cyrilzakka/clinical-trials huggingface dataset:
Treatment for Elderly Patients With High Risk Breast Cancer

This open-label, multicenter study explored primary and secondary prophylaxis treatment with a single, fixed-dose, subcutaneous (SC) injection of pegfilgrastim in elderly subjects with high-risk breast cancer receiving myelosuppressive chemotherapy. The primary objective was to provide preliminary information on the incidence of protocol defined neutropenic events in chemotherapy cycle 1.


Eligibility Criteria:
Inclusion Criteria: - High-risk, stage II-III breast cancer suitable for treatment with up to 6 cycles of FEC-100 - Chemotherapy - Histologically proven greater than or equal to 1 axillary nodes positive - Oestrogen receptor negative or positive - Chemotherapy naïve - VES 13 (Vulnerable Elders Survey) score less than or equal to 3 - ECOG performance status less than or equal to 2 - ANC greater than or equal to 1.5 x 10\^9/L - Platelets greater than or equal to 100 x 10\^9/L - Adequate renal function (serum creatinine less than 1.5 x upper limit of normal (ULN)) - Before any study specific procedure the subject must give written informed consent for participation in the study Exclusion Criteria: - Total serum bilirubin greater than ULN according to institutional standard - Clinically significant cardiac disease that would preclude the use of epirubicin (e.g., LVEF (left ventricular ejection fraction)) less than 45% at rest by MUGA or echocardiogram - Prior bone marrow or stem cell transplantation - Any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukaemia) - History of prior malignancy other than breast cancer with the exception of curatively treated basal cell carcinoma, in situ cervical carcinoma or surgically cured malignancies - Prior radiation therapy - Active infection or administration of systemic antibiotics or anti-infectives within 72 hours before start of chemotherapy - Known hypersensitivity to E coli-derived products (e.g., Filgrastim, HUMULIN®, Insulin, L-Asparaginase, HUMATROPE®, Growth Hormone, INTRON A®) - Previous exposure to pegfilgrastim or previous entry into this study - Known HIV infection - Inability to understand the nature of the study and provide written informed consent - Subject currently enrolled in another investigational device or drug trial(s) or has received other investigational agent(s), with the exception of placebo-treated subjects, within the last 30 days - Concerns for subject's compliance with the protocol procedures
Neoadjuvant ABI-007, Carboplatin and Gemcitabine in Locally Advanced Bladder Cancer

Study participants will have been diagnosed with bladder cancer that has invaded the muscle wall of the bladder. Surgery is used to remove cancer when it is in the muscle of the bladder. Unfortunately, approximately 50% of people may have their cancer return in another location. For this reason, researchers are focusing on new chemotherapy regimens to be given before surgery (to remove the bladder) that may decrease the likelihood of cancer spreading.

Paclitaxel, carboplatin and gemcitabine are chemotherapy drugs known to destroy bladder cancer cells.

ABI-007 (brand name Abraxane™) is a form of the chemotherapy drug called paclitaxel. Standard paclitaxel is formulated with ethanol and a substance called Cremophor EL (polyoxyethylated castor oil). However, these additives are felt to contribute to the side effects (possibly severe) associated with paclitaxel. ABI-007 does not contain these additives and may deliver more drug to tumor cells. ABI-007 is approved by the United States Food and Drug Administration (FDA) in the treatment of metastatic (advanced) breast cancer, and is being evaluated in other cancers in research studies.

This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin and gemcitabine in the treatment of bladder cancer prior to surgery to remove the bladder.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven locally advanced (T2-4,N0,M0 or Tany,N1-3,M0) urothelial carcinoma of the bladder and be candidates for cystectomy following chemotherapy. Tumor specimens must be available for assay of molecular markers (correlative research).
* Performance status of 0, 1 or 2 by Eastern Cooperative Oncology Group (ECOG) criteria.
* Serum creatinine \<2.0 mg/dl and/or creatinine clearance \>40 ml/min.
* Granulocyte count \> 1,500/mm3, platelet \> 100,000/mm3, and hemoglobin \> 9.0 g/dl.
* Adequate liver functions: AST and ALT \< 2.5 X upper limit of normal, alkaline phosphatase \< 2.5 X upper limit of normal, and bilirubin \< 1.5 mg/dl.
* Pre-existing peripheral neuropathy \> grade 2
* Recovered from any effects of surgery.
* Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. Women with reproductive potential must have a negative pregnancy test.

Exclusion Criteria:

* Prior systemic or intra-arterial chemotherapy and rior radiotherapy. (intravesical chemotherapy allowed.)
* Pre-existing peripheral neuropathy \> grade 2
* Prior malignancy \[except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for 2 years\]
* Unresolved bacterial infection requiring active treatment with antibiotics. (Treatment may begin at the conclusion of antibiotic therapy.)
* Pregnant or lactating women may not participate.
Factors and Characteristics of Heart Rate Variability in Runners

The purpose of this study is to describe the variation characteristics and factors of the heart rate variability during long-distance running.

Heart rate variability is recognized as the indicator to measure the autonomic nerve activity. By monitoring the heart rate variability of runners during long-distance running, we could monitor the status of the runners' cardiovascular system and predict the exercise risk of runners during long-distance running.

Eligibility Criteria:
Inclusion Criteria:

People have below conditions could be included:

1. age is 18-60 years.
2. have normal ECG .
3. agree to participate in the study.

Exclusion Criteria:

People have below conditions will be excluded:

1. have known Congenital heart disease and rheumatic heart disease.
2. have known Hypertension and cerebrovascular disease.
3. have known Myocarditis and other heart diseases.
4. have known Coronary artery disease and severe arrhythmia.
5. have known Diabetes with high or low blood glucose.
6. have a cold within two weeks before the study.
7. have other diseases considered unsuitable for participants in this study.

   -
Fenretinide in Treating Patients With Cervical Neoplasia

RATIONALE: Chemoprevention uses drugs to try and prevent development of cancer. Fenretinide may be effective in treating cervical neoplasia and preventing cervical cancer.

PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of fenretinide to placebo in treating patients with cervical neoplasia.

OBJECTIVES: I. Determine the efficacy of fenretinide (N-(4-hydroxyphenyl) retinamide; 4-HPR) at regressing cervical intraepithelial neoplasia (CIN). II. Document the qualitative and quantitative toxicity of 4-HPR in women with CIN.

OUTLINE: This is a double blinded study. Patients are randomized to receive either fenretinide or placebo. Patients are administered fenretinide or a placebo by mouth (PO) daily for 6 months with 3 days of rest every month. Patients undergo colposcopy, colpophotography, and Pap smears at 3, 6, 9, and 12 months. Patients undergo cervical biopsy at 6 and 12 months to assess changes.

PROJECTED ACCRUAL: 84-100 patients will be accrued.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically diagnosed new or recurrent cervical intraepithelial neoplasia grade 2-3 lesion involving at least one quadrant of the transformation zone of the cervix

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 months Hematopoietic: Absolute granulocyte count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Other: Fertile patients must use effective contraception Fasting triglyceride less than 2 times normal No prior malignancy Must consent to colposcopy and cervical biopsy

PRIOR CONCURRENT THERAPY: Not specified
Contralateral Isokinetic Training on Strength and Reaching Skill

The study aimed to ascertain how cross-education affected the activity of the paretic muscles in the upper limb and how that affected function in children with spastic hemiplegia and cerebral palsy. Additionally, it sought to determine how unilateral isokinetic resistance training affected children with spastic hemiplegia of the contralateral limb in terms of strength development.


Eligibility Criteria:
Inclusion Criteria:

* hemiplegic CP children from both genders with age ranged from five to seven year
* had mild to moderate spasticity according to the Modified Ashworth Scale
* able to follow verbal instructions
* able to stand unassisted and ambulate with abnormal pattern

Exclusion Criteria:

* children who had any visual or auditory problems, fixed deformities in upper limb that interfere with fine motor functions, with history of any surgical interference in upper limbs for less than one year, and un-cooperative children were excluded.
Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes

This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis typ 2 diabetes mellitus
* Male and female on diet and exercise regimen, pre-treated with metformin 12 weeks prior to randomisation
* HbA1c equal or greater than 7.0% and less than or equal to 10% at visit 1
* 18 years or more
* BMI equal or less than 45Kg/m2

Exclusion criteria:

* Uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/L after overnight fast during placebo run-in
* Any other antidiabetic drug within 12 weeks prior to randomisation except metformin
* Acute coronary syndrome (non-STEMI, STEMI unstable angina pectoris), stroke or transient ischemic attack within 12 weeks of informed consent
* Indication of liver disease
* Moderate to severe renal impairment
* Bariatric surgery within past 2 years
* Medical history of cancer or treatment for cancer within last 5 years
* Blood dyscrasias or any disorders causing haemolysis or unstable red blood cell
* Contraindications hypersensitivity to concomitant drugs
* Treatment with anti-obesity drugs
Fermented Milk Supplementation on Symptoms of Disease and Treatment in Patients With Multiple Myeloma

This trial investigates the effect of fermented milk supplementation on symptoms of disease and treatment in patients with multiple myeloma. Patients with multiple myeloma may experience symptoms related to the disease and/or treatment that affect quality of life. Supplementing usual diet with a probiotic fermented milk product called kefir may contribute to reducing disease and treatment-related side effects through changing the intestinal bacteria community structure and related metabolism.

PRIMARY OBJECTIVE:

I. Determine the effect of a 3-month randomized dietary intervention with a probiotic kefir beverage in multiple myeloma (MM) patients on biomarkers of metabolism, and patient-reported pain and fatigue, gut health, and quality of life (QoL).

SECONDARY OBJECTIVE:

I. Determine the effect of kefir supplementation on gut microbial phylotype and predicted bacterial metabolic function, and assess associations with biomarkers of metabolism, and patient-reported pain and fatigue, gut health, and QoL.

EXPLORATORY OBJECTIVE:

I. Feasibility of a probiotic lifestyle intervention in MM patients.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients consume commercial kefir beverage daily for 3 months.

ARM II: Patients maintain usual diet for 3 months.

After completion of study, patients are followed up at 30 days or until resolution of any study related toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Neutrophil values \> 1,000/uL
* Diagnosis of multiple myeloma: on maintenance or continued treatment
* Show no signs of comorbidities, myeloma symptoms, or treatment side effects that would put them in danger when participating in the study according to the physician's discretion
* Able to understand and comply with study instructions, including willing to purchase and consume study beverage daily if in intervention arm or, avoid regular consumption of fermented dairy foods (kefir, yogurt, lassi, etc.) if in the control arm
* Understand the investigational nature of the study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Allergies to milk
* Lactose intolerance
* Current habitual (\> 3 times per week) consumption of yogurt, kefir, lassi, over-the-counter probiotic dietary supplements
* Chronic inflammatory bowel disease
* Autologous stem cell transplantation or chimeric antigen receptor (CAR)-T cell therapy within the last 6 months
* Prior allogeneic stem cell transplantation
* Major comorbidities that would cause danger to the patient when participating in the study
* Pregnant or nursing female participants
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to take part in study intervention
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Folic Acid and Omega -3 Fatty Acid Supplementation in Depressed Older Adults

Our specific aim is to determine the impact of folic acid and omega-3 supplementation on the severity of depressive symptoms among depressed adults aged 65 and above.


Eligibility Criteria:
Inclusion Criteria:

1. Age 65+ (year of birth -1942 or below)
2. Depression (as defined by the DSM-IV diagnostic criteria for depression: major or minor depression or dysthymia)

Exclusion Criteria:

1. Co-existing psychiatric disorder (except anxiety disorders)
2. Moderate and severe cognitive impairment
3. Current treatment with anticoagulants, antithrombotics and fibrinolytics
4. Current severe angina with exertion
5. Chronic renal insufficiency
6. Liver cirrhosis
7. Alcohol or drug abuse
Dynamic Neuromuscular Stabilization Training in Dysfunctional Voiding

In this study, the effect of dynamic neuromuscular stabilization (DNS) exercise on urinary flow and quality of life in individuals with dysfunctional voiding was investigated. The 34 participants included in the study were randomized into two groups: the experiment in which DNS exercises were applied and the standard therapy group in which the manual application was applied. Uroflowmetry, Voiding Symptom Score (DVSS), Short Form-36 Quality of Life Assessment Short Form were applied to all participants at baseline and at week 6.

In this study, the effect of dynamic neuromuscular stabilization (DNS) exercise on urinary flow and quality of life in individuals with dysfunctional voiding was investigated. This experimental study was conducted with patients who applied to UroKlinik in Istanbul between March 2021 and June 2023 and were diagnosed with dysfunctional voiding. The 34 participants included in the study were randomized into two groups: the experiment in which DNS exercises were applied and the standard therapy group in which the manual application was applied. Voiding Symptom Score (DVSS), Short Form-36 Quality of Life Assessment Short Form and Uroflowmetry test were applied to all participants before and at week 6.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with dysfunctional voiding,
* Being between the ages of 18-75,
* Not having a neurogenic bladder
* Not having a urinary tract infection
* Not having an obstacle to exercise,
* Accepting and signing the Approval Form,
* Not having undergone surgery in the last 6 months,

Exclusion Criteria:

* Not being cooperative
* Not being able to participate in the treatment,
* The use of drugs that will affect urination
NADPH Oxidase Polymorphisms in Obstructive Sleep Apnea Syndrome (OSAS)

Obstructive Sleep Apnea (OSA) is associated with increased oxidative stress. The major sources of Reactive Oxygen Species (ROS) in the vasculature are the NADPH oxidases. Several polymorphisms related to NADPH oxidase expression or NADPH oxidase activity has been identified. The investigators are going to compare the distribution of the allelic frequencies of A-930G and C242T polymorphisms and their possible relationship with the levels of 8-isoprostanes as a marker of oxidative stress in patients with OSA and in a control group without OSA.

DESIGN: CASE-CONTROL STUDY METHODS: We are going to determine the A-930G and C242T p22phox genotypes in patients with OSA and healthy subjects recruited from sleep unit of Son Dureta University Hospital, (Palma de Mallorca, Spain). 8-Isoprostane is going to be measured as an oxidative stress marker with an 8-isoprostane EIA kit (Cayman Chemicals Company, USA) in plasma samples.

Eligibility Criteria:
Inclusion Criteria:Polyysomnografic study with Apnoea/Hypoapnoea Index higher to 10 in patients and lower in controls.

Exclusion Criteria:

* chronic obstructive pulmonary disease, liver cirrhosis, thyroid dysfunction, rheumatoid arthritis, chronic renal failure and/or psychiatric disorders.
Phase II Study of Irinotecan and Cisplatin in Extensive-stage Small Cell Lung Cancer

Patients with untreated extensive-stage small cell lung cancer(SCLC) were randomly assigned to receive either irinotecan/cisplatin (IP) or etoposide/cisplatin(EP), The association of efficacy and toxicity of IP regimen was analyzed.

This is a randomized, multicenter study. Patients are randomized to irinotecan/cisplatin (IP) or etoposide/cisplatin (EP) treatment arms. The IP regimen consisted of at most 6 cycles of irinotecan 65 mg/m2 of body-surface area on days 1, 8 and cisplatin 75mg/m2 of body-surface area on day 1. The EP regimen consisted of at most 6 cycles of etoposide 100 mg/m2 of body-surface area from day 1 to 3 and cisplatin 75mg/m2 of body-surface area on day 1. Cycle length for the two arms was 3 weeks. The dose adjustment was allowed in at most within ±5% per investigator discretion if necessary.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) of 0 to 2
* A life expectancy of at least 3 months
* Measurable lesions
* Adequate hematologic function

Exclusion Criteria:

* Infection
* Myocardial infarction within the preceding three months
* Symptomatic brain metastases or receiving radiotherapy less than 4 weeks
* Pregnancy or breast-feeding
Chronic Hepatitis B Virus Infection in Zambia

Chronic hepatitis B virus infection is a common condition in Zambia. Among Zambian blood donors, up to 8% are chronically infected with HBV. Despite the burden, awareness of HBV is low in Zambia and the Ministry of Health is in early stages of development of guidelines for HBV screening, treatment, and prevention. The purpose of this clinical cohort study is to characterize the clinical features of chronic HBV infection at UTH and describe treatment and care outcomes. The investigators will enroll 500 adults and follow the cohort for up to 5 years to assess short and long-term viral, serologic, and liver outcomes such as cirrhosis and liver cancer.

Viral hepatitis is the #7 cause of death worldwide, yet it has been neglected when compared to other infectious diseases such as HIV/AIDS, tuberculosis, and malaria. Chronic viral hepatitis is caused by hepatitis C virus and hepatitis B virus and these infections are most common in low and middle-income countries, notably Asia and sub-Saharan Africa. In Zambia there are limited data, but from an HIV cohort, the investigators of this study described 10-12% prevalence of chronic HBV. To raise awareness of viral hepatitis in Zambia and to generate local data to guide policymakers, the investigators will recruit 500 adults with chronic HBV infection and follow the cohort in an observational cohort study. In the study patients would be managed according to standards of care and no experimental or investigational drugs would be used. The investigators will carefully describe patient clinical characteristics and among those who receive drug treatment, the investigators will describe the effectiveness of that treatment in reducing liver disease.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* HBV-infected, defined as any single positive HBsAg assay

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* HIV-positive
Trial of DA-EPOCH Regimen for NHL With HLH

The major purpose of this clinical study is to assess clinical outcome of dose-adjusted EPOCH regimen for patients with non-Hodgkin's lymphoma(NHL)-associated hemophagocytic lymphohistiocytosis

Lymphoma-associated hemophagocytic lymphohistiocytosis(LA-HLH) has a high fatality rate and the worst outcome. The major cause of LA-HLH is aggressive non-Hodgkin's lymphoma(NHL), especially T/NKT cell lymphomas. Until now, there is no recommended therapeutic schedule for this fatal disease. Dose-adjusted(DA) EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) shows effective activity in patients with aggressive NHL, which also contains the critical drugs for HLH of HLH-94/04. The investigators therefore developed DA-EPOCH regimen to treat non-Hodgkin's lymphoma with hemophagocytic lymphohistiocytosis and assess its clinical outcome including safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

1 .Histologically confirmed non-Hodgkin's lymphoma; 2. Patients whose clinical findings satisfy either of HLH 2004 standard: 3. newly-diagnosed and untreated; 4. understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.

HLH2004 standard at least 5 criteria out of the following: Fever ≥ 38.5 ℃ for ≥ 7 days; hepatosplenomegaly; Cytopenias affecting ≥ 2 of 3 lineages in PB Hb \< 9 g/L Platelet \< 100 x 109 /L ANC \< 1.0 x 109 /L; Hypertriglyceridemia and/or hypofibrinogenemia (fasting triglycerides ≥ 265 mg/dL, fibrinogen ≤ 1.5 g/L); Hemophagocytosis in BM or spleen or LN; Low or absent NK-cell activity ( according to local laboratory reference); Serum-ferritin ≥ 500 mcg/L ; Soluble CD25(sIL-2 receptor) ≥ 2,400 U/ml ; 3.New-diagnosed and untreated; 4.Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.

Exclusion criteria

1. primary HLH;
2. HLH from rheumatic disorder (such as systemic Lupus Erythematosus, adult onset still disease, antiphospholipid antibody syndrome);
3. pregnancy (as determined by serum or urine test) or active breast feeding;
4. concomitant malignancy other than NHL and need to treat;
5. concomitant with other hematologic diseases (such as leukemia, hemophilia primary myelofibrosis) which investigators considered it unsuitable to be enrolled into this clinical trial;
6. any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment;
7. in any conditions which investigator considered ineligible for this study