cyrilzakka/clinical-trials huggingface dataset:
Safety Study of TAK-593 Given Orally in Subjects With Nonhematologic Advanced Cancer

The purpose of this study is to determine the safety and toxicity profile of TAK-593 and determine the maximum tolerated dose of TAK-593.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age diagnosed with advanced solid tumor cancer that failed to respond to standard therapies and where no other treatment options are available.
* No prior chemotherapy
* Able to understand and follow study requirements
* Subject or subject's legal representative signs a written, informed consent form prior to beginning any study procedures.
* Women who are post-menopausal for at least 1 year before screening or surgically sterile
* Women of childbearing potential agree to practice two effective methods of birth control from the time of signing the informed consent form through 30 days after the last dose of the study drug or agree to completely abstain from heterosexual intercourse.
* Men who agree to practice an effective method of birth control for the entire study treatment period and through 30 days after the last dose of study drug or completely agree to abstain from heterosexual intercourse.
* Ability to swallow and retain oral medication
* Meet study specific laboratory test standards for bone marrow function, liver function, blood pressure, and renal function.

Exclusion Criteria:

* Cancer has spread to the brain
* History of another cancer diagnosed or treated within the past 3 years.
* Severe cardiovascular issues including heart attack within the past 6 months, unstable angina or arrhythmias that require treatments.
* Severe thyroid disease
* Unstable angina
* Arrhythmia issues
* History of bleeding issues
* Serious wounds, ulcers or bone fractures that do not heal
* Subject is pregnant or breast feeding
* Subject has illnesses or conditions that may affect their ability to participate in the study
* Subject participated in another clinical study/post marketing clinical study within 4 weeks prior to the start of this trial.
Effect of a Dual-task Intervention Program on Physical and Cognitive Function

Aim: to compare the effects of single-task (ST) and dual-task (DT) training on physical and cognitive function in institutionalized older adults in 1 month.

Methods: Participants were assigned randomly into two groups, ST (multicomponent physical exercise) and DT training (multicomponent physical exercise + cognitive tasks). Both groups performed the exercise three times per week for 1 month. Short Physical Performance Battery (SPPB), handgrip strength, Barthel Index and Montreal Cognitive Assessment (MoCA) were used to assess physical and cognitive performance, respectively. Variables were measured at the beginning (V1),at the end of the exercise (V2), as well as one month later (V3). Paired Student's t-test and lineal logistic regressions models were used to explore the effect of the exercise interventions.


Eligibility Criteria:
Inclusion Criteria:

* Institutionalized older people between 65 and 75
* mild to moderate cognitive impairment

Exclusion Criteria:

* Acute or chronic pathologies that prevent exercise
Epimedium Prenylflavonoid (EP) Extract for Osteoporosis and Cardiovascular Disease

The primary objective of the trial is to develop Epimedium Prenylflavonoid (EP) extract as a pharmaceutical-quality intervention for post-menopausal osteoporosis and cardiovascular disease. There will be 3 cohorts of 10 healthy men each for the Phase 1 study. In each cohort, 8 men will receive the Epimedium capsules and 2 men will received the matched controls.

Prenylflavonoids and its glycoside derivatives isolated from the Traditional Chinese Medicine (TCM), Epimedium, have potent estrogenic properties. The principal bioactive compounds in Epimedium are the prenylflavonoids, icaritin, and their glycosylated derivatives which can enhance osteoblastic differentiation and mineralization, inhibits bone resorption, and induces apoptosis of osteoclasts. Animal experiments indicate that icariin can prevent bone loss induced by ovariectomized (OVX) in rats, through its stimulatory effects on osteoblast growth and function, and inhibitory action on osteoclast cells.

Epimedium has also demonstrated significant cardiovascular benefits with positive actions on vascular reactivity, endothelial function and thrombosis in human subjects. Notably, icariin, demonstrated a significant nitric oxide (NO)-dependent vasorelaxation of precontracted coronary arterial rings with intact endothelium in a concentration-dependent manner, via the activation of endothelial nitric oxide synthase protein and NO-cyclic guanidine monophosphate (cGMP) pathway. Epimedium prenylflavonoids (EP) can prevent steroid-associated osteonecrosis in rabbit model and notably, reduce thrombosis incidence and shrink fat-cell-size significantly. This striking combination of properties highlights the immense potential in EP for osteoporosis and cardiovascular health.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men.

Exclusion Criteria:

* Hepatitis B patients
Impact of Ceftriaxone and/or Fluoroquinolone (FQ) Treatment on the Gut Microbiota of Hospitalized Patients.

Observational study of the effects of antibiotics on commensal flora. Realization of stool samples and nasal swabs before and after antibiotic therapy.

The emergence of resistance to fluoroquinolone (FQ) and is a major problem worldwide. The commensal flora is the main reservoir for antibiotic resistance. Understanding the factors (environmental, patient-related, dosis-related, drug-related...) involved in the emergence of resistance to fluoroquinolones in the commensal flora of patients treated with a FQ, may help prevent it and preserve the efficiency of these important antibiotics. Samples of digestive flora will be collected from hospitalized patients before receiving a FQ or Ceftriaxone, at the end of the treatment and 3 month after the end of treatment. Clinical data will be collected.

Eligibility Criteria:
Inclusion criteria for the patients treated with antibiotics

* Adult patient hospitalized in a participating ward of the hospital for an expected duration of more than 24 hours.
* Treatment by ceftriaxone and / or a fluoroquinolone started by the attending physicians during hospitalization.
* No hospitalization or stay in nursing home in the previous three months.
* No use of antibiotics in the last 3 months
* Not receiving other antibiotics than ceftriaxone or FQ
* Informed consent

Inclusion criteria for the patients in the reference group

* Adult patient hospitalized in a participating ward of the hospital for an expected duration of more than 24 hours.
* Not receiving any antibiotic and not expected to receive any during hospitalization
* No hospitalization or stay in nursing home in the previous three months.
* No use of antibiotics in the last 3 months
* Informed consent

Exclusion criteria

* Pregnant or nursing women
* Patient who underwent colectomy or suffering from chronic intestinal disease (inflammatory intestinal disease or short bowel syndrome)
* Patient who used a bowel preparation solution for colonoscopy during hospitalization or in the previous week.
* Protected adult patient (deputyship or guardianship)
Effectiveness of Telerehabilitation Program in Subacromial Syndrome (Telerehab Sis)

Shoulder pain is a common and high prevalence in the general population. Subacromial Syndrome (Shoulder Impingement Syndrome (SIS)) is the most frequent cause. SIS patients suffering pain, muscle weakness and loss of movement in the affected joint. Initial treatment of the SIS is predominantly conservative. Surgical option has high success rates and is often used when conservative strategy fails. Traditional Physiotherapy and Postoperative exercises is needed to the recovery of joint range, muscle strength, stability and functionality. This Research evaluates the feasibility and effectiveness of a telerehabilitatión Program in SIS after surgery compared with traditional therapy.

In addition to traditional physiotherapy, Telerehabilitation programs have proven their effectiveness, validity, noninferiority and important advantages in various neurological, cognitive diseases and musculoskeletal disorders; meaning an opportunity to define new social and intervention policies.

Subjects are randomly assigned to 1) Telerehabilitation Group 2) Traditional Therapy Group. After randomization, patients in both groups received an initial evaluation. Data will be collected by a blinded evaluator.

The Telerehabilitation group receives a standardized and customized exercises to perform, through a web application that allows the Physiotherapist generate videos, images and parameters of each exercise program and send them via email for each patient.

Telerehabilitation program describes the exercises to be performed, the number of repetitions depending on the level of training and criteria for progression.

Patients are initially supervised by a physiotherapist who will conduct three training sessions through individual videoconference, to ensure proper execution of exercises and encourage patient adherence. Patients are instructed to perform self-workout video exercises following Telerehabilitation program as well as a supporting document we call Telerehabilitation Manual Patient.

Traditional group receives assistance in a physiotherapy center through the usual procedure of rehabilitation in Spain, personalized therapy consisting of 1 to 1 with a physical therapist and exercise programs at home.

Eligibility Criteria:
Inclusion Criteria:

* Adult between 18 and 65 years
* Subacromial Syndrome Diagnosis ICD-9 CM 726.10, 726.12, 726.19 issued by specialist in Orthopaedic Surgery and Rehabilitation Specialist
* Receive Surgical Procedure (arthroscopy or open approach (subacromial decompression with partial acromioplasty, with or without coracoacromial release) and prescription of rehabilitation process.
* He lives in Spain during the investigation period
* Provides in home computer with internet technology (personal computer, laptop, tablet or Smartphone)
* Skills and knowledge to access email

Exclusion Criteria:

* Previously Surgery intervention in same shoulder.
* Patients receiving non-surgical procedure based on the recommendations for Subacromial Syndrome
* Unfit cognitive ability to use technological tools
Health Benefits of Functional Oil (Mega 3 Fatty Acids From Fish Oil) on Obese People

Examine the effects and safety of functional oil (olive oil with omega 3 fatty acids from fish oil) on different inflammatory markers in obese subjects with dietary intervention for weight lost.


Eligibility Criteria:
Inclusion Criteria:

* Men and women from 30 to 75 years old.
* Body mass index (BMI) ≥ 30 kg/m2
* Signed informed consent.

Exclusion Criteria:

* Individuals with special diet due to disease as celiac disease, chronic renal failure, etc.
* Individuals with Diabetes Mellitus insulin dependent.
* Individuals with disorders associated with eating behaviour.
* Individuals with mental disease or low cognitive function.
* Individuals with consumption of drugs to weight lost.
* Individuals treated with drugs whose direct effect is on lipid profile (statins, fibrates, diuretics, corticosteroids or oral anti-inflammatory).
* Individuals with diseases that could be involucrate in weight lost (not controlled hypothyroidism, serious psychiatric illness, etc.)
* Pregnant women or lactating.
* Individuals with recurrent infections.
* Individuals with regular consumption of anti-inflammatory or glucocorticoids.
* Individuals with consumption of oil fish supplements (except if they gave up its consumption 1 month before).
* Individuals with fish allergy.
* Individuals with consumption of more than two fatty fish servers twice a week.
* Individuals with physical problems complying with the recommendations of physical activity and diet indicated.
Spanish Mixed HEXA/PENTA/HEXA Schedule (V419-010)

To evaluate the immune response and the safety of a primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age

Primary objectives

* To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B (HB) one month after completion of the mixed schedule
* To demonstrate that the mixed schedule induces acceptable responses for Haemophilus influenzae type b (Hib) one month after completion of the mixed schedule

Secondary objectives

* To describe the antibody response to all PR5I antigens one month after completion of the mixed schedule
* To describe the antibody response to meningococcal serogroup C (MCC) conjugate vaccine one month after the second dose of MenC vaccine
* To describe the safety profile after each dose of study vaccines administered


Eligibility Criteria:
Inclusion Criteria:

* Healthy infant 46 to 74 days (both inclusive)
* Documented receipt of only one dose of monovalent hepatitis B vaccine within the 3 days after birth
* Parent(s)/legal representative able to comply with the study procedures

Exclusion Criteria:

* Participation in any study with an investigational compound or device since birth
* History of congenital or acquired immunodeficiency
* Chronic illness that could interfere with study conduct or completion
* Hypersensitivity to any of the study vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines
* Contraindication to Pediacel®, NeisVac-C®, Prevenar 13®, and RotaTeq®
* History or maternal history of HBsAg seropositivity
* Coagulation disorder that contraindicate intramuscular injection
* History of vaccination with a Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acelullar or whole-cell), poliovirus, meningococcal serogroup C conjugate, pneumococcal conjugate containing vaccine(s)
* History of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, or serogroup C meningococcal infection
* Receipt of immune globulin, blood or blood-derived products since birth
* Receipt of systemic corticosteroids for more than 14 consecutive days within one month of the study start
* Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
Non-Pharmacological Methods for Reducing Pain During Vaccination in Infants

Pain management in infants is a medical responsibility of all members of the healthcare team, and nurses hold a privileged role in this regard. The primary goal of pain management is to accurately assess and identify the infant's pain at an early stage, support the development of coping mechanisms through both pharmacological and non-pharmacological methods, and minimize the pain experience as much as possible. Pain management achieved through non-pharmacological interventions constitutes a safe, non-invasive, cost-effective, and independently performed nursing practice. This randomized controlled study was conducted to determine the effect of non-pharmacological methods, specifically maternal holding and breastfeeding, on reducing pain during vaccination in infants.


Eligibility Criteria:
Inclusion Criteria:

* Being healthy,
* Aged between 4 weeks and 6 months,
* Parents have given verbal and written consent to participate in the study,
* Born at term (37 weeks of gestation or later),
* Scheduled for vaccination under the Ministry of Health's vaccination program,
* Not having taken analgesics/antipyretics in the last 4 hours before the procedure,
* Having a normal body temperature (between 36.5°C and 37.1°C).

Exclusion Criteria:

* Having a chronic or mental illness, or a congenital anomaly,
* Being older than 6 months,
* Having a body temperature above 37.1°C,
* Receiving analgesics, sedatives, or any other medication.
Effectiveness of Acceptance and Commitment Therapy Self-Help for Carers of People With Multiple Sclerosis

This is a feasibility study to evaluate whether it is possible to conduct a larger study to evaluate whether providing psychological support to carers of people with MS is effective in reducing carer strain. Whilst not all carers experience distress as a result of their caring duties, some do. This study is testing the use of Acceptance and Commitment Therapy (ACT) in a self-help format. Participants will learn about and use ACT by reading a book provided to them by the study. One group will receive the ACT book, another will receive the same book alongside weekly telephone support to use the book, and a third group will act as a control group and therefore will not have extra support. Participants are allocated to the groups based on chance (a computer will decide group allocation). Participants will complete questionnaires before group allocation, and then again 3 months after they were allocated to a group, and one final time 6 months after group allocation. Those who receive the self-help book will get sent chapters each week for 8 weeks. The groups will be compared on scores from the questionnaires and complete feedback interviews with a subgroup of those who receive the book, to gain feedback about their experiences of the study.


Eligibility Criteria:
Inclusion Criteria:

* primary carer for a person with MS,
* English speaking (intervention and assessments are in English),
* able to give informed consent.
* score at least 21 on the Zarit Burden Interview (demonstrating a minimum of mild distress)

Exclusion Criteria:

* diagnosis of MS themselves
* psychiatric diagnosis
* inability to commit to the intervention
Feasibility of an Individualized Goals of Care Discussion Guide for Advanced Breast Cancer

This research study is evaluating whether asking patients to fill out a brief survey about their goals and preferences for care and giving this survey to their clinician before the next visit helps improve communication and decision-making in breast cancer care.

The purpose of this study is to understand patient preferences for communication and decision-making for advanced breast cancer. The investigators want to better understand what topics the participant wants their doctors and nurses to address with the participant in clinic, and the investigators want to evaluate whether asking patients to fill out a brief survey about their goals and preferences for care and giving this survey to their clinician before the next visit is a good idea that helps to improve communication and decision-making in breast cancer care.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Diagnosed with stage IV breast cancer within the past 3 years
* Receiving care at the MGH Cancer Center
* Verbal and written fluency in English
* Within 6 weeks of a new line of breast cancer therapy and/or progression on scans and/or a change in current breast cancer therapy regimen

Exclusion Criteria:

* Unwilling or unable to participate in the study
* Is medically or otherwise unable to participate (as determined by a physician or study PI)
* Enrolled in hospice
Cancer End Of Life Evaluation

The aim of this study is to culturally adapt and to validate Quality Of Life tools dedicated to the end of life for French cancer patients.

French clinical research in palliative care is confronted with a lack of tools allowing to estimate in a standardized way a patient related outcome. Scales used today are not specifically adapted to quality of life (QoL) at the end of life patient evaluation. So all the relative dimensions to this disease stage are not estimated. What establishes a brake in the improvement of a quality support.

The dimensions of pain, psychological distress, fatigue, decrease of the autonomy are essential points estimated in "classic" questionnaires and frequently used at the palliative disease stage. However the end of life also recovers the domains of the spirituality, oneself's completion, relationship. These elements are essential to dread better QoL at end of life, but are not or do not little approach on the French questionnaires.

The Missoula-Vitas Quality Of Life Index is a questionnaire developed by Byock, Merriman and Kinzbrunner and specifically designed for palliative situations \[I. Byock, 1998\]. This QoL tool provides an exhaustive assessment of important dimensions in this setting. The short version is composed of 15 items and asks patients to evaluate 5 dimensions: symptoms, function, interpersonal relationships, well-being and transcendence \[I. Byock, 1998\].

Another tool, the QUAL-E, is longer with 25 items concerning 5 domains: life completion, relations with the health care system, preparation for end of life, symptom severity and affective social support \[KE. Steinhauser, 2002\]. However, these QoL tools have not been translated and adapted to French. Another concern is that the lack of specificity for cancer patients.

The first step to improve evaluation of how French patients feel about this phase of their disease is to translate these specific end of life QoL tools. Assessing QoL at the end of life with dedicated tools could help to compare therapeutic strategies and could result in improvements in palliative care.

Eligibility Criteria:
Inclusion Criteria:

* Palliative advanced cancer patient (Palliative chemotherapy, analgesic radiotherapy, surgery of comfort accepted).
* All cancer locations and cancer type
* Patient having the knowledge of their palliative disease stage.
* Patient follow-up at least once a month by a palliative caregiver.
* Age \> or = 18 years.
* Dated and signed consent.
* PS \> or = 2
* Life expectation \> or = 1 month.

Exclusion Criteria:

* Psychiatric Disease or cognitive disorders disrupting the trial understanding and the enlightened and voluntary consent character.
* Patient who can not submit itself to the formal follow-up for psychological, social, family or geographical reasons
Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases

Randomized phase II trial. The study aims to investigate a different and potentially safer radio therapeutic treatment method for brain metastases. The current standard of stereotactic radiotherapy (SRT) in one or three fractions is compared to fractionated stereotactic radiotherapy (fSRT) in five fractions.

Randomized phase II trial. Stereotactic radiotherapy is one of the most frequently chosen treatment options for brain metastases. There are an increasing number of long term survivors. Brain necrosis (e.g. radio necrosis) is the most important long term side effect of the treatment, occurring in up to 40% of patients, dependent on the size of the metastasis and delivered radiotherapy dose. Retrospective studies have shown that the incidence of radio necrosis, as well as local tumor recurrence, can be decreased with a risk difference of around 20% by administrating fractionated stereotactic radiotherapy (fSRT, e.g. five fractions) over single fraction stereotactic radiotherapy, especially in large brain metastases. In this trial, one group is treated with SRT in one or three fractions. The other group is treated with fSRT in five fractions. Survival, toxicity and patient reported quality of life are monitored.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* At least one brain metastasis of large cell cancer suitable for SRT
* Karnofsky Performance Status ≥ 70
* Ability to provide written informed consent
* New brain metastases during follow-up after surgery allowed (when outside of resection cavity area)
* New brain metastases during follow-up after previous SRT allowed (when outside of previous irradiation field)

Exclusion Criteria:

* Contra-indication for MRI scan
* Primary tumor of small cell lung cancer, germinoma or lymphoma
* Prior whole brain radiotherapy or SRT on the current target brain metastases (in field re-irradiation)
* Presence of leptomeningeal metastases
* Previous inclusion in the SAFESTEREO study