cyrilzakka/clinical-trials huggingface dataset:
A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer

This study is designed to randomly assign breast cancer patients requiring and agreeing to chemotherapy into two groups. One group will be receive an exercise prescription aimed at increasing physical activity by a minimum of 10 MET (metabolic equivalent task) hours per week. The other group will not receive a exercise prescription but their activity will be recorded. The hypothesis is that participants that are most active will exhibit improved chemotherapy completion rates, improved fitness, less fatigue and lower levels of markers for inflammation in their blood.

This is a prospective, randomized, single institution feasibility trial. The efficacy of an exercise intervention during chemotherapy for sedentary breast cancer patients will be tested. The investigators goal is to recruit 120 women and men. Assuming 20% attrition rate, 96 will be randomized to two arms, comparing patients assigned to a physical activity program plus general health education materials versus patients assigned to receive standard general health education materials only. Study measures will be obtained before intervention, at 24 weeks, and at the end of the intervention, approximately week 32.

Eligibility Criteria:
Inclusion Criteria:

1. Women or men with histologically confirmed breast cancer and no evidence of metastatic disease with a recommendation to begin chemotherapy within 4 weeks.
2. Patients must have recovered from prior surgery.
3. Patients must be able to walk unassisted without oxygen
4. Patients must complete the Physical Activity Readiness questionnaire with "No" answers to all questions; if patient responds with YES answers, OR IS OVER AGE 69, approval must be obtained from the patient's Primary care physician or treating medical oncologist to participate in the study.
5. Able to fast for 12 hours for blood work and Basal Metabolic Rate measurement.
6. Karnofsky performance status \> or = to 80%.
7. Previous or ongoing Physical therapy treatments are acceptable.
8. Participants may be enrolled on other treatment-based clinical trials but may not be enrolled on any other weight loss trials.
9. Participants must have a baseline activity level of \< 150 minutes/wk of moderate to vigorous activity as calculated using the moderate to vigorous components of the LTEQ (leisure time exercise questionnaire) for physical activity (completed during screening).

Exclusion Criteria:

1. Patients less than 18 years of age.
2. Patients with history of acute MI (myocardial infarction) or CVA (cerebral vascular accident) within the last 12 months.
3. Patients who are oxygen dependent.
4. Patients unable to give informed consent indicating they are aware of the investigational nature of this intervention prior to entry into the study.
5. Patients with a Karnofsky performance status of \< 80%.
6. Pregnant.
7. Unable to read or write in English.
Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2022/23

This is an enhanced passive safety surveillance conducted in routine clinical care setting. Spontaneously reported ADRs will be collected by study staff following routine vaccination.

The primary objective of this surveillance is to estimate the vaccinee reporting rate (RR) of suspected adverse drug reactions (ADRs) occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, during the Northern Hemisphere (NH) influenza season 2022/23.

The secondary objectives of the study are:

* To estimate the vaccinee reporting rate of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, according to the pre-defined age groups (not applicable for Efluelda®)
* To estimate the vaccinee reporting rate of serious suspected ADRs after vaccination with VaxigripTetra® and Efluelda®, respectively, at any time following vaccination, within the EPSS

Study duration per participant 2 months (including 6 weeks for VC distribution + 2 weeks for vaccinee reporting) following the first vaccination

Eligibility Criteria:
Inclusion Criteria:

* There are no formal inclusion criteria. Individuals who approach the site for vaccination and agree to receive a vaccination card will be included and vaccinated with the respective vaccine brand according to the country of their location,
* recommendations for the individual vaccines as well as national recommendations

Exclusion Criteria:

* none
Quadratus Lumborum Block Reduced Postpartum Uterine Pain After Virginal Childbirth

With the continuous advancement of ultrasonic technology, nerve block in which drugs are injected into the periphery of the target nerve through ultrasonic guidance has become the mainstream method for postoperative pain control. The quadratus lumborum nerve block has been effectively and safely used in abdominal surgery (such as laparotomy, caesarean section, etc.), effectively reducing postoperative wounds and visceral pain. There is no research on the use of quadratus lumborum nerve block to control the pain of natural postpartum uterine contractions in the current literature, so the purpose of this experiment is to explore whether the quadratus lumborum nerve block can effectively reduce the pain of uterine contractions after vaginal delivery.


Eligibility Criteria:
Inclusion Criteria:

* Females over twenty years of age
* Maternal vaginal delivery
* Postpartum moderate to severe pain with uterine contractions (Numerical Pain Scale (NRS) ≥ 4 points) after delivery.
* Subject's consent signed by the subject

Exclusion Criteria:

* Severe coagulation abnormalities (PLT\<100000、INR\>1.2、PT\>13)
* Infection of the epidermis at the anticipated relevant site of injection
* Allergy to local anesthetics
* Allergy to or abuse of pain control medications
* Episiotomy is more painful than uterine contractions
* Inability to cooperate with associated pain assessment
* Body Mass Index (BMI) ≧ 35 kg/m2
Evaluation of Energy Expenditure, Body Composition and Recovery Rates in Children With Severe Acute Malnutrition

This project is being conducted with an aim to find out energy expenditure, body composition and recovery rates in children with severe acute malnutrition (SAM) receiving community-based nutritional rehabilitation therapy

Objectives

1. To assess energy expenditure and body composition by stable isotope techniques in children with Severe Acute Malnutrition
2. To evaluate the potential usefulness of body composition assessment as a predictor of outcome in children with SAM, based on stable isotope technique and multi-frequency bioelectrical impedance analysis (BIA)

Inclusion criteria

* Parents of children of age 6 months to 3 years
* Resident of study area

Exclusion criteria

* Children with congenital malformations
* Chronic debilitating illnesses
* Refusal by parents to enroll in study

Eligibility Criteria:
Inclusion Criteria:

* Parents of children of age 6 months to 3 years
* Resident of study area

Exclusion Criteria:

* Children with congenital malformations
* Chronic debilitating illnesses
* Refusal by parents to enroll in study
Transarterial Chemoembolization (TACE) Therapy of Hepatocellular Carcinoma (HCC) With Blocking Tumor Blood Temporarily and Enhancing Perfusion

According to radiology imaging, the patients of HCC are divided into two groups(hypovascular tumor group and moderately vascular tumor group). Every group is divided into TACE therapy with balloon catheter subgroup and regular TACE therapy subgroup. Patients take the TACE therapy each 45 days, and have MRI diffusion examine or CT one week before next therapy. All objects are observed until the end event happening or in the group for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* sign the written informed consent form provided.
* diagnosed clinically as HCC,need to take TACE.

Exclusion Criteria:

* have had an allergic reaction following iodine.
* have been in any TACE or radiotherapy or biotherapy within 30 days before the study.
* HCC of diffuse type,failure of hepatic function, chronic illness or disease including failure of heart function, uncontrolled high blood pressure, heart disorders, serious infection, uncontrolled diabetes mellitus.
Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III NSCLC

This is a phase II, single-arm study to evaluate the efficacy and safety of Afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.

This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the efficacy and safety of afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.

The primary endpoint was the rate of NSCLC converting to resectable tumors. The secondary endpoints included R0 resection rate, major pathological response (MPR) rate, pathological complete response (pCR) rate, tumor downstaging rate, objective response rate (ORR), disease control rate (DCR), 1-year event-free survival (EFS) rate, EFS and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* Pathologically or cytologically confirmed diagnosis of unresectable Stage III non-small cell lung cancer as judged by the investigator.
* Tissue or blood samples tested and confirmed to be positive for EGFR sensitive mutation
* ECOG Performance Status of 0-1
* At least one measurable lesion according to RECIST 1.1
* Adequate organ and marrow function

Exclusion Criteria:

* Histologically or cytologically confirmed combined SCLC and NSCLC, large cell neuroendocrine carcinoma, and sarcoma-like carcinoma
* The presence of malignant pleural effusion
* Prior systemic anti-cancer therapy for non-small cell lung cancer
* Prior local radiotherapy for NSCLC
* Patients with uncontrolled gastrointestinal diseases that may affect the absorption of test drugs (such as Crohn's disease, ulcerative colitis, absorption disorders, or diarrhea of any cause ≥ Grade 2 CTCAE) according to the investigator's assessment
The Impact of Creative Interventions on Symptoms of Postnatal Depression (Cohort Study)

Post-natal depression (PND) is anticipated to affect 12.9% of new mothers with at least 75,000 cases per year in the UK alone. However, despite this, there is currently a worrying lack of support for new mothers, with data suggesting that 64% of healthcare trusts in the UK do not have a strategy for treating PND, and flaws in the current pharmacological and psychological treatment models. Consequently, research into promising psychosocial interventions such as music is critical to developing new paradigms for treating PND.

This project is an ambitious programme of research that investigates links between the mental health of women in the later stages of pregnancy and first 9 months post birth and their use of psychosocial interventions including music.

The study uses an online questionnaire to achieve a cross-sectional view of the mental health of women across England in the final stages of pregnancy and the first 9 months post birth, how much and in what ways music is used by these women, and whether there are any associations between music and mental health. The study aims to recruit between 1,000 and 5,000 women to take the anonymous questionnaire. However, women who complete the questionnaire while still pregnant will be invited to complete three further questionnaires shortly post-birth and 3 months later to gather longitudinal data to analyse change across pregnancy into post-birth (aiming for 500 of the 1,000 undertaking this repeated measurement).

Phase A of the study will be open to NHS sites around England to take part.

Eligibility Criteria:
Inclusion Criteria:

* Women who are more than 28 weeks pregnant OR up to 9 months post-birth

Exclusion Criteria:

* Outside the limits of the number of weeks pregnant/post birth
* Living outside England
* Refusal to participate
A Study of LY3561774 in Participants With Dyslipidemia

This is a 3-part study. In Parts A and B, the main purpose is to evaluate the safety and tolerability of the study drug known as LY3561774 in participants with dyslipidemia (high blood fat levels). How the body processes the study drug and the effect of the study drug on blood fat levels will also be investigated. Part C will mainly evaluate the safety and tolerability of LY3561774 as well as how the body processes the study drug in Japanese participants. The study may last up 52, 56 and 28 weeks for each participant in Parts A, B and C, respectively. There are up to 22, 26 and 16 visits in Parts A, B and C, respectively.


Eligibility Criteria:
Inclusion Criteria:

* For Parts A and B, have a fasting triglyceride (TG) level greater than or equal to (≥) 150 milligram/deciliter (mg/dL) and less than 500 mg/dL, as well as low density lipoprotein cholesterol (LDL-C) level greater than or equal to (≥) 70 mg/dL
* For Part C, participants should be first-generation Japanese origin.
* Have a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m²)
* Male participants must agree to adhere to contraception restrictions and female participants must not be able to get pregnant

Exclusion Criteria:

* Have taken any prescription medications that are for lowering serum TGs within the past 2 months (use of statins is allowed if the dose has been stable for 8 weeks)
* Have Type 1 diabetes
* Are currently participating in or completed a clinical trial within the last 30 days
* Are heavy alcohol drinkers or heavy cigarette smokers
* Have donated blood of more than 500 millilitres (mL) in the last 3 months
Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses

The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision performance of three monthly replacement sphere lenses.

This is a 40-subject, double masked, randomized, bilateral, non-dispensing fitting trial comparing hydrogel and silicone hydrogel lens materials. It is anticipated that this study will involve 2 visits for each lens pair, as follows: Visits: V1 (lens dispensing), V2 (1 hour post lens settling). Each subject will be randomized to wear each pair bilaterally in a series of three short fitting comparisons.

Eligibility Criteria:
Inclusion Criteria:

* A person is eligible for inclusion in the study if he/she:

  * Is between 18 and 40 years of age (inclusive).
  * Has had a self-reported visual exam in the last two years.
  * Is an adapted soft CL (Contact Lens) wearer who is not wearing any of the study lenses.
  * Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
  * Has a spectacle cylinder up to 0.75D (Diopter) in each eye.
  * Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
  * Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
  * Has clear corneas and no active ocular disease.
  * Has read, understood and signed the information consent letter.
  * Patient contact lens refraction should fit within the available parameters of the study lenses.
  * Is willing to comply with the wear schedule.
  * Is willing to comply with the visit schedule.

Exclusion Criteria:

* A person will be excluded from the study if he/she:

  * Has never worn contact lenses before.
  * Currently wears rigid gas permeable contact lenses.
  * Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
  * Has a CL prescription outside the range of - 1.00 to - 6.00D
  * Has a spectacle cylinder ≥1.00D of cylinder in either eye.
  * Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
  * Presence of clinically significant (grade 2-4) anterior segment abnormalities.
  * Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
  * Slit lamp findings that would contraindicate contact lens wear such as:

    * Pathological dry eye or associated findings
    * Pterygium, pinguecula, or corneal scars within the visual axis
    * Neovascularization \> 0.75 mm in from of the limbus
    * Giant papillary conjunctivitis (GCP) worse than grade 1
    * Anterior uveitis or iritis (past or present)
    * Seborrheic eczema, Seborrheic conjunctivitis
    * History of corneal ulcers or fungal infections
    * Poor personal hygiene
  * Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
  * Has aphakia, keratoconus or a highly irregular cornea.
  * Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
  * Has undergone corneal refractive surgery.
  * Is participating in any other type of eye related clinical or research study.
Efficacy on Height in SGA Children Treated With Growth Hormone

This trial is conducted in Europe and Middle East. Growth hormone in SGA Children This trial compares a treated group of patients with an untreated group of patients.


Eligibility Criteria:
Inclusion Criteria:

* Born small for gestational age with length and/or weight at -2 SDS or below at time of birth, according to country specific references.
* Severe growth failure with no catch up and with height at -2.5 SDS or below, according to country specific references, for chronological age at time of inclusion

Exclusion Criteria:

* Growth Hormone Deficiency (GHD)
* Treatment with any medical product which may interfere with GH effects
* Growth retardation associated with infections, severe chronic diseases including chromosomal anomaly or nutritional disorders
Prospective Study of White Blood Cells

The purpose of this study is to investigate white blood cells from volunteering donors to support the development of engineered regulatory T cell therapies.


Eligibility Criteria:
No additional inclusion/ exclusion criteria will be applied by Quell other than those specified by the consenting institutions.
NEURESCUE Device as an Adjunct to In-Hospital Cardiac Arrest (ARISE)

The NEURESCUE device is the first intelligent catheter for aortic balloon occlusion, an emergency technique that supercharges blood flow to the heart and brain within one minute from deployment.

The catheter-based device is delivered via the femoral artery, temporarily inflating a soft balloon in the descending aorta to redirect blood flow towards the upper body.

The objective of this study is to investigate the feasibility of the NEURESCUE device as an adjunct to Advanced Cardiac Life Support (ACLS) in adults with cardiac arrest.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 and ≤80 years
2. CPR initiated within 7 min of presumed arrest
3. 8 min of continuous ACLS without ROSC

Exclusion Criteria:

1. Traumatic cardiac arrest
2. Intraoperative cardiac arrest
3. Known pregnancy
4. Known terminal disease
5. Known do-not-attempt-CPR order
6. Subjects whose femoral arterial access site cannot accommodate an 8 Fr introducer sheath
7. Subjects currently on mechanical circulatory support
Multislice Spiral Computed Tomography and Cardiomyopathy

Conventional coronary angiography is the recommended procedure in detection of coronary stenosis in patients with idiopathic cardiomyopathy. The aim of this prospective study is to assess diagnostic accuracy of multislice spiral computed tomography coronary angiography in patients with idiopathic cardiomyopathy in sinus rhythm, compared to conventional coronary angiography.

The principal aim of this study is to assess the diagnostic accuracy (sensitivity, specificity, predictive values) of multislice spiral computed tomography (MSCT) coronary angiography among patients having idiopathic hypokinetic dilated cardiomyopathy in sinus rhythm, compared to conventional coronary angiography. The secondary aims are to assess the performance of MSCT in coronary sinus anatomy assessment, and in quantitative measurement of left ventricular anatomical criteria (telediastolic diameter, septal and posterior wall thickness, and ejection fraction) compared to echocardiography. Lastly, renal tolerance of MSCT will be studied. This prospective monocentric study will include 120 patients scheduled to undergo coronary angiography for etiologic diagnosis of idiopathic cardiomyopathy (defined by a left ventricle echographic ejection fraction ≤ 40 %, without anamnestic or electrocardiographic arguments in favour of coronary artery disease) in sinus rhythm. MSCT will be performed within 3 months after conventional coronary angiography, with blinded analysis.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to undergo coronary angiography,
* etiologic diagnosis of idiopathic cardiomyopathy (defined by a left ventricle echographic ejection fraction ≤ 40 %, without anamnestic or electrocardiographic arguments in favour of coronary artery disease),
* in sinus rhythm,
* informed written consent.

Exclusion Criteria:

* allergy to iodine,
* history of coronary artery bypass graft,
* history of percutaneous coronary angioplasty,
* history of myocardial infarction,
* known coronary artery disease,
* Q waves on the ECG,
* unstable haemodynamic status,
* urgent revascularisation or urgent valvular surgery,
* heart rate \> 80 bpm (before MSCT),
* pregnancy,
* enrollment in another study.
* severe renal or respiratory insufficiency.
A Behavioral Intervention to Decrease Vomiting and Improve Weight Loss in Post-Operative Laparoscopic Adjustable Gastric Banding (LAGB) Patients

The purpose of this study is to reduce problematic vomiting and associated gastrointestinal symptoms in post-operative LAGB patients. We hypothesize that our behavioral intervention will yield greater reductions in vomiting and associated symptoms compared to our control condition.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 70 years.
2. Received LAGB surgery with either a standard Lap-Band or a standard Realize Band.
3. Report vomiting at least 3x/week.
4. Agree to allow researchers to communicate with their surgeon regarding their care.
5. Fulfilled all hospital surgery criteria.

Exclusion Criteria:

1. Report a condition that in the judgment of the Principal Investigator would render them potentially unlikely to follow the protocol (e.g., major illness, plans to move out of the area, substance abuse or other significant psychiatric problems, organic brain disease).
2. Report planning to become pregnant during the time frame of the investigation.
3. Report a history of upper gastrointestinal dismotility.