cyrilzakka/clinical-trials huggingface dataset:
Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer

RATIONALE: Diagnostic procedures, such as thoracoscopic sentinel lymph node biopsy, may help find breast cancer that has spread to lymph nodes between the breasts. It may also help doctors plan the best treatment.

PURPOSE: This clinical trial is studying how well thoracoscopic sentinel lymph node biopsy finds sentinel lymph nodes that are located between the breasts in patients with stage I or stage II breast cancer.

OBJECTIVES:

* Determine the occurrence rate of internal mammary sentinel lymph nodes in patients with medially or centrally located stage I or II breast cancer.
* Determine the safety, feasibility, and success rate of thorascopic internal mammary sentinel lymph node biopsy in these patients.
* Determine the rate of metastatic disease in internal mammary sentinel lymph nodes obtained thoracoscopically in these patients.

OUTLINE: Patients undergo standard axillary sentinel lymph node dissection during surgery (i.e., lumpectomy or mastectomy). Patients receive a radioactive tracer (i.e., technetium Tc 99m sulfur colloid) and isosulfan blue by peritumoral injection for identification of the axillary and internal mammary sentinel lymph nodes (IMSLN). Identified axillary sentinel lymph nodes are dissected. Identified IMSLNs are removed through the lumpectomy/mastectomy incision, if accessible. If they are not accessible, patients undergo thorascopic IMSLN biopsy to remove the nodes.

All removed sentinel lymph nodes (axillary or internal mammary) are examined for gross and microscopic carcinoma for future therapy planning.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed breast cancer

  * Stage I or II disease (T1-T2, N0, M0/MX disease)

    * No chest wall invasion by tumor (T3 disease)
* Medially or centrally located lesion
* No multicentric disease

  * Multifocal disease allowed
* No clinically positive axillary nodes
* No enlarged internal mammary nodes by CT scan
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Male or female
* Menopausal status not specified
* American Society of Anesthesiologists (ASA) physical status classification 1-2
* Not pregnant or nursing
* Negative pregnancy test
* No other concurrent known, invasive malignancy
* No known chronic pulmonary disease
* No known allergy to methylene blue or isosulfan blue

PRIOR CONCURRENT THERAPY:

* No prior thoracic or cardiac surgery
* No prior ipsilateral chest tube placement

  * Contralateral chest tube placement allowed
* No prior neoadjuvant chemotherapy
* No prior radiotherapy to the mediastinum
Safety and Effectiveness Assessment of the MakAir Artificial Ventilator

The objective of our study is to carry out an evaluation of the safety and the effectiveness of the use of the MakAir respirator as useful supplement in situation of shortage of technical devices of assistance to the mechanical invasive ventilation, related to COVID-19 through a protocol in 3 successive sequences.


Eligibility Criteria:
Inclusion Criteria:

Sequence 1 :

* Patient for whom a certificate has been signed by a support person / family member / close relative independent of the sponsor.
* Adult
* Non-hypoxemic patient (PaO2 / FiO2\> 300)
* Patient requiring invasive mechanical ventilation\> 24 hours
* Stabilized patient, i.e. not needing an increase in oxygenation for at least 6 hours

Sequence 2 :

* Patient for whom a certificate of consent has been signed by a support person / family member / close relative independent of the sponsor.
* Adult
* Patient with mild to moderate Acute respiratory distress syndrome (300\> Pa02 / FiO2\> 100)
* Patient requiring invasive mechanical ventilation\> 3 days
* Stabilized patient, i.e. having not required an increase in oxygenation for at least 6 hours

Sequence3 :

* Patient for whom a certificate of consent has been signed by a support person / family member / close relative independent of the sponsor or waiver due to life-threatening emergency.
* Adult
* Patient with mild to moderate Acute respiratory distress syndrome (PaO2 / FiO2\> 100) or without Acute respiratory distress syndrome
* Patient requiring invasive mechanical ventilation for any duration
* Situation of shortage among centers investigating technical devices for invasive ventilation to treat all patients

Exclusion Criteria:

Sequence 1 and sequence 2:

* Patient positive or showing signs of Covid-19 infection
* Tracheotomized patient
* History of pulmonary emphysema or severe to moderate chronic obstructive pulmonary disease
* Patient in recovery and withdrawal phase of ventilatory assistance
* Pneumothorax or pneumomediastinum
* Hemodynamic instability
* Intracranial hypertension
* Pregnant woman (A urine or blood pregnancy test must be performed for women of childbearing age)
* Major protected (guardianship, curatorship and under the protection of justice)
* Lack of affiliation to the French social security system
* Participation in another interventional clinical trial

Sequence3 :

* Tracheotomized patient
* History of pulmonary emphysema or severe to moderate moderate chronic obstructive pulmonary disease
* Patient in recovery and withdrawal phase of ventilatory assistance
* Pneumothorax or pneumomediastinum
* Hemodynamic instability
* Intracranial hypertension
* Pregnant woman (A urine or blood pregnancy test must be performed for women of childbearing age)
* Major protected (guardianship, curatorship and under the protection of justice)
* Lack of affiliation to the French social security system
* Participation in another interventional clinical trial on mechanical ventilation
Effect of Silibinin(A) as a Potential Anti-obesity Agent

Our preliminary reports have found in silico and in vitro that the milk thistle derivative Silibinin(A) is able to inhibit pancreatic lipase, in a similar way that the classical anti-obesity drug orlistat.

Therefore, the investigators want to carry out the present trial in order to confirm that Silibinin(A) is able to in vivo inhibit pancreatic lipase, which will reduce the fat absorption and therefore will decrease the amount of energy from food intake.

Considering that milk thistle has been extensively studied in humans as liver-protector, the investigators consider that the use of human subjects will be of great interest to accelerate the employment of this compound to improve the effectiveness of dietary treatment in overweight/obese subjects.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 24,9
* Voluntarily participate in the study

Exclusion Criteria:

* significant cognitive impairment
* psychiatric disorders
* chronic pharmacological treatment that may affect the effectiveness of the dietary intervention (corticosteroids, thyroid hormones, oral antidiabetic agents or lipid-lowering drugs)
* chronic disease that may interfere with dietary therapy (cancer, renal or hepatic impairment, chronic gastrointestinal conditions)
* acute disease episodes during the study
* subjects who followed a hypocaloric diet at the allocation time or in the 3 months prior to the beginning of the study
* pregnant women
Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal

The purpose of this study is to compare the reductions in skin flora of newborns after a single cleansing of the body with three concentrations of chlorhexidine (0.25%, 0.5%, 1.0%) and to examine the safety of skin cleansing in neonates in Nepal.

Studies in Malawi, Egypt, and Nepal suggest that neonatal skin cleansing with chlorhexidine solutions may reduce the risk of infection and mortality. Cleansing with 0.25% chlorhexidine in Nepal resulted in a 28% reduction in mortality among low birth weight infants, while there was no impact on infants of normal weight. The mechanism of action for this observed benefit is not clear. Chlorhexidine may remove pathogens from the skin of the newborn and/or prevent exposure to pathogens that may otherwise cause infection and lead to sepsis. The benefit of chlorhexidine cleansing may be extended with higher concentrations of chlorhexidine.

Infants born at the Tribhuvan University Teaching Hospital in Katmandu, Nepal will be randomized to skin cleansing with chlorhexidine at one of three concentrations (0.25%, 0.50%, 1.00%). Skin swabs will be collected before wiping, and two and twenty-four hours after wiping in order to compare levels of bacteria on the skin across the treatment groups. A small quantity of blood will be collected at 24 hours after wiping to determine the potential for absorption of chlorhexidine

Eligibility Criteria:
Inclusion Criteria:

* babies born at Tribhuvan University Teaching Hospital
* greater than 1500 grams

Exclusion Criteria:

* less than 1500 grams
* requires major surgical procedure
* clinically evident skin infection
* generalized skin disease
* major congenital anomoly
Predictive Equations for Resting Energy Expenditure

Predictive equations are the main clinical tool for determining resting energy expenditure (REE). Thus, it is important to investigate the accuracy and agreement of these equations in different populations and context of diseases. The purpose of this study is to investigate the accuracy and agreement of predictive equations of REE in overweight women with polycystic ovary syndrome (PCOS). The REE of all participants was measured (mREE) by means of indirect calorimetry and predicted (pREE) through ten equations basing on the anthropometric parameters (Harris \& Benedict, WHO/FAO/UNU including weight, WHO/FAO/UNU including weight and height, Owen, Mifflin-St. Jeor, Institute of Medicine, Ireton-Jones, Müeller, De Luis and Lazzer).


Eligibility Criteria:
Inclusion Criteria:

* Women treated in an endocrinology centre specialising in hyperandrogenism at the university hospital of University Federal of Minas Gerais (Belo Horizonte, Minas Gerais, Brazil)
* The patients were of reproductive age (range: 18-45 years)
* were overweight or obese (Body mass index ≥ 25.0 kg/m2) and
* signed an informed consent statement

Exclusion Criteria:

* Women who were pregnant,
* were lactating,
* had a diagnosis of hypothyroidism or hyperthyroidism or
* had high physical activity levels were excluded from the sample.
Neurobiological and Immunological Mechanisms of Dyspnea in ALS (BIOPNEA)

Dyspnea; subjective experience of respiratory discomfort; which produces negative emotional experience, is the most common symptom of patients afflicted with chronic respiratory failure and its treatments are limited. Amyotrophic Lateral Sclerosis (ALS) related - dyspnea, due to diaphragmatic dysfunction, is similar to dyspnea during mechanical inspiratory load (activation of the supplementary motor area, SMA). The perception of pain and dyspnea is processed in similar brain areas (insula, dorsal anterior cingulate cortex, amygdala and medial thalamus) and in ALS; relieving dyspnea by noninvasive ventilation (NIV) is associated with decreased pain thresholds. Otherwise, it is reported systemic elevations of pro-inflammatory cytokines in chronic pain patients, correlating with intensity of pain, and during respiratory load in healthy volunteers.

The objectives are to evaluate the cytokines and endorphins rates variations after initiation of NIV in ALS patients, and to correlate cytokines and endorphins rates with the intensity of the affective component and the intensity of the sensory component of dyspnea.

The investigators will perform a prospective, experimental study, including 30 ALS patients. Dyspnea, ventilatory and cardiac settings, electromyographic recording of the scalene muscle and biological assays (ACTH, endorphin, Neuropeptide P, BDNF, IL1, IL6, IL8, IL10, TNF), will be measured during spontaneous breathing and during NIV at different times after initiation.

The investigators expect a reduction of immunological and neurobiological markers after relieving dyspnea by NIV. This work could lead to the development of new treatments for dyspnea.


Eligibility Criteria:
Inclusion Criteria:

- Patients with chronic respiratory failure with diaphragmatic dysfunction linked to amyotrophic lateral sclerosis and requiring long-term NIV

Exclusion Criteria:

* Other respiratory disease (COPD, asthma, obstructive sleep apnea)
* Alcohol or psychotropic drug the lasts 24 hours
* Cognitive impairment
* Smoking \> 10 PA
* Exacerbation or infection 6 weeks earlier
* Endstage of illness
* Chronic or acute pain (VAS \> 3)
Gut Microbiota Diversity: Wrong Message in Autism, Wrong Architecture in Formation

Our dietary diversity has changed day by day in industrial age. A low dietary diversity may alter gut microbiota diversity and functional capacity. Wrong messages sourced from gut microbiota were speculated to have a bad influence on autism spectrum disorder (ASD) severity. A new nutritional model aiming to increase microbiota diversity in children with ASD can improve social and communicative behaviors in these children. The investigators compared 220 ASD patients who regularly followed a specific diet program for at least 12 months with randomly selected 100 children with ASD who did not have diet compliance in terms of nutritional status and regular behavioral assessments with special scales (ATEC, ABC, QoLA-P scales). The investigators arised a question that the Microbiota-Diversity Enhancing Diet on Children with ASD (MIND-DASE) which is a specific dietary intervention may have benefits on the neurodevelopmental outcomes of children with ASD.

Since industrialization has altered human diet models, we faced with a low dietary diversity, reduced gut microbiota diversity and functional capacity day by day. These changes in gut microbiota have been speculated to associate with severity of autism spectrum disorder (ASD). The investigators researched the possible therapeutic effects of a new nutritional model aiming to increase microbiota diversity in children with ASD. Question is: Can we improve social and communicative behaviors in children with ASD by increasing microbiota diversity through a specific diet? A total of 2000 children diagnosed with ASD and followed in Autism Nutrition Research Center in investigators' hospital were screened: a) a total of 220 participants aged between 2-18 years who regularly followed the specific diet program for at least 12 months were identified as a study group, and b) randomly selected 100 children with ASD who did not have diet compliance were identified as control group. Assessments included dietary adherence and behavioral evaluations using baseline, 6th and 12th month Autism Treatment and Evaluation Checklist (ATEC), Aberrant Behavior Checklist (ABC), The Quality of Life in Autism Questionnaire- Parent version (QoLA-P) scales. The investigators compared diet and non-diet groups by evaluating demographic data, clinical symptoms, diet compliance status and ATEC, ABC, and QoLA-P scores in 12-month time period. The investigators foced on The Microbiota-Diversity Enhancing Diet on Children with ASD (MIND-DASE) which is a specific dietary intervention may have significant benefits on the neurodevelopmental outcomes of children with ASD.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who were diagnosed ASD by a pediatric psychiatrist or a pediatric neurologist according to the DSM-V criteria
* Having continued follow-up in our center at least 12 months regularly
* Being between the ages of 2-18

Exclusion Criteria:

* Having a genetic syndrome (such as Rett, Angelman syndrome)
* Having an additional chronic disease
* Following a different diet program other than our center
Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure Patients

To demonstrate the efficacy and safety of acarbose and metformin loose-dose combination as compared to metformin monotherapy in the treatment of subjects with T2DM that is inadequately controlled by metformin alone


Eligibility Criteria:
Inclusion Criteria:

* Males and females, aged 18 to less than 80 years
* Diabetes mellitus type 2, that is insufficently controlled with metformin defined by HbA1c between 7.0 % and 10.0%, inclusive
* Body mass index between 22 and 45 kg/m\^2, inclusive
* Women and men of reproductive potential must agree to use adequate contraception when sexually active

Exclusion Criteria:

* Fasting plasma glucose \> 14.0 mmol/L
* Severe metabolic diabetic complications
Utilization of Platelet Gel for Treatment of Diabetic Foot Ulcers

Diabetes is a multiorgan disease and considered a major health problem in different societies. One of the complications the pain particularly in the extremities resulting from a process known as diabetic foot ulcer. The diabetic patients are subjected to many complications because of foot ulcers, many of them like as chronic wound disease or pressure ulcers (bed sore). Routinely used medical measures for diabetic foot ulcers are depended to nursing care and take too long until pain relief. Among many tested materials and works for wound healing such as debridement, tissue oxygenation, and skin transplantation, platelet-derived compounds are allocated the pivotal position between investigators to tissue regeneration and shortening the wound healing process.

Many of platelet components are procured from platelet rich plasma (PRP) from whole blood donation. Furthermore, it requires to an additional purification step to diminish the volume and facilitate handling in some studies. It means that platelet concentrates (PCs) may be obtained leading to more concentrated platelets in lower volume.

Two types of granules in platelet is responsible for storage of many useful and different growth factors: dense or delta and alpha granules. Platelet-derived growth factors have the ability to growth and differentiation of numerous cells. Also, the antibacterial effect of these growth factors has been reported.

To better efficacy and comfortable utilization of platelet, it is feasible to form the platelet gel and then apply on wound sites.

This study is a double blind randomized controlled trial to evaluate the positive effects of umbilical cord blood-derived platelet gel in 244 patients with diabetic foot ulcers.

In this study all qualified patients (based on the inclusion and exclusion criteria) were randomly allocated into three study groups by a Stratified Permuted Block randomization method: group A received platelet rich plasma gel, group B (placebo) received platelet poor plasma gel, and group C received lubricant gel.

All of the patients underwent a standard long protocol for knee osteoarthritis. All patients with diabetic foot ulcer are selected.On average,in each instance, the amount of platelets in the peripheral bloodis4 to6 times the baseline level.

Group A (interventional): application of 20-30mL of gel from platelet rich plasma (PRP) Group B (placebo): application of 20-30mL of gel from platelet poor plasma (PRP) Group C (control): application of 20-30 mL of lubricant gel (used typically for sonography)

Eligibility Criteria:
Inclusion Criteria:

* History of at least 4 weeks hospitalization
* Uncontrolled diabetes
* ejection fraction \> 30%

Exclusion Criteria:

* mechanical origin for wound
* history of infectious, systemic diseases, Immune deficiency and coagulation disorders
Correspondence of Folate Dietary Intake and Biomarker Data

This NHANES analysis compares self-reported dietary folate with serum and red blood cell folate status in U.S. adults.

Background: Public health concerns of both low and high folate status exist in the U.S. Recent publications have questioned the utility of self-reported dietary intake data in research and monitoring.

Objective: The purpose of this analysis was to examine the relationship between self-reported folate intakes and folate status biomarkers, and to evaluate their usefulness for several types of applications.

Design: Usual dietary intakes of folate were examined using the National Cancer Institute (NCI) method to adjust 2, 24-hour dietary recalls (including dietary supplements) for within-person variation and compared these intakes with serum and red blood cell (RBC) folate among 4,878 non-pregnant, non-lactating participants ≥19y in NHANES 2011-2012, a nationally representative, cross-sectional survey, with respect to consistency across prevalence estimates and rank order comparisons.

Eligibility Criteria:
Inclusion Criteria:

* adults, ages 19+ years

Exclusion Criteria:

* missing data
* non-pregnant
* non-lactating
A Pilot Study of OPC-8212 (Vesnarinone) in Persons With AIDS-Related Kaposi's Sarcoma

To examine the safety and efficacy of two doses of vesnarinone in patients with AIDS-related Kaposi's sarcoma.

Twenty-eight patients (14 per cohort) receive daily vesnarinone at one of two doses. At least seven patients at the lower dose must have completed 2 weeks of therapy before subsequent patients are entered at the higher dose. Patients who successfully complete 16 weeks of treatment may receive maintenance therapy for the duration of the study (approximately 12-18 months).

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Chemoprophylaxis for Pneumocystis carinii, candida, and mycobacteria.
* Acyclovir as acute treatment for herpes outbreaks.

Concurrent Treatment:

Allowed:

* Limited electron-beam radiation therapy to non-marker lesions for treatment of Kaposi's sarcoma.

Patients must have:

* Documented HIV infection.
* Kaposi's sarcoma.
* No current constitutional signs of HIV disease or AIDS-defining conditions other than Kaposi's sarcoma.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Active malignancy other than Kaposi's sarcoma, cutaneous basal cell carcinoma, or in situ carcinoma of the cervix.
* Current significant cardiac disease or anomaly (including prolonged QTC on EKG).
* Abnormal cardio-thoracic ratio on chest x-ray.

Concurrent Medication:

Excluded:

* Antiretroviral agents, including ddI, ddC, AZT, and d4T.
* Immunosuppressive agents.
* Investigational HIV drugs/therapies including vaccines (except those on treatment IND for approved indications).
* Other anti-Kaposi's sarcoma/HIV drugs.
* Corticosteroids (other than topical).
* Biologic response modifiers.
* Megestrol acetate.
* Agents known to cause neutropenia.
* Trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg sulfamethoxazole thrice weekly.
* Cytotoxic chemotherapy.

Concurrent Treatment:

Excluded:

* Radiation therapy including electron beam irradiation (other than limited electron-beam radiation to non-marker lesions for treatment of Kaposi's sarcoma).

Patients with the following prior conditions are excluded:

* Prior history of significant cardiac disease or anomaly.
* History of agranulocytosis or severe grade 3 drug-induced neutropenia or documented abnormalities in granulocyte function.

Prior Medication:

Excluded:

* AZT within 14 days prior to study entry.
* Acyclovir as prophylaxis for herpes within 48 hours prior to study entry.

Excluded within 30 days prior to study entry:

* Interferon.
* Biologic response modifiers.
* Cytotoxic chemotherapy.

Prior Treatment:

Excluded within 30 days prior to study entry:

* Blood or cellular blood product. Active illicit drug abuse (specifically cocaine, amyl nitrate, heroin, or other cardioactive agents).