cyrilzakka/clinical-trials huggingface dataset:
The Effects of a Mobile Health Intervention and Health Coach Text Messaging on Cardiovascular Risk of Older Adults

This study, "Fitness Intensive Therapy (Get FIT) to Promote Healthy Living in Older Adults", will test a mobile-health based intervention which includes use of a Fitbit activity tracker for 3 months, a smartphone application that tracks daily food intake, and one 45 minute counseling session to create personal goals and provide patient education by a health coach; versus Get FIT+ (the same items) plus personalized text messages focusing on participant's activity and nutrition progress as monitored in the app, from the health coach for 3 months. The investigators will measure the impact on participant's diet, physical activity, clinical outcomes, psychosocial well-being, and engagement.

This study, "Fitness Intensive Therapy (Get FIT) to Promote Healthy Living in Older Adults", will test 2 behavioral interventions in community-dwelling older adults (age ≥ 60 years) at intermediate and high risk of cardiovascular disease.

1. Get FIT: use of a Fitbit activity tracker, smartphone application to track daily food intake, one 45 minute counseling session to create personal goals and provide patient education by a health coach; vs.
2. Get FIT+: use of a Fitbit activity tracker, smartphone application to track daily food intake, one 45 minute counseling session to create personal goals and provide patient education by a health coach, and personalized push-only text messages from the health coach based on participant's progress as monitored electronically in the application.

Each intervention lasts 3 months, with outcomes measured at baseline, 3 months, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* aged 60 or greater
* at intermediate (10-20%) or high risk (\>20%) of developing cardiovascular disease (as measured by Framingham Risk Assessment Tool)
* poor eating behaviors (as measured by Block Fruit/Vegetable/Fiber Screener)
* reduced physical activity (as measured by Block Adult Physical Activity Screener)

Exclusion Criteria:

* cognitive impairment (as measured by Mini-Cog) that impairs ability to understand consent process, surveys, or use of mobile health devices
* chronic drug use
* end stage renal, liver, or pulmonary disease
* current active cancer (i.e., undergoing active treatment for cancer)
* gastrointestinal disease which requires a special diet (e.g. Crohn's, celiac, etc).
Willebrand International Non-interventional Global Surveillance

Collect information about WILLFACT or WILFACTIN in their real life clinical use and identify the therapeutic practices in an international environment.

Non-interventional, prospective, non comparative, international, multicentre study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with inherited von Willebrand disease
* Patients treated with WILLFACT or WILFACTIN
* Patient or parent/legal representative who has provided written signed and dated informed consent before any data collection.

Exclusion Criteria:

* Patients who usually do not keep injection log up to date, when treated.
Mindfulness-Based Yoga Intervention for Women With Depression

The purpose of this study was to examine the efficacy of a 12-week mindfulness-based yoga intervention on depressive symptoms and rumination among depressed women.

This study was a prospective, randomized controlled intervention pilot study conducted in a metropolitan city in the upper Midwest of the United States. Forty women who met the criteria for depression based on the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders IV (SCID-I; First, Spitzer, Gibbon, \& Williams, 1997)were randomized to an experimental mindfulness-based yoga condition (n=20) or a walking control condition (n=20). Both programs were home-based motivational sessions delivered over the telephone and lasted 12 weeks. Assessments were conducted at baseline, three months (i.e., post-intervention), one-month follow-up (i.e., one month after the intervention ended). Participants were instructed to continue their usual depression care. The primary dependent variable was depressive symptoms based on the Beck Depression Inventory (BDI). The secondary dependent variable was rumination scores on the Ruminative Responses Scale (RRS). This protocol was approved by the University of Minnesota's Institutional Review Board (IRB). Participants completed informed consent forms sent through the mail; consent to participate in physical activity was also obtained from the participant's healthcare provider. Recruitment for this trial occurred from February, 2013 to January, 2014 and follow-up assessments were completed by May, 2014.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* a personal history of depression (i.e., ever being told by a healthcare provider that they had depression or given an antidepressant for depression)
* able to read and write in the English language
* able to commit to two sessions (yoga or walking) per week for 12 weeks
* demonstrate a willingness to be randomly assigned to either of the study arms
* be yoga naïve, defined as not taking more than four yoga classes in the past two years and not more than one class in the past month.

Exclusion Criteria:

* individuals with a history of bipolar disorder or schizophrenia and/or who had been hospitalized for a psychiatric disorder within six months prior to the eligibility screening
* individuals not providing signed informed consent
* individuals reporting any other health problems that would interfere with regular yoga practice or walking sessions
* individuals who engaged in more than 90 minutes of moderate intensity physical activity per week during the month prior to the eligibility screening.
Paroxetine and Interpersonal Psychotherapy for Maintaining Health and Well-being in Elderly Individuals With Depression

This study will evaluate the effectiveness of paroxetine versus interpersonal psychotherapy and a combination of the two in helping elderly patients with depression remain well and improve quality of their lives.

This is primarily a study of maintenance therapies, not a study of acute therapeutic efficacy, in late-life major depression. The study aims to identify factors that encourage maintenance of treatment gains and to identify which patients need which kinds of treatment to remain well. The following questions are to be addressed:

* Is the probability of recurrence different among the treatment groups?
* What variables may be related to, or predictive of, differences among groups?
* After 1 to 2 years of maintenance therapy, will patients assigned to maintenance combined treatment with both paroxetine and interpersonal psychotherapy remain well at higher rates than patients assigned to paroxetine alone, interpersonal psychotherapy alone, or placebo?
* Will the time to recurrence differ across treatment groups, and what variables may be related to, or predictive of, time to recurrence?

The major study hypothesis is that combined treatment with paroxetine and interpersonal psychotherapy will be superior to either treatment alone (and to placebo) in preventing recurrence of major depressive episodes in patients aged 70 and above.

For information on related studies, please follow these links:

http://clinicaltrials.gov/show/NCT00000377

http://clinicaltrials.gov/show/NCT00177671

Eligibility Criteria:
Inclusion Criteria:

* Age 69 or older
* meets DSM-IV criteria for current unipolar major depression
* HRSD (17 item) score of 15 or higher
* Folstein Mini Mental Status exam score of 18 or higher

Exclusion Criteria:

* Lifetime diagnosis of any psychotic disorder or bipolar disorder
* alcohol or drug abuse within the past six months
* MATTIS Dementia Rating Score of 120 or less
* Contraindication to SSRI therapy
* Hyponatremia
Feasibility and Preliminary Efficacy of a Group-based Telerehabilitation Program in People With Post-COVID-19 Sequelae (TEPCO).

The goal of this study pilot randomized controlled study is to evaluate the feasibility of the study procedures and to compare the preliminary efficacy of a rehabilitation program given in a "remote" (telerehabilitation) or "face-to-face" model for adult patients who had confirmed SARS-CoV-2 infection and still have symptoms after eight weeks of infection. The main question it aims to answer is:

* Are the study procedures feasible?
* Will the two groups have similar results for the preliminary efficacy outcomes?

Researchers will compare group telerehabilitation to a face-to-face group to see if it's comparable.

Participants will:

* Take part in a 60-minute training session, 3 times a week in person or remotely
* Visit the clinic before starting the training program and after 8 weeks of training
* Keep a diary of their symptoms, if any


Eligibility Criteria:
Inclusion Criteria:

* adult patients (≥18 years)
* confirmed SARS-CoV-2 infection defined by positive polymerase chain reaction (PCR) testing and/or antigen test results
* referred to the pneumology clinic for a modified British Medical Research Council (mMRC) dyspnea score of 2-3 after a minimum of eight weeks of infection
* VO₂max of less than 80% of the predicted value
* receiving a medical prescription for rehabilitation following initial assessment by a pulmonologist
* being able to walk independently
* providing informed consent
* having a good internet connection (i.e., a minimum download speed of 4 Mbps and an upload speed of 4 Mbps)
* being in possession of a computer or tablet equipped with a camera enabling videoconferencing.

Exclusion Criteria:

* requiring in-hospital rehabilitation at discharge
* evidence of medical instability (i.e., moderate or severe cardiac disease, ischemic or severe hemorrhagic stroke, or neurodegenerative disease, unstable fracture)
* history of severe cognitive or mental impairment
* already enrolled in another rehabilitation program
The Effect of Relaxation Response on Provider Burnout

Hypothesis: Relaxation Response training is an effective intervention in reducing the prevalence and severity of burnout and its components from baseline levels among physicians receiving the training intervention. The intervention is hypothesized to moderate the relationship between Areas of Worklife (AWS) and burnout by improving physician's ability to cope with the demands of their workplace. This increased coping ability is hypothesized to reduce burnout.

Physician practices are as unique as the individual practitioners and the environment in which they practice. Traditional instruction of relaxation or self-care techniques has required participants to travel to locations remote from the workplace. The time commitment required for this behavior is additive to the time required to learn the intervention and of itself may induce extra stress increasing the potential for burnout. This study proposes that bringing the intervention to the workplace will increase provider willingness to participate and diminish the stress introduced by deployment of the intervention. Since inpatient and outpatient medicine have different practice characteristics and demands on the time of the practitioners, this study will need to develop and test the logistics necessary to bring the training to the different physician populations.


Eligibility Criteria:
Inclusion Criteria:

* Providers at designated clinic and hospital

Exclusion Criteria:

-
Efficacy of an Early Rhythmic Intervention in Infancy

The present project develops from a wide research line aiming at identifying very early electrophysiological risk markers for neurodevelopmental disorders. Long-term goals of the study include the characterization of language/learning developmental trajectories in children at high risk for language disorders and the implementation of ecological interventions based on enriched auditory experience to be employed to these children in an attempt to modify their atypical developmental trajectory before the emergence and crystallization of any behavioural symptoms and within the early period of known maximum cerebral plasticity.

Specifically, the main aim of this study is the development and implementation of an innovative and ecological early intervention based on environmental auditory enrichment (labelled "rhythmic intervention"). This intervention is tested both on a sample of typically developing infants and on a sample of infants at high familial risk for language disorders during a time span between 7 and 9 months of age. The efficacy of the intervention is tested on the electrophysiological markers tested before and after the intervention activities and on the linguistic outcomes within a longitudinal approach. The efficacy of such an intervention is compared to the spontaneous development observed in comparable groups of infants with and without familial risk for language disorders. In addition, only in a group of typically developing infants, a control intervention providing passive exposure to the same auditory stimulation is tested, in order to verify the specific contribution of the active participation of the children to the intervention.

The investigators hypothesize that the rhythmic intervention may modify the electrophysiological markers underlying auditory processing and the linguistic skills of all children, with a larger increase in infants at familial risk for language disorders who are specifically impaired in such skills.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants aged between 6 and 9 months
* Infants with and without familial risk for language disorders (Infants are assigned to the group with familial risk for language disorders if at least one first-degree relative had a certified (clinical) diagnosis of language and/or learning disorders.
* Both parents are native-Italian speakers

Exclusion Criteria:

* Gestational age \< 37 weeks and/or birth-weight \< 2500 grams
* APGAR scores at birth at 1' and 5' \< 7
* Bayley Cognitive Score \< 7
* Presence of certified diagnosis of intellectual deficiency, attention-deficit disorder, sensorial and neurological disorders or autism within first-degree relatives.
Potatoes, Hypertension RIsk and Endothelial Function Study

White potatoes have recently been allowed back in the cash value voucher of the government food stamp program after it was stated that there were no known adverse health effects of potatoes. However, the association of potatoes with heart health, especially elevated blood pressure is not known. This study will examine the effects of potatoes on blood pressure in different populations of adults and children, and assess, in a feeding trial, the effects of an additional serving of potatoes per day on the possible mechanisms that link potatoes to high blood pressure. The investigators will also analyze the intake of potatoes in participants of the government food stamp program.

Potatoes are one of the most consumed vegetables in the US and the world. In recent years, several changes have been made to government sponsored food programs with respect to potatoes, such as lifting the restriction on the number of servings of starchy vegetables (including potatoes) established by the Healthy Hunger-Free Act, and re-allowing white potatoes in the cash-value voucher for fruits and vegetables of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), after the Institute of Medicine asserted that there was insufficient evidence that white potatoes had adverse health effects. However, the investigators recently reported an increased incidence of hypertension with increasing potato consumption in three large prospective US cohort studies after adjusting for sodium intake and other potential confounders. The investigators also analyzed the association of short-term potato intake from a 24-hr dietary recall with endothelial-dependent vasodilation measured by brachial artery ultrasonography in the Modifiable Effectors of Renin System Activation Treatment Evaluation (MODERATE) trial. Participants who consumed one or more than one serving of boiled, baked or mashed potatoes during the previous day had a 1.7% lower endothelial-dependent vasodilation when compared with participants with no potato intake (p-value= 0.01) after adjusting for other factors. This is a relevant difference in endothelial function - by comparison, every 10 year increase in age was associated with a 1.2% lower endothelial function. Therefore, the investigators plan to analyze the effect of one serving of boiled, baked or mashed potato per day on endothelial function in a crossover feeding trial of healthy adult men and women.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years of age
* without known cardiovascular risk factor

Exclusion Criteria:

* History of hypertension, diabetes or cardiovascular disease
Sevoflurane in Chronic Obstructive Pulmonary Disease Exacerbation

Prospective, open-label, single-center, study to investigate the effect of sevoflurane sedation compared to a propofol-controlled arm during COPD exacerbation requiring invasive mechanical ventilation in ICU.

Primary outcome measure:

Evolution of airway resistance before and after sevoflurane in COPD patients,

Secondary outcomes measures:

Respiratory mechanics (Maximum pressure, PEEPi and PEEPtot, trapped volume), Gas exchange by the help of blood gases, The heterogeneity of alveolar ventilation by electro-impedancemetry, Evolution of pulmonary inflammation, Trophicity and contractility of the diaphragm,


Eligibility Criteria:
Inclusion Criteria :

* COPD exacerbation
* Invasive mechanical ventilation and sedation for a planned duration of at least 24 hours
* Consent
* Age ≥ 18 years
* Affiliation or beneficiary of a social security scheme

Exclusion Criteria :

* Contraindication to the administration of sevoflurane (personal or family history of malignant hyperthermia, allergy or halogenated anesthetic accident, chronic myopathy, halogenated toxic hepatitis, uncontrolled intracranial hypertension, unexplained leukocytosis after anesthesia with a halogenated agent)
* Contraindication to the administration of propofol (known hypersensitivity to propofol, soy, peanut or any of the excipients of the emulsion, antecedent of Propofol Related Infusion Syndrome)
* Refusal of consent
* Guardianship
* Age \< 18 years
* Pregnant or lactating woman
Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis

The overall goal of this study is to develop regenerative cell therapy for use in patients with osteoarthritis (OA). The primary objective of this proposal is to conduct a pilot study that assesses the safety and feasibility of using concentrated bone marrow aspirate containing MSC to treat patients with painful knee OA.

Patients with symptomatic mild to moderate bilateral knee osteoarthritis will be candidates for this pilot study. Baseline data includes radiographs, MRI imaging, clinical data on knee pain and analysis of synovial fluid inflammatory markers. Bone marrow will be aspirated from the patient's iliac crests and the cellular rich portion will be concentrated. Randomly, one knee will be injected with the bone marrow concentrate. The contralateral knee will be injected with only sterile saline for placebo. Follow-up analysis of synovial fluid will be at one week and 6 months after injection; clinical data will be obtained at 3, 6 and 12 months and MRI imaging will be performed at 6 months after injection, with repeat radiographs at 12 months

Eligibility Criteria:
Inclusion Criteria:

1. Male and Female subjects are both eligible
2. Subjects must be 18 years of age or older
3. Subjects must have bilateral OA and pain in both knees.
4. Osteoarthritis may be primary or secondary. Knees must have Kellgren-Lawrence Grades 1-3.
5. Subjects must have previously tried 6 weeks of one of the following conservative treatments Activity modification, weight loss; physical therapy, anti-inflammatory or injection therapy
6. Patients can provide written informed consent after the nature of the study is fully explained

Exclusion Criteria:

1. Patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory results.
2. Patients taking anti-inflammatory medications (prescription or over-the-counter), including herbal therapies, within 14 days of baseline visit.
3. Patients taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within the 3 months prior to study entry.
4. Patients receiving injections to the treated knee within 2 months prior to study entry.
5. Patients who are pregnant or currently breast-feeding children.
6. Patients with systemic, rheumatic or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis.
7. Patients with ongoing infectious disease, including HIV and hepatitis
8. Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or diabetes
9. Patients participating in a study of an experimental drug or medical device within 30 days of study entry.
Dynamic Laryngotracheal Separation for Aspiration

People who aspirate after neurologic insults such as stroke often develop fatal pneumonia. This study examines the effects of dynamic vocal cord closure on swallowing. Implants placed over the chest wall are connected to electrodes placed around the nerve that closes the vocal cords. The patient triggers closure by flipping the switch of a coil taped over the skin covering the internal stimulator. Vocal cord motion is verified by videotaping through an endoscope, and the status of swallowing is documented radiologically by a modified barium swallow.

Data pending

Eligibility Criteria:
Inclusion Criteria:

* Aspiration pneumonia after neurological insults (e.g. stroke)
* Ability to understand the purpose of the research
* Appropriate hand motor control
* Inability to improve under standard treatments (speech-language pathologists)
* Acceptance of a tracheostomy

Exclusion Criteria:

* Lack of understanding the research
* Poor hand motor coordination
* Uncontrolled seizures
* Pregnancy
* Refusal to accept a tracheostomy
Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant or Definitive Chemoradiation in Patients With Esophageal Cancer

Prospective observational study to evaluate the Quality of life based on standardized EORTC questionaires as well as toxicities, functional and oncological outcomes in patients treated with neoadjuvant or definitive chemoradiation for esophageal Cancer.

Prospective observational study to evaluate the Quality of life based in patients treated with neoadjuvant or definitive chemoradiation for esophageal Cancer. QoL will be evaluated by standardized EORTC questionaires. Acute and late toxicity will be assessed according to CTCAE 4.03. Outcome measures will include local Control, distant Control, freedom from Treatment failure and overall survival. Correlations are planned between Patient- and physician-assessed functional Outcome.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven esophageal Cancer (SCC or adenocarcinoma) without distant metastases (except supraclavicular nodes)
* indication for neoadjuvant or definitive chemoradiation using either cisplatin/5-FU or carboplatin/paclitaxel with curative intent
* age \>= 18 years
* written informed consent
* ability to answer the standardized questionaires according to the treating physician

Exclusion Criteria:

* age \< 18 years
* Treatment with palliative intent
* distant metastases (except supraclavicular nodes)
* second malignancy
* Prior systemic treatment for esophageal Cancer
* Treatment in an interventional study