cyrilzakka/clinical-trials huggingface dataset:
Impact on Pain Sensitivity of Clinical Interaction

Pain can currently be quantified using quantitative sensory tests (QSTs). However, we lack knowledge concerning how relational and contextual factors impact these quantitative tests. We will examine how a standard QST battery is affected by "removing" the social and human interaction from the test session compared to usual QST testing where the participant is guided through the assessment by a research assistant.

Our objectives are:

1. How is the QST affected when guided by a research assistant compared to guided by a computer
2. Does the level of the assessor's empathy affect the QST outcome
3. How do psychological factors affect the QST testing
4. are these outcomes affected by the patient profile (low back pain patients vs healthy controls)


Eligibility Criteria:
Inclusion Criteria:

* Primary complaint of low back pain
* No pain for healthy controls
* No serious psychological or somatic disorders potentially interfering with the QST

Exclusion Criteria:

* Incomplete QST data
Topotecan for Irinotecan-Refractory SCLC

Although the efficacy of topotecan as second-line chemotherapy for SCLC has been consistently demonstrated in phase II/III clinical trials, the choice of irinotecan as first-line therapy prevented use of the evidence-based option.

This pilot study will be conducted to determine the activity and safety of topotecan in SCLC patients refractory to first-line therapy with irinotecan and platinum.

Current commonly used second-line approaches for SCLC include re-induction with first-line therapy for chemosensitive disease, or single-agent topotecan. Although the efficacy of topotecan as second-line chemotherapy for SCLC has been consistently demonstrated in a number of clinical studies, the choice of irinotecan as first-line therapy prevented use of the evidence-based option such as topotecan. Topotecan and irinotecan are cytotoxic agents that inhibit same intracellular pathway, namely topoisomerase I, which is an enzyme involved in DNA replication and RNA transcription.

Although their mechanism of action is similar, the preclinical and clinical data of these two drugs have some notable differences. Topotecan and irinotecan have different spectra of antitumor activity in various models of human cancer. Clinical data support that these agents may have different spectra of activity. The differences in antitumor activities may also reflect different mechanisms of resistance. Furthermore, topotecan and irinotecan have different limiting toxicities (myelosuppression and diarrhea, respectively).

Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically proven SCLC
* refractory to prior irinotecan-based chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* age between 18 and 75 years
* no active brain or leptomeningeal metastases
* adequate hematologic, hepatic and renal functions
* at least one measurable lesion(s)

Exclusion Criteria:

* pregnant or lactating women
* patients with active infection
* extensive radiotherapy within the previous 4 weeks
* previous other malignancies with the exception of adequately treated non-melanoma skin cancer or in situ cervical cancer
* any severe comorbid illness
* a known history of anaphylaxis of any origin
* history of severe adverse events to the drug used in this study
Image Guided VATS vs. VATS Resection

To evaluate workflow and outcomes of iVATS and standard VATS for small pulmonary nodules. The outcomes of the patients will be evaluated separately as there will be no direct comparison of the two arms.

This is a prospective phase II clinical study to evaluate iVATS and standard VATS for small pulmonary nodules. We have successfully completed and published a phase I/pilot study with 25 patients demonstrating safety and optimal procedural workflow for combining image-guidance with VATS. This phase II clinical study will further expand upon the safety and feasibility of this procedure. Additionally, this data will be used to design a phase III comparison study between iVATS and standard VATS.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be 18 years and older
* Subject must be deemed a candidate for the iVATS surgery, by their treating Thoracic Surgeon
* Subject must have nodules/GGO or other abnormal opacity that can be accurately measured in at least one dimension with longest diameter ≤ 20 mm or 2cm
* Subject's lesions that are located in the outer half portion of the lung/lobe.
* Subjects must be evaluated at BWH and/or DFCI Thoracic Surgery outpatient clinics

Exclusion Criteria:

* If participant is a pregnant woman or breast feeding they will not be eligible.
* If treating thoracic surgeon deems the participant not eligible for the study.
Exercise Program to Increase Breast Milk

In this study, the effects of an exercise program aimed at increasing breast milk on breastfeeding self-efficacy, breastfeeding success, and breast milk quantity will be evaluated.

The research is a randomized controlled trial. The research will be conducted with 122 mothers who are in their 8th week postpartum and have healthy babies. Mothers in the exercise group will be given 1 hour (60 minutes) of exercise to increase breast milk three times a week for 6 weeks. The control group will be given routine breastfeeding education. Data will be collected using a sociodemographic form, Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), LATCH- Breastfeeding Charting system, IMDAT: a tool for assessing the level of maternal milk intake scale.

Eligibility Criteria:
Inclusion Criteria:

* Those who are over 18 years old,
* Who gave birth at term pregnancy (38-42 weeks),
* Who have a healthy baby,
* Who are between 8 weeks postpartum.

Exclusion Criteria:

* Those with diagnosed mental illness (e.g., antidepressants, antianxiety or antipsychotic medications),
* Those with chronic systemic illnesses,
* Those with physical illnesses that may prevent them from exercising,
* Those with any postpartum complications (hemorrhage, postpartum infection, mastitis, thromboembolic disease or postpartum psychiatric disorder).
Genotype-guided Treatment in DLBCL

A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP-X) versus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with diffuse large B-cell lymphoma


Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed diffuse large B-cell lymphoma (without central nervous system involvement)
* Availability of archival or freshly collected tumor tissue before study enrolment
* International Prognostic Index (IPI) score of 2-5 or 1 with bulky disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
* Life expectancy greater than or equal to (\>/=) 6 months
* The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research

Exclusion Criteria:

* Previous chemotherapy.
* Previous stem cell transplantation.
* History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
* Patients with central nervous system (CNS) lymphoma
* Primary mediastinal large B-cell lymphoma
* Left ventricular ejection fraction\<50%
* Laboratory measures meet the following criteria at screening (unless caused by lymphoma):

  1. Neutrophils\<1.5×10\^9/L
  2. Platelets\<75×10\^9/L (Platelets\<50×10\^9/L in case of bone marrow involvement)
  3. ALT or AST is 2 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN.
  4. Creatinine is 1.5 times higher than the ULN.
* HIV-infected patients
* Positive test results for chronic hepatitis B and hepatitis C infection
* Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
* Pregnant or lactation
* Require treatment with strong/moderate CYP3A inhibitors or inducers.
* Inability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, post-bariatric surgery, inflammatory bowel disease and complete or incomplete intestinal obstruction
* Other medical conditions determined by the researchers that may affect the study
A Study on Application of Adjustable Headrest in Painless Curettage Surgery for Overweight and Obese Patients

The aim of this study is to observe the effect of adjustable headrests on ventilation function in overweight and obese patients through clinical experiments, and to explore the impact on the incidence of hypoxemia during painless curettage in overweight and obese patients.

Participants will be randomly allocated to three groups: the supine head-straight position group(Group A), the supine head-lateral position group(Group B), and the adjustable headrest group(Group C). These three groups of patients underwent painless curettage surgery in the daytime operating room and the occurrence of hypoxemia will be observed.


Eligibility Criteria:
Inclusion Criteria:

* patients who choose to have painless surgical abortion
* Body mass index greater than 24
* the American Society of Anesthesiologists (ASA) physical status ranked I-II
* competent to provide informed consent

Exclusion Criteria:

* Abnormal lung function or respiratory system diseases
* Airway obstruction or respiratory malformation
* cervical spondylosis
* psychiatric disorders
Pilot Testing of a Real-Time Oncogeriatric Teleconsultation System Using the Total Cancer Care™ Database

The main purpose of this study is to pilot a real time electronic consultation with an Oncogeriatric Information Team (OGIT) located at Moffitt using Total Cancer Care (TCC). Investigators want to see for which type of patients this information is the most useful, and work out the practical ways of making this process work.

This is a multicenter study to test a real time consultation system using the Total Cancer CareTM database (TCC) cohort at the H. Lee Moffitt Cancer Center, Tampa, Florida, USA. The purpose is to make Moffitt's expertise available to private practice oncologists throughout Florida. An oncologist seeing an older patient with a difficult case could send key patient parameters to a senior adult expert at Moffitt. The TCC concierge would extract from the TCC database patients with similar characteristics. The oncogeriatric information team (OGIT) would review those cases and provide a summary report of treatments received and outcomes. The treating oncologist could then use that as an on-demand case series to help in the decision making. In order to pilot and build up the large scale intervention, several steps are necessary. The first step was a scenario testing with vignettes, which allowed tracing the most effective way of retrieving and formatting the information. The next step will be a pilot testing of the intervention in real time with one private practice.

Primary Aims:

To assess which format of expert-vetted database consultation and patient selection is the most useful to a private practice oncologist. We will test a model of approach and gain feedback on subjective utility and objective treatment modification profiles, in order to target a future study towards the stakeholders most likely to benefit. Impact of the consultation on treatment plan (per pre-post e-mails). Availability of similar patients in the TCC database.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 70 or older with a documented malignancy seen at Lynn Cancer Institute (LCI), as a new or established patient, and for whom a treatment decision has to be made.
* Signed written informed consent

Exclusion Criteria:

* Patients younger than 70 years of age
* Inability to consent
* Inability to complete the study questionnaires (assistance for physical impairments is allowed)
* Urgent treatment decision need
Lactobacillus Reuteri DSM 17938 in the Prevention of Antibiotic-associated Diarrhea in Children: Protocol of a Randomized Controlled Trial

The aim of this study is to assess the effect of Lactobacillus reuteri DSM 17938 administration for the prevention of diarrhea and AAD in children.

Introduction:

Addition of some probiotics appears to reduce the risk of antibiotic-associated diarrhea (AAD). Effects of probiotics are strain specific, thus the efficacy and safety of each probiotic strain should be established separately. We aim to assess the effect of Lactobacillus reuteri DSM 17938 administration for the prevention of diarrhea and AAD in children.

Methods and analysis:

A total of 250 children younger than 18 years treated with antibiotics will be enrolled into a double-blind, randomized placebo-controlled trial in which they will additionally receive L reuteri DSM 17938 at a dose 2 x 10\^8 colony-forming units or an identically appearing placebo, orally, twice daily, for the entire duration of antibiotic treatment. The primary outcome measures will be the frequency of diarrhea and AAD. Diarrhea will be defined according to one of 3 definitions: (a) ≥3 loose or watery stools per day for a minimum of 48 hours during antibiotic treatment; (b) ≥3 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment; (c) ≥2 loose or watery stools per day for a minimum of 24 hours during antibiotic treatment. AAD will be diagnosed in cases of diarrhea, defined clinically as above, caused by C. difficile or for otherwise unexplained diarrhea (i.e. negative laboratory stool tests for infectious agents).

Eligibility Criteria:
Inclusion Criteria:

* age younger than 18 years;
* oral or intravenous antibiotic therapy which started within 24 hours of enrollment;
* signed informed consent.

Exclusion Criteria:

* pre-existing acute or chronic diarrhea,
* history of chronic gastrointestinal disease (e.g., inflammatory bowel disease, cystic fibrosis, celiac disease, food allergy) or other severe chronic disease (e.g., neoplastic diseases), immunodeficiency,
* use of probiotics within 2 weeks prior to enrollment,
* use of antibiotics within 4 weeks prior to enrollment,
* prematurity, and exclusive breastfeeding.
Dosing and Outcomes Study of Erythropoietic Stimulating Therapies in Patients With Chemotherapy Induced Anemia

The purpose of this study is to describe patient characteristics, treatment patterns, and clinical outcomes in adult patients with cancer who are receiving erythropoiesis-stimulating therapy (EST).

The Dosing and Outcomes Study of Erythropoietic Stimulating Therapies (DOSE) is a prospective, observational multicenter registry of approximately 1200 adult cancer patients receiving treatment with EST; eg, epoetin alfa or darbepoetin alfa. The planned duration of the DOSE Registry is three years. Based on initial results, the registry sponsor may elect to extend the duration of the registry.This study does not specify treatment protocols, require any particular assignment of patients to treatment protocols, or in any other way require participating physicians to alter their practice patterns. Participating physicians are instructed to continue to treat all patients according to their own best clinical judgment, but to submit information on baseline patient characteristics, treatment patterns, and clinical outcomes. Baseline determinations will include patient demographics, tumor and treatment type, hematologic parameters, and patient reported outcomes. Data will be collected over the 16-week study period with regard to EST treatment, hematologic outcomes and patient reported outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cancer who are being treated with an erythropoiesis-stimulating therapy (EST) for anemia of cancer or cancer-related treatment
* Must be EST ''naive'' globally or must have been off treatment with an EST for at least 90 days
* Must speak and read english and be able to answer the type of simple questions presented in the patient questionnaires
* If the patient is identified for the study while an inpatient, they must be able to be followed for up to 16 weeks
* The patient must give consent to participate in the registry by signing the informed consent form

Exclusion Criteria:

* Patients currently participating in any other clinical study of EST (however, the patient may be undergoing treatment under an investigational cancer treatment protocol)
* Have or had been on dialysis for end stage renal disease in the past
* Has myelodysplasia or any myelodysplastic syndrome
* Patients are known to need stem cell transplant
* Patient who will self-administer the epoetin alfa or darbepoetin alfa
Gene Expression Profiles in Patients With Metastatic Pancreatic Cancer

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study uses gene expression profiling to compare primary tumor cells with metastatic tumor cells in patients with metastatic pancreatic cancer.

OBJECTIVES:

* Compare the gene expression profiles of pancreatic cancer cells from the primary and metastatic sites in patients with metastatic pancreatic cancer.
* Characterize the function of the differentially upregulated and downregulated genes identified by comparing the gene expression profiles of primary and metastatic cells in these patients.

OUTLINE: Fresh biopsy samples are collected for gene expression profiling and other biomarker/laboratory analyses.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of pancreatic adenocarcinoma of exocrine origin
* Metastatic disease
* Fresh biopsy material available from primary site of disease and a metastatic focus, including liver, peritoneum, or lymph node

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy or radiotherapy for pancreatic cancer
Clinical Efficacy and Long Term Effects of Transcranial Direct Current Stimulation (tDCS) in Children With Attention Deficit/Hyperactivity Disorder (ADHD)

Attention-Deficit/Hyperactivity Disorder (ADHD) is the most commonly diagnosed neurodevelopmental disorder in childhood. Patients with ADHD present inattention, impulsivity and hyperactivity causing severe impairments on academic achievement, social and professional life and daily functioning. Medications are effective in a majority of children with ADHD, but about 30% do not respond or tolerate stimulants, and some parents refuse pharmacological treatments.Transcranial Direct Current Stimulation is a safe and non-invasive technique of brain stimulation used in several neurological and psychiatric disorders, and recently in ADHD. In patients with ADHD, tDCS stimulations targeted frontal regions improve executive and attentional functioning and daily life symptoms. The objective of this project is to evaluate the efficacy of tDCS (vs sham) during cognitive-remediation exercises on ADHD symptoms (inattention, impulsivity and hyperactivity as defined by DSM-5) in children with ADHD between 7 and 14 years of age.


Eligibility Criteria:
* Children, male or females presenting a sufficient compliance for participate aged 7-14 years at the time of Visit 1 (Enrolment/baseline).
* Children's parent or legally authorised representative must sign informed consent. The children must sign assent if applicable (depending of age and understanding). The principal investigator of the center where the child is included signs the document, certifying that the family and the child, or their authorised representative, have received informed consents.
* Children meet DSM-5 criteria for ADHD (combined presentation) based on a clinical evaluation using questionnaire ADHD-Rating-Scale (ADHD-RS) and the Kiddie Schedule for Affective Disorders and Schizophrenia French version (Kiddie-SADS).
* Subjects have a minimum ADHD-RS total score of 32 at Visit 1.
* Children have a minimum CGI of 4 at Visit 1.
* Children have an age-appropriate intellectual level evaluated with WISC-5 (Full IQ \>80).
* Children in which stimulant medication have been tested previously and stopped for adverse effects could be included in the study after a wash out of at least seven days.

Exclusion Criteria:

* Children have a neurological pathology or handicap: Epilepsy, cerebral palsy, sequelae of brain injury (traumatic or ischemic or inflammatory...)
* Children have a comorbid psychiatric disorder: conduct disorders, autism, severe obsessive-compulsive disorder, mood disorder, bipolar illness, conduct disorder, psychosis, and substance abuse.
* Children under medication (stimulant or other psychotropic treatment, benzodiazepine, antidepressant, hypnotics and melatonin) or who did not respond previously to stimulant will not be included.
* Severe sleep disorder.
* Contraindication to tDCS.
Lipid-lowering Therapies in Vietnamese Chronic Kidney Disease Population

This study aims to determine the mechanisms underlying dyslipidemia in chronic kidney disease (CKD) and effect of lipid-lowering therapies in patients with CKD via parameters of lipid, oxidative stress, tryptophan delegation as well as renal function and side effects. Thirty 3,4 CKD patients with low-density lipoprotein (LDL) \> 100 mg/mL (2,59mmol/l), randomly receive three different LDL lipid-lowering therapies: Simvastatin (40 mg/day) or ezetimibe/simvastatin combination (10/20 mg/day or 10/40 mg/day).

The prevalence of chronic kidney disease (CKD) in Vietnamese population is increasing along with hypertension and diabetes. In CKD patient, cardiovascular disease (CVD) is the leading cause of mortality. The lipidemic disorder is one of the CV risk factors in CKD but it was not fully concerned in Viet Nam.

Hypocholesterolemia therapy has shown many benefits; however, its effects on OS and endothelial function are still not fully evidenced.

In clinical practice, physicians always concern the effects and safety before giving the prescription. However, despite the high frequency of statin treatment, only 1/3 of CKD patients achieved the LDL-C goal. Whether high-dose of statins mono-therapy is more effective in LDL-C lowering is still unclear, but are associated with a high rate of hepatotoxicity, myopathy.

Lowering LDL-C with statin mono-therapy and statin/ezetimibe combination reduces the risk of CVD in population without kidney disease. Which Cholesterol-lowering therapies are suitable for stage 3,4 CKD patients in term of e-GFR reduction and side effects? There is no data related to this field in the Vietnamese CKD population.

Thus, more advanced lipid-lowering therapies and a better understanding of the mechanism is needed for treatment strategy of hyperlipidemia in Vietnamese patients with CKD.

Eligibility Criteria:
Inclusion Criteria:

* Ages Eligible for Study:

  * ≥ 50 years old but not treated with chronic dialysis or kidney transplantation
  * In adults aged 18-49 years with CKD but not treated with chronic dialysis or kidney transplantation, statin treatment in people with one or more of the following: known coronary disease (myocardial infarction or coronary revascularization); diabetes mellitus; prior ischemic stroke; estimated 10-year incidence of coronary death or non-fatal myocardial infarction \> 10%.
* CKD in the 3,4 stage: (e-GFR: 15-60 ml/min/1.73 m2)
* CKD proteinuria (defined as Creatinine clearance \>20 ml/min/1.73 m2 combines with urinary protein excretion rate \>300mg/24 h)
* LDL cholesterol concentration \> 100 mg/dl (2,59 mmol/l)

Exclusion Criteria:

In adults with dialysis-dependent CKD

* Heart failure (New York Heart Association class III or more)
* Previous or concomitant treatment with corticoids, statin, immunosuppressive agents, vitamin B6, B12, folate.
* Pregnancy
* Patients who do not agree to participate the research
* Patients are unable to understand the purposes and the risks of the study