cyrilzakka/clinical-trials huggingface dataset:
Symptom Recognition Improves Self-care in Patients With Heart Failure.

Describe a behaviour intervention to analyse self-care engagement in heart failure patients. Allocate patients with heart failure into 2 arms study: a control group and an intervention group.

According to medical record at admission, a pilot study was described and included 63 patients in New York Heart Association (NYHA) functional class II-III. Patients were recruited in a hospital setting after discharge from a heart failure unit.

Patients were allocated into a control group (n=33) and an intervention group (n=30) through the computerised random allocation generator at http://random.org.

The pilot study was performed during three months per patient, with four moments of assessment (baseline, first-week follow-up, first-month follow-up, third-month follow-up).

Eligibility Criteria:
Inclusion Criteria:

* adults aged \>18 years old, with diagnosed HF and with no cognitive disability associated.

Exclusion Criteria:

* patients placed on the heart transplant waiting list and patients in class IV NYHA.
Role of the Gut Microbiota in Pediatric Epilepsy

Nearly a third of children with epilepsy are refractory to pharmacotherapy. The ketogenic diet (KD) is a highly effective alternative therapy reducing seizure frequency by 50% in more than half of treated children. The exact mechanisms of KD remain poorly understood, and recent studies have implicated the gut microbiota (GM). This pilot study aims to determine the feasibility of a 12-week dietary intervention with prebiotic fiber in children with epilepsy. The investigators hypothesize that consumption of inulin will alter gut microbiota and may have effects on seizure frequency.


Eligibility Criteria:
* Inclusion Criteria:

  * Children with epilepsy:

    1. Age 2-18.
    2. Attended the epilepsy clinic for a minimum of 6 months.
    3. On a stable number and type of medications for 4 weeks.
    4. Have not previously been on the ketogenic diet.
  * Healthy controls:

    1. Aged 2-18.
    2. Immunocompetent.
    3. No medical comorbidities (e.g. autoimmune, metabolic, cardiovascular, renal, or gastrointestinal conditions).
* Exclusion Criteria:

  1. Health conditions such as disorders of fatty acid transport and oxidation, porphyria, and pancreatitis, Glucose transporter 1 deficiency, pyruvate dehydrogenase deficiency, diabetes, and other autoimmune diseases.
  2. Presence of HIV infection, chronic wound infection, or osteomyelitis
  3. Presence of or treatment for periodontal infection
  4. Inflammatory bowel disease, chronic diarrhea, current Clostridium difficile infection
  5. Treatment with immunosuppressive agents in the past 6 months
  6. Significant changes in dietary intake (i.e. excluded sugar, lactose or gluten from their diet, started consuming a vegetarian or vegan diet) over the past 6 months.
  7. Gastrointestinal illness in the past month or food intolerances leading to gastrointestinal symptoms.
  8. Use of antibiotics in the 3 months preceding the study.
  9. Use of probiotic or prebiotic supplements in the month preceding the study.
  10. Consumption of probiotic yoghurt in the past 2 weeks.
  11. Use of laxatives, proton pump inhibitors, or gastric motility medications in the month preceding the study.
  12. History of allergic reaction or intolerance of maltodextrin or inulin.
The Effects of Green Exercise Program Consisting of 12-week Aerobic and Resistance Exercises on Sleep Quality, Alexithymia, Anxiety and Depression in Elderly People

The aim of this study is to investigate the effects of combination of aerobic and resistance exercises in the green exercise concept on depression, anxiety, alexithymia and sleep quality of elderly individuals. Elderly individuals over the age of 65 will be included in the study. Two groups of 20 people each will take part in the study. One group will be given aerobic and resistance exercises for 12 weeks, 2 days a week in the green exercise concept, the other group will be the control group and will not be included in the exercise program. Participants will be evaluated twice, at the beginning of the study and at the end of 12 weeks.

Forty volunteer participants aged 65 years over will be included in the study. Participants will be randomly divided into two groups as experimental and control group. While experimental group will receive both aerobic and resistance exercises and control group will receive no exercise. Exercises will be held in an open and green area. Depression, anxiety, alexithymia and sleep quality of elderly individuals will be evaulated at the beginning of the treatment and at the end of the twelfth week. The exercise program will be done for 12 weeks, 2 days a week.

Eligibility Criteria:
Inclusion Criteria:

* people aged over 65 years
* Be fit to participate in exercise program after the first cardiac examination by the physician
* Having a score above 24 in the Minimental Test

Exclusion Criteria:

* Having neuromuscular disease
* Serious medical condition (for example, advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.)
* Having an orthopedic disease that interferes with walking
* Having a score below 24 in the Minimental Test
Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy

This study will compare the effect of constant low-level energy \[150 joules\] to an escalating energy \[200-300-360 joules\] regimen of biphasic waveform defibrillation on multiple patient outcomes.

This pilot, which will enroll 200 subjects, will allow a reasonable estimate of effect size and this will, in turn, allow for the accurate design and planning of a definitive randomized controlled trial. The following outcomes will be evaluated:

1. Important Clinical Outcomes:

   * Successful conversion,
   * Resuscitation to one hour,
   * Survival to hospital discharge,
   * Neurological function, and
   * Quality of life.
2. Process Outcomes:

   * Number of shocks required,
   * Recurrences of VF, and
   * Responsiveness to varying periods of pulselessness.
3. Adverse Outcomes:

   * Myocardial damage.

Eligibility Criteria:
Inclusion Criteria:

* Witnessed cardiac arrest out-of-hospital requiring defibrillation and given by first responder using an automated external defibrillator

Exclusion Criteria:

* Terminal illness or do-not-resuscitate (DNR) status
* No cardiopulmonary resuscitation (CPR) x 10 minutes
* Acute trauma
* Exsanguination
* Cardiac arrest experienced while in hospital
Correlation of Fecal Microbiome and Its Metabolites With Outcome of Radiotherapy in Head and Neck Carcinoma

Preclinical studies have shown that the response of solid tumors and normal tissues to radiotherapy can be regulated by gut microbiota and its metabolites. In this study, the composition of gut microbiota in patients with locally advanced head and neck cancers undergoing definitive radiotherapy will be analysed together with bacterial metabolites in stool and blood and a possible correlation with treatment outcome and treatment toxicity will be determined.

Head and neck cancer patients commonly present with unresectable locoregionally advanced disease in which radiotherapy is the mainstay of curative-intent treatment albeit at the cost of substantial acute and late toxicity. Recently discovered mechanisms by which gut microbiota and its metabolites impact tumor's and normal tissue's response to radiotherapy offer new ways to improve the therapeutic index of radiotherapy in solid tumors.

COMRAD-HNSCC is a prospective study assessing the correlation between gut microbiota composition and its metabolites and the response to radiotherapy in patients with unresectable locoregionally advanced head and neck cancer. Stool and serum samples will be collected at the beginning and at the end of curative radiotherapy treatment. The composition of gut microbiota will be analysed by ribosomal DNA high-throughput amplicon sequencing of the DNA isolated from stool samples, whereas targeted metabolomics using liquid chromatography-mass spectrometry will be performed on stool and serum samples.

The long-term goal of this study is to deepen the understanding of the role of gut microbiome and its metabolites in efficacy and toxicity of radiotherapy in head and neck cancer, and provide a basis for subsequent exploration to increase therapeutic index by regulating gut microbiota.

Eligibility Criteria:
Inclusion Criteria:

* Signed written and voluntary informed consent.
* Patient must be willing and able to provide collection for stool specimen analyses at 2 time points.
* Age \> 18 years, male or female.
* Patient must be diagnosed with histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, hypopharynx, or nasopharynx).
* Patients must be eligible for curative-intent treatment with either radiotherapy or concurrent chemo-radiotherapy.
* Overall disease stage III-IV based on 8th edition of American Joint Committee on Cancer staging system.

Exclusion Criteria:

* Receipt of induction chemotherapy.
* Presence of distant metastases.
* Any previous head and neck cancer.
* Any other known concurrent malignant disease.
* Any condition that, in the opinion of the Investigator, would interfere with patient safety, or evaluation of the collected specimen and interpretation of study result.
Hip Fractures in Chile: Implications for Public Health Policy and Healthcare Delivery

Hip fractures in individuals aged 60 and above pose significant challenges in terms of morbidity, mortality, and healthcare costs. While countries like the United Kingdom and Australia have optimized their healthcare systems for timely management of hip fractures, the situation in Chile presents distinct challenges due to its mixed healthcare system. This study aims to assess survival rates following hip fractures in Chile and identify associated risk factors using national databases from 2012 to 2018. A comprehensive analysis of 35,520 patients revealed that factors such as age, type of health insurance, access to surgery, and treatment in public hospitals significantly influence mortality rates after hip fractures. The study found that patients with hip fractures experience lower 5-year survival rates compared to the general population, particularly when affiliated with public insurance and treated in public institutions. Modifiable factors like delayed surgery and prolonged hospital stays contribute to increased mortality rates. The findings underscore the urgent need for optimized public health policies and healthcare delivery systems to enhance outcomes for hip fracture patients in Chile.Hip fractures in individuals aged 60 and above pose significant challenges in terms of morbidity, mortality, and healthcare costs. While countries like the United Kingdom and Australia have optimized their healthcare systems for timely management of hip fractures, the situation in Chile presents distinct challenges due to its mixed healthcare system. This study aims to assess survival rates following hip fractures in Chile and identify associated risk factors using national databases from 2012 to 2018.


Eligibility Criteria:
Inclusion Criteria:

All patients in the national database between 2012 and 2017 which his principal was hip fracture. Diagnoses are classified using the International Classification of Diseases, 10th Revision (ICD-10) codes. A search was conducted for codes S72.0 (head and neck fracture of the femur), S72.1 (pertrochanteric fracture), and S72.2 (subtrochanteric fracture of the femur).

Exclusion Criteria:

missing IDs ID with inconsistent socio-demographic information. Patients with primary diagnosis of hip fracture that underwent surgery but the national code surgery was not one of the following: : 2104128, 2104129, 2104131, 2104132, 2104135, 2104228, 2104229 and 2104231
Darvadstrocel for Crohn's Fistula in the Realworld

Background Perianal fistula may affect 15-50% of patients with Crohn's disease (CD). Treatment is complex, requiring a multidisciplinary approach. Darvadstrocel (allogeneic mesenchymal cells obtained from lipoaspirates) was approved in 2018 by the European Medicines Agency and Spanish Agency of Medicines and Medical Products as a treatment for fistulas in CD. Recent European Crohn's and Colitis Organisation (ECCO) andSpanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) guidelines state that darvadstrocel is effective with a favourable safety profile,with a strong level of evidence (level 2).With this study we want to see the real efficacy of darvadstrocel in a Spanish population after 6 months of follow-up.

Methods: The criteria for the Spanish National Health System to fund darvadstrocel treatment are: 1)complex fistula in a patient with CD; 2)failure of conventional and anti-tumour necrosis factor treatment; and 3)absence of collection s\>2cm confirmed by pelvic MRI scan at the time of surgery. From November 2019 to April 2022, 73 patients were treated with darvadstrocel at 14Spanish centres and evaluated clinically and radiologically 6 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* 1)complex fistula in a patient with CD
* 2)failure of conventional and anti-tumour necrosis factor treatment
* 3)absence of collection s\>2cm confirmed by pelvic MRI scan at the time of surgery

Exclusion Criteria:

* Patients with a diagnosis of rectovaginal fistula, rectal stenosis or severe active proctitis were excluded
A Phase III Clinical Trial of PROCRIT (Epoetin Alfa) Versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer

The purpose of this study is to determine whether it is possible to measure temporary difficulty with thinking and/or short-term memory in women who are receiving chemotherapy for early stage breast cancer and to determine whether or not treatment with PROCRITÂ® will help decrease any problems with thinking or short-term memory that chemotherapy may cause.

Studies of the effect of erythropoietin on rat and mouse brain suggests a neuroprotective and cognitive-enhancing effect of this hormone. The objective of this study was to quantify and compare the incidence of chemotherapy-related impairment of cognitive and executive function in breast cancer patients randomized to receive PROCRIT versus placebo while receiving adjuvant anthracycline-based chemotherapy with or without a Taxane and to evaluate the effect of PROCRIT® on the incidence of asthenia (severe fatigue), quality of life (QoL), and mood. Patients received study medication injections (40,000 units) under their skin once every week for 12 to 24 weeks of chemotherapy. Doses were adjusted depending on the patients' hemoglobin level up to a maximum of 60,000 units.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of Stage I, II or III cancer (chemotherapy naïve for breast cancer) with anthracycline-based adjuvant chemotherapy with or without a taxane
* Hemoglobin \>=9 and \<=14 g/dL unrelated to transfusion
* Able to read, understand and complete QoL \& Cognition tools
* Patients with reproductive potential must have a negative serum pregnancy test within 7 days of study enrollment and use an adequate contraceptive method

Exclusion Criteria:

* Patients who will receive more than a total of 24 weeks of chemotherapy
* psychiatric or neurologic condition that would prevent informed consent and completion of questionnaires or that is poorly controlled with the current treatment regimen
* severe hemiparesis or other condition, distal neuropathy, action tremor or other motor dysfunction, visual deficiencies preventing/decrease bimanual keyboard operation
* severe bradyphrenia (slow thinking) or bradykinesia (slow movement)
The Effects of an Oral Probiotic Intervention With or Without a Novel ADP-1 Toothpaste

* Randomized double-blind, placebo-controlled trial on the effects of an oral probiotic intervention with or without a novel ADP-1 toothpaste Objective
* Determine the safety and effectiveness of oral probiotic intervention with or without a novel toothpaste and compare with placebo

Hypotheses:

1. Subjects using oral probiotics will have better oral health than subjects using placebo toothpaste and placebo lozenges.
2. Subjects using oral probiotics and ADP-1 toothpaste will have better oral health than subjects using oral probiotics and regular toothpaste, and subjects using regular toothpaste and placebo lozenges.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 to 65 years old
* Fluent in English
* Have mild to moderate gingivitis (i.e., probing depth between 3mm and 5mm)
* Bleeding on probing on 30%+ areas
* Able to perform oral hygiene adequately after formal instructions
* Able to understand and comply with study procedure
* Able to provide written informed consent
* Able to come to Roseman Dental Clinics in South Jordan for a 90-minute pre-screening to determine eligibility
* Able to complete five (90-minute) clinic visits in 2-week intervals

Exclusion Criteria:

* • Probing depths less than 3mm

  * Breastfeeding, pregnant or trying to become pregnant
  * Currently taking or have taken any of the following within 30 days of enrollment:

    * Oral probiotics
    * Antibiotic medications
    * Antifungal medications (e.g., nystatin, clotrimazole, ketoconazole, griseofulvin)
    * Antiseptic medications
    * Immunosuppressant and/or chemotherapeutic medications
    * Medications that could affect gum response measurement (e.g., calcium channel blockers, cyclosporin, anti-seizures like phenytoin and related drugs, anti-inflammatory agents)
  * Frequent alcohol consumption (\> 2 drinks per day, or \> 8 per week for women, or \> 15 per week for men)
  * Use of marijuana (which can cause dry mouth or other conditions) or recreational drugs
  * Use of tobacco products including chewing tobacco and all types of cigarettes (e-cigarettes)
  * Known allergy to any product ingredient (ingredient list provided by USANA)
Safety and Immunogenicity of Three Commercially Available Influenza Vaccines in Children Aged 6 to <36 Months

This phase IV protocol is designed to evaluate the safety, clinical tolerability and immunogenicity of the 2005-2006 formulation of three widely used conventional influenza vaccines in children aged 6 to 35 months


Eligibility Criteria:
Inclusion Criteria:

* children of 6 months to \<36 months of age, whose parents or legal guardians have given written informed consent prior to study entry

Exclusion Criteria:

* Any severe acute respiratory disease and infections requiring systemic antibiotic or antiviral therapy ongoing or resolved within 30 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable)
* Other serious diseases such as: cancer, autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic or renal disease, surgery planned during the study period.
* Known or suspected impairment/alteration of immune function
* History of hypersensitivity to any component of the study vaccine, egg products or other vaccine component, or impairment/alteration of immune function
Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer

The purpose of the study is to verify non-inferiority of survival time between Isovorin/5-fluorouracil (1-LV/5FU) therapy and TS-1 therapy in patients with inoperable advanced or recurrent gastric cancer. Secondary endpoints include response rates, duration of responses, time to progression (TTP) safety and quality of life (QOL).


Eligibility Criteria:
Inclusion Criteria:

* Gastric cancer diagnosed histologically or cytologically
* Normal organ function of bone marrow, heart, liver and kidney
* Age of 20-77

Other inclusion applies

Exclusion Criteria:

* Serious infection, heart disease, complication or organ disorder
* Ongoing administration of flucytosine
* Pregnant or breastfeeding women

Other exclusion applies
Enhancing Influenza Vaccination in Seniors With TLR (Toll Like Receptor) Agonists

The application of the TLR7/8 (Toll Like Receptor) agonist gel (immune response helper) resiquimod will enhance the immune response to the intradermal influenza vaccine in seniors 65-75 years of age.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent provided by the subject, who can be male or female
* subjects who the investigator believes can and will comply with the requirements of the protocol (i.e. return for follow-up visits, record safety observations and able to converse with study personnel including by personal telephone
* male or female age 65-75 years at visit 1
* in generally good health (stable chronic conditions acceptable), living independently or with minimal assistance (clinical frailty score 1-5) and able to attend clinic appointments
* receipt of influenza vaccination for the 2012-2013 influenza season

Exclusion Criteria:

* receipt of any live vaccine within 4 weeks or inactivated vaccine within one week of visit 1 or planned administration of any non-study vaccines between visits 1 and 2
* systemic hypersensitivity to influenza vaccine, hen's eggs or other vaccine constituent e.g. neomycin sulphate, kanamycin, formalin
* severe reaction to any previous influenza vaccine or vaccine component
* bleeding disorder, including anticoagulant therapy or thrombocytopenia, that contraindicates IM (intramuscular) injection or blood collection (does not include daily low dose ASA (acetylsalicylic acid), Plavix, and certain other mild anticoagulants with minimal bleeding risk)
* incapacity to provide fully informed consent or be attentive to follow-up observations, resulting from cognitive impairment, abuse of alcohol, or drug addiction
* lack of telephone access, inadequate fluency in English, uncertain availability during the 4 week study participation
* immune compromise resulting from disease or immunosuppressive systemic medication use within 3 months of visit 1
* receipt of blood or blood products within 3 months of visit 1
* unstable medical conditions, as indicated by a requirement for hospitalization or a substantial medication change to stabilize said condition within 3 months.
* personal frailty, determined by Clinical Frailty score of 6-7 (moderately frail or severely frail)or failure on the TUG test (Timed Up and Go time greater than 10 seconds) or inability to walk 1/4 mile, based on self report
* history of Guillain-Barre Syndrome
* psoriasis
* recent or current febrile illness with oral temperature greater or equal to 38.0 degrees centigrade or other moderate to severe illness within the previous 48 hours (may vaccinate once condition has resolved)
Wound Architecture and Functional Outcome After Cataract Surgery With Manual vs.Femtosecond Laser Assisted Procedures

This study is the long term analysis of two types of FSL 3-plane corneal wound profiles, namely CT1 and CT2 obtained after a FSL cataract surgery.

Femtosecond laser cataract surgery offers several major advantages for wound construction, including high precision, repeatability and a large variety of corneal wound profiles. The aim of this study is the long term analysis of two types of FSL 3-plane corneal wound profiles, namely CT1 and CT2, CT2 being constructed with a reversed front corneal incision segment to ensure tigher wound closure and better corneal wound reapposition. The traditional manual wound performed with a standard keratome will be used as a reference. As FSL cataract surgery may be associated with a greater incidence of wound leaks at the end of surgery as compared to manual wound construction with keratomes, this study will also aim at determining wich clinical and OCT wound parameters are associated with a higher likelihood of wound leaks.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive cases of cataract surgery performed between January 2015 and june 2015 by a single surgeon (PH) at the clinique d'ophtalmologie Bellevue, using either the Catalys or a manual technique.
* One eye per patient, the first eye
* Uneventful cataract only

Exclusion Criteria:

* Combined glaucoma filtering surgery
* Any previous corneal surgery in this eye
* Any pathology of the interior segment
* Inflammatory eye disease of the interior segment