cyrilzakka/clinical-trials huggingface dataset:
Combination Chemotherapy in Treating Patients With Refractory or Recurrent Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with paclitaxel and cisplatin plus flavopiridol in treating patients who have refractory or recurrent solid tumors.

OBJECTIVES: I. Determine the maximum tolerated dose of flavopiridol when administered in combination with paclitaxel and cisplatin in patients with refractory adult solid tumors. II. Investigate the clinical pharmacokinetics of intravenous flavopiridol when administered in combination with paclitaxel in these patients. III. Obtain preliminary data on the therapeutic activity of flavopiridol when administered in combination with paclitaxel in these patients. IV. Evaluate surrogate markers of activity such as inhibition of PKC or CDK1 in these patients.

OUTLINE: This is an open label, dose escalation study. Patients receive paclitaxel IV over 3 hours on day 1. On day 2, patients receive cisplatin IV over 20 minutes followed by a 24 hour infusion of flavopiridol. Courses are repeated every 21 days in the absence of disease progression or unacceptable toxicity. Sequential dose escalation of flavopiridol is followed by sequential dose escalation of cisplatin. Dose escalation in cohorts of 3-6 patients each continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed every 6 weeks.

PROJECTED ACCRUAL: Approximately 46-73 patients will be accrued for this study within 6 more months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven solid tumors that are refractory or recurrent -No CNS primary or metastatic disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky at least 60% Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST and ALT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: At least 6 months since prior cardiac arrhythmias, myocardial infarction, or congestive heart failure Other: Not pregnant or nursing Effective contraceptive method must be used for 2 months after study completion Not HIV positive No uncontrolled or serious infection No pre-existing grade 3 or greater neurotoxicity Must be mentally capable of understanding the explanation of the study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified Other: No presence of toxic effects from prior therapy
Long COVID and Post-exertional Pulmonary Diffusion

Aim of investigators was to study whether abnormalities of lung diffusing capacity for nitric oxide (DLNO) and carbon monoxide (DLCO) in long COVID may have a clinical impact in relation to exercise intolerance.

Prolonged recovery from acute coronavirus disease 2019 (long COVID) is characterized in about 30% of subjects from breathlessness and fatigue also during daily activities often associated to decreased lung diffusing capacity for carbon monoxide (DLCO) at rest. Aim of investigators was to study whether abnormalities of lung diffusing capacity for nitric oxide (DLNO) and DLCO in long COVID may have a clinical impact in relation to exercise intolerance. Combined DLNO and DLCO were simultaneously measured at rest and immediately after a short bout of treadmill walking in 32 dyspneic subjects ≥3 months after the COVID-19 acute phase. A group of healthy subjects served as a control group.

Eligibility Criteria:
Inclusion Criteria:

* History of dyspnea, fatigue, and exercise intolerance persisting or occurring at least 3 months after the COVID-19 acute phase and lasting ≥2 months.

Exclusion Criteria:

* History of diseases potentially causing dyspnea or affecting pulmonary gas transport, i.e., bronchial asthma, lung bullous disease, chronic obstructive pulmonary disease, pulmonary interstitial fibrosis or vasculitis, hematological diseases, systemic collagen diseases, congestive heart failure, liver or renal diseases, and morbid obesity.
Effects of a Structured Education Program on Blood Pressure in Essential Hypertensive Patients

The purpose of this study is to evaluate the effects of a structured educational program for hypertensive patients. The program was developed at the University of Dusseldorf, Germany. The contents of the program are as follows: teaching of the background of hypertension, techniques of self estimation of blood pressure, life style and dietary habits, some information concerning the different pharmacological properties to treat hypertension

see brief description section

Eligibility Criteria:
Inclusion Criteria:

* Intellectual and physical ability to attend teaching program,
* Capability to do and document blood pressure self-measurement,
* Systolic blood pressure \>160 and/or diastolic blood pressure \>95 mmHg,
* At least 3 months of preexisting medicamentous anti-hypertensive treatment,
* 15% or higher risc in New Zealand Risc Scale

Exclusion Criteria:

* Failing inclusion criteria
The Treatment of Stage I and II Carcinoma of the Breast With Mastectomy and Axillary Dissection Versus Excisional Biopsy, Axillary Dissection, and Definitive Irradiation

Patients with biopsy proven breast cancer, clinical stage I and II, will be randomized to receive treatment by one of two methods: (1) total mastectomy and axillary dissection; or (2) excisional biopsy, axillary dissection, and definitive irradiation.

Data from single institutions and from retrospective comparisons suggest that definitive irradiation with cosmetically acceptable breast preservation offers survival and local control results equivalent to extirpative surgery. This study will test this hypothesis in a prospective, randomized manner. After primary therapy, subjects will be followed for: (1) survival; (2) sites of recurrence; (3) anatomic function; (4) complications of therapy; and (5) cosmesis.

Patients with biopsy proven breast cancer, clinical stage I and II, will be randomized to receive treatment by one of two methods: (1) total mastectomy and axillary dissection; or (2) excisional biopsy, axillary dissection, and definitive irradiation.

Data from single institutions and from retrospective comparisons suggest that definitive irradiation with cosmetically acceptable breast preservation offers survival and local control results equivalent to extirpative surgery. This study will test this hypothesis in a prospective, randomized manner. After primary therapy, subjects will be followed for: (1) survival; (2) sites of recurrence; (3) anatomic function; (4) complications of therapy; and (5) cosmesis.

Eligibility Criteria:
* INCLUSION CRITERIA:

Female patients of any age with a dominant breast mass meeting the following requirements are eligible for this protocol:

On clinical evaluation the tumor must be confined to the breast and axillary lymph nodes (stage I and II).

Biopsy of the tumor must be classified as a primary breast neoplasm of epithelial origin.

Patients must be geographically accessible for follow-up and willing to return for the follow-up at the NCI.

Patient must be mentally competent to understand and give informed consent for the protocol.

EXCLUSION CRITERIA:

Patients will be excluded from this protocol for the following reasons:

Advanced local disease or distant metastases (stage III and IV);

Inflammatory cancer;

Chronic diseases such as heart, lung, liver, kidney, blood, or metabolic disorders which may render the patient a poor operative risk;

History of another cancer other than skin cancer (non-melanoma);

Concurrent pregnancy or lactation;

Non-palpable lesions manifested only by nipple discharge or skin rash (Paget's disease);

Previous therapy to the breast cancer other than excisional biopsy;

Multiple masses or multiple suspicious areas on mammogram unless all but one are proven histologically benign; and

Bilateral breast carcinoma, either invasive or in-situ.
Estrogen Administration for the Treatment of NASH in Postmenopausal Women

Non-alcoholic fatty liver disease (NAFLD) is a growing epidemic in the United States. Despite this, the treatment options remain limited. Preclinical and preliminary clinical data suggest that estrogen deficiency plays an important role in the pathology of steatosis, inflammation and fibrosis in non-alcoholic steatohepatitis (NASH), the progressive form of NAFLD. Post-menopausal women are a growing population with particularly high risk of NASH due to their lack of estrogen. This study will examine the effect of estradiol on hepatic fibrosis and fat in post-menopausal women with NASH.


Eligibility Criteria:
Inclusion criteria:

* Postmenopausal women 45-70 years old
* NASH by biopsy or NAFLD by imaging within 6 months of screen
* Hepatitis C antibody and hepatitis B surface antigen negative
* Negative mammogram within 1 year

Exclusion criteria:

* Heavy alcohol use
* Use of NASH pharmacotherapies within 12 months of study entry
* Known cirrhosis, stage 4 fibrosis on biopsy, or clinical evidence of cirrhosis or portal hypertension on imaging or exam
* Participation in NASH clinical trial within 6 months of study entry
* Chronic use of corticosteroids, methotrexate, amiodarone, or tamoxifen within 6 months of entry
* Known diagnosis of chronic liver disease other than NAFLD or found on biopsy
* Contraindication to liver biopsy including INR \> 1.5, platelets \< 50,000/mL, ascites, chronic anticoagulation (other than aspirin), biliary obstruction, peritonitis, inability to lie supine for 30 minutes
* Hgb \< 10.0 g/dL or glomerular filtration rate \< 60 mL/min
* Contraindications to estrogen therapy
* Any vaginal bleeding, including spotting, within the last year
* Active malignancy
* Severe chronic illness
* Use of estrogen or progesterone within a year of baseline visit
* Routine MRI exclusion criteria such as the presence of a pacemaker or cerebral aneurysm clip
Office-Based Asthma Screening Intervention

In prior work, we found that even children who have been seen by their physicians within the prior six months were frequently misclassified as having mild rather than persistent asthma. This study evaluations whether systematic office-based screening assists primary care physicians in identifying children with significant asthma and improves preventive care for asthma. We hypothesize that standardized screening in the office setting will improve the physician's ability to (a) identify children with significant asthma and (b) prescribe appropriate preventive medications.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 2-12
* Children arriving for an office visit in two Rochester, NY pediatric clinics
* Children with a prior diagnosis of asthma AND an exacerbation of symptoms within the previous 2 years

Exclusion Criteria:

* Children arriving at the office visit with an adult that is not their parent or guardian
* Children arriving at the office visit with a parent or guardian that does not speak English
* Children with other medical conditions making the assessment of asthma severity difficult (cystic fibrosis, heart conditions, etc.)
Dietary Fish Protein in Subjects With Insulin Resistance

The objective of our research project is to determine the effects of fish protein, present in fish, on insulin sensitivity in insulin-resistant human individuals, and its mechanism of action on glucose metabolism. Our hypothesis is that fish protein improves insulin sensitivity, glucose tolerance and plasma lipid profile through an improvement in a primary defect in insulin signaling in overweight and insulin-resistant subjects.

Recent data show that cod protein prevents the development of insulin resistance in rats. Dietary fish protein may also enhance insulin sensitivity in overweight insulin-resistant subjects by improving a primary defect in insulin signaling to PI 3-kinase, leading to reduced activation of the downstream effectors Akt and PKC. To determine whether this is the case, we will study the effects of fish protein on insulin sensitivity in humans, and how it improves the ability of muscles to use glucose. Such studies will help to advise individuals with insulin resistance or type 2 diabetes about eating fish.

Eligibility Criteria:
Inclusion Criteria:

* overweight or obese (BMI between 25 and 40 kg /m2)
* waist circumference above 88 cm for women and 102 cm for men
* fasting plasma insulin above 90 pmol/L
* fasting plasma glucose below 7.0 mmol/L and 2-h plasma glucose below 11.1 mmol/L

Exclusion Criteria:

* Individuals with diagnosed diabetes or any chronic, metabolic or acute disease
* Individuals who had a major surgery within the last 3 months
* Individuals who had a significant weight loss (±10%) within the last 6 months
* Individuals taking any medication known to affect lipid or glucose metabolism
* Subjects with dietary incompatibility with fish consumption (allergy, intolerance or dislike) and/or calcium supplementation
* Smokers
Major Depressive Disorder With Mixed Features

Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features.


Eligibility Criteria:
Inclusion Criteria:

Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.

Subject is 18 to 75 years of age, inclusive. Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured Clinical Interview for DSM-IV Disorders - Clinical Trial version \[SCID-CT\]).

Subject is currently experiencing a major depressive episode (diagnosed by DSM-IV-TR; at least 2 weeks in duration) AND two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT modified for Study D1050305):

* Elevated, expansive mood
* Inflated self-esteem or grandiosity
* More talkative than usual or pressure to keep talking
* Flight of ideas or subjective experience that thoughts are racing
* Increase in energy or goal-directed activity (either socially, at work or school, or sexually)
* Increased or excessive involvement in activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments)
* Decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia) Subject has a rater-administered Montgomery-Asberg Depression Rating Scale (MADRS) total score of ≥ 26 at screening and both a rater-administered and self-rated (administered by computer) MADRS total score ≥ 26 at baseline.

Exclusion Criteria:

Subject has Axis I or Axis II diagnosis other than MDD that has been the primary focus of treatment within the 3 months prior to screening Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at screening or baseline visit.

Subject has attempted suicide within the past 3 months. Subject has a lifetime history of any bipolar I manic or mixed manic episode. Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator.
Clinical Study on Malodor

This 3-week clinical study was designed to investigate the clinical efficacy on oral malodor of a 0.454% stannous fluoride toothpaste with nitrate and pyrophosphate (referred to as SNAP) compared to Colgate Cavity Protection Toothpaste containing 0.76% sodium monofluorophosphate 12 hours post-brushing after 3 weeks of product use.


Eligibility Criteria:
Inclusion Criteria:

* Must be male or female 18 to 70 years of age
* Must be in good general health
* Must be in good oral health based on self-assessment
* Must be available during the weeks of this study for all appointment time points
* Should have a minimum of 20 natural uncrowned teeth (excluding third molars)
* Should have a baseline mean oral malodor score greater than or equal to 6.0 and less than or equal to 8.0
* Must give written informed consent
* No known history of allergy to personal care/consumer products or their ingredients

Exclusion Criteria:

* Participation in any other oral clinical studies for the duration of this study
* Full or partial (upper or lower) dentures
* Pregnant or lactating (breast feeding)
* Use of tobacco products
* History of allergy to common toothpaste ingredients
* Use of phenolic flavored products, such as mint flavored candies and chewing gum, the morning of the study and during the sampling periods
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
* Individuals who, due to medical conditions, cannot go without eating or drinking for the post use treatment evaluation time points (6 hrs. + overnight)
Investigating Integrative Therapies for Symptom Management in Adults With Acute Leukemia

This pilot study will use a mixed methods approach to evaluate the feasibility and acceptability of Integrative Therapies, a bedside service offering mindfulness-based interventions (still meditation, meditative movement, relaxation techniques, and massage therapy) as non-pharmacologic treatment for symptom management in newly diagnosed adult Acute Myeloid Leukemia (AML) patients undergoing induction chemotherapy

UF Health Integrative Therapies inpatient program offers mindfulness-based interventions consisting of still meditation, meditative movement, relaxation techniques, and massage therapy to patients at the bedside. This mixed methods feasibility pilot aims to move toward optimal use of the Integrative Therapies service amongst AML patients undergoing induction chemotherapy by: 1) examining the feasibility and acceptability of this intervention and describing the distribution of variables, 2) developing a greater understanding of patient experience, and 3) exploring facilitators and barriers to engagement with the service. The investigators intend to use the data collected from this study to inform a subsequent multi-site study with a larger sample size and adjustments depending on the results from this investigation.

The study team will also explore the acceptability to participation in Integrative Therapies bedside service by conducting a qualitative, phenomenological thematic analysis of patient interviews. The intent of a convergent design is to merge the analyses of the quantitative and qualitative data that are gathered during the implementation of Integrative Therapies bedside service.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to local area Bone Marrow Transplant Unit or Hematology/Oncology during the study period
* Diagnosed with acute leukemia
* Receiving high-grade MDS induction chemotherapy
* Within first 3 days of chemotherapy initiation
* Age \> 18 years
* Able to speak/read English

Exclusion Criteria:

-Altered mental status or diminished level of consciousness as established by daily progress note documented by health care provider, nursing assessment, or at the discretion of the Integrative Therapies practitioner
Real-life Clinical Experience With Ialuadapter Study

A retrospective study from a single center was performed. Quantitative and qualitative data was obtained on the use of the syringe adapter (IALUADAPTER®) in 61 patients with IC/BPS (n=48), rUTI (n=6) and mixed /other diagnoses (including OAB; n= 7) who were receiving intravesical therapy. The evaluation period was 6 months during 2018-2019. Reasons for trying the syringe adapter, reasons for continuing with it and occurrence of UTIs before and during the evaluation period were recorded. In addition, 3 year follow-up data were obtained to assess long-term usage of the syringe adapter.

Introduction Intravesical treatment is currently dependent on catheterization which can cause urethral discomfort and risk of urinary tract infections in selected patient groups such as interstitial cystitis / bladder pain syndrome (IC/BPS), overactive bladder syndrome (OAB) and recurrent urinary tract infections (rUTI). This study describes real-life clinical experience of a minimally invasive syringe adapter (Ialudapter®) for catheter-free instillation of intravesical treatment.

Methods A retrospective study from a single center was performed. Quantitative and qualitative data was obtained on the use of the syringe adapter (IALUADAPTER®) in 61 patients with IC/BPS (n=48), rUTI (n=6) and mixed /other diagnoses (including OAB; n= 7) who were receiving intravesical therapy. The evaluation period was 6 months during 2018-2019. Reasons for trying the syringe adapter, reasons for continuing with it and occurrence of UTIs before and during the evaluation period were recorded. In addition, 3 year follow-up data were obtained to assess long-term usage of the syringe adapter.

Eligibility Criteria:
Inclusion Criteria:

* Patients with IC/BPS, recurrent UTIs and/or OAB
* Receiving intravesical instillations with a conventional single-use catheter before the syringe adapter evaluation period which took place between September 2018 and the end of February 2019 (6m).

Exclusion Criteria:

* Patients with a high post-void residue of \>100ml or with an indwelling catheter were excluded from the analyses.
* Patients who cannot sign informed consent.
Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis

The use of lipid lowering agents in patients with idiopathic inflammatory myopathies is controversial. Therefore, the aim of the present study is to assess clinically and laboratory the impact of lipid-lowering agents in this population.

Impact of the lipid lowering agents on patients with dermatomyositis and polymyositis.

Eligibility Criteria:
Inclusion Criteria:

* fullfill all criteria of Bohan and Peter (1975)
* dyslipidemia
* age\> 18 years
* prednisone ≤ 0.25 mg/kg/day (or ≤ 15mg/ ay) in the last three months
* without changing nutritional habits in the last three months, and during the study period
* no change of lifestyle in the last three months, and during the study period

Exclusion Criteria:

Patients with:

* disease relapsing
* overlapping myositis
* neoplasia associated myositis
* diabetes mellitus
* current and/or chronic infections
* patients undergoing major surgery within six months prior to the study
* pregnant patients
* previous use of lipid-lowering agents in the last 6 months
* in the use of cyclosporin, erythromycin, clarithromycin, fibrates, niacin, azole antifungals, cimetidine, diltiazem
* active liver disease or persistent elevations of hepatic enzymes, with no apparent cause, exceeding three times the upper limit of normality
Effects of Nefazodone on Treatment of Female Cocaine Abusers - 3

The purpose of this study is to determine the effects of nefazedone on cocaine self-administration in depressed and non-depressed female cocaine users.

This study evaluated the effect of nefazodone on reducing cocaine use and craving in both depressed and nondepressed women and if there was a greater effect in depressed women.

Eligibility Criteria:
Inclusion Criteria:

Females, ages 18-55, minimum use of 8 days of the last 30, minimum of 8th grade education, current diagnosis of cocaine abuse/dependence

Exclusion Criteria:

Unstable medical illness, dx of MR, OBS, bipolar