples may also be submitted.

Eligibility Criteria:
Inclusion Criteria:

* All osteosarcoma patients seen at COG institutions are eligible, including the following:

  * Newly diagnosed patients
  * Patients with recurrent disease who were not enrolled at the time of diagnosis
* The following specimens from the initial biopsy (and/or definitive surgery if an up-front resection is performed) are required:

  * Paraffin embedded block OR 30 unstained slides
  * Pretreatment blood consisting of 5 mL serum, 10 mL plasma, and 10 mL heparinized whole blood
  * Fresh and frozen tumor specimens
* Patients are not required to enter a therapeutic study to enroll on this study
Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Joint Pain Using the Sinergy System

to evaluate the effectiveness of cooled radiotherapy denervation of the sacroiliac region using the sinergy system by comparing a treatment group to a placebo group


Eligibility Criteria:
Inclusion Criteria:

* Predominantly axial pain below L5 vertebrae
* greater than 75%pain relief from 2 seperate lateral branch blocks done on different days
* chronic axial pain lasting longer than 6 months, 3 day average VAS between 4 and 8
* age greater than 18
* failed to acheive adequate improvemnet with comprehensive non-operative treatments, includingbut not limited to: activity alteration, non0steriodal anti-iflammatory, physical and/or manual therap, and flurpscopically guided steriod injections in and around the area of pathology
* all other possible sources oflow back pain have been ruled out, including but not limited to the intervertebral discs, bone fracture.

Exclusion Criteria:

* Beck Depression greater than 20%
* irreversible psychological barriers to recovery
* spinal pathology that may impede recovery such as spins bifida occulta,
* moderate to severe foraminal or central canal stenosis
* systemic infection or localized infection at inducer site
* concomitant cervical or thoracic pain greater than 2/10 on VAS
* uncontrolled or acute disease
* chronic severe condition such as rheumatoid arthritis
* preganancy
* active radicular pain
* immunosuppression
* workers compensation
* allergy to injectants or medications used in procedure
* high narcotis use greater than 30 mg hydrocodone or equivalent
* smokers
* body mass index greater than 29.9
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of RO7303509 treatment in participants with systemic sclerosis (SSc) during a multiple-ascending-dose (MAD) portion of the trial. In the MAD phase, increasing doses of study drug will be tested sequentially. For each dose tested, the MAD stage will consist of a treatment period of 12 weeks followed by either a safety follow-up period of 13 weeks or continued treatment in an optional open-label safety extension (OSE) stage of 52 weeks to assess the long-term safety. All patients in the OSE stage will receive RO7303509 and no patient will receive placebo.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for the MAD Stage:

* Weight of 45-150 kg at screening
* Diagnosis of SSc, as defined by 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria and ≤ 10 years disease duration from first non-Raynaud's symptom
* Agreement to remain abstinent or use an effective contraceptive method among males and females with childbearing potential for 4 months after last dose of study drug

Inclusion Criteria for the OSE Stage:

* No clinically significant change in eligibility status
* Completion of the MAD and ability to roll over into the OSE within 5 days

Exclusion Criteria:

* Active rheumatic autoimmune disease other than SSc requiring treatment with disease-modifying therapy
* Pulmonary disease with forced vital capacity (FVC) ≤ 50% of predicted
* History or clinical manifestations of significant metabolic, hepatic, renal, pulmonary, cardiovascular, hematologic, gastrointestinal, urologic, neurologic, or psychiatric disorders
* History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 4 months after the final dose of study drug
* Major surgery within 8 weeks prior to screening, or major planned surgery during the study or within 3 months after the final dose
* Positive hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody test at screening
* Any serious medical condition or abnormality in clinical laboratory tests
KUL0401: An Open-label Pilot Study of Oxatomide in Steroid-Naive Duchenne Muscular Dystrophy

This study will help to determine the safety and efficacy of the mast cell stabilizer Oxatomide as a treatment for Duchenne muscular dystrophy (DMD). Boys with DMD who are enrolled in this study will should not have taken steroids to treat DMD for at least twelve months, and should not have taken any nutritional supplements for at least three months. Subjects will complete a two screening visits within a one-week period, and if enrolled will then have their strength tested monthly for three months before beginning therapy with Oxatomide. Once Oxatomide therapy is started, participants will have their strength tested monthly for six months. Following the six month treatment period, participants will be given the option to remain on Oxatomide until the study is completed.


Eligibility Criteria:
Subject Inclusion Criteria

1. 5 to 10 years of age
2. ambulatory
3. diagnosis of DMD confirmed by at least one of the following:

   * Positive x-linked family history of DMD in older male relatives (onset by 5 years, wheelchair bound by 12 years), or;
   * Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin deficiency, and clinical picture consistent with typical DMD, or;
   * Gene deletion test positive (missing one or more exons) in the central rod domain (exons 25-60) of dystrophin, where reading frame can be predicted as 'out of frame', and clinical picture consistent with typical DMD.
4. glucocorticosteroid-naive (i.e. has not been treated with prednisone or deflazacort within the past year)
5. Evidence of muscle weakness by MRC score or clinical functional evaluation
6. QMT biceps score variability no greater than 10% between screening visits

Subject Exclusion Criteria

1. Failure to achieve one or more of the inclusion criteria listed above
2. Inability to suitably cooperate with strength assessments
3. Symptomatic DMD carrier
4. Use of oxatomide (or other anti-histamine drugs) within the last 6 months for DMD or any other disease
5. Use of creatine monohydrate or glutamine within the last 6 months
6. Use of carnitine, Coenzyme Q10, other amino acids or any herbal medications within the last 3 months
7. History of symptomatic cardiomyopathy
8. History of impairment of hepatic function
9. History of significant concomitant illness or significant impairment of renal function.
Patient-centered Educational Material to Improve Colposcopy Adherence

The long-term goal is to develop, test, and disseminate a social needs navigator intervention that improves colposcopy adherence. Based on stakeholder feedback, this study addresses the need to include patient-centered educational material to the navigator program in order to improve patients' health literacy regarding cervical cancer prevention.

The investigators will evaluate the effectiveness of the colposcopy educational material. The investigators aim to recruit 25 newly referred colposcopy patients before their appointment, ask them to take a 5-minute test about their knowledge of colposcopy, have them view an online demo of the educational resources, and then retake the test.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 years or older
* Abnormal cervical screen confirmed by cytology or pathology
* Referred to Washington University School of Medicine (WUSM) colposcopy clinic

Exclusion Criteria:

* History of cervical cancer
* Unable to consent
Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262)

This is a study comparing the incidence of hypoglycemia while using sitagliptin treatment versus sulfonylurea (SU) treatment in participants with type 2 diabetes mellitus (T2DM) who regularly take an SU drug, and choose to fast during the month of Ramadan. The primary hypothesis is that during the 30 days of Ramadan fasting, treatment with sitagliptin (with or without metformin) compared to SU treatment (with or without metformin) results in a lower incidence of hypoglycemia in participants with T2DM.

This study and NCT01131182 (MK-0431-263) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Muslim, with type 2 diabetes mellitus
* Intends to fast during the month of Ramadan
* Hemoglobin A1c (HbA1c) ≤10% at screening
* On a stable dose of a SU drug (glibenclamide, glimepiride, or gliclazide), for at least three months, with or without metformin therapy at a stable dose

Exclusion Criteria:

* Type 1 diabetes mellitus
* Pregnant or breast feeding or with gestational diabetes
* Hypersensitivity or contraindication to dipeptidyl peptidase-4 (DPP-4) treatment
* Serum creatinine ≥1.5 mg/dL (males), ≥1.4 mg/dL (females)
* History of severe hypoglycemia (defined as a hypoglycemic event requiring the assistance of another individual, and/or resulting in a emergency department admission, physician office visit and/or hospitalization)
* Any use of insulin (prior to or during Ramadan)
* Use of any class of oral antidiabetic therapy other than an SU or metformin
* Current participation in another interventional study
Effects of Walking Apnea At Low Lung Volume on Hypoalgesia

The aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent walking apneas training session at low lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic subjects aged between 18 and 64 years.

Exclusion Criteria:

* Cardiovascular, respiratory, metabolic, neurological or osteomuscular signs or pathologies.
* History of epilepsy.
* Pregnant
* Pharmacological treatment.
* Participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 4 weeks.
Longitudinal Use of Protective Behavioral Strategies

This study tested a deviance regulation theory intervention in a sample of university freshman. The aims were to (a) increase use of protective behavioral strategies, (b) decrease alcohol use, and (c) decrease alcohol-related consequences.

College student freshmen were invited to participate in a study on the use of alcohol protective behavioral strategies. They were randomly assigned to receive a positive message about individuals that used protective strategies, a negative message about individuals that did not use protective strategies, or an assessment control. They were then followed for the next 12 months. Assessments were completed at weeks 0, 1, 2, 3, 4, 5, 12, 26, and 52.

Eligibility Criteria:
Inclusion Criteria:

* College freshman at UCF
* Endorse alcohol consumption in the past two weeks

Exclusion Criteria:

* Severe mental illness
* Under 18 years of age
* Over 21 years of age
* Unable to speak English fluently
Classification of Heart Failure in Children

Evaluation of Severity of Heart Failure in Children Attending Cardiology Unit, Assiut University Children Hospital

Heart failure (HF) has been defined as an abnormality of cardiac structure or function leading to failure of the heart to deliver oxygen at a rate commensurate with the requirements of the metabolizing tissues, despite normal filling pressures (or only at the expense of increased filling pressures). Heart failure may result from ventricular pump dysfunction, volume overload with preserved pump function, and pressure overload with preserved pump function.Determinations of the degree of heart failure severity are essential for clinical assessment and treatment evaluation. Remarkably, no readily applied standardized method of quantifying heart failure severity exists for pediatric patients. Although standard index methods from the adult population, such as the New York Heart Association Classification, have been applied to non-infant pediatric populations, none have been validated in children. The NYHA classification measures functional capacity, not heart failure severity. The NYHA classification is inappropriate for use in pediatrics because functional capacity and responses to heart failure states differ in children compared with adults. Children have markedly different cardiac physiology, clinical presentations, and compensatory mechanisms. Moreover, the etiologies of heart failure in children are very different from those in adults. For these reasons, Ross et al.,developed a scale that is useful for grading heart failure severity in infants from birth to 6 months of age but is not applicable to older children and adolescents (Original Ross Classification).

Many have since used the "Ross Classification," including Wu et al., who confirmed an incremental rise in PNE (Plasma Norepinephrine) concentrations and progressive down-regulation of β-receptor density in children with increasing Ross class. In 1994, the Canadian Cardiovascular Society's Consensus Conference statement on the "Diagnosis and Management of Heart Failure," adopted the Ross Classification as their official scoring system for children. Ross propose an age-based Ross classification using the original variables that proved to be sensitive and specific and adding the new evidence-based data. The age ranges of 0-3 months, 4-12 months, 1-3 years, 4-8 years, and 9-18 years were chosen because the variables in the classification are generally stable during these periods but vary between them. The scoring system can be used as a continuous data set for comparison with outcomes, or it can be categorized by points.

Eligibility Criteria:
Inclusion Criteria:

* Cases admitted at Pediatric Cardiology Unit, Assiut University with Heart Failure Manifestations.

Exclusion Criteria:

* Primary liver diseases.
* Hematological diseases associated with organomegaly.
Clinical Outcome of Pediatric Dermatofibrosarcoma Protuberans

Retrospective review of clinical outcome of pediatric Dermatofibrosarcoma Protuberans (PDFSP) after active invitation

Soft tissue sarcoma was rarely seen in pediatric patients, and pediatric Dermatofibrosarcoma Protuberans (PDFSP) was even rare. To our knowledge, the largest report constituted of 19 cases (five of them had no follow-up (FU) status) (1). So we proposed this retrospective study based on the cancer registry of our hospital. Twelve cases who were diagnosed as DFSP before age of 18 were identified. But all of them had been lost of FU for at least two years. So we will try to contact these patients and asked them to be back to our clinic for routine surveillance (history taking and physical exam and optional local image/chest xray) and quality of life (QoL) evaluation after pathological review if this clinical study was approved (2)

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as DFSP before age of 18 after pathological review according to the cancer registry of our hospital

Exclusion Criteria:

* age \> 18 at diagnosis
ProGRP, CgA, NSE and TUM2-PK in in Patients With Neuroendocrine Tumors

The purpose of this study is to determine whether monitoring of levels of Serological Markers ProGRP, CgA, NSE and Pyruvate Kinase M2 are effective in the Evaluation of Diagnosis, Monitoring Therapeutic Effects and Predicting response to somatostatin analogues in Patients with Malignant Neuroendocrine Tumors.

Assessment of the anatomical spread and disease progression in neuroendocrine tumor patients has become an essential part of disease management, but sometimes in many patients difficult to be measured. Therefore, the evaluation of serum markers could represent a useful tool for monitoring the course of the disease and the response of patients to therapy or palliative treatment.Clinical data considers CgA and NSE as available today blood biomarkers for neuroendocrine tumors.Until now the usefulness of serum ProGRP as a clinical tumor marker has been evaluated mainly in Small Cell Lung Carcinoma, while its role in the management of NE tumors has not been elucidated.Available in the literature limited data suggests that ProGRP may be a potential tumor marker in NE tumors.

Pyruvate kinase type M2 is the key glycolytic regulator in tumor cells.It catalyzes the dephosphorylation of phosphoenolpyruvate to pyruvate with ATP production.The dimeric form of this enzyme (TUM2-PK) has been detected in the blood of patients with different cancers.High TUM2-PK expression was suggested to be an important element of tumor cell metabolism adaptation to an inadequate oxygen and nutrient supply.Recently, it has been shown that somatostatin and its structural analogues pass through cell membrane and actively bind to cytosolic TUM2-PK. In response to this binding TUM2-PK translocates into the nucleus and induce programmed cell death. It is suggested that TUM2-PK enzyme may contribute significantly to response of neuroendocrine tumors to somatostatin analogues.

Eligibility Criteria:
Inclusion Criteria:

* The patients at diagnosis of neuroendocrine tumors before therapy will be approached to participate in the study.
* Older then 18 years old
* Patients who agree to participate will receive a detailed explanation and sign an informed consent form.

Exclusion Criteria:

* Pregnant women
* Coexistence of another primary malignant tumor other then neuroendocrine tumors
To Evaluate the Feasibility, Safety, and Efficacy of TET for FMT Via Colonic Approach

No technique by placing a tube through anus into cecum for whole colon administration. This study aimed to evaluate the feasibility, safety, and efficacy of transendoscopic enteral tubing (TET) in fecal microbiota transplantation (FMT) through whole colon.

The previous reported fecal microbiota transplantation (FMT)through whole colon. delivering ways were involved with upper digestive tract, middle digestive tract and lower digestive tract. FMT via colonoscope is the most common approach, participants have to endure the discomfortable of bowel preparation and colonoscopy, and FMT by colonoscopy was recommended for repeat FMT treatment in short period. Traditional enema infuses bacteria solution into rectal and sigmoid colon but cannot spread to whole colon.No technique by placing a tube through anus into cecum for whole colon administration, which could be maintained for repeat FMTs.To solve these problems, investigators designed a new technique called transendoscopic enteral tubing (TET).the TET tube was fixed at cecum by clips under endoscopy. This study aimed to evaluate the feasibility, safety, and efficacy of TET for FMT via colonic approach.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate ulcerative colitis (Montreal classification)

Exclusion Criteria:

* Diagnosed as ulcerative colitis first time.
* No history of using Biologic, immunomodulatory therapy or corticosteroid therapy.
* With contraindication of endoscopy.
Mucus Dehydration and Evolution of Chronic Obstructive Pulmonary Disease (COPD) Lung Disease

The purpose of this research is to understand the properties of mucus in persons with COPD, specifically Chronic Bronchitis. We hypothesize that those with Chronic Bronchitis have dehydrated mucus, and thus have a harder time coughing it out of their lungs. This leads to a greater vulnerability for lung infection, inflammation and airflow obstruction. Ultimately, our goal is to understand how mucus dehydration contributes to the progression of COPD/Chronic Bronchitis so that better therapies and interventions can be developed for future generations.

Specific Aim I directly tests the hypothesis that mucus clearance is impaired due to mucus dehydration. It measures 1) COPD Mucociliary and Cough Clearance 2) mucus hydration 3) the concentrations of the dominant regulators of airway hydration and 4) the consequences of mucus dehydration on mucus biophysical properties and bacterial infection.

Specific Aim II tests the hypothesis that COPD acute exacerbations are associated with failures of mucus clearance. Measurements will be similar to that of Specific Aim I, but conducted during periods of baseline health, acute exacerbation and recovery.

Specific Aim III tests whether airway surface hydration with 7% Hypertonic Saline will restore clearance in the basal state and during a COPD acute exacerbation. COPD subjects will be exposed to inhaled Hypertonic Saline during periods of baseline health and acute exacerbation. Acute efficacy via measures of mucus clearance and spirometry will studied.

Eligibility Criteria:
Inclusion Criteria:

* history of COPD/chronic bronchitis defined as having a productive cough for three months of the year for at least two successive years
* greater than or equal to a 10 pack year cigarette smoking history
* ability to perform spirometry

Exclusion Criteria:

* unstable lung disease
* allergy to study medications
* radiation exposure within past year exceeding Federal Regulation Limits