cyrilzakka/clinical-trials huggingface dataset:
Effects of Periodized and Autoregulated Resistance Training in Haematological Cancer Patients During the Treatent.

Several clinical trials have demonstrated the positive impact of physical functioning and fatigue in patients who received training programs during the myeloablative chemotherapy with stem cell transplantation. However, the heterogeneity among the forms of physical activity results in moderate to very low evidence available about benefits of physical exercise. In this randomized and controlled clinical trial, we will study the effects on physical performance and fatigue of periodic resistance training programs, with an autoregulated approach within a non-linear model, based on the individual patient response to cancer treatment.

The sample will consist of 66 patients diagnosed with leukemia and lymphoma undergoing high-dose chemotherapy, with or without hematopoietic stem cell transplantation, who will be randomized into two groups. The physical performance and fatigue outcomes will be compared between the control and the experimental group. The control group will perform an exercise program based on the standard protocol of physical therapy, consisting of bicycle ergometer endurance training for 5 minutes, with resistance individually adjusted based on the patient's feedback (from 70% of maximum heart rate) and resistance exercises for muscle groups hip flexors, knee extensors and ankle plantar flexors and resistance training form arms, with weigths of 0,5 to 1,0 kg (10 repetitions, 1 set).

The experimental group will perform a periodic resistance training program, with an auto-regulated and a non-linear model, using the Submaximal Ergometer tests with incremental load (from 85% of maximaum heart rate or maximum effort related), 30-Second Chair Stand, Hand Grip strenght and submaximal effort of arms with weights of 0,5 to 1,0 kg.

Eligibility Criteria:
Inclusion Criteria:

* Patients clinically diagnosed with Leukemia or Lymphoma, in the first or second line of treatment, undergoing high-dose chemotherapy, with or without hematopoietic stem cell transplantation;
* Neurological and cognitive functions preserved;
* Physical conditions that enable participation in physical rehabilitation.

Exclusion Criteria:

* Clinical Complications that contraindicate physical therapy exercises, including the practice of cycle ergometer and resistance exercises;
* Previous musculoskeletal alteration that interferes in physical performance evaluation tests;
* Recent cardiovascular or pulmonary disease;
* Psychiatric or neurological disorder;
* Inability to walk on its own or presence of bone metastasis;
* Adherence on less than 50% of the total sessions of the study.
Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis

Pancreatic exocrine insufficiency is known to impair nutrient absorption, especially fat, but few data exist about protein absorption. We aimed to investigate this question and assess the enzyme substitution efficiency using a sensitive method.


Eligibility Criteria:
Inclusion Criteria:

* Chronic pancreatitis
* Pancreatic insufficiency
* Enzyme therapy treatment

Exclusion Criteria:

* Hepatic failure
* Pregnancy
* Positive serology to HIV, HCV, AGHbS, gastro-intestinal disease
Second-Line Irinotecan or Gefitinib in Docetaxel Pretreated NSCLC

To determine whether in docetaxel pretreated advanced NSCLC patients with favorable clinical parameter(s) gefitinib can produce different outcomes from patients without favorable clinical parameter treated with irinotecan.

It has been suggested that some clinical parameters, including women, no smoking history and a histologic diagnosis of adenocarcinoma, are associated with favorable outcomes of gefitinib therapy. We will conduct a phase II study in docetaxel pretreated advanced NSCLC patients treated with gefitinib or irinotecan according to these clinical parameters in order to determine whether in patients with favorable clinical parameter(s) gefitinib will produce difference outcomes from patients without favorable clinical parameter treated with irinotecan.

Eligibility Criteria:
Inclusion Criteria:

* aged 75 years or less
* histologically or cytologically confirmed non-small cell lung cancer
* advanced, metastatic or recurrent
* ECOG performance status 0 to 2
* one prior palliative chemotherapy including docetaxel
* measurable or evaluable indicator lesion(s)
* normal marrow, hepatic and renal function
* provision of written informed consent

Exclusion Criteria:

* active infection and/or severe comorbidities
* pregnant or breastfed women
* active CNS metastasis
* active bleeding in GI tract or elsewhere
Motivational Interviewing to Promote Sustained Breastfeeding

1. Evaluate the cultural appropriateness of an intervention protocol related to: a) motivational interviewing technique; b) stool, urine, and breast milk sample collection; and c) infant breastfeeding test weight procedure.
2. Compare Motivational Interviewing with an attention intervention (infant safety) on: a) breastfeeding self-efficacy, b) intended length of breastfeeding, and c) duration of breastfeeding.
3. Examine urine samples of infants for the presence of the inflammatory cytokine (LTE4) and evaluate fecal and breast milk samples of infants for human milk oligosaccharide levels.

The incidence of asthma, the most common serious chronic inflammatory disease among children, is rising each year. Therefore nursing interventions aimed at promoting infant immunity and mitigating factors to which the infant may be exposed may reduce the complications of this chronic illness. Breastfeeding is an ideal initial prevention strategy that strengthens the infant's immune system. In addition, the identification of biomarkers that reflect infant immune response sets the stage for the evaluation of nursing interventions targeted to decrease the impact of this chronic inflammatory disease. Although more mothers currently initiate breastfeeding, they do not sustain breastfeeding for the recommended 6 to 12 months. In general, Native American mothers' breastfeed for a shorter period of time and mothers in rural setting have fewer resources to support breastfeeding.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for mothers include ≥ 19 years of age and enrolled in Northern Plains Healthy Start program.
* Inclusion criteria for infants are birth weight of \> 2500 gms, \> 37 weeks gestation, a bilirubin of 15 mg%, and no NICU admission to provide a sample of stable infants.

Exclusion Criteria:

* Mothers who report that they will not breastfeed will be excluded.
* Infants with a birth weight \< 2500 gms, are \< 37 weeks gestation, or diagnosed with any significant health problems, significant postnatal problems requiring NICU admission, symptoms of drug withdrawal, or a bilirubin \> 15 mg% will be not be recruited for the study.
Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer

The purpose of the study is to determine the efficacy and relapse rate of low dose, short duration treatment with tamoxifen in benign breast disease amenable to hormonal therapy with respect to etiology and estrogen receptor status and to realize its side-effects and cost of therapy.

To do a comparative analysis of the results with evening primrose oil which is one of the first line management in benign breast disease.

Benign breast disease is frequently encountered in female patients, a significant proportion of who are premenopausal women. Established methods of treatment do not yield significant results. This is not only a social burden but also entails high economic cost. As such the quality of life of these patients is a matter of concern for both the patients and their families and to attending physicians. Reported effects of tamoxifen on benign breast disease in premenopausal non high risk patients are scarce. Moreover published data has not yet revealed association of estrogen receptors in different benign breast lesions.The variability of response and its relation with estrogen receptor status is still a field of active investigation.

Eligibility Criteria:
Inclusion Criteria:

* Clinical, Radiographic and Histological diagnosis of Benign Breast Disease.
* Benign Breast disease amenable to hormonal therapy.

Exclusion Criteria:

* Postmenopausal women.
* Premenopausal women with pregnancy or other contraindications to tamoxifen.
* Girls less than 16 years.
* Very large lesions which require surgery for cosmesis.
* High risk breast lesions like epitheliosis, atypia or atypical hyperplasia on histopathology or susceptible lesions prone to develop malignancy.
* Lesions like duct ectasia where hormone therapy is not likely to be of benefit.
* Inflammatory lesions which are amenable to antibiotic therapy or surgical drainage for treatment.
* Patients unwilling to undergo treatment.
Renal Metabolism of Glycolate to Oxalate

This study will determine the contribution of glycolate metabolism to urinary oxalate excretion in healthy subjects, using carbon 13 isotope glycolate tracer technique and a low-oxalate controlled diet.

It is known that glycolate, an intermediary molecule in normal metabolism, can be converted into oxalate. The origin of urinary oxalate is of interest as calcium oxalate is a main component of kidney stones. In the rare disease primary hyperoxaluria, excessive production of oxalate by the body results in frequent kidney stones and can cause loss of kidney function. Primary hyperoxaluria is caused by deficiencies in one of several enzymes involved in the glycolate pathway.

This study will seek to determine how much oxalate is formed from glycolate in normal subjects. After consuming a controlled diet, subjects will either ingest or have an intravenous infusion of carbon 13 glycolate, a stable isotope of glycolate that can be tracked and will also label downstream metabolic products. Blood and urine samples will be assessed for their amounts of labeled glycolate and labeled oxalate to provide an accurate measure of how much oxalate is made from normal glycolate breakdown in healthy human subjects.

Eligibility Criteria:
Inclusion Criteria:

* Mentally competent adults, able to read and comprehend the consent form
* 18-75 years of age
* Body Mass Index (BMI) between 19 and 40
* In good health as judged from a medical history, reported medications, and a complete blood metabolic profile
* Acceptable 24 hour urine collections (performed twice for screening)

Exclusion Criteria:

* History of any hepatic, renal, bowel, or endocrine disease or any other condition that may influence the absorption, transport or urine excretion of ions
* Abnormal urine chemistries or blood metabolic profiles
* Poor 24 hour urine collections completed during screening, judged by 24 hour urine creatinine excretion (indicative of not collecting all urine in the 24 hour period)
* Pregnancy, intention to become pregnant in the near future, or lactation
* Aged \<18 or \>75
* BMI \<19 or \>40
Prevention of CIPN Using Compressive Therapy

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of treatment with taxanes and platinum-based drugs, significantly impacting the quality of life of oncology patients. Symptoms such as reduced sensitivity and pain may persist even after treatment ends. Research has shown that compression therapy using gloves and stockings effectively reduces the incidence of CIPN, improves patient adherence to treatment, and has no severe side effects. A study at the Chemotherapy Unit of the Comprehensive Oncology Care Clinic, Masaryk Memorial Cancer Institute, will investigate the efficacy of this therapy. Tight-fitting gloves and compression stockings will be used to limit the flow of cytotoxic agents to peripheral areas. Effectiveness will be assessed through quality-of-life questionnaires, hand strength and coordination tests, and laboratory analyses to identify predictive markers of neuropathy. The study aims to enhance CIPN prevention and integrate this method into clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years at the time of signing the informed consent (IC).
* Signed informed consent.
* Breast cancer stages I-III
* ECOG performance status 0-2.
* (Neo)adjuvant treatment with paclitaxel weekly.

Exclusion Criteria:

* Metastatic disease.
* History of neuropathy/vasculopathy and its pharmacological treatment.
* Type I or II diabetes.
* Stroke within the last 6 months.
* Prior treatment with taxanes and/or cisplatin derivatives.
* Peripheral arterial ischemia.
Clinical Study of a Conventional and Flexible Extended Oral Contraceptive of EE/DRSP With or Without Metafolin in Latin America

The objective of this three-arm study is to evaluate the effect of a flexible extended regimen of an EE+DRSP containing OC on bleeding pattern and to investigate the compliance with daily pill intake when the investigational product is provided in a blister package or a compliance aiding dispenser with a pill reminder function. The third treatment arm will be a reference comparator arm of a standard 24+4 regimen of the identical hormone combination.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteers between 18 and 35 years of age (smokers up to 30 years, inclusive) who request contraceptive protection

Exclusion Criteria:

* Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
* Body mass index (BMI) \>/= 30.0 kg/m2
* Presence or a history of venous or arterial thrombotic/thromboembolic events
* Repeated measurements of systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg
* Presence or history of liver tumors (benign or malignant), severe hepatic disease, jaundice and/or pruritus related to cholestasis, cholestatic jaundice associated with pregnancy or previous combined oral contraceptive (COC) use
* Uncontrolled diabetes mellitus and/or diabetes mellitus with vascular involvement
* Severe dyslipoproteinemia
* Malignant or premalignant disease
* Uncontrolled thyroid disorder
* Chronic inflammatory bowel disease
Studying Stored Samples From Patients With Localized Prostate Cancer Treated on Clinical Trial NCI-00-C-0154

RATIONALE: Studying samples of blood in the laboratory from patients before and after treatment may help doctors learn more about the effects of the treatment on cells.

PURPOSE: This clinical trial is studying samples collected from patients with localized prostate cancer who received treatment on clinical trial NCI-00-C-0154.

OBJECTIVES:

Primary

* Evaluate the formation of antibody complexes in serum samples taken before initiation of treatment and after completion of therapy in prostate cancer patients previously enrolled on clinical trial NCI-00-C-0154.
* Evaluate immunologic response.

Secondary

* Clone the underlying tumor antigens discovered through SEREX.

OUTLINE: Samples previously collected on clinical trial NCI-00-C-0154 (whole blood, serum, and peripheral mononuclear blood cells) are analyzed for immunologic responses and evidence of formation of anti-tumor antibodies. Western blot is used to detect any evidence of vaccine-induced autoantibody responses. If there is an indication of response, SEREX is used to clone the underlying antigens.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of localized adenocarcinoma of the prostate
* Received treatment on clinical trial NCI-00-C-0154

PATIENT CHARACTERISTICS:

* Consented the use of their collected blood cells for future research while enrolled on NCI-00-C-0154

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Population Pharmacokinetics and Dose Optimization of Caspofungin in Adolescents

Caspofungin (CAS) is used to prevent and treat invasive fungal infections patients older than 3 months. However, the optimal dosing strategy of CAS is lacking in adolescents from 12 to 17 years old, especially those undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT), who are vulnertable to fungal infections. The study aimed to establish a population pharmacokinetic (PPK) model and assess the dosing schemes of CAS in adolescents with allogeneic hematopoietic stem cell transplantation (allo-HSCT).


Eligibility Criteria:
Inclusion Criteria:

* The adolescents (12 - 17 years) underwent allo-HSCT
* Use caspofungin for the prevention or treatment of fungal infections

Exclusion Criteria:

* Intolerable to caspofungin
* Participate into other clinical studies
* There are conditions that researchers do not consider it appropriate to join the research.
Safety and Pharmacokinetics of Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile

The purpose of this study is to better understand how clindamycin works in children who fall in the 85th percentile or higher for body mass index (BMI - a ratio of weight to height). The results of the study will help better understand if children in higher BMI ranges process the medication differently and whether dosing should be adjusted in these children.

This is a prospective, open-label pharmacokinetic and safety study of multiple doses of IV and oral clindamycin in overweight and obese children ages 2 to 17 years of age. The total study duration is expected to be approximately 24 months; each subject will participate in the study for up to 18 days (screening day; treatment days 1-14 \[may be as short as 2 days\] followed by an observation period of 3 days post discontinuation of clindamycin therapy or after day 17 (on day 18) of therapy in those who are treated with more than 14 days of clindamycin).

Eligibility Criteria:
Inclusion Criteria:

* 2 years - \< 18 years of age at the time of first dose of study drug
* Suspected or confirmed infection OR receiving IV clindamycin per routine care
* Negative serum pregnancy test (if female and has reached menarche) within 24 hours of first dose of study drug and agreement to practice appropriate contraceptive measures, including abstinence, from the time of the initial pregnancy test through the last dose of study drug
* BMI ≥ 85th percentile for age and sex, based on Centers for Disease Control (CDC) recommendations
* Signed informed consent/Health Insurance Portability and Accountability Act (HIPAA) documents by the parent/legal guardian and assent (if applicable)

Exclusion Criteria:

* The following apply only to those who are NOT already receiving clindamycin per routine care:

  1. History of hypersensitivity or allergic reaction to clindamycin or lincomycin
  2. History of C. difficile colitis with previous administration of clindamycin
  3. Aspartate aminotransferase (AST) \> 120 units/L
  4. Alanine aminotransferase (ALT) \> 210 units/L
  5. Total bilirubin \> 3 mg/dL
  6. Serum creatinine \> 2 mg/dL
  7. Receiving a neuromuscular blocker as part of their therapy
* Previous participation in the study
* Subject is on prohibited medication or herbal product (see Appendix II)
* Subject is receiving extracorporeal life support (ECLS)
* Subject is post-cardiac bypass (within 24 hours)
* Subject on inotropes/pressors
* Any other condition or chronic illness that, in the opinion of the principal investigator, makes participation unadvised or unsafe
Electro-acupuncture for the Prevention and Treatment of Oxaliplatin-induced Neurotoxicity in Colorectal Cancer Patients

In this study, a 24-week randomized, sham-controlled, single-blind, multicenter clinical trial will be conducted to explore the effect of electroacupuncture for prevention and treatment of both acute and chronic neurotoxicity through both clinical and biological indicators.

This is a prospective, randomized, sham-controlled, double-blinded and multiple center trial on electro-acupuncture for preventing and treating symptoms of chemotherapy-induced neurotoxicity in patients with colorectal cancer. A total of 150 candidates will be recruited in this study four weeks before chemotherapy for best preventive effect. They will be assigned randomly into either the electro-acupuncture or the sham-control group with 1:1 ratio. Both groups will receive a total of 24 sessions of interventions (4 weeks before chemotherapy and 8 weeks during chemotherapy, with 2 session per week), and will be followed up regularly for up to 12 weeks after completion of the acupuncture.

Eligibility Criteria:
Inclusion Criteria:

* are aged ≥18 years old;
* are newly diagnosed with stage II to IV colorectal cancer;
* going to receive adjuvant oxaliplatin-based chemotherapy within 4 weeks;
* had not received any acupuncture in the previous 3 months and had a life expectancy ≥ of six months.

Exclusion Criteria:

* are not able to comprehend and communicate;
* are not able to read Chinese;
* have prior peripheral neuropathy caused by other diseases including diabetes, stroke, cardiovascular diseases such as arrhythmia, heart failure, myocardial infarction, and patients with cardiac pacemakers;
* have a bleeding tendency;
* are pregnant or breastfeeding;
* have impaired hepatic or renal function;
* using any pharmaceutical agents e.g., vitamin B6 and vitamin E, or herbal medication. All the above medication prescribed by physicians or Chinese medicine practitioners during the study will be recorded.
The Effect Of Balance Training With Dual Task On Cognitive Status And Functionality In Elderly

Aging is a dynamic process that affects motor and cognitive functions. Activities of daily living and functionality, including dual task performance, are also negatively affected by these functions. The purpose of this study is to determine of balance training with dual task on cognitive function and functionality.

While physiological changes occur at the level of cells, tissues and systems with aging, these changes are reflected in motor and cognitive functions. The decrease in motor functions can be cause as balance and fall problems, which are the most serious and frequently encountered problems among the elderly. Especially the fall is one of the main reasons causing the elderly to be hospitalized in the hospital and nursing home.

Balance system is one of the most affected by aging process. The balance is maintained by receiving input from several systems, for this reason it is the system that is easily and primarily affected by changes in any of these inputs. Balance disorders have been shown to be risk factor for falling in elderly. Studies have shown that balance training has been observed to improve postural control, so it is especially recommended for to reduce risk and rate of falls in the elderly.

While general cognitive capacity decreases with aging, information processing, use and recall performance is lower than younger. Therefore, elderly have difficulty in tasks that require the use of more than one information at same time.

In daily life, a motor function is often accompanied by another task. Dual task performance is a secondary motor or cognitive task that must be implemented during a main task. Therefore, ın order for the exercises to be functional, it is not enough to be focused only on motor skills, besides adding a motor or cognitive dual task is more effective than exercise alone.

The changes in neuromusculoskeletal and movement-related functions during the aging process causes a decrease in functional ability. Most daily activities require the management of motor-cognitive tasks while simultaneously processing external information. The ability to perform in daily life activities decline in elderly.

Investigators hypothesized that balance exercises with dual task would show greater significant improvements functionality and cognitive improvements than the balance exercises only.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 65-85
* Being able to communicate
* Able to walk without mobility aids
* Be volunteer for intervention

Exclusion Criteria:

* Cognitive impairment (\<17 point on the Minimal Mental State Examination )
* In physiotherapy treatment that trains balance
* Balance impairment (\< 20 point on the berg balance test)
* having an orthopedic problem that may affect balance performance