cyrilzakka/clinical-trials huggingface dataset:
Adequate Protein Intake Per Meal and Physical Disability in Mexican Adults Aged 60 Years and Older

This study sought to determine if the number of meals per day with an adequate protein content (defined as eating \>30 g protein or \>0.4 g protein/kg body mass each) is associated with presenting physical disability in Mexican adults aged 60 years and older. Physical disability was evaluated with self-reported questionnaires for different activities of daily living.

Detailed dietary information was obtained for each participant to estimate dietary protein intake per meal (breakfast, lunch, dinner). One meal was considered with adequate protein content if it contained \>30 g or \>0.4 g/kg. Then, the number of meals with an adequate protein content was counted and classified as Zero meals, One meal, or Two or Three meals.

Physical disability was assessed with two validated questionnaires. One for instrumental activities of daily living (Lawton) and another for activities of daily living (Barthel). Disability was classified for each questionnaire item according to the authors' scales. Most items considered a physical disability if the participant reported any difficulty performing that task.

To analyze the association between the number of meals with adequate protein content (predictive variable) and physical disability (outcome variable), we used binomial logistic regression for each item. For the number of meals, we set the group of Zero meals as the reference. The analyses were adjusted for age, BMI categories, number of diagnosed diseases, sex, and inadequate protein intake per day (\<1.2 g/kg/d).

Eligibility Criteria:
Inclusion Criteria:

* Subjects able to stand up and walk independently or with walking sticks only.
* Subjects able to answer questionnaires independently or with minimum caregivers' assistance.

Exclusion Criteria:

* Subjects reporting any kind of hospitalization within the last year.
Smoking Cessation Assistance With LIBERTAL, A Phospholipid Mixture

It has been shown in rodent models that chronic substance abuse is associated with a rigidification of cell membrane fluidity due to a change in the membrane cholesterol/phospholipids ratio. Upon substance withdrawal the membrane undergoes reequilibration of this ratio, a process resulting both in an acute and a prolonged severe withdrawal syndrome. MBM has developed a patented,phosphatidic acid-enriched phospholipid platform ("LIBERTAL"), which is supposed to facilitate the membrane fluidity recovery. The company has focused on nicotine withdrawal in smoking cessation,as primary target.

A randomized,double-blind, dose-finding,phase IIB study with Libertal has been performed in 493 volunteer smokers, wishing to quit. They were divided into 5 arms: 4 treatment groups of 0.5, 1.0, 2.0 and 4.0g/day respectively, and one placebo, divided BID. Treatment was administered during one week prior to smoking cessation, then continued during 8 weeks (56 days), followed by another 4 weeks without treatment (up to day 84). The primary endpoint was complete smoking cessation during at least 28 consecutive days. There were 6 on-site visits and 4 telephone interviews.

Eligibility Criteria:
Inclusion Criteria:

* Smokers of at least 1 year duration
* Smoking at least 10 cigarettes/day
* Having failed at least one previous smoking cessation effort.
* Without a major cardio-vascular or metabolic disease or condition.

Exclusion Criteria:

* An uncontrolled major cardiovascular, metabolic, or other condition condition.
* Need for surgery during the period of participation in the trial.
* Any treatment for smoking cessation during the 2 months preceding enrollment in the present trial.
Disseminating a Model Intervention to Promote Improved Attention-deficit Hyperactivity Disorder (ADHD) Care in the Community

The American Academy of Pediatrics (AAP) has established a set of consensus guidelines for pediatricians to follow. These guidelines can be challenging to implement in typical community-based practices. Cincinnati Children's Hospital Medical Center (CCHMC) has developed a program called the ADHD Collaborative to promote the adoption of these guidelines among community pediatricians. The program focuses on modifying the office system using academic detailing and quality improvement (QI) methodology to accommodate prescribed practice changes. The ADHD Collaborative has been very successful at recruiting practices in the Greater Cincinnati area, changing practice behaviors, and sustaining these practice behaviors over time at minimal cost to the project and to the office practice. Now that sustainability and effectiveness have been established, the next step is to modify the ADHD Collaborative model to make it amenable to widespread dissemination. The primary goal of the proposed study is to modify the ADHD Collaborative intervention to make it transportable and then evaluate this version in terms of effectiveness, consumer satisfaction, and costs.. A transportable intervention is described that utilizes telehealth videoconferencing, a web portal, and long-distance data collection. Initially, three pediatric practices will be recruited to test and refine the distal intervention delivery methodology. Then, eight new pediatric practices will be randomly assigned to receive the distal intervention or to a control group (treatment as usual). Information about pediatric practice behavior will be collected at baseline, 6-months, and 1-year post-baseline. The study design will allow for a preliminary assessment of the feasibility and effectiveness of the distal intervention in terms of rates of evidence-based practice behaviors to patients, change in pediatrician attitudes, consumer satisfaction, and costs.


Eligibility Criteria:
Inclusion Criteria:

* pediatric practice with at least 2 physicians

Exclusion Criteria:

* no electronic billing system
Pilot for The Breast Cancer Endocrine Therapy Adherence (BETA) Trial

Pilot study to assess feasibility and patient acceptance of a text message cell phone application for patients with stage I-III, hormone receptor positive breast cancer who start adjuvant endocrine therapy.

Approximately 75% of breast cancers express the estrogen and/or progesterone receptor (hormone receptors). The standard of care for women with hormone receptor positive breast cancer is five to ten years of adjuvant endocrine therapy with drugs such as tamoxifen or aromatase inhibitors (AIs). In women with stage I-III breast cancer, treatment with adjuvant endocrine therapy has been shown to reduce recurrences by 30-50% and improve survival. Unfortunately, it is estimated from large population databases that up to 35-40% of patients may discontinue adjuvant endocrine therapy before completing the recommended 5 years for various reasons, and non-adherence may reduce survival.

The current protocol is a pilot study in women with hormone receptor positive breast cancer who are beginning adjuvant endocrine therapy, the purpose of which is to assess the feasibility of a two-way text messaging application, with goals for a larger randomized control study to assess if the application will increase adherence and therefore improve disease free survival. This application includes daily text message medication reminders and periodic assessment of side effects and barriers to medication adherence and simultaneously offers assistance for treatment related issues. The investigators will collect information on QOL and financial burden during the 3 month period and will correlate these metrics with adherence. This larger randomized control study would be the first such interventional study to increase adherence with adjuvant endocrine therapy in breast cancer in the US. Our larger randomized control trial would provide the first longitudinal prospectively collected information on QOL, financial burden and adherence over the entire 5-year treatment period in the routine clinical practice setting.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed stage I-III, estrogen and/or progesterone receptor positive, as defined by ASCO-CAP guidelines, invasive breast cancer for whom adjuvant hormonal therapy is indicated following standard NCCN practice guidelines
* Patients may enter the study before or within one month of starting endocrine treatment
* Patients with synchronous bilateral breast cancers are eligible if both tumors are hormone receptor positive
* Patient must be able to provide informed consent and agree to:
* Complete questionnaires according to the pre-specified study design
* Own a personal cell phone, agree to receive text messages on a monthly basis (including any costs), and share their personal cell phone number to receive text message reminder
* sign consent to allow research staff to contact their pharmacies to determine prescription refill dates

Exclusion Criteria:

* Patients with ductal carcinoma in situ
Prognostic Indicators for Radiation-induced Breast Fibrosis

To study the inflammatory response during and after radiotherapy, especially by measuring the concentration of an enzyme called autotaxin and its product LPA in the blood plasma.

To study the inflammatory response during and after radiotherapy, especially by measuring the concentration of an enzyme called autotaxin and its product LPA in the blood plasma. Autotaxin and LPA cause fibrosis in other situation, but they have not been tested in radiation-induced fibrosis. We will determine if the duration and magnitude of the autotaxin and LPA responses are prognostic for the 15-28% of patients who will develop fibrosis. This fibrosis will be detected by ultrasound and a novel application of elastography, which should provide much earlier and quantifiable fibrotic changes compared to conventional physical examination.

Eligibility Criteria:
Inclusion Criteria:

1. Female participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf
2. Age 40 and above.
3. Treatment with breast conserving surgery.
4. Intended adjuvant whole breast radiotherapy dose to a dose of 40-42.5 Gy in 15-16 fractions.
5. Luminal A subtype as determined by clinipathologic factors (ER/PR positive, Her-2 negative, low Ki-67 or low OncotypeDx recurrence score

Exclusion Criteria:

1. Women who have smoked within the last 5 years
2. Patients requiring adjuvant chemotherapy.
3. Requirement for regional nodal radiotherapy.
4. Requirement for tumour bed boost.
5. Breast implants
6. Patients to be treated with partial breast irradiation.
7. Uncontrolled intercurrent illness or active infection.
8. Patients who have previously received chemotherapy.
9. Patients who have previously received chemotherapy.
Evaluation of The Stanford Tobacco Prevention Toolkit

The Stanford Tobacco Prevention Toolkit is a free online curriculum developed for use by educators and health professionals in providing tobacco-specific prevention education to middle and high school students. The aims of this study are to determine: (1) whether the Curriculum is effective in changing middle and high school students' resistance to using tobacco as well as knowledge of, attitudes towards, and intentions to use different tobacco products; and (2) whether the Curriculum is effective in changing middle and high school students' actual use of tobacco in the short-term.


Eligibility Criteria:
Inclusion Criteria:

* Middle school and high school students

Exclusion Criteria:

* Non English-speakers
A Real-world Study of Donafenib Combined With TACE-based Treatment in Patients With Unresectable HCC

This study is a prospective, single-center, observational real-world study. It is planned to enroll 150 patients with unresectable hepatocellular carcinoma treated with Donafenib combined with TACE-based treatment, so as to observe and evaluate the efficacy and safety of Donafenib combined with TACE-based treatment in patients with unresectable HCC.


Eligibility Criteria:
Inclusion Criteria:

1. Patients voluntarily entered the study and signed informed consent form (ICF);
2. Age: Be at least 18 years old and and there is no limit on the gender;
3. Clinically or histologically diagnosed as unresectable HCC;
4. There is at least one measurable lesions that meet the mRECIST standard;
5. Child-pugh classification A or B (score≤7);
6. The maximum number of TACE procedures allowed before enrolment was 2. All of those patients who had a history of prior TACE achieved complete response by previous TACE, but recurred more than 6 months later at the study entry
7. ECOG : 0 \~ 2 ;
8. Before the patients were enrolled in the study, doctors had decided to treat them with donafenib in combination with TACE.

Exclusion Criteria:

1. Donafenib forbidden population:

   * Those who are allergic to any component of the medicine;
   * Active bleeding;
   * Active peptic ulcer;
   * Hypertension not controlled by drugs;
   * Those with severe liver insufficiency.
2. Medical conditions that affect absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.);
3. Patients with a clear past history of neurological or psychiatric disorders;
4. The patient had been treated with another study drug or study device in the 4 weeks prior to initial dosing;
5. Pregnant or breastfeeding women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures;
6. Unable to follow the research protocol for treatment or scheduled follow-up;
7. Any other researcher who thinks they cannot be included.
A Trial To Evaluate Two Antibiotics For The Treatment Of Acute Exacerbation Of Chronic Bronchitis (AECB)

This trial is a research drug study to compare the effects of two antibiotics for the treatment of acute exacerbation of chronic bronchitis


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic bronchitis (chronic cough and sputum production on most days for three consecutive months for more than two consecutive years) and clinical evidence of AECB as demonstrated by both the following symptoms:
* Production of purulent sputum as defined by Gram stained sputum specimen
* Presence of all of the following:
* Increased sputum production
* Increased dyspnea
* Increased cough
* At least two exacerbations of AECB in the past 12 months
* Documented FEV1 less than 80% of predicted

Exclusion Criteria:

* A chest radiograph consistent with pneumonia
* Treatment with any systemic antibiotic within the twenty-one days prior to study entry or those with a chance of receiving other systemic antibiotics during study participation
Single-Breath Measurement Underestimates Ventilatory Volume According to Emphysema Severity

Although single breath helium (He) dilution measurement (VASB) is currently used in pulmonary function laboratories to assess functional alveolar volume and diffusing capacity for carbon monoxide, the extent to which VASB reflects ventilatory and thoracic volume has not been prospectively determined in emphysema. We hypothesized that VASB underestimates rebreathe helium dilution volume (VARB), and plethysmographic volume (VApleth) as clinical and physiologic severity of emphysema increases.

VASB, VARB, and VApleth were measured in 52 consecutive stable outpatients with clinical and radiographic emphysema. Thirteen patients with an obstructive ventilatory defect without emphysema (OVD) and 18 normal controls were similarly studied. All subjects underwent spirometry followed by whole body plethysmography and He dilution volume measurements; VASB and VARB order was randomized.

Eligibility Criteria:
Inclusion Criteria:

* All outpatients between the ages of 18 and 81 years referred to the Columbia University Medical Center Pulmonary Diagnostic Unit between 1/18/06 and 7/30/07 for full pulmonary function evaluation, and with an obstructive ventilatory defect on spirometry, were considered eligible.

Exclusion Criteria:

* Patients who did not want to undergo the re-breathe diffusing capacity testing
* Patients who could not give informed consent;and
* Patients who were too physically compromised to undergo full testing including the re-breathe maneuver as deemed by our technicians.
Evaluation of Toddler Milk Containing L.Reuteri, Galacto-oligosaccharides and Palm-Oil Free Fat Blend

The purpose of this study is to evaluate the effects of experimental growing up milk (EXPL) as compared to traditional children's fortified milk (CTRL) fed for 6 months on bone mass index.

A randomized, double-blind controlled clinical trial was chosen to study the effects of toddler milk containing L. reuteri and GOS (4g/L) and a low sn-1, -3 fat blend when compared to a control formula. There is an additional unblinded habitual intake reference group (REF) for "real-world" comparison (including 58% non-dairy drinkers according to observational data).

Eligibility Criteria:
All subjects must comply with all the following criteria:

1. Written informed consent has been obtained from the parent(s)/legally acceptable representative (LAR).
2. Singleton, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
3. Child is between 24 months ±1 week to 36 months ±1 week.
4. Child is not currently consuming nor has consumed any formulas or taking any supplements with pre- or probiotics at enrolment or in the past month.
5. Child's parent(s)/guardian is of legal age of consent, must understand the informed consent and other study documents, and is willing and able to fulfill the requirements of the study protocol.

All subjects presenting one or more of the following criteria are excluded from participation in the study:

1. Chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or growth.
2. History of bone, malabsorption, metabolic, congenital or chromosomal abnormality known to affect feeding or growth.
3. Use of systemic antibiotics or anti-mycotic medication in the 4 weeks preceding enrollment.
4. Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, or severe food allergies that impact diet.
5. Current breast milk feeding in place of all other milk, and/or milk alternatives.
6. Clinical signs of severe micronutrient deficiencies.
7. Parents not willing / not able to comply with the requirements of study protocol.
8. Child's participation in another interventional clinical trial.
ChAracterisation of ItaliaN Severe Uncontrolled Asthmatic patieNts Key Features When Receiving Benralizumab

This is an observational, Italian multi-center, retrospective cohort study with enrollment visit on patients suffering from severe eosinophilic asthma who started benralizumab in the Sampling Program or as per normal clinical practice in Italy.

A retrospective cohort study design involving secondary data collection was chosen to appropriately address the primary objective in a relatively short period of time after enrollment phase initiation: in fact, since the Italian Sampling Program on benralizumab was active since July 2018, clinical data on patients exposed to benralizumab are already available. No treatments will be administered per protocol requirement, but instead according to normal clinical practice; since benralizumab first administration occurs before inclusion in the study (as per chosen study design), the decision to include the patient in the study is clearly separated from the prescription of benralizumab, in accordance with the observational nature of the study. In order to be eligible for the study, for each patient, the index date shall be at least 3 months prior to enrollment.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (age ≥18 years) at the start of benralizumab treatment within the sampling program or per clinical practice ("index date").
2. Patients with severe eosinophilic asthma requiring a stable treatment of high doses of inhaled corticosteroids and a long acting β2 agonist ± additional asthma controller (according to clinician's judgment).
3. Patients who started benralizumab and received at least one injection at least 3 months before enrollment, either within the sampling program or as per routine clinical practice.
4. Patients who signed the informed consent and privacy form at enrollment visit.
5. Patients with available hospital medical chart since the start of benralizumab treatment within the sampling program or per clinical practice ("index date").

Exclusion Criteria:

1. Patients who, during the observation period, received benralizumab in a clinical experimental trial.
2. Patients who, during the observation period, participated in studies imposing a specific patient's management strategy which does not correspond to the site's normal clinical practice.
A Non-interventional, Epidemiological, Registry-based Evaluation of Anaemia in Swedish Patients With Chronic Kidney Disease

The primary purpose of this study is to describe renal anemia treatment patterns in non-dialysis dependent (ND) and dialysis dependent (DD) populations, with a particular focus on iron use in erythropoiesis stimulating agent (ESA) treated patients.

This study will also provide an epidemiological description of chronic kidney disease (CKD) associated anemia in relation to CKD stage, dialysis modality and underlying morbidity, as well as describe the relationship between inflammation and ESA treatment and describe the associated cardiovascular illness in ESA treated patients.

Data from year 2015 will be used for the prevalence analysis.The prevalent population of CKD patients \> 18 years in the Swedish Renal Registry in 2015 both dependent on dialysis (DD) and not on dialysis (ND).

Eligibility Criteria:
Inclusion Criteria:

* For ND-CKD population:

  * all prevalent patients with a CKD with Estimated Glomerular filtration rate (eGFR) \< 45ml/min/1.73m2 with a recorded visit pre-dialysis in Swedish Renal Registry (SRR) in 2015
  * Not on dialysis
* For DD-CKD population

  * All prevalent patients taking part in the yearly cross-sectional dialysis investigation in SRR in 2015
  * Dialysis dependent

Exclusion Criteria:

* not applicable