cyrilzakka/clinical-trials huggingface dataset:
Korean Vascular Intervention Society Multicenter Registry Study on Outcomes of Endovascular Therapy in Lower Limb Artery Diseases (K-VIS ELLA): (A Retrospective & Prospective Observational Study)

1. Study design: multicenter retrospective and prospective observational study
2. Study Cohort :

   1. Retrospective cohort: This cohort retrospectively enrolls patients with lower extremity artery disease who underwent endovascular treatment from January 2006 to the date of approval by IRB in the participating hospitals. Informed consent was waived by IRB.
   2. Prospective cohort: This cohort prospectively enrolls patients with lower extremity artery disease who undergo endovascular treatment from the date of approval by IRB to July, 2018 in the participating hospitals. Informed consent will be obtained prior to enrollment.
3. Baseline clinical and lesion characteristics, procedural and post-procedural data, clinical outcomes, hemodynamic, and imaging follow-up data are investigated. Primary patency and target lesion revascularization rates of the total cohort and patient subgroups are evaluated. Risk factors of restenosis and target lesion revascularization are determined.

This is an observational study. The study includes patients who underwent endovascular treatments for lower extremity artery diseases and investigates immediate and late outcomes of the treatments. The investigator does not assign any specific interventions.

Eligibility Criteria:
Inclusion Criteria:

* Retrospective data Patients who underwent or attempted endovascular treatment for symptomatic peripheral artery disease from January 2006 until IRB approval date
* Prospective data

  1. Age 20 years of older
  2. Patients in the treatment or trying about symptomatic peripheral artery disease from IRB approval date
  3. Symptomatic peripheral artery disease:

     * Intermittent claudication (Rutherford category 1 to 3)
     * Critical limb ischemia (Rutherford category 4 to 6)

Exclusion Criteria:

1. Pregnant women or women with potential childbearing
2. Moderate Alzheimer's disease, mental illness or neurological disease of more than those who can not understand the purpose of this clinical trials and Methods
3. Life expectancy \<1 year due to comorbidity
The Use of FlowMet-R Technology to Predict Wound Healing in CLI Patients in a Wound Care Center Setting

Single-institution, prospective nonrandomized pilot study of critical limb ischemia patients with planned lower extremity revascularization will undergo Flowmet-D measurements in a wound care center setting to determine threshold values associated with wound healing and amputation. A subset of patients will undergo hyperbaric oxygen therapy and will have Flowmet-D measurements to determine those who respond best to therapy.

A single-institution, prospective nonrandomized pilot study will be conducted at Stanford Hospital and the Stanford Advanced Wound Care Center (AWCC). Patients with CLTI by WIfI criteria (ABI or toe pressures) and a concomitant non-healing lower extremity wound will be recruited. Inclusion criteria will include CLTI, at least one active lower extremity wound and planned lower extremity revascularization. ABI/TBIs will be recorded preintervention, post intervention and at one and three month intervals. Intraprocedural characteristics including the number and location of vessels revascularized, patent runoff vessels pre and post procedure, pedal arch anatomy and presence of angiographic "blush" to wound will be documented.

Post-operatively, patients will be followed at the AWCC where they will receive standard of care wound management including offloading, regular debridement, infection and edema management. FlowMet-R perfusion values will be obtained prerevascularization, immediately post revascularization as well as weekly at each follow up AWCC visit for a total of up to 6 months or until wound healing.Wound size will be recorded.

Patients who undergo hyperbaric oxygen therapy (at the discretion of AWCC surgeon) will have perfusion values performed before and after hyperbaric oxygen therapy sessions 1, 2, 10, 20, 30 and 40. Hyperbaric oxygen therapy will be conducted 5 days a week for duration of 90 minutes. Patients who undergo other advanced wound care treatments such as stem cell therapies or skin substitutes will also received FlowMet-R prior to and after treatment. Primary outcomes will be wound healing defined as complete skin epithelialization, wound improvement rate, major and minor amputations as well as need for repeat revascularization.

Eligibility Criteria:
Inclusion Criteria:

CLI Cohort:

* CLI by WIfI criteria (ABI or toe pressures)
* Non-healing lower extremity wound
* Planned lower extremity revascularization
* Able to provide informed consent
* Able to comply with study procedures

HBO Cohort:

* All of the above
* Enrolled in HBO therapy post revascularization (at the discretion of the provider)

Exclusion Criteria:

* Under 30
* Wound not suitable for FlowMet-D probe attachment
Study of the Evaluation of Patient Education Efficacy in Pharmacy of National Taiwan University Hospital

The primary purpose of this study is to evaluate the patient education efficacy of the pharmacists in National Taiwan University Hospital. We randomize patient family into one of the following three groups:

1. To read the package insert of the drug
2. To read the education information provided by Pharmacy of NTUH
3. Oral education provided by the pharmacist

Then we will evaluate the difference on patient knowledge of reconstitution, storage, and administration of oral antibiotic suspension from powder dosage form between these three groups.

The primary purpose of this study is to evaluate the patient education efficacy of the pharmacists in National Taiwan University Hospital. We designed twelve questions about reconstitution, storage, and administration of oral antibiotic suspension from powder dosage form in a questionnaire. We will recruit pediatric patients who are prescribed one of the two oral antibiotics powder for suspension, Augmentin and Zithromax. We will randomize the family of these patients into one of the following three groups:

1. To read the package insert of the drug
2. To read the education information provided by Pharmacy of NTUH
3. Oral education provided by the pharmacist

Then we will ask them the twelve questions in the questionnaire and record their answer. Eventually, we will be able to compare the number of the correct answer, and to evaluate the difference on patient knowledge of reconstitution, storage, and administration of oral antibiotic suspension from powder dosage form between these three groups.

Eligibility Criteria:
Inclusion Criteria:

* Family of pediatric patient who is prescribed one of the two oral antibiotics granule for suspension, Augmentin and Zithromax, in NTUH

Exclusion Criteria:

* Family of pediatric patient who can not read Chinese
Effects of Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease (COPD)

The additional effect of inspiratory muscle training as an adjunct to a general exercise training program in patients with COPD with inspiratory muscle weakness will be studied. The main hypothesis is that inspiratory muscle training combined with an exercise training program improves functional exercise capacity more than an exercise training program without the addition of an inspiratory muscle training program.


Eligibility Criteria:
Inclusion Criteria:

* Patients with COPD
* Eligible to participate in an inpatient pulmonary rehabilitation program of 3 weeks
* Pi,max \<60 centimeters of water or \<50% of the predicted normal value

Exclusion Criteria:

* Major comorbidities preventing successful participation in an 8 week exercise training intervention
* use of non-invasive ventilation
The Impact of Minimally Invasive Restorative Techniques on Dental Pain in Pregnant Women

The aim of the present study was to compare the effectiveness of chemo-mechanical caries removal using Papacarie-Duo and Atraumatic Restorative Treatment (ART) in reducing dental pain in pregnant women.

A randomized controlled clinical trial was conducted in 2019 and included 162 pregnant women visiting family health centers in Alexandria, Egypt with dental pain due to caries not extending to pulp who were randomly assigned into Papacarie-Duo group (n=82) and ART group (n=80) after stratification by number of treated surfaces

Eligibility Criteria:
Inclusion Criteria:

* Pregnant females in the first or second trimester
* Having at least mild dental pain as identified by a score of at least 5mm on a Visual Analogue Scale (VAS) 100-mm-long
* Having at least one carious lesion involving dentine clinically classified as a shallow or medium cavity. This cavity should be accessible to hand instruments (International Caries Detection and Assessment System (ICDAS) score= 5 or 6.

Exclusion Criteria:

* Pregnant women with acute pulpitis, swelling or fistula.
* Uncooperative patients.
* Patients with severe gingivitis (Gingival Index (GI) score=3).
* Patients who are unable to read and/or write and those who refused to participate.
Safety and Immune Response of COVID-19 Vaccination in Patients With Basic Disease

On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SAＲS-CoV-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, COVID-19).Due to the decline of immunity and cardiopulmonary function in patients with basic diseases (hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, cancer diseases, etc.), COVID-19 's severe illness and mortality mainly increase in these special population. Vaccination of COVID-19 vaccine can effectively prevent COVID-19 virus infection and delay or prevent patients from developing into critical illness and reduce mortality.To evaluate the safety and effectiveness of the population vaccinated with COVID-19 vaccine, and to play a scientific and theoretical supporting role in guiding COVID-19 vaccination scientifically, reasonably and effectively, so this study was carried out.

Due to the decline of immunity and cardiopulmonary function in patients with basic diseases (hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, cancer diseases, etc.), COVID-19 's severe illness and mortality mainly increase in these special population. At present, there is no evidence that these special population have been vaccinated against COVID-19, but CDC vaccination and the guidelines and consensus of various professional societies hold that: (1) the people with underlying diseases have low immunity and are easy to develop into severe patients with high mortality; (2) although there is no direct evidence of evidence-based medicine, it is best to be vaccinated with COVID-19 vaccine in the absence of disease progression activities to reduce high risk. To evaluate the safety and effectiveness of the population vaccinated with COVID-19 vaccine, and to play a scientific and theoretical supporting role in guiding COVID-19 vaccination scientifically, reasonably and effectively, so this study was carried out.

Eligibility Criteria:
Inclusion Criteria:

* The selection criteria should follow the disease diagnosis guidelines developed by various colleges and the consensus of expert recommendations on vaccination.

Exclusion Criteria:

* The exclusion criteria should follow the disease diagnosis guidelines developed by various colleges and the consensus of expert recommendations on vaccination.
Treatment of Fecal Incontinence and Functional Defecation Disorders Using Non-instrumental Biofeedback

Background. Rehabilitation and re-education using instrumental anorectal biofeedback are the main treatment of anorectal functional disorders producing incontinence and outlet obstructed defecation. These treatments imply intubation of patient and several sessions of treatment leading to high consumption of resources and costs.

Hypothesis. A cognitive intervention based on original audiovisual programs developed specifically for the management of anorectal functional disorders is effective in correcting anorectal function disorders that cause fecal incontinence and evacuation disorders.

Aim. To prove in two different protocols (fecal incontinence and dyssinergic defecation) the efficacy of specifically developed non-instrumental biofeedback techniques.

Selection criteria. Patients with fecal incontinence and altered sphincter function and patients with outlet obstructed evacuation referred for biofeedback treatment.

Intervention. In separate studies (incontinence and dyssynergic defecation) patients will be randomized into biofeedback and placebo groups. One session of either biofeedback or placebo intervention will be performed at the beginning of the intervention period and patients will be instructed to performed the assigned daily treatment at home. A visit for outcome assessment will be performed at 3 months in incontinence study and at 4 weeks in the dyssinergic defecation study. In addition, in the incontinence study a phone call will be performed after 6 months of the beginning of the study to evaluate treatment outcome.

Biofeedback: patients will be taught to control anal and abdominal muscular activity by providing instructions using original video supports. Patients will be instructed to perform the same exercises daily at home in scheduled times.

Placebo: a pill of placebo containing 0.3 g glucose will be administered every day at home.


Eligibility Criteria:
Inclusion Criteria:

Incontinence studies

* Patients who have at least 4 episodes of fecal incontinence during the last 14 days.
* Patients able to follow instructions and attend study visits.

Dyssinergic defecation studies

* Patients with constipation who present less than 3 complete spontaneous bowel movements per week and/or who have Bristol 1 or Bristol 2 type stools in more than 25% of the bowel movements in the 2 weeks prior to the study
* Patients able to follow instructions and attend study visits.

Exclusion Criteria:

* Patients with organic digestive diseases such as inflammatory bowel disease, celiac disease, gastro-duodenal ulcer...
* Patients with neurological diseases (spinal cord injury, multiple sclerosis, Parkinson's disease).
* Patients with previous of active colon and/or rectal cancer.
* Patients with rectal fistula.
* Patients with rectal prolapse.
* Patients with total colectomy.
* Patients who have had any radiation to the pelvis in the last month.
Intellectual Impairment in Women With Breast Cancer

RATIONALE: Breast cancer and its treatment may cause changes in a patient's ability to think, learn, and remember. Gathering information about a woman's genes, brain function, and personal history may help doctors learn more about the disease and plan the best treatment.

PURPOSE:

1. To determine changes in brain function that occur following breast cancer chemotherapy.
2. To gain further understanding of the individual differences in brain function changes and recovery based on demographic, medical and treatment variables.

This study aims to determine some of the genetic, neurobiologic and demographic factors that are associated with cognitive outcome following breast cancer (BC). Additionally, it aims to test novel behavioral interventions designed to improve executive function skills following BC treatment.

Eligibility Criteria:
Inclusion Criteria:

3.1.1 Primary, non-metastatic breast cancer

3.1.2 Newly diagnosed patients who have not yet begun treatment.

3.1.4 Female participants age 40-65 years of all ethnicities who speak fluent English will be recruited.

3.1.5 There are no life expectancy restrictions.

3.1.6 Karnofsky Performance Status 70% minimum. ECOG will not be employed.

3.1.7 There are no requirements for marrow function. The brain must be free from gross neuropathology and metastases in order to participate.

3.1.8 Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

3.2.1 History of cognitive, psychiatric or medical conditions prior or unrelated to cancer diagnosis and/or known to significantly impact assessments (e.g. premature birth, developmental delays, learning disabilities, severe psychiatric conditions, brain injury, stroke). Non-English speaking. Major sensory impairment (e.g. hearing loss, blindness) that would render assessments invalid. MRI contraindications (e.g. metallic implants or devices). Distant metastases. See also section 4.2.1.

3.2.2 Participants currently involved in studies specifically aimed at improving cognitive symptoms will be excluded.

3.2.3 Participants with significant co-morbid diseases known to significant impact neuropsychological function such as Alzheimer's or Parkinson's will be excluded.

3.2.4 There are no known risks for allergic reactions to any of the study procedures.

3.2.5 Participants taking certain medications that affect neuropsychological and/or brain function including Haldol, Aricept, Ritalin, etc. will be excluded. Most anti-depressants are acceptable. Some anti-anxiety medications may not be. Each case will be individually reviewed.

3.2.6 There are no other agent-specific exclusion criteria.

3.2.7 Pregnant individuals will be excluded as this is a contraindication for the 3 Tesla research MRI scanner employed by this study but not because of the treatment programs per se. Nursing individuals can enroll.

3.2.8 Patients who are HIV positive will be excluded given the known effects of this condition on cognitive function which would confound the effects of anti-cancer treatments on cognitive outcome.
A Prospective, Observational Study in Adults With Retinitis Pigmentosa (RP)

The natural history in individuals with severe retinitis pigmentosa (RP) is variable and there remains an unmet need to better understand disease progression in this population. The goal of this study is to determine which visual assessments individuals with RP and low visual acuity can reliably perform and to evaluate the annual decline of visual function in severe RP.

This is a 12-month, single-center, prospective observational study in adults with RP. Approximately 12 subjects will be enrolled into the Observation Period.

The primary objective of this study is to determine which visual assessments RP subjects with low visual acuity can reliably perform. Other objectives are 1) to determine which visual assessments are most sensitive to annual change in RP subjects with low visual acuity, 2) to evaluate adverse events, 3) to evaluate the safety and tolerability of study assessment procedures, and 4) to evaluate the subject's experience in this study, relevance of visual assessments and patient-reported outcome measures, and perception of improvement in visual function.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age at the time of informed consent.
* Subject has a clinical diagnosis of nonsyndromic retinitis pigmentosa.
* Subject is willing to consent to genetic testing, if not already done.
* Subject has BCVA in the worse eye between hand motion and 35 Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score (approximately ≤ 20/200 Snellen equivalent), inclusive.
* Subject has a central visual field diameter (ie, excluding temporal islands) of \< 20 degrees in the worse eye as measured with the V4e stimulus using kinetic perimetry.

Exclusion Criteria:

* Subject has an eye disease or visual disorder other than retinitis pigmentosa that impairs visual function.
* Subject has any other eye condition, which in the opinion of the Investigator, would preclude an accurate evaluation at any time during the study.
* Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.
* Subject has received treatment with any nonapproved, experimental, or investigational therapy in either eye (systemic, topical, intravitreal) and/or received treatment in an interventional clinical trial for an eye disease or disorder within 90 days or 5 half-lives, whichever is longer, prior to Screening or anticipates the need to receive treatment in an interventional clinical trial during their participation in this study.
* Subject has previously received cell therapy, gene augmentation therapy, genome editing therapy, or any subretinal administered therapy for an eye disease or disorder or anticipates the need for these therapies during their participation in this study.
* Subject has previously received LUXTURNA (voretigene neparvovec-rzyl) or anticipates the need for this therapy during their participation in this study.
Mechanical Stimulation Improve the Fertilization in ICSI Cycle

Most fertilization failures after ICSI are caused by failure of oocyte activation defects. But, to date, there is no effective method to overcome this obstacle. To investigate the effect of mechanical stimulation on fertilization failures, investigators plan to recruit women undergoing ICSI treatment cycles. The retrieved sibling oocytes from the patients were randomly divided into two groups. The control group conducted the standard ICSI procedure, while the experimental group conducted the modified ICSI procedure.Consequently, the fertilization rate, 2PN (two pronuclei) rate, 1PN rate, oocyte degradation rate,and exploitable embryos on D3 were recorded to evaluate ICSI cycle outcomes.

Normal fertilization is the critical for the success of ICSI. To investigate the effect of mechanical stimulation on fertilization, investigators plan to recruit women undergoing ICSI treatment cycles. Exclusion criteria: Patients older than 40 years, the maturation oocytes less than 6. The retrieved sibling oocytes from the patient were randomly divided into two groups. The control group conducted the standard ICSI procedure, while the experimental group conducted the modified ICSI procedure. The modified ICSI procedure involved a micromanipulation mechanical stimulation between insertion of the microinjection needle into the oocyte and expulsion of the spermatozoon from the needle to the ooplasm, without additional reagents treatment. Consequently, the fertilization rate, 2PN rate, 1PN rate, oocyte degradation rate, and exploitable embryos on D3 were recorded. The investigators aim to evaluate whether the mechanical stimulation can be used to improve the normal fertilization and embryo quality in ICSI cycles.

Eligibility Criteria:
Inclusion Criteria:

* oocytes number ≥ 8;
* women undergoing intracytoplasmic sperm injection cycle.

Exclusion Criteria:

* maturation oocytes number less than 6.