cyrilzakka/clinical-trials huggingface dataset:
The Impact of Social Media-delivered Chemotherapy Side Effects Education for Breast Cancer Patients Receiving Chemotherapy

The goal of this clinical trial is to learn if a standardized pharmacists-provided education module by social media can improve patients' knowledge of chemotherapy-related side effects. The main questions it aims to answer is:

• Do patients who received a standardized pharmacists-provided education module by social media improve their knowledge of chemotherapy-related side effects? Researchers will compare standardized chemotherapy education +video (experimental group) versus chemotherapy handouts (control group).

Participants will:

* Received standardized chemotherapy education + video or chemotherapy handouts at the first and second chemotherapy section.
* Fill out a questionnaire for outcomes assessment.

The pharmacist-provided video education model for patients undergoing first time chemotherapy was developed. The content of the education video included the mechanism of side effects, its recognition, preventive measures, non-medical management, and further instructions when to visit hospital were included.

Patients were randomly assigned into two groups with different education strategies:

Standardized chemotherapy education +video (experimental group) versus chemotherapy handouts (control group). Every patient was asked to fill out a questionnaire prior to the implementation of the education model in both groups. The pre-test questionnaires consisted of baseline knowledge and personal information. Patients in the experimental group would receive standardized chemotherapy education by pharmacists, including chemotherapy regimen, the purpose of chemotherapy, the number of cycles, duration of chemotherapy and the common side effects of chemotherapy on the first day of chemotherapy cycle. Videos will be provided with patients and they will watch videos during the visit. The information regarding the prevention and management of side effects and further instructions when to visit hospital. Patients will have access to videos and watch videos after leaving the hospital for the entire treatment course. The education time will be last around 15 to 20 minutes. In terms of control group, pharmacists will briefly explain and provide chemotherapy handouts, including chemotherapy regimen, the purpose of chemotherapy, the number of cycles, duration of chemotherapy and the common side effects of chemotherapy. The duration of visit will be around 5 to 10 minutes. After the education section, patients will be asked to do a post-test questionnaire of their knowledge and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients aged 18 or older undergoing their first chemotherapy.
* Possess a smartphone and are able to watch videos on it.

Exclusion Criteria:

* Unable to read or complete questionnaires in Chinese.
* Cognitive impairments.
* Pregnant women.
Prognostic Biomarker for CRC

The purpose of this clinical research project is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in colorectal cancer.

This is a prospective observational study. Tumor tissue specimens and surgical specimens are obtained from the Sixth Affiliated Hospital, Sun Yat-sen University. The samples are analyzed for biomarkers. The biomarkers are correlated with clinical outcomes (failure-free survival, overall survival, tumor response to treatment (e.g. tumor regression grade for rectal cancer), distant metastasis, recurrence and death).

The aim of the analysis is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in . This will lead to the definition of risk groups and stratification of patients and will help to precision medicine of colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Colon or rectal cancer diagnosed by endoscopic biopsy histopathology;
2. Complete sample information, including sample number, gender, age and clinical molecular diagnostic information, etc.;
3. Sufficient surgical tissue samples are available for testing;
4. untreated colon or rectal cancer patients;
5. Patient able to understand and sign written informed consent
6. No evidence of distant metastasis (M0)

Exclusion Criteria:

1. Previously treated CRC, including cytotoxic drug therapy, targeted drug therapy, etc.;
2. Other malignant tumors;
3. Pregnant women;
4. Hereditary colorectal cancer linked to familial colonic polyposis or Lynch syndrome
Postoperative Analgesic Effect of Esketamine

The aim of this study was to determine whether the addition of esketamine to morphine would improve postoperative analgesia after caesarean section.

Parturients who planned for a caesarean delivery using combined spinal-epidural anaesthesia with a request for postoperative anaesthesia were randomly divided into four groups (A, B, C and D). When the surgery was completed, the parturients in groups A, B, C and D were administered 2 mg morphine, 0.25mg/kg of esketamine, 0.25mg/kg of esketamine plus 2 mg morphine sulfate and 0.25mg/kg of esketamine plus 1 mg morphine through the epidural catheters, respectively. The postoperative pain at rest, pain with movement, the number of rescue analgesics and adverse effects were evaluated for 48 h after caesarean delivery.


Eligibility Criteria:
Inclusion Criteria:

* nulliparous parturients who scheduled for elective caesarean delivery under spinal-epidural anaesthesia;
* parturients who had requested postoperative analgesia;
* parturients aged between 20-35 years old;
* parturients who had a full-term pregnancy;
* parturients who were identified as having a singleton pregnancy; and
* parturients who were categorised as having an American Society of Anaesthesiologists (ASA) physical status

Exclusion Criteria:

* parturients with severe internal, surgical or obstetric comorbidities (including spinal deformities, hypertension, placental abruption, cholestasis in pregnancy, asthma, heart disease and abnormal coagulation parameters)
* parturients with a known allergy to the drugs used in this study
* parturients with severe mental illness who could not comply with doctors' instructions
* parturients with chronic pain syndrome, which is defined as pain that persists for a period longer than 3 months
A Trial of Sertraline in Young Children With Autism Spectrum Disorder

This study is a control trial of sertraline (Zoloft) in children aged 2 to 5 years old inclusive with Autism Spectrum Disorder. The trial is six months long, and each participant will receive a series of tests at both the beginning and end of the study. The researchers hope to show improvements in language and social deficits.

This is a single center study and the UC Davis MIND Institute for Autism Spectrum Disorder (ASD) patients aged between 2 years and 5 years old inclusive funded by the Health Resources and Services Administration (HRSA). It is a double-blind control trial of sertraline (Zoloft), an anti-depressant typically used in the treatment of depression, obsessive-compulsive disorder, panic disorder, and other conditions. The researchers are investigating the use of this selective serotonin reuptake inhibitor (SSRI) in ASD because a retrospective study has shown significant improvements in language and social deficits. There is also emerging evidence regarding the stimulation of brain-derived neurotrophic factor (BDNF) and the stimulation of neurogenesis when an SSRI is given early on in the development of animal models of Down syndrome. The researchers hope to see improvements in language stimulation, social gaze and social reciprocity, spatial attention, and a decrease in autistic behaviors.

The aim of this study is to carry out a double-blind placebo controlled trial of sertraline in children with ASD who are between the ages of 2 years and 5 years old inclusive. At baseline, the researchers will assess behavioral and cognitive development. Each participant will be involved in this trial for a period of six months. This will include three visits to the UC Davis MIND Institute and eight phone calls. The researchers will also assess the side effects of the sertraline treatment throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Documentation of Autism Spectrum Disorder with Diagnostic and Statistical Manual for Mental Disorders-Fifth edition, criteria as well as a standardized autism assessment such as the Autism Diagnostic Observation Schedule or the Autism Diagnostic Interview-Revised.
* Subject between the ages of 24-72 months of age.
* A reliable parent or caregiver who can report the side effects and communicate effectively with the research team.
* Stable medications during the two months prior to enrollment.
* Currently receiving interventions in the community or school for Autism Spectrum Disorder

Exclusion Criteria:

* Current or past Selective Serotonin Reuptake Inhibitor treatment.
* Other serious co-morbid medical disorders affecting brain function and behavior, including uncontrolled seizures.
Comparison of Biphasic Insulin Aspart (30, 50 and 70) and Insulin Aspart in Healthy Subjects

This trial is conducted in Europe. The aim of this trial is to demonstrate a difference between the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 30, biphasic insulin aspart 50, biphasic insulin aspart 70 and insulin aspart in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18 and 28 kg/m\^2 inclusive
* HbA1c within the normal laboratory range
* Non smoker for at least three months
* Females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (IUD) , the oral contraceptive pill or barrier methods

Exclusion Criteria:

* Subjects who have received any investigational drug in the 3 months prior to the start of dosing
* Any disease requiring regular use of non topical prescription medicines
* Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug
* Any intercurrent illness or endocrine disorders that may affect blood glucose
* Subject with a history of drug or alcohol dependence
* Subject with a first degree relative with diabetes mellitus
* Subject with a history of clinically relevant allergic reactions to medical products
* Subjects who have donated any blood or plasma in the past 3 month preceding screening
Circulating Tumor Cells in Non-Small Cell Lung Carcinoma

The purpose of this study is to establish the circulating tumor cell (CTC) assay as a surrogate for tissue diagnosis of suspected primary lung cancer. This is done through evaluating clinical and molecular markers to stratify the outcome/survival in patients with thoracic malignancies treated at Yale University/Yale-New Haven Hospital, University of California San Diego/Moores Cancer Center, Billings Clinic Cancer Center.


Eligibility Criteria:
Inclusion Criteria:

* Suspected lung cancer
* Planned to undergo tissue biopsy. Tissue biopsy does not need to be limited to an intrathoracic structures. Biopsies of the supraclavicular lymph nodes are allowed
* Age \>18

Exclusion Criteria:

* Patients with history of a separate (not a primary lung cancer) malignancy within past two years.
* Recent history (past two weeks) of trauma (INCLUDING diagnostic surgery, biopsy, etc)
* Prior lung cancer treatment chemotherapy, radiation, surgery, etc. in past two years.
* Inability to provide informed consent.
* Hgb less than 8.
Exercise Training Program for Cerebellar Ataxia

The purpose of this study is to determine whether a person's ability to adapt (i.e. short term motor learning) predicts their ability to benefit from physical therapy exercises.

The cerebellum is important for coordination of movement and for motor learning. No medications systematically improve cerebellar ataxia, and little is known about the effectiveness of rehabilitation exercises, which are often the only treatment option. Here, we ask whether a person's ability to adapt (i.e. short term motor learning) predicts their ability to benefit from physical therapy exercises. This pilot-clinical trial will test a subject's ability to adaptively learn a new walking pattern in a single session, and then any improvement of walking and balance over a 13 week time period during which they participate in a specialized home exercise training program. Our prediction is that those individuals with some preserved adaptive learning ability will be the best rehabilitation candidates.

Eligibility Criteria:
Inclusion Criteria:

* Cerebellar damage from stroke, tumor, or degeneration
* Able to stand and take steps with or without assistance
* Age 18-95

Exclusion Criteria:

* Extrapyramidal symptoms
* Peripheral vestibular loss (e.g. absence of VOR)
* Congestive heart failure
* Peripheral artery disease with claudication
* Pulmonary or Renal Failure
* Unstable angina
* Uncontrolled hypertension ( \> 190/100 mmHg)
* Dementia (Mini-Mental State exam \> 22)
* Severe aphasia
* Orthopedic or pain conditions
* Pregnancy
* Prisoner
* Evidence of chronic white matter disease on MRI
Study Comparing Immune Response to, and Safety of, Fluviral and Fluzone Influenza Vaccines in Persons 50 y.o. and Over

The goal of this study is to determine whether the immune responses induced by Fluviral, the investigational vaccine, are comparable to those induced by Fluzone, which is an influenza vaccine currently licensed in the U.S. The study focuses on persons 50 years old and over. In addition, the study will compare the rate of reactions to the two vaccines, and the general health of persons who receive them over the 42 days after immunization.

Yearly influenza epidemics are responsible for excess hospitalizations and deaths in the elderly population, and also cause lost work and productivity among the healthy, working elderly. Fluviral, a product now licensed in Canada, is being tested to determine whether it is as active in causing immune responses, and as safe as a currently licensed U.S. vaccine in persons 50 y.o. and over.

Eligibility Criteria:
Inclusion Criteria:

* Stable health status
* Access to a consistent means of telephone contact.
* Comprehension of study requirements, availability for study duration
* Availability and ability to attend scheduled visits
* Females post menopausal, sterile or using accepted contraceptive measures
* Competence to provide informed consent

Exclusion Criteria:

* Presence of significant acute or chronic medical or neuropsych. illness
* New medical or surgical treatment w/i 1 month
* Change in medication dose due to uncontrolled symptoms w/i 1 month
* Hospitalization w/i 1 month
* Any unusual risk (for age group) of serious adverse events w/i 1 month
* Any neuropsychiatric condition altering competence for consent
* Any neuropsychiatric condition preventing accurate safety reports
* Febrile illness on day of treatment
* Employment in professions at high risk of influenza transmission
* Residence in a long-term-care facility or with an immunocompromised person
* Systolic BP over 150, diastolic over 90, resting pulse under 50 or over 100
* Cancer w/i 3 years
* Immunosuppressive of immunodeficient conditions
* Treatment with systemic glucocorticoids \> replacement
* Treatment with cytotoxic or immunosuppressant drugs
* Treatment with immune globulins
* Clotting disorders that increase the risks of intramuscular injections
* History of demyelinating disease or GBS
* Pregnancy or nursing
* Absence of contraceptive practices in women with childbearing potential
* Planned administration of non-influenza vaccines within 30 days
* Receipt of any investigational drug within 30 days
* Receipt of immune globulin treatment within 3 months
* Known or suspected allergy to egg proteins, gelatin, or thimerosal
* History of severe adverse reactions toflu vaccines
* Prior receipt of 2005-6 influenza vaccine
Early Exercise Training in Critically Ill Patients

This randomized controlled trial was designed to investigate whether a daily training session using a bedside cycle ergometer, started early in stable critically ill patients with an expected prolonged ICU stay, could induce a beneficial effect on exercise performance, quadriceps force and functional autonomy at ICU and hospital discharge compared to a standard physiotherapy program.

Inactivity during prolonged bed rest leads to muscle dysfunction. Muscle function decreases even faster in ICU patients due to inflammation, pharmacological agents (corticosteroids, muscle relaxants, neuromuscular blockers, antibiotics), and the presence of neuromuscular syndromes, associated with critical illness. A recent recommendation document advices to start early with active and passive exercise in critically ill patients. However, no evidence is available concerning the feasibility of an early muscle training intervention in the acute ICU phase when patients are still under sedation. A rather new method to train bed-bound patients is the use of a bedside cycle ergometer. This randomized controlled trial was designed to investigate whether a daily training session using a bedside cycle ergometer, started early in stable critically ill patients with an expected prolonged ICU stay, could induce a beneficial effect on exercise performance, quadriceps force and functional autonomy at ICU and hospital discharge compared to a standard physiotherapy program.

Eligibility Criteria:
Inclusion Criteria:

* ICU stay \> 5 days
* Expected prolonged stay of at least 7 more days
* Cardiorespiratory status that allows at least passive exercise therapy

Exclusion Criteria:

* Persistent or progressive neurological or (neuro)muscular disease
* Coagulation disorders (INR \> 1.5, \[BP\] \< 50000/mm³)
* Intracranial pressure \> 20 mmHg
* Psychiatric disorders or severe confusion
Clinical Study of Bone Graft Substitutes in Orthopaedic and Spinal Applications.

This is an observational, prospective, non-randomised, multi-centred post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical setting in long bone and extremity defects and in spinal fusion procedures.


Eligibility Criteria:
Inclusion Criteria:

Long Bone and Extremity Indications: patients requiring bone grafting after post-traumatic or surgically created bone defects afflicting the long bones and extremities.

Spine Indication: patients with degenerative disc disease or trauma who require spinal fusion of 1 or more vertebral bodies and where conservative treatment has been unsuccessful.

Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center;

Exclusion Criteria:

Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.

Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion); The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.
The SsRI/NIE Recombinant Antigen ELISA for the Follow up of Patients Infected by Strongyloides Stercoralis

This is a single-center interventional study with an IVD medical device.

The main objective of this study is to evaluate the ELISA SsIR/NIE test for the post-treatment follow-up of patients suffering from strongyloidosis, using well-characterized sera from a previous study.

All sera available in the Tropica biobank and coming from the Strong Treat study, for which serum samples collected at baseline and at 12-month follow-up are available, will be eligible for the study.

The test The InBios Strongy Detect TM IgG ELISA detects specific IgG antibodies against recombinant Strongyloides NIE and SsIR antigens in serum. It consists of an enzymatically amplified sandwich immunoassay. Positive and negative control samples are provided in the kit. The test will be performed and interpreted according to the manufacturer's instructions. The results are expressed as OD and nOD. Clinical interpretation of the results will be performed by receiver operating characteristic (ROC) curve analysis generated using data from confirmed positive and confirmed negative samples.

The laboratory technicians will receive from the PI of the study a list of pseudo-anonymized sera to be tested with SsIR/NIE ELISA, they will check their availability and proceed with the test according to the Manufacturer's instructions. Laboratory personnel performing and reading the tests will be blinded to the results of any previously performed tests (and the classification of the sample in the Strong Treat study). A single run will be performed for each sample, unless the test needs to be repeated due to any technical problem. Both baseline and follow-up sera will be tested. The resulting OD and nOD will be reported in an Excel file by the laboratory technicians performing the tests.


Eligibility Criteria:
Inclusion Criteria:

* All sera available in our biobank and originating from the Strong Treat trial
* availability of the baseline and the 12-month follow up serum of each included case

Exclusion Criteria:

* unavailability of the baseline or of the 12-month follow up serum of each included case
Role of Liver and Visceral Fat in Glucose and Lipid Metabolism During Pregnancy

Obesity, increased abdominal fat, fat stored in the liver, and insulin resistance may all be associated with adverse maternal and fetal pregnancy outcomes. This study will examine how fat storage changes during pregnancy; and if how the body stores fat impacts one's ability to metabolize glucose (sugar) during pregnancy.

This study aims to serially evaluate liver and visceral fat stores during pregnancy and their relationship with glucose and lipid metabolism, placental function, and newborn size. To do this we will conduct both a prospective cohort study of pregnant women without pre-gestational or early gestational diabetes assessed at both 12-16 weeks gestation and at 32-36 weeks gestation and a case-control study of women with normal and impaired glucose tolerance in the early third trimester. Physical assessments will be performed by the Oregon Health and Science University bio-nutrition unit and will include the use of magnetic resonance imaging, ultrasound, and blood draws.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant and enrolled members of Kaiser

Exclusion Criteria:

* Women with multiples pregnancy; history of: cardiovascular disease, bariatric surgery, anemia, chronic hypertension or renal disease.
* Non-English speaker