cyrilzakka/clinical-trials huggingface dataset:
FIRE AND ICE II Trial Pilot

The FIRE AND ICE II Trial (Pilot) is the pilot phase of a prospective, randomized, single-blinded, multi-center, interventional post-market clinical trial, comparing efficacy and safety of isolation of the pulmonary veins (PVI) using a Cryoballoon catheter or radiofrequency ablation with a ThermoCool® Smarttouch® catheter in subjects with persistent atrial fibrillation (AF).

60 patients with persistent AF will be randomized 1:1 between Cryoballoon ablation and Radiofrequency ablation in the FIRE AND ICE II Trial Pilot at 5 clinical sites in Europe.

The data collected within the pilot phase will be reviewed and a decision on extending the trial with an extended number of patients and sites as main phase will be taken.

Eligibility Criteria:
Key Inclusion Criteria

* Documentation of symptomatic persistent AF (following the European Society of Cardiology (ESC) guideline 2016) defined as: Persistent AF - AF that lasts longer than 7 days, including episodes that are terminated by cardioversion, either with drugs or by direct current cardioversion, after 7 days or more
* Date of first diagnosis of persistent AF within the last 12 months preceding the date of screening
* Documented treatment failure or intolerance of at least one Class I or Class III antiarrhythmic drug

Key Exclusion Criteria

* Known pre-existing hemi-diaphragmatic paralysis
* Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
* History of right atrial flutter, not ablated prior to enrollment
* Any cardiac surgery, myocardial infarction, percutaneous coronary intervention or coronary artery stenting which occurred within the 3 months before the eligibility assessment
* Unstable angina pectoris
* Primary pulmonary hypertension
* Any condition contraindicating chronic anticoagulation
* Any cerebral ischemic event (stroke or transient ischemic attack \[TIA\]) which occurred within the 6 months before the consent date
* Presence of any cardiac prosthetic valves
* Long-standing persistent AF lasting for ≥ 1 year (even when it is decided to adopt a rhythm control strategy)
* New York Health Association (NYHA) class III or IV heart failure and/or documented left ventricular ejection fraction (LVEF) \< 40% measured by acceptable cardiac testing (e.g. TTE)
* Acute cardiac condition, including endocarditis, pericarditis or pericardial effusion
* Presence or likely implant of a permanent pacemaker, biventricular pacemaker or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
Web-based Education on Oral Cancer for Primary Care Physicians in Ohio

Objective:

The experimental design is a one-site, randomized experimental web-based educational feasibility intervention trial, with approximately 50% primary care physicians (PCPs) in the intervention group and approximately 50% PCPs on the control group, giving a total of 159 participants. All 159 participants have willingly provided their e-mail addresses, as part of a survey they previously completed entitled, "Survey of Health Professionals on Oral Cancer in Ohio- Intervention to Prevent Delayed Diagnosis of Oral Cancer."

The main specific aim is to determine the short-term effectiveness of a web-based educational intervention for primary care physicians (PCPs) in Ohio to improve the following:Index of knowledge of risk factors for oral cancer, and Index of knowledge of diagnostic procedures for oral cancer

The following hypothesis will be explored: The use of a web-based educational module for PCPs in Ohio regarding oral cancer will increase the proportion of the PCPs in the high score category for the following indices: Index of knowledge of risk factors of oral cancer, and Index of knowledge of diagnostic procedures for oral cancer

Eligibility Criteria:
Inclusion Criteria:

* The PCP's who participated in Specific Aim #2 (Survey of Healthcare Professionals on Oral Cancer in Ohio ) of the NIH K23 grant proposal, "Intervention to Prevent Delayed Diagnosis of Oral Cancer", will be eligible to participate in this Web-Based Education on Oral Cancer.
* Possessing the ability to give voluntary consent to participate. Participating in the web-based educational intervention is am implication of consent.
* All participants are expected to be relatively healthy.

Exclusion Criteria:

• Unable to have access to the internet to be able to participate in the web-based education.
Yoga as a Treatment for Insomnia

The purpose of this study is to evaluate the effectiveness of a daily, 8-week treatment for insomnia using yoga, relaxation exercises or sleep hygiene.

Insomnia is a sleep disorder characterized by a chronic difficulty in initiating and maintaining sleep which has a relatively high prevalence and a significant socioeconomic cost. There is good evidence that cognitive and/or physiological arousal, associated with sustained sympathetic activation, is one of the underlying causes of insomnia. Relaxation treatments such as progressive relaxation and meditation which address the cognitive and somatic arousal associated with insomnia have been found to be effective. Yoga is a comprehensive discipline which includes physical exercises, postures, breathing techniques, and meditation, for the purpose of improving health and well being. Research studies have documented the effectiveness of yoga in reducing sympathetic activation and cognitive and somatic arousal and in the treatment of specific medical disorders. Although it has been used and recommended for the treatment of insomnia, its effectiveness has not been evaluated in a randomized, controlled study. The aim of this proposal is to evaluate the effectiveness of yoga, relaxation exercises or sleep hygiene in the treatment of chronic psychophysiological insomnia. A subjective measure of sleep onset latency will be derived from daily sleep diaries, and an objective measure will be drawn from polysomnographic recordings. Sleep onset latency will be evaluated before and after a two month treatment period in a total of 48 young men and women who have been carefully screened for psychiatric and medical disorders. Subjects will be assigned to a yoga, relaxation exercise, or sleep hygiene treatment group. We anticipate that yoga practice will prove to be an effective treatment for insomnia which will yield significant improvements in sleep onset latency. We also anticipate that these improvements will be maintained at long-term follow up evaluation.

Eligibility Criteria:
Inclusion criteria

* A primary complaint of sleep-onset insomnia for at least 6 months.

  * Reside in the metropolitan Boston area

Exclusion Criteria

* No current other nonpharmacological treatment for insomnia.
* Ability or willingness to discontinue use of hypnotic medications.
* No rotating or night shift work, or transcontinental travel throughout the course of the study protocol.
* No recent or anticipated major life stressors over the course of the study protocol (e.g. impending divorce or terminal illness of a relative).
Motor Control Prevention Strategies in Basketball Players

Ankle sprains have always been considered as isolated injury entities, in which the passive ankle stabilisation system suffered an elongation due to trauma. Today, this concept of an isolated injury has evolved into a more holistic concept, interrelated with various components from different sources.


Eligibility Criteria:
Inclusion Criteria:

* Basketball players aged between 10-18 years old who play regularly in one of the basketball clubs in the city of Salamanca.

Exclusion Criteria:

* previous injuries
* fractures
* use of orthoses and technical aids
Integrative Medicine Consultation for Patients With Pain or Fatigue

Patients with a diagnosis of chronic fatigue or pain benefit minimally from a conventional medical evaluation yet consume a large amount of medical resources and time. The question is to see if patients with a diagnosis of chronic pain or fatigue benefit from an Integrative Medicine medical evaluation conducted by physician who has additional training in Integrative Medicine. Patients who call for a general medical examination with a complaint of chronic fatigue or pain will be set up with the integrative medical specialist or standard general medical evaluation.


Eligibility Criteria:
* Patients seeking a medical evaluation for a primary complaint of pain or fatigue.
Evaluation of Lymphodepletion With ALLO-647 in Adults With R/R Large B Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy

The purpose of the EXPAND study is to assess the safety and clinical efficacy of ALLO-647 combined with fludarabine and cyclophosphamide compared to fludarabine and cyclophosphamide alone in a lymphodepletion regimen prior to ALLO-501A CAR T therapy in adults with relapsed or refractory large B-cell lymphoma


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse
* Relapsed or refractory disease after at least 2 lines of chemotherapy
* ECOG performance status 0 or 1
* Absence of significant donor (product)-specific anti-HLA antibodies (DSA)
* Adequate hematological, renal and liver function

Exclusion Criteria:

* Active central nervous system involvement by malignancy
* Autologous or allogeneic HSCT within last 6 months prior to lymphodepletion
* Hypocellular bone marrow for age
Study on the Effect of Prostacyclin Compared to Placebo in Traumatic Brain Injury

This study is a prospective consecutive double-blinded randomized study on the effect of PGI2, prostacyclin (epoprostenol, Flolan®) versus placebo (saline)in patients with severe traumatic brain injury. All patients with severe traumatic brain injury were eligible for inclusion. Inclusion criteria: verified traumatic brain injury, Glasgow Coma Score (GCS) at intubation and sedation of ≤ 8, age 15-70 years, a first-recorded cerebral perfusion pressure (CPP) of \> 10 mm Hg, and arrival within 24 hours after trauma.

Tne primary aim was to evaluate whether treatment with epoprostenol would reduce a lactate/pyruvate ratio,as measured by cerebral microdialysis after 24 hours of treatment.

A secondary aim was to evaluate the effect of epoprostenol on systemic inflammatory markers, measured by different cytokines.


Eligibility Criteria:
Inclusion Criteria:

* traumatic brain injury, Glasgow coma scale ≤ 8

Exclusion Criteria:

* pregnant or lactating women
Adaptation of High Activity Arthroplasty Score to Turkish

The objectives of this study were the translation, cross-cultural adaptation, and assessment of the psychometric properties of the Turkish High-Activity Arthroplasty Score (HAAS) in patients with primary TKA.

The purpose of this study is to translate and cross-culturally adapt the HAAS instrument into Turkish and investigate its psychometric properties. For cross-cultural adaptation, two bi-lingual translators used the back-translation procedure. Within a 5-to-7-day period after the first assessment, the participants will complete the Turkish version of HAAS to evaluate test-retest reliability. Cronbach's alpha (α) will use to assess internal consistency. The correlations with the Turkish version of the KOOS, SF-36 and FJS-12 will determine to check the validity.

Eligibility Criteria:
Inclusion Criteria:

1. Primary THA/TKA due to primary osteoarthritis for \>6 months,
2. Age \<65
3. To be able to communicate in Turkish
4. Agree to participate in the study

Exclusion Criteria:

1. who do not agree to participate in the study 2- who will undergo 2nd revision TKA 3- who have undergone lower extremity surgery and thus have sequelae 4-having cognitive impairment
Female Upper Genital Tract in HIV-infected Women

The female upper genital tract is a unique compartment involved in HIV pathogenesis.

The persistent detection of HIV in the female genital tract in spite of ART is unexplained, and it is possible the uterine endometrium serve as a reservoir. There are limited data regarding the interaction between HIV expression, antiretroviral therapy (ART) and host immune system in the uterine endometrium.

Eligibility Criteria:
Inclusion Criteria:

* Regularly menstruating women (between 21-42 days)
* between ages 25-50 years
* Fully suppressed by antiretroviral therapy with plasma HIV RNA \< 40 copies/mL within the last 6 months.

Exclusion Criteria:

* Pregnant or planning pregnancy
* Unwilling to use 2 forms of contraception (condoms + hormonal) if they did not have previous bilateral tubal ligation procedure
* Intrauterine device in place
* Untreated cervical infection (N. gonnorhea, C. trachomatis)
* Taking immunosuppressive medications
The Effectiveness of Improving Self-care After Counseling for the Diabetics Mellitus Foots Around Chiayi Region

Objectives:

Preventing diabetic foot problems (DFP) and associated consequences, such as amputation, is a critical in rural regions. The objective is to present on the association of non-invasive DFP assessment tools and physiological indicators for the early detection of DFP among rural cases of diabetes in Taiwan.

1. Peripheral neurological assessment was carried out using Michigan Neuropathy Screening Instrument (MNSI). The diabetes nurse educators assessed five parameters on both feet and counted the total points, ranging from 0 to10: (1) Appearance of feet (normal/abnormal with 0 and 1 point); if abnormal, then inspection of lower limbs for deformities, dry skin, fissure, calluses or infection was carried out; (2) Identification of foot ulceration (yes/no with 0 and 1 point); (3) Vibration perception of the big toe (present/decreased/absent, with 0, 0,5 and 1 points); (4) Ankle reflexes (present/reinforcement/absent, with 0, 0,5 and 1 points); (5) touch-pressure sensation test with a 10 g Semmes-Weinstein monofilament (normal/reduced/absent, with 0, 0,5 and 1 points). When an MNSI summative score was ≥2 points with neuropathy, patients were referred to the teaching hospitals for further evaluation. The MNSI procedures took 6-8 minutes for each participant.
2. Peripheral vascular assessment: three parameters were used to assess peripheral vascular function by trained nurses. (a) The Cardio-Vision Model MS-2000 was used to detect Ankle Brachial Index (ABI), assessed by research nurses. Values of ABI were classified as ≥0.9 normal and \<0.9 abnormal. (b) Palpable pedal, posterior tibias and popliteal pulses were recorded as absent, weak or present. (c) Capillary refill time was done by pressing the tip of the toenail for two seconds, and taking the time for the blanched area to turn pink again. If the return time took \>2 seconds, this was taken as ischemia. Assessing of all 3 parameters of peripheral vascular assessment took 10-15 minutes for each participant.
3. Diabetic foot risk assessment was assessed by plastic surgeons: (a) King's College classification (KC) contained six stages of condition: not at risk, at risk, ulcer, cellulites, necrosis and amputation. (b) the Texas risk classification (TRC) system was divided into six categories in origin. We re-categorized three levels: low risk, at risk, and high risk.
4. The blood glucose, total cholesterol, and low density of lipoprotein cholesterol were drawn from the last 1-2 month diabetes passport record for each subject. Blood pressure was measured according to standard procedures by the nurses during the study. Body mass index was calculated for each participant using the standard formula (weight in kilograms divided by square of the height in meters). Waist circumference in centimeter was used to measure central obesity, measuring the mid-abdominal distance between the last rib margin and the iliac crest.

Eligibility Criteria:
Inclusion Criteria:

* diabetics mellitus patients
Childhood Trauma, Exercise, and Cognition

This study aims to identify and compare the effects of acute and chronic exercise interventions on cognition in middle-aged adults with cognitive complaints and a history of abuse or neglect in childhood. Each participant will be enrolled in the study for up to 78 days, in five parts following verification that the participant meets criteria to be included in the study: 1) initial assessment; 2) first acute exercise condition in lab, symptom measures, and neuropsychological testing; 3) second acute exercise condition in lab, symptom measures, and neuropsychological testing; and 4) 9-week exercise intervention or activity as usual outside of lab, with interview, symptom measures, and neuropsychological testing at three-week intervals.


Eligibility Criteria:
Inclusion Criteria:

* between 40 and 60 years of age
* history of child abuse or neglect
* have a complaint about memory, attention, or executive function
* native or fluent English speaker
* normal or corrected to normal vision and hearing
* medically healthy

Exclusion Criteria:

* Score indicating a history of moderate-intensity activity, hard-intensity activity, or very-hard intensity activity on the Stanford Brief Activity Survey
* current excessive alcohol or other substance use
* eating disorder, bipolar disorder, schizophrenia spectrum disorders, or those judged to be an immediate suicide risk based on having an active plan with intent
* autism spectrum disorder, attention-deficit/hyperactivity disorder (ADHD), or other neurodevelopmental disorder
* neurocognitive disorder, or illnesses or history of neurological events known to cause neurocognitive disorders (e.g., traumatic brain injury, status epilepticus, stroke)
* reported chest pain or dizziness during exercise; any endorsed and not controlled medical condition that could make exercise contraindicated, including hypertension; heart disease; heart failure; hear rhythm disorders; heart valve disease; metabolic conditions; chronic obstructive pulmonary disease; pulmonary hypertension; cystic fibrosis; asthma; and bone, joint, or soft tissue problems
* pregnancy, major medical disorders such as cancer, or any other condition believed to put a participant at risk
Long Term Outcomes of Vivity Intra Ocular Lens(IOL) Versus Control

Evaluate the long-term (\>1 yr) outcomes of the Vivity IOL. The investigator will use similar measurements and procedures to the ones performed on these subjects during the FDA clinical trial.


Eligibility Criteria:
Inclusion Criteria:

Must have participated in the FDA study at one of the included sites

Exclusion Criteria:

None
Cardiac Function and Inspiratory Muscles Performance

The purpose of this study is to determine whether ejection fraction and peak oxygen uptake have correlation on inspiratory muscle strength, chest wall volumes and quality of life in individuals with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Will be included individuals diagnosed with heart failure, both sexes, aged 18-65 years;
* hemodynamically stable (systolic blood pressure ≤ 140 mmHg; diastolic blood pressure ≤ 90 mmHg; heart rate = 90 bpm);
* self-reported sedentary.

Exclusion Criteria:

* Will be excluded individuals with unstable angina were excluded;
* acute myocardial infarction or previous surgery up to three months before the survey;
* musculoskeletal changes, respiratory or chronic metabolic diseases;
* treatment with steroids, hormones or chemotherapy;
* gestation;
* smokers and former smokers assets or liabilities;
* inability to comply with verbal commands appraiser or unsuitability to the evaluation devices.
Pilot Study: Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain

The main objective of the pilot study is to investigate the process that includes recruitment (to estimate the rate of enrollment), feasibility, protocol refinement, and willingness of the subject to be randomized. To provide a sample estimate of the population parameter which is the true value in the target population to be used in the planning of a larger confirmatory study.

Secondary objectives include:

To examine the efficacy of pre/post-operational administration of dexamethasone vs Vicodin (acetaminophen and hydrocodone) for post-operative pain control following periodontal surgery at the Henry M. Goldman School of Dental Medicine.

To examine how BMI alters the response to dexamethasone and hydrocodone following periodontal surgery since obese patients have shown higher pain scores and increased pain sensitivity in previous experimental models of pain.


Eligibility Criteria:
Inclusion Criteria:

* Must be scheduled for periodontal surgery
* Subjects must be aged 21 years old and above
* Able and willing to provide informed consent
* 20 non-obese patients with BMI less than 30kg/m2
* 20 obese patients with BMI greater than or equal to 30kg/m2
* Diabetic and hypertensive patients included

Exclusion Criteria:

* Patients allergic to any formulations used in the study
* Patients with chronic use of nonsteroidal anti-inflammatory drugs or chronic use of narcotics; chronic defined as frequent use or misuse/ abuse so much as once a month
* Pregnant or lactating female patients; pregnancy test will be performed alongside the medical history
* Patients with kidney dysfunction
* Patients at risk for infective endocarditis determined by the medical history or past medical records
Study on the Sociopsychoemotional Mechanism of Dysfunction in Patients With Acute and Chronic Low Back Pain

Low back pain is defined as pain that extends from the 12th rib to the iliac bone, and its increasing incidence makes it one of the major causes of decreased productivity worldwide. Dysfunction is one of the important complications in patients with chronic low back pain, and related studies have shown that depression, pain catastrophization and other emotions can affect the occurrence and development of dysfunction. So we wanted to study which psychological emotions affect the development of dysfunction in patients with low back pain.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75;
2. Patients with low back pain;
3. Have good communication skills to ensure the collection of scale information

Exclusion Criteria:

1. Suffering from serious mental or mental illness;
2. Unwilling to participate in the interview;
3. Patients with pain in other areas
Study to Test Genetic Alterations Among Different Dermoscopic Types of Melanocytic Nevi.

This project is a multicenter study in which we will investigate a dual concept of nevogenesis. Study location is the Department of Dermatology at the Medical University of Graz in collaboration with centers in Austria (Vienna), Italy (Naples, Benevento, Modena), Spain (Barcelona) and the United States (New York).

The hypothesis is that small congenital melanocytic nevi (CMN), "early" acquired melanocytic nevi in childhood (AMN) and dermal nevi, all dermatoscopically characterized by globular pattern, belong to the same spectrum of genetically determined melanocytic proliferations that develop due to endogenous pathways, in contrast to "true" acquired melanocytic nevi, dermatoscopically showing reticular pattern, that develop due to exogeneous factors such as UV-exposure.

The investigations to this study will verify whether small CMN, "early" AMN and dermal nevi, characterized by globular pattern differ in their genetic alterations compared to reticular typed nevi. It will be expected that globular typed nevi and eventually dermal nevi lack B-RAF mutations whereas reticular nevi show alterations in the B-RAF gene. Study location: Graz

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals aged 9 to 80 years showing one or more dermoscopically benign nevi with either uniform globular-cobblestone pattern or reticular pattern or a combination of both types

Exclusion Criteria:

* Children under the age of 9 years
* Pregnant woman
* Patients with atypical nevi (i.e., melanoma cannot be clinically ruled out)
* Patients with immunosuppression
* Patients with sun exposure 4 weeks before enrollment