cyrilzakka/clinical-trials huggingface dataset:
S9624 Ifosfamide in Treating Patients With Meningeal Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of ifosfamide in treating patients with meningeal tumors that have recurred or that cannot be removed surgically.

OBJECTIVES:

* Estimate failure free survival, overall survival, and response in patients with residual or recurrent/progressive aggressive meningeal tumors (malignant meningioma, hemangiopericytoma, and primary nervous system sarcoma) treated with ifosfamide.
* Evaluate toxicities of ifosfamide in this patient population.

OUTLINE: All patients receive ifosfamide IV continuously over 72 hours on days 1-3 of each 21 day treatment course. Patients are evaluated for response/progression after every 2 courses. Patients with stable disease receive up to 8 courses of therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven recurrent or unresectable:
* Malignant meningioma
* Intracranial hemangiopericytoma
* Primary central nervous system sarcoma, including:
* Fibrosarcoma
* Rhabdomyosarcoma
* Chondrosarcoma
* Leiomyosarcoma
* Measurable or evaluable disease on CT or MRI scan
* Persistent disease following biopsy or incomplete resection OR
* Recurrent disease following complete resection
* No benign meningioma
* No prior or current systemic sarcoma

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* SWOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 3,000/mm\^3
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Not specified

Renal:

* Creatinine no greater than 2.0 mg/dL

Cardiovascular:

* No myocardial infarction within the past 3 months
* No active angina
* No unstable heart rhythms
* No congestive heart failure

Other:

* HIV negative
* No allergy to study drugs
* No serious concurrent medical or psychiatric illness
* No uncontrolled peptic ulcer disease
* No prior malignancy within past 5 years except adequately treated:
* Basal or squamous cell carcinoma of the skin
* Carcinoma in situ of the cervix
* Not pregnant or nursing
* Effective contraception required of fertile patients

PRIOR CONCURRENT THERAPY:

* Recovered from toxic effects of prior therapy and/or from postoperative complications

Biologic therapy:

* Not specified

Chemotherapy:

* No prior ifosfamide
* No other concurrent chemotherapy

Endocrine therapy:

* No concurrent hormonal therapy (except estrogen replacement therapy)
* Corticosteroids allowed if dose is stable or decreasing

Radiotherapy:

* At least 4 weeks since prior radiotherapy
* Progressive disease following radiation required
* No concurrent radiotherapy

Surgery:

* See Disease Characteristics
Probiotics and Intestinal Microbiome in Preterm Infants

The gut microbiome plays a significant role in balancing the inflammatory system in the immature gut. A breakdown in this balance with altered colonization of the microbiota in very low birth weight (VLBW) preterm infants is associated with increased feeding intolerance, necrotizing enterocolitis (NEC) and sepsis. Probiotics are proposed to normalize microbial populations and decrease intestinal disease in preterm infants. There is limited data linking clinical outcomes with the biology of probiotics. We aim to study the colonization of the GI tract with probiotic species contained in a specific probiotic blend - Florababy - in VLBW preterm infants.

Stool microbiome will be analyzed at 4 time points in 2 groups (one given Florababy and the other no) of infants less than 1000 grams birth weight and \< 29 weeks gestation. A comparison of stool microbiome analysis and the incidence of feeding intolerance and time to reach full feeds in the two groups will be made.


Eligibility Criteria:
Inclusion Criteria:

* Infants born less than 29 weeks gestation and \<1000 g birth weight admitted to the Neonatal Intensive Care Unit (NICU) at Foothills Medical Centre in Calgary.

Exclusion Criteria:

* Infants with major congenital anomalies, hypoxic-ischemic injury, NEC or bowel perforation before 72 hours of life.
Assessment of Oncological and Functional Outcomes After Robot Assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy

Currently, partial nephrectomy (PN) is considered as the gold standard treatment modality for small renal masses. In this setting, robot-assisted and conventional laparoscopic approaches are gaining more consensus every day. However, until now, no superiority of one technique over the other has yet been demonstrated, especially on postoperative function recovery.

This study compares oncological and functional outcomes after laparoscopic partial nephrectomy versus robot assisted partial nephrectomy.

Renal cell carcinoma (RCC) represents 2-3% of all cancers, with the highest incidence in Western countries. Due to increased detection of tumors by ultrasound (US) and computed tomography (CT), the number of incidentally diagnosed RCCs has increased. These tumors are usually smaller and of lower stage. Currently, partial nephrectomy (PN) is considered as the gold standard treatment modality for small renal masses. In this setting, robot-assisted and conventional laparoscopic approaches are gaining more consensus every day. However, until now, no superiority of one technique over the other has yet been demonstrated, especially on postoperative function recovery. This is a single center prospective randomized trial investigating the functional and oncological outcomes of minimally invasive (laparoscopic and robot-assisted) nephron sparing surgery. Patients will be assessed with renal scintigraphy and 24 hours creatinine clearance pre- and postoperatively. Furthermore, duration of the operation, resection and suturing times will be assessed. Renal function recovery is defined as primary endpoint; oncological outcome and positive surgical margin rate are defined as secondary measures. In addition, kidney volume variation will be calculated to describe the amount of healthy tissue preserved in both procedures.The aim of the study is to assess whether robot assisted partial nephrectomy in selective ischemia is superior to laparoscopic partial nephrectomy in global ischemia in terms of functional and oncological outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Men and women \>18 years
* Organ-confined renal cancer (tumor stage cT1-cT2), assessed by MRI/CT
* Patient qualifies for robotic or laparoscopic partial nephrectomy
* Written informed consent

Exclusion Criteria:

* Renal masses necessitating radical tumor nephrectomy
* Patients with single kidney
* Bilateral kidney cancer when simultaneously operated
* Previous partial nephrectomy
* Renal insufficiency: Chronic Kidney Disease (CKD) stages 4-5
Effects of Pre-event Massage Over the Neuromuscular Response

The study observes the effect of a pre-event massage on the gastrocnemius muscles over the neuromuscular response of the gastrocnemious muscles.


Eligibility Criteria:
Exclusion Criteria:

* Muscle injury in the last two months
* To not understand the study orders
* Suffer a musculoskeletal disorder that doesn't allow the subject to do the study protocol
Evaluation of the Influence of New Adhesives of Output on Skin

The study investigates the impact real output has on peristomal skin covered by a newly developed adhesive and a standard adhesive


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had an ileostomy for more than one year
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Participating in other interventional clinical investigations or have previously participated in this evaluation
A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects

This Is A Multicenter, Active-Controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis


Eligibility Criteria:
Inclusion Criteria:

* Polyarticular (both rheumatoid factor positive and rheumatoid factor negative),oligoarticular and extended oligoarticular JIA for ≥3 months meeting the International League of Associations for Rheumatology (ILAR) criteria for Juvenile Idiopathic Arthritis (JIA)
* Subjects with Systemic JIA with active arthritis in at least 1 joint but without active systemic features are eligible
* ≥2 years of age and \<18 years of age prior to the Baseline visit
* Body weight ≥10 kg at the Baseline visit
* Candidate for chronic NSAID therapy in the Investigator's judgment

Exclusion Criteria:

* Psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis types of JIA
* Active systemic features over the prior 12 weeks in children with systemic Juvenile Idiopathic Arthritis (JIA)
* Subjects with psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis should be excluded
* Subjects with active Systemic JIA should not be enrolled
Effects of Behavioural Activation on Emotional Cognition and Mood

Behavioural activation (BA) is widely accepted as an efficacious treatment for depression. It has been suggested that several depression treatments work via early changes in emotional processing (e.g. affective bias in the processing of facial expressions) and that these could help predict treatment success, but it has not yet been examined whether the same applies in behavioural interventions. The investigators will examine how BA affects early emotional information processing in participants who are currently experiencing low mood, to see whether this can predict eventual changes in mood and to gain a better understanding of the treatment mechanisms of BA. Participants will be in three groups undergoing either behavioural activation, or activity monitoring alone (active control) for 4 weeks, or they will be on a waiting list (passive control). The investigators will also examine whether other factors, such as anxiety, social support and environmental reward, can predict the success of BA. This could help us understand how BA works and who may be most suitable for this intervention.


Eligibility Criteria:
Inclusion Criteria:

* Female or male
* Age: 18 to 65 years
* Competency to give informed consent
* Scores above 14 on BDI-2 (bottom criterion for mild depression)

Exclusion Criteria:

* Previous participation in a study that used the emotional test battery (ETB)
* Currently undergoing any form of psychotherapy or counselling
* Taking antidepressant medication for less than 3 months, or changing existing psychiatric medication within the past month
* Current or past a diagnosis of psychosis or a bipolar disorder
* Current diagnosis of an eating disorder, a borderline personality disorder, or a substance abuse disorder
* Any other factor that would indicate the participant isn't able to comply with the requirements of the study according to the opinion of the chief investigator (severe insomnia, chronic fatigue syndrome, neurological conditions impairing cognitive function etc.)
* Symptoms of depression are too severe (score 20 and above on the PHQ-9 questionnaire or according to the evaluation of study psychiatrist)
The Influence of Non-Caloric Artificial Sweeteners on Youth With Type 1 Diabetes

The investigators aim to further the understanding of environmental factors that may underlie variations in body composition seen in youth with Type 1 diabetes (T1D). Non-caloric artificial sweeteners, broadly consumed in many individuals with T1D, are a modifiable dietary factor that may be associated with negative health outcomes, particularly those relevant to the future risk of diabetes-related complications.

Investigators will measure body composition (the amount of fat and muscle in the body and where the fat is stored) using a bioelectrical impedance analysis machine and DEXA scanner. Blood will be drawn for the following labs: HbA1c, lipid panel, comprehensive metabolic panel and leptin. Participants will also answer questions about their diets and consumption of artificial sweeteners.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females aged 5-17 years with a clinical diagnosis of T1D of ≥ 6 months in duration
2. BMI between the 5th and 95th percentile

Exclusion Criteria:

1. Presence of severe, active disease that requires the use of chronic medication, with the exception of well-controlled autoimmune thyroiditis/hypothyroidism or celiac disease that is well-controlled on a gluten free diet.
2. Diabetes other than T1D
3. Chronic illness known to affect glucose metabolism
4. Psychiatric impairment, with the exception of well-controlled depression or anxiety, that will affect the ability to participate in the study
5. Female participants of child-bearing age with reproductive potential must not be knowingly pregnant
6. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results
The Changes of Cytokines During Antiviral Therapy

Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, cytokines played a vital role. This study was aimed at investigating the changes of cytokines during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α therapy resulted in the secretion of cytokines.

Pegylated interferon α-2a(Peg-IFN-α)and Nucleoside analog(ue) drugs can inhibit viral replication , but Peg-IFN-α also play an important role in immune regulation . In hepatitis B infection, cytokines including Fit-3L, IFN-alpha2, IFN-gama, IL-10, IL-17A,IL-2, IL-6, TNF-alpha, TGF-beta1, TGF-beta2,TGF-beta3, played a vital role.Peg-IFN-α recommended as the first-line treatment has a higher chance to achieve HBeAg seroconversion and even HBsAg disappearance than nucleoside analog(ue) drugs, which might be related to the increase of cytokine secretion in the case of hepatitis and during Peg-IFN-α therapy.This study was aimed at investigating the changes of cytokines during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to clarify whether Peg-IFN-α therapy led to the secretion of cytokines.

Eligibility Criteria:
Inclusion Criteria:

* HBsAg and HBeAg positive for more than 6 months, HBV DNA detectable with ALT level abnormal lasted for three months and at least time190 IU/L or liver puncture biopsy demonstrated apparent inflammation, never treated before enrolled.

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver
ThickenUp® Gel Express for Patients with Dysphagia

Evaluation of swallowing function and hydration following consumption of ThickenUp® Gel Express in patients with dysphagia.

ThickenUp® Gel Express for Patients With Dysphagia ("Hydra-01 Study"): Effect on Swallowing Function as Assessed by a Videofluoroscopy (VFS) One Day Study With Bolus of Various Viscosities (Study Part 1) and Followed, in a Subset of Patients, by a United Kingdom Advisory Committee on Borderline Substances (UK ACBS) Acceptability 14 Days Study Combined With an Exploratory Hydration Assessment Study at a Prescribed Viscosity (Study Part 2).

Eligibility Criteria:
Key inclusion criteria (for study part 1 and part 2):

1. Aged ≥ 18 years;
2. Diagnosed with oropharyngeal dysphagia and with a documented impaired safety of swallow by V-VST and PAS \>1 during VFS;
3. History and/or current of swallowing difficulties;
4. Willing to adhere to the restrictions specified in the protocol;
5. Must be competent to understand the nature of the study and capable of giving written informed consent. In case patients are not capable of providing written informed consent (i.e. affected by dementia) a family/legal representative could provide the consent for the study.
6. Willing to report for the scheduled study visits and communicate to study personnel about adverse events and concomitant medication use.

Key exclusion criteria (for study part 1 and part 2):

1. Patients suffering from idiosyncratic phenomena or who are allergic to iodinated contrast media;
2. Major respiratory disease requiring oxygen or undergoing any type of surgery in the three months prior to the study;
3. Current diarrhea, vomiting or abdominal pain;
4. Alcohol or drug dependence (based on anamnesis only);
5. COVID-19 positive patients (with or without symptoms) at the time of enrolment;
6. Patients who, in the judgment of the investigator, are likely to be noncompliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
7. Having participated in a clinical study in the last 4 weeks and received compensation beyond a certain approved and predefined limit;
8. Having a clinical condition that is contraindicated with the study product;
9. Positive urine pregnancy test at screening for women of childbearing potential;
10. Allergy towards milk, mustard, egg, or celery.

Additional inclusion criteria for study part 2 only:

1. Patient willing to participate in study part 2;
2. Patient/caregiver able to record daily GI symptoms, compliance and fluid intake;
3. Patient able to respond to acceptability questionnaire (organoleptic properties, texture, appearance).
4. Patient willing to only use study product as the sole thickening agent during the Part 2.

Additional exclusion criteria for study part 2 only:

1. Undergone a major gastrointestinal surgery less than 3 months prior to enrolment in this study;
2. Obstruction of the gastrointestinal tract.
Real-World Treatment Patterns and Outcomes Among Patients With Chronic Myeloid Leukemia in Earlier Lines of Therapy

This was a retrospective, non-interventional, observational cohort study using Optum's de-identified Clinformatics® Data Mart Database. Adult patients newly diagnosed with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors (TKIs) were identified using the Optum database and classified into the following cohorts:

* First treatment cohort: Patients newly diagnosed with CML who received first treatment with a TKI.
* Second treatment cohort: Patients from first treatment cohort with a subsequent line of therapy (i.e., second treatment) with a TKI.

The observation period spanned from the start of data availability (i.e., 01 January 2007) to the earliest of end of data (i.e., 30 June 2022), end of continuous health plan enrollment, or death (if available). The index date was defined as the first treatment initiation for the first treatment TKI cohort and as the second treatment initiation for the second treatment TKI cohort. The baseline period consisted of the 6 months prior to the index date. The follow-up period started on the index date and ended at the earliest of end of observation period or hematopoietic stem cell transplantation (HSCT).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who initiated their first treatment with imatinib, dasatinib, nilotinib, or bosutinib (conditional on Food and Drug Administration (FDA) approval dates) with 6 months continuous health plan enrollment prior to the first prescription fill date.
* Patients with 2 or more diagnoses for CML (adult as of the first diagnosis for CML).
* Patients had index date on or after first CML diagnosis.
* Patients had no diagnoses for CML remission/relapse prior to index date.
* Patients had no gastrointestinal stomach tumor (GIST) or chronic myelomonocytic leukemia (CMML) at any time.
* Patients had no medical claims associated with a clinical trial during the baseline period.
* Patients had no hematopoietic stem cell transplantation (HSCT) during the baseline period.
* Patients had no CML-related chemotherapy treatments for accelerated phase (AP)/blast crisis (BC) during the baseline period.
* First treatment cohort:

  * Patients started first treatment for CML with imatinib, dasatinib, nilotinib, or bosutinib in 2012 or later.
  * Patients had no HSCT during the first treatment baseline period.
  * Patients had no CML-related chemotherapy treatment for AP/BC during the first treatment baseline period.
* Second treatment cohort:

  * Patients started second treatment for CML with imatinib, dasatinib, nilotinib, or bosutinib in 2012 or later.
  * Patients had no HSCT from the first treatment baseline period up to second treatment initiation.
  * Patients had no CML-related chemotherapy treatment for AP/BC from the first treatment baseline period up to second treatment initiation.