cyrilzakka/clinical-trials huggingface dataset:
Patient Agenda Setting and Clinic Efficiency in Outpatients

The purpose of the study is to determine whether patients who use a prompt sheet to identify their important issues before they see a doctor are more likely to feel that their important issues have been discussed during their consultation. The study will be conducted in a respiratory outpatient clinic.

Evidence suggests that most patients come to a consultation with issues they wish to raise, but they may not actually raise them and clinicians may not elicit them. This can adversely affect the consultation outcome, e.g. through misunderstandings, unwanted prescriptions, non-adherence and unnecessary follow-ups. In a review of methods used before consultations to help patients address their information needs Kinnersely et al. (2009) found that there were small but statistically significant increases in patient satisfaction and the number of questions patients asked, and no effect on consultation length. However, they identified several gaps in the evidence including the need to assess a wider range of outcome measures, to identify the impact of the methods on the types of questions asked and the need to measure consultation length accurately.

This study aims to assess the impact of a written agenda form in a respiratory outpatient clinic. The form prompts the patient to identify their questions and issues, provides a list of frequently asked questions and invites the patient to write down the issues they wish to discuss with their doctor. We wish to identify whether use of the form increases the extent to which patients perceive that their important issues are discussed in the consultation. We will also assess whether patients feel more able to raise these issues and get the outcome they wanted, their confidence to manage their condition and consultation length.

The study is a randomised controlled trial (RCT) with a sample size of 158 patients. On arrival at the clinic patients will be randomly allocated to either the intervention group (who will receive an agenda form) or to standard practice. Patient reported outcomes will be collected after the patient has seen the doctor and consultation times will be recorded by an independent observer outside the consultation room.

Eligibility Criteria:
Inclusion Criteria:

* have an outpatient appointment at one of the designated clinics
* are able to understand the Patient Information Sheet and complete the agenda form and the feedback form, or are accompanied by a person who meets this criteria and who is willing to complete the form on the patient's behalf
* willing and able to give informed consent for participation in the study

Exclusion Criteria:

* No further criteria apply
Evaluate the Efficacy and Safety of Activated T-lymphocyte Cell Therapy in Advanced Pancreatic Cancer

Phase 2 Clinical trial to Evaluate the efficacy and safety of activated T-lymphocyte ("Immuncell-LC") cell therapy in Gemcitabine refractory advanced pancreatic cancer

This was designed as a single-center, single group clinical trial, and subjects include patients with pathologically-confirmed Gemcitabine refractory advanced pancreatic cancer.

If subjects agree to participate in the clinical trial by signing a written consent, only appropriate subjects, who meet the criteria on the examinations and tests, will undergo this clinical trial. To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 2 weeks before administration. Subjects should visit to hospital according to the protocol and receive a study drug. Therapeutic response rate, overall survival rate, time to progression and the quality of life should be investigated.

Eligibility Criteria:
Inclusion Criteria:

1. Subject who signed the written consent form by themselves, protectors or legal representatives prior to the clinical trial after the person in charge explained fully about objectives, procedure and the characteristics of the study drug.
2. Patient aged 18 to 75
3. Patient with pathologically-confirmed, advanced pancreatic cancer
4. ECOG scale (ECOG-PS) ≤2 (Appendix 4. Performance status scale/score)
5. Patient with anticipated survival period of more than 3 months
6. Patient with progressed disease after Gemcitabine-based primary anti-cancer chemotherapy
7. Patient whose blood test, renal function test and liver function test results meet the following conditions.

Exclusion Criteria:

1. Patient with the medical history of immunodeficiency or autoimmune disease that could be aggravated by immunotherapy (examples: rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, adolescent Insulin-Dependent Diabetes Mellitus, etc.)
2. Confirmed immunodeficient patient
3. Patient with the history of cancer other than skin cancer, local prostate cancer or carcinoma in situ of cervix within the last 5 years of the start of study
4. Patient who has received systemic anti-angiogenic agent
5. Patient who has received a chemotherapy other than Gemcitabine based chemotherapy
6. Obvious myocardial failure or uncontrolled arterial hypertension
7. Patient who has experienced serious allergy (judged by the investigator)
8. Patient with serious psychological disease (judged by the investigator)
9. Pregnant woman, breast-feeding woman or woman who want to be pregnant during the trial period
10. Patient who has participated in another clinical trial within the last 4 weeks of the start of study
Five-year Outcomes of Rapid-deployment Aortic Valve Replacement With the Edwards Intuity TM Valve

Objectives:

This report presents 5-year outcomes of the rapid-deployment Edwards Intuity TM valve in a single-center prospective study.

Methods:

All consecutive patients who underwent an aortic valve replacement with an Edwards Intuity TM bioprosthesis at La Timone Hospital, Marseille, France, were prospectively included between July 2012 and June 2015 and were followed for 5 years. The primary outcome was overall mortality at 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients implanted by the Intuity TM bioprosthesis
* For severe aortic valve stenosis or severe aortic regurgitation
* Including reoperation and combined surgery
* Between July 2012 and June 2015

Exclusion Criteria:

* absence of patient's authorization for anonymous publication of their clinical data for research purposes
A Comparison of the Accuracy of Toric Intraocular Lens Formulas

To compare the accuracy of the Abulafia-Koch, the Barrett, the Barrett Post ,the EVO , the new Holladay with total surgical-induced astigmatism, the Kane and and the Næser-Savini toric intraocular lens (IOL) power formulas using a large database of toric IOL refractive outcomes

To compare the accuracy of the Abulafia-Koch, the Barrett, the Barrett Post ,the EVO , the new Holladay with total surgical-induced astigmatism, the Kane and and the Næser-Savini toric intraocular lens (IOL) power formulas using a large database of toric IOL refractive outcomes.Retrospective consecutive case series.One hundred seventy-two eyes of 172 patients who had a toric IOL inserted during surgery.One eligible eye from patients having uncomplicated cataract surgery with insertion of an Alcon SN6AT(2-9) IOL (Alcon Laboratories, Inc, Fort Worth, TX) from 1 surgeon were included in the study. pre-operative were measured using either the IOLMaster 500 or 700 (Carl Zeiss Meditec AG, Jena, Germany). Using vector calculation, the predicted postoperative refractive astigmatism was calculated for each formula. This was compared with the actual postoperative refractive astigmatism to give the prediction error.

Eligibility Criteria:
Inclusion Criteria:

* uncomplicated cataract surgery with a temporal clear corneal incision,with preoperative biometry using either the IOLMaster 500 (softwareversions 5.5 and 7.7) or 700 (software version 1.50; Carl Zeiss Meditec AG, Jena, Germany)
* subjective manifest refraction performed by any of the orthoptists in the practice and measurement of the actual postoperative axis of the IOL alignment performed in the same visit an average of 1 or 3months after surgery.

Exclusion Criteria:

* any corneal disease (keratoconus, other ectasia, pterygium, or previous trauma);
* previous ophthalmic operations, including laser vision correction, vitrectomy, pterygium surgery, penetrating glaucoma surgery, or scleral buckling procedures
* intraoperative or postoperative complications
* postoperative corrected distance visual acuity worse than 6/9
Central Arterial Hemodynamics and Resistance Training

Resistance exercise training is one of the popular exercise modes that has been drawn the public's attention. However, existing evidence showed high-intensity resistance exercise training-induced negative adaptation on vascular function and blood pressure responses. Upper-body resistance exercise training is more likely to induced arterial stiffening, which has been shown to be gender-dependent. It is still unknown whether age also plays a role. We like to test the hypothesis that high-intensity upper body resistance exercise may lead to a higher increase of arterial stiffness, central blood pressure, and hemodynamic parameters in younger adults than older adults. We also hypothesize high intensity resistance training could contribute to greater central hemodynamic responses and muscle stiffness than the control; the change of muscle stiffness correlates with the change of hemodynamic parameters. Collectively, study 1 in this project is aimed to recruit 40 apparently healthy young (20-35yrs) and middle-aged to older adults (50-75yrs) into this study followed by upper-body or lower-body high-intensity exercise (80% 1 repetition maximum, 10 reps, 4 sets) by a randomized order. Blood draw, central blood pressure, hemodynamics will be performed and obtained at pre-, immediately-post, 20min, 40mins, and 60 mins post-exercise. Study 2 is aimed to investigate the effects of 8-week whole-body resistance exercise training followed by a 4-week detraining on above-measured variables in order to determine the long-term effects on resistance training. We will employee state-of-art ultrafast ultrasound to obtain muscle stiffness and carotid local pulse wave velocity. Endothelin-1 and catecholamines will also be measured to discover its underlying mechanisms on such stiffening effects induced by high-intensity resistance exercise.


Eligibility Criteria:
Inclusion Criteria:

* Healthy middle-aged to older adults

Exclusion Criteria:

* (1)BMI≧27, (2) Smoking habits for more than six months in the past, (3) Hypertension (blood pressure\>140/90 mmHg), (4) Personal diabetes history (fasting blood sugar \>126 mg /dL), heart disease, or other cardiovascular diseases, (5) bone damage, (6) regular use of supplements or vitamins
Assessment of the NIPE in Very Premature Infant Ventilated and Sedated in Neonatal Reanimation.

The Newborn Infant Parasympathetic Evaluation (NIPE) was developed as a method of analysis of the heart rate variability. The monitor gives a value between 0 (low value of the parasympathetic component) and 100 (high value of the parasympathetic component).

So far, the measure of the heart failure variability by using the NIPE in infant born very premature ventilated and sedated in neonatal reanimation has not been realised and validated as an evaluation method of the pain and discomfort related to neonatal care.


Eligibility Criteria:
Inclusion Criteria:

* Infant born very premature before 34 weeks of amenorrhoea + 0 day
* Age ≤ 7 days
* Admitted in neonatal reanimation
* Sedated, intubated, ventilated

Exclusion Criteria:

* High frequency oscillation ventilation
* Heart rate non sinusal
* Inotropes and atropine
* Opposition from the guardian of parental authority
* Difficulty of comprehension or communication making the parental information impossible
Cervical Nodal Mets in Squamous Cell Carcinoma of H&N - MRI, FDG-PET, & Histopathologic Correlation

The purpose of this study is to determine the value of novel non-invasive medical imaging methods for detecting the spread of head and neck squamous cell carcinoma to the lymph nodes in the neck by comparing their results to findings at the time of surgery.


Eligibility Criteria:
Inclusion Criteria:- Adult patients with newly diagnosed (biopsy-proven), untreated squamous cell carcinoma (SCC) of the head and neck who will undergo neck dissection as part of primary surgical therapy. Exclusion Criteria:- A prior adverse reaction to the contrast/tracer agents being used in the imaging methods being studied.

- Pregnancy.
A Multisite Trial of ACQUIREc Therapy

A multisite trial to testing different dosage levels of a systematic form of Pediatric Constraint-Induced (CI) Therapy called ACQUIREc Therapy. The high dosage treatment involved 6 hours of daily therapy services for 21 days. This was compared to a moderate dosage level of 3 hours of daily therapy services for 21 days. It was hypothesized that children receiving the higher therapy dosage would have greater and more clinically significant benefits from ACQUIREc Therapy but that both groups of children would benefit from the therapy services.


Eligibility Criteria:
Inclusion Criteria:

* Children 3-6 years of age
* Hemiparetic CP

Exclusion Criteria:

* No prior CI therapy treatments
* No Botox for 6-months
High Intensity Interval Versus Focused Ultrasound on Insulin Resistance in Diabetics With Abdominal Obesity

Obesity and diabetes share a common insulin resistance pathway and contribute to chronic hyperglycemia. Both high-intensity interval exercise (HIIE) and focused ultrasound (FUS) have been explored in the context of managing insulin resistance in diabetic individuals with abdominal obesity, though they operate through different mechanisms and have different implications.

Forty diabetic females aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will participate in this study. They will be assigned into two equal groups, Group A will receive high intensity interval exercise 2 times per week for 4 months in addition to intermitted fasting diet. Group B will receive focused ultrasound 2 times per week for 4 months in addition to intermitted fasting diet. Assessment of abdominal obesity will be applied pre and post treatment through measuring Body mass index (BMI), Waist circumference (WC) in addition to Value of HbA1c and HOMA-IR hormone will be measured to determine effect of treatment on insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

They will be recruited from El_shinnawy physical therapy Centre.

* All are suffering from abdominal obesity
* Their age between 25-35 years old
* Their body mass index more than 30 kg/m2,
* Their waist circumference ranged from 88 cm
* The fat thickness at the treatment area was at least 2.5 cm

Exclusion Criteria:

* Females having any skin diseases in the abdomen.
* Female suffering from any physical or mental disorders.
* Females suffering from abdominal scars or hernia
* Females didn´t take any medication that might affect their weight all over the study period.
* Females complaining from any cardiovascular disorders.
Parental Knowledge and Beliefs About Infant Sleep Position

In the United States, Sudden Infant Death Syndrome (SIDS)is the leading cause of death in infants between the ages of 1 and 12 months. The etiology of SIDS is still not clear although a number of risk factors have been identified. Sleeping on the stomach has been identified as a major risk for SIDS. The rates of SIDS have dropped substantially in countries in which the usual sleep position has changed from the stomach to the side or back. Back sleep has been shown to be the most stable and safest position. The American Academy of Pediatrics now recommends the back sleeping position for all healthy infants. Since the American Academy of Pediatrics began advocating the back sleep position, the incidence of SIDS has decreased by more than 40% in this country. However, the decrease has not been uniform across segments of the population. Black infants continue to have a higher rate of SIDS compared with other groups. This discrepancy could be related to infant sleep position practices. Several studies have shown that infants born to low income, minority, inner-city families were more likely to be placed on the stomach to sleep. Education appears to influence choice of sleep position and may explain, at least to some degree, the difference in choice of sleep position among certain groups. We believe that uniform education of parents will influence the sleep position that parents choose for their baby. We will undertake this initial study to document what parents choose to do with their infants regarding sleep position and why they make these choices so that we can improve our educational approach.


Eligibility Criteria:
Inclusion Criteria:

* Parent of a two-week old infant born in the Well Newborn Nursery at Yale-New Haven Hospital. Infant is brought for well child care at Yale-New Haven Hospital Primary Care Center
Effect of Long Term Cocoa Flavanol Intake on Blood Pressure and Platelet Function in Healthy Adults, Part 2

Flavanols are plant-derived compounds commonly present in the human diet. Examples of flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. The consumption of flavanol-containing foods and beverages has been associated with improvements in cardiovascular health. In this study, the investigators hope to learn more about the effects of long term consumptions of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans. This study is a continuation of a previous study investigating the consumptions of increasing amounts of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans


Eligibility Criteria:
Inclusion Criteria:

* 30-55 years old
* A normal blood chemistry and liver function
* BMI \< 30 kg/m2
* previously consumed cocoa and peanut products, with no adverse reactions

Exclusion Criteria:

* A history of cardiovascular disease, stroke, hypertension, renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery, metabolic syndrome, diabetes, taking cholesterol-lowering medication, hormone replacement therapy, antioxidant supplements, on aspirin therapy or taking anticoagulants, or on a medically prescribed diet.
* Allergies to nuts, cocoa and chocolate products
* Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight loss diet or using herbal dietary supplements
DAHANCA 35: Proton Versus Photon Therapy for Head-neck Cancer

Patients with squamous cell carcinoma of the pharynx or larynx and an anticipated benefit of proton radiotherapy in reducing the risk of late dysphagia or xerostomia are randomized to proton or photon radiotherapy (2:1)

DAHANCA 35 is two parallel conducted, but separate randomized studies, within the same trial (DAHANCA 35D and DAHANCA 35X) by the Danish Head-Neck Cancer Study Group (DAHANCA). In patients with squamous cell carcinoma of the pharynx or larynx planned for primary radiotherapy a proton and a photon doseplan is prepared. If proton radiotherapy reduces the anticipated absolute risk of dysphagia \>= grade 2 (DAHANCA scale, DAHANCA 35D) or severe xerostomia \>= grade 4 (EORTC Head-Neck 35, DAHANCA 35X) more than 5%, the patient is randomised to either proton therapy or photon therapy, 2:1. The anticipated risk of xerostomia and dysphagia is estimated using Normal-Tissue Complication Models (NTCP). Patient are analysed according to the primary endpoint (dysphagia and/or xerostomia) after which they were enrolled. DAHANCA 35D is expected to enroll 360 patients and DAHANCA 35X 240 patients (in total 600 patients).

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven squamous cell carcinoma of the pharynx or larynx planned for primary radiotherapy with curative intent
* A predicted clinical significant reduction in the risk of any of the two primary endpoints (\>= grade 2 observer-rated dysphagia or grade 4 patient-reported xerostomia) after proton therapy compared to photon therapy based on comparison of the individual patient dose plans
* No current or earlier malignancies, which may influence treatment, evaluation or outcome of the head-neck cancer
* Informed consent as required by law
* Above 18 years of age

Exclusion Criteria:

* Patient with cancers of the glottic larynx (stage I/II), skull base, sino-nasal area, unknown primary tumor and prior malignancies.
* Patients with contraindications for proton therapy. Per October 2020, this includes pacemakers, implanted defibrillators and tracheostomy
* Inability to attend full course of radiotherapy or follow-up visits in the outpatient clinic
* Distant metastasis
* Previous radiotherapy of the head and neck
* Previous surgery for the primary cancer with curative intent
Trima Non-DEHP Leukoreduced Red Blood Cell In Vivo Recovery Study

This is an in vivo 24-hour in-vivo recovery study of leukoreduced red blood cells (RBCs) collected on the Trima Accel System using Non-DEHP disposable sets and stored for 42 days.


Eligibility Criteria:
Inclusion Criteria:

1. Given written informed consent.
2. Age 18 years or older.
3. Normal health status as per AABB criteria for healthy donor.
4. Able to commit to the study schedule.
5. Meets the inclusion criteria defined by site SOPs for automated blood component collection systems or whole blood donation. These criteria are based on AABB standards and FDA regulations.

   a. Note: Participants who are deferred from volunteer community donations due to certain restrictions may participate in the study, as products are not used for allogeneic transfusion; however, sites may or may not implement this depending on their standard procedures.
6. Participants of childbearing potential (either male or female) must agree to use a medically acceptable method of contraception throughout the study.
7. Female participants of childbearing potential must agree to take a pregnancy test prior to the apheresis procedure and prior to reinfusion of radiolabeled LR-RBCs.
8. Participants must agree to report AEs throughout their participation in the study

Exclusion Criteria:

1. Currently pregnant or nursing females.
2. Serum ferritin less than12 ng/mL
3. Has previously completed this study with data included in the EAS.
4. Participation currently, or within the past 30 days, in another investigational trial that would potentially interfere with the analysis of this investigation (eg, pharmaceutical trial).
5. As determined by the Investigator:

   1. Has been diagnosed with a blood disorder(s) affecting RBC characteristics (eg, Glucose 6 Phosphate Dehydrogenase Deficiency \[G6PD\]),
   2. Reported history of RBC autoantibodies/autoimmune hemolytic anemia, RBC alloantibodies,
   3. Clinically significant acute or chronic disease, or
   4. Reported history of hypersensitivity to technetium or chromium
   5. Other unspecified reason that, in the opinion of the Investigator, makes the healthy adult volunteer unsuitable for enrollment.
6. Treatment with any medication as specified in site deferral list (based on AABB medication deferral list for apheresis donors).
7. Previously transfused/reinfused with RBCs within the last 120 days.