cyrilzakka/clinical-trials huggingface dataset:
CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve

The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis.

This is a non-randomized, prospective, multi-center safety and device success study. Up to two hundred (200) patients are planned to be implanted at up to 35 participating investigational centers in Europe, Australia and New Zealand. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, discharge, 30 days, 6 months, 1 year and annually thereafter through 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Heart team (including cardiac surgeon) agrees on eligibility including as-sessment that TAVI is appropriate.
2. High surgical risk: 8 ≤ STS Score ≤ 15 or 15 ≤ Logistic EuroSCORE I ≤ 40.
3. NYHA ≥ II.
4. Study patient is an adult of legal consent age.
5. Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits.

Exclusion Criteria:

1. Acute myocardial infarction ≤ 30 days before the intended treatment.
2. Untreated clinically significant coronary artery disease requiring revascularization.
3. Aortic valve is a congenital unicuspid or congenital bicuspid valve.
4. Mixed aortic valve disease (with predominant aortic regurgitation).
Binge Eating Syndrome Treatment for Older Women (BESTOW)

Twenty women, ages 60 or older, will be consented and enrolled in a single-arm, pilot implementation trial of the age-tailored cognitive-behavioral based BE intervention. Participants will complete assessments at baseline, post-intervention, and at two follow-up timepoints; weekly BE frequency will be collected to monitor progress during the intervention period.

The intervention being studied will be an age-tailored, cognitive-behavioral therapy (CBT) based behavioral intervention for binge eating (BE), delivered by the PI, a licensed clinical psychologist, in small group format (4-6 participants per group) over 12-16 weeks. The intervention will utilize behavioral-based strategies to reduce BE and improve health behaviors, with content including strategies to improve body image, regulation of eating behaviors, and integration of physical activity with an emphasis on body function, health, and longevity. The final session number, frequency, content, and timeline will be determined during intervention-tailoring process not a part of this clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Age 60 years and over
* Binge eating (BE) ≥1/week during the past ≥3 months
* Community-dwelling
* Able to provide informed consent
* Consistent medication regimen for 3 months

Exclusion Criteria:

* Significant cognitive impairment
* Nursing home, long-term care facility
* Psychosis or imminent suicide risk
* Current BE treatment
The Effect of Reiki on Executive Nurses

In this study, the traditional Usui Reiki protocol was applied for distant healing. Each session; It was applied approximately once a week, for 30 minutes, for two weeks. A certified Reiki practitioner (one of the researchers) received an energy transfer from his home, 80 km away. The practitioner is trained in the reiki line and has been practicing and continuing to practice reiki for over 5 years.

The practitioner made an appointment over the phone to conduct individual sessions during the morning hours when each participant was available. Before the first session, the online pre-assessment tools (Google form) of the study were delivered to the participant, and then a statement of intent was sent to the participant. The person who will take the session is requested to be in a comfortable position. During the application, he/she can talk, sleep, work if he/she wishes. However, he was warned not to use tools and cutting tools. The second session will be held at the same time, one week later, and the online final evaluation forms were asked to be filled one day later. The group will be re-evaluated after 21 days. No intervention was made in the control group. The same measurement tools were used in all groups.

Eligibility Criteria:
Inclusion Criteria:

Holding a managerial position, Executive nurses who have not received reiki therapy before will be included in the study.

Exclusion Criteria:

Previous or current reiki therapy Reiki practitioner or instructor, Nurses who are not in a managerial position will not be included in the study.
Care Plans for Cancer Predisposition

Develop and evaluate acceptability, feasibility, and preliminary efficacy of digital care plan and accompanying text message reminders for children and adolescents with a known Cancer Predisposition Syndromes (CPS).

As over 15% of pediatric cancers are associated with a cancer predisposition, it is increasingly becoming standard of care for children with cancer, as well as those with suspected hereditary risk, to be evaluated for germline cancer predisposition. Unfortunately, the increase in pediatric genetic testing has exceeded the pace of research supporting effective cancer surveillance in positive cases. Additionally, guidelines for cancer predisposition management are not easily accessed or understood by families; thus, there is often a disconnect between the understanding and retention of such information relayed to families.

In this study, Investigators will develop and evaluate the acceptability, feasibility, and preliminary efficacy of digital care plans for Cancer Predisposition Syndromes (CPS) with accompanying text message reminders for children and adolescents with a known CPS. Digital care plans and text messages will be created for 10 common CPS. Investigators will use a quasi-experimental design with pre and post testing of the same cohort, before and after delivery of care plan and accompanying messages. To evaluate the impact of the digital care plans, Investigators will compare assessments of the same cohorts at 3 and 6 months time points.

Eligibility Criteria:
Inclusion Criteria:

Parents

1. Parent or Legal Guardian of a patient with a known cancer predisposition syndrome diagnosed within the last 5 years
2. Received care at the Cancer Predisposition clinic at the Children's Hospital of Philadelphia (CHOP), or other medical institutions (does not need to be receiving follow-up care at CHOP)
3. Appropriate to approach per oncology team/cancer predisposition team
4. No cognitive impairment limiting ability to complete measures
5. Ability to read and speak English fluently

Adolescent/Young Adult (AYA) probands

1. Child proband with a known cancer predisposition syndrome diagnosed within the last 5 years
2. Ages 12+
3. Received care at the Cancer Predisposition clinic at the Children's Hospital of Philadelphia (CHOP), or other medical institutions (does not need to be receiving follow-up care at CHOP)
4. Appropriate to approach per oncology team/cancer predisposition team
5. No cognitive impairment limiting ability to complete measures
6. Ability to read and speak English fluently

Exclusion Criteria:

* Not meeting any of inclusion criteria
Lidocaine VS Hemodynamic, Metabolic and Hormonal Response

Intravenous lidocaine - a potent local anesthetic with analgesic and anti- inflammatory properties has been shown to be an effective adjunct that reduces intra and postoperative opioid consumption and facilitates pain management in adults. In children population promising but limited evidence is available. The study has been planned to evaluate the efficacy of continuous intravenous infusion of lidocaine in alleviation of hemodynamic reaction to tracheal intubation, as well as metabolic and hormonal response to laparoscopic procedure in children.

Laryngoscopy and endotracheal intubation are associated with noxious stimulation. Exacerbated circulatory system response may present as hypertension or arrhythmias including cardiac arrest. A sudden change in hemodynamic status connected with painful stimulation may precipitate deterioration in cerebral blood flow, especially in patients with intracranial hypertension (traumatic brain injury, intracranial hemorrhage, active hydrocephalus, etc). Many interventions have been applied to attenuate harmful hemodynamic reaction. One of them is intravenous lidocaine infusion. According to available data lidocaine is superior to placebo in attenuating systolic, diastolic and mean arterial pressure changes in children. Our study will focus on assessing hemodynamic stability preserving properties during induction of anesthesia and tracheal intubation. Blood pressure will be recorded and analyzed. The secondary aim is to examine intravenous lidocaine infusion in terms of reducing systemic response to surgical stress. Cortisol and glucose levels will be measured before skin incision, and immediately after the end of surgery. Side effects and serum lidocaine levels will be recorded to determine safety of the examined intervention. Similar pattern of infusion was investigated in RCT concerning children population - the toxic plasma level of 5 mcg/ml was not reached. Studies on children population have promising results but high quality randomized controlled trials are still missing. The proposed study has been planned to evaluate the efficacy of continuous infusion of lidocaine as an adjunct to standard general anesthesia (involving intravenous induction and opioid with sevoflurane maintenance) in attenuating hemodynamic reaction to tracheal intubation, as well as metabolic and hormonal response to surgical procedure in children undergoing laparoscopic appendectomy.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status class 1E, 2E, 3E;
* Patients undergoing laparoscopic appendectomy.

Exclusion Criteria:

* Allergy to local anesthetics or contraindications for the use of lidocaine;
* ASA physical status class 4E or higher;
* Severe cardiovascular disease;
* Preoperative bradycardia;
* Preoperative atrioventricular block;
* Renal failure;
* Chronic treatment with analgesics;
* Legal guardians' refusal.
Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)

The primary objective is to evaluate the impact of afamelanotide on the severity of skin disease in patients with Variegate Porphyria (VP). The secondary objectives are to evaluate the safety and tolerability of afamelanotide in patients with VP and evaluate the impact of afamelanotide on the quality of life of patients with VP.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with confirmed diagnosis of VP.
* Patients with VP-related skin symptoms.
* Aged 18-70 years.

Exclusion Criteria:

* Allergy to afamelanotide or polymer or to local anaesthetic to be used if applicable.
* Had two or more acute attacks of hepatic porphyria, as defined by the occurrence or acute porphyric symptoms within 12 months prior to the Screening period.
* Individual history of malignant or premalignant skin lesions.
* Individual or family history of melanoma.
* Presence of severe hepatic disease.
* Renal impairment.
* Female who is pregnant or lactating.
* Females of child-bearing potential not using adequate contraceptive or a life-style excluding pregnancy.
* Sexually active man with a partner of child-bearing potential not using adequate contraceptive measures.
* Use of any other prior and concomitant therapy which may interfere with the objective of the study, within 30 days prior to the Screening period.
* Participation in a clinical trial within 30 days prior to the Screening period.
Rapid Diagnostic Testing and Artemisinin-Based Combination Therapy for Uncomplicated Malaria by Community Health Workers

The purpose of this study is to evaluate the efficiency of a rapid diagnostic test (Paracheck Pf) for the diagnosis of uncomplicated Plasmodium falciparum malaria by community health workers at village level in Tanzania and how the use of rapid diagnostic test may influence prescription of antimalarial drugs.

The hypothesis is that rapid diagnostic tests used by community health workers will reduce the use of antimalarial drugs (Coartem; Novartis) by 30% without affecting the health outcome.


Eligibility Criteria:
Inclusion Criteria:

* Fever
* Informed consent

Exclusion Criteria:

* Severe clinical manifestations, which require immediate referral
* Pregnancy
* Previous enrollment in the study within the last 28 days
Patient Education in Children With Functional Gastrointestinal Disorders

This pilot-study aims to evaluate the effect size and feasibility of patient education for children and adolescents (age 8-17 years) with pain-predominant functional gastrointestinal disorders (irritable bowel syndrome, functional abdominal pain and functional dyspepsia according to the Rome III criteria).

The patient education will be provided in a group setting and the children will participate along with one of their parents. Education consists of 2-hour long group sessions, given at 2 different occasions within a month.

The hypothesis is that patient education will reduce gastrointestinal symptoms and pain and also improve quality of life in this group of patients.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents between 8-17 years (until their 18th birthday) who have been diagnosed with any of the diagnoses irritable bowel syndrome, functional dyspepsia or functional abdominal pain according to the Rome III criteria.
* Blood samples, with normal outcome, in terms of complete blood count (CBC), Erythrocyte Sedimentation Rate (ESR), Anti-tissue Transglutaminase Antibody (tTG), and dipstick urinalysis. Faecal Calprotectin should be measured if diarrhea is present.

Exclusion Criteria:

* Insufficient skills in the Swedish language.
* Severe psychiatric comorbidity (as suicidality, psychosis etc).
* Severe somatic comorbidity.
Evaluation of Postprandial Glycaemia in a Healthy Population After Intake of Milk and Oat Based Products

The objective of this study is to investigate the effect on postprandial glycaemia in a healthy population after intake of milk and oat based products.

Postprandial glycaemia, insulinaemia and GLP-1 will be measured after intake of test meals with equal amount of carbohydrates (adjusted using bread) and equal amount of total water.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female 20 to 40 years of age
2. BMI 20-27 (±0.5) kg/m²
3. Agree to maintain consistent dietary habits and physical activity levels for the duration of the study
4. Healthy as determined by medical history and information provided by the volunteer
5. Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits
6. Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

1. Elevated fasting blood glucose (at or above 6.1 mmol/L at fasting on visit 2, 3, 4 or 5)
2. Elevated fasting insulin (above 25 mIE/L)
3. Women who are pregnant or breast feeding
4. Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the SI
5. Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the SI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless recommended by their physician.
6. Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
7. Use of antibiotics within 2 weeks of enrollment
8. Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
9. Allergy to ingredients included in investigational product, placebo or standardized meal
10. Participants restricted to a vegetarian or vegan diet
11. Intolerance to lactose or gluten
12. Individuals who are averse to venous catheterization or capillary blood sampling
13. Currently active smokers (or using other tobacco products, and e-cigarettes)
14. Unstable medical conditions as determined by SI
15. Participation in other clinical research trials
16. Individuals who are cognitively impaired and/or who are unable to give informed consent
17. Acute infection
18. Any other condition which in the SI's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual
Safety and Feasibility of Transulnar Artery Approach for Coronary Angiography or Angioplasty

The transradial approach for coronary angiography and angioplasty is now widely used in catheterization laboratories worldwide, which had been shown as advantages over the conventional femoral and brachial approaches due to the lower incidence of bleeding and other cardiovascular complications. However, the transradial approach does not seem suitable for 5-15% of patients undergoing coronary angiography and angioplasty. The ulnar artery which is one of the two terminal branches of the brachial artery is usually larger than radial artery and it may be as a potential approach for cardiac catheterization. Recently, some reports have demonstrated that the transulnar approach may be both feasible and safe for coronary angiography and angioplasty in selective patients.we performed this study to evaluate the safety and feasibility of transulnar approach coronary catheterization in real world non-selective patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of coronary artery disease
* Needed to perform coronary angiography or angioplasty

Exclusion Criteria:

* Arterial circulatory disease in an upper limb
* History of deformity
* Forearm trauma
* Forearm amputated
* Hemodialysis
* Symptomatic peripheral artery disease
* Raynaud's syndrome
* Hemorrhagic disease
* Cardiogenic shock
* Others who were unwilling to participate the study
Improving Older Adults' Decision Making for OSAT

This study evaluates the feasibility of conducting a randomized controlled trial that tests a patient decision aid for obstructive sleep apnea in older adults with newly-diagnosed obstructive sleep apnea treated in an outpatient sleep clinic. Half of the participants will use a patient decision aid, while the other half will receive general information about sleep.

Patient decision aids are one strategy for helping older adults make informed decisions about treatments. Patient decision aids improve patients' knowledge about therapies and encourage them to actively weigh the risks and benefits of each therapy.

Eligibility Criteria:
Inclusion Criteria:

1. age \>= 60 years
2. diagnosed with obstructive sleep apnea on a sleep study
3. able to read English-language newspaper text (if needed, using contact lens/glasses)
4. able to write words in a paper booklet
5. scheduled for a sleep clinic appointment with a UCLA sleep provider
6. able to attend a sleep educational session prior to sleep clinic appointment

Exclusion Criteria:

1. unable to provide informed consent
2. dementia
3. mild cognitive impairment diagnosis or Mini-Cog score \< 3
4. treated for obstructive sleep apnea for \> 30 days prior to scheduled sleep education intervention
5. severe physical or mental illness (e.g., hospitalized within past 7 days prior to scheduled sleep education intervention, substance abuse within 90 days of sleep education intervention)
Phase II Study of Preoperative IMRT Combined With Capecitabine and Bevacizumab in Locally Advanced Rectal Cancer

Pathological complete response, (pCR) correlates with a favourable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative IMRT combined with bevacizumab and capecitabine. primary endpoint is pathological complete remission rate.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with histologically proven adenocarcinoma of the rectum ,T3/4 or any node positive disease (clinical stage according the TNM classification system)
* No evidence of metastatic disease.
* Age 18 - 65 years
* Kps 80-100
* No prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer
* Normal hematological, hepatic and renal function, Ability to swallow tablets
* Signed informed consent
* Patients must be willing and able to comply with the protocol for duration of the study

Exclusion Criteria:

* Malignancy of the rectum other than adenocarcinoma

  * Other co-existing malignancy or malignancy within the past 5 years, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin
  * Significant heart disease (uncontrolled hypertension despite of medication (\> 150/100 mmHg), NYHA class III or IV heart disease,unstable angina or myocardial infarction within the past 1 year prior the study entry, history of significant ventricular arrhythmia requiring treatment)
  * Evidence of active peptic ulcer or upper GI bleeding
  * Evidence of bleeding diathesis or coagulopathy
  * Patients receiving a concomitant treatment with drugs interacting with capecitabine such as flucitosine, phenytoin, or warfarin
  * Known hypersensitivity to biological drugs
  * Treatment with any investigational drug within 30 days before beginning treatment with the study drug
  * Pregnant or lactating patient