cyrilzakka/clinical-trials huggingface dataset:
Chronic Total Occlusion Crossing With the Wildcat Catheter

This is a prospective, multi-center, non-randomized study of the Wildcat Catheter to cross a single femoropopliteal chronic total occlusion (CTO). Safety and efficacy will be evaluated during the index procedure through 30-day follow-up.

Patients with a CTO, defined as 99% to 100% stenosis of a peripheral artery, will be approached for enrollment in the study. Following providing informed consent, the CTO will be addressed by the Wildcat catheter, which will provide a route for the advancement of guidewires and other tools beyond the CTO. Data will be collected to assess the safety efficacy of use of the device during the procedure and up to 30 days post-procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is willing and able to provide informed consent.
2. Patient is willing and able to comply with the study protocol.
3. Patient is \> 18 years old.
4. Patient has peripheral arterial disease requiring revascularization as evidenced by contrast, CT or MR angiography.
5. Patient has an occluded femoropopliteal artery that is 99-100% stenosed and is ≥ 1 cm and ≤ 30 cm in length by visual estimate.
6. Target femoropopliteal vessel is ≥ 3.0 mm in diameter.
7. Patient has Rutherford Classification of 2-5.

Exclusion Criteria:

1. Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated.
2. Patient has a known sensitivity or allergy to anti-platelet medications.
3. Patient is pregnant or lactating.
4. Patient has a co-existing disease or medical condition contraindicating percutaneous intervention.
5. Target vessel is severely calcified as evidenced by angiography.
6. Target lesion is in a bypass graft.
7. Target lesion is in a stent (i.e., in-stent restenosis).
8. Patient has had a procedure on the target limb within 7 days.
9. Patient has had a procedure on the target limb within the past 30 days and is unstable.
10. Patient is simultaneously participating in an investigational device or drug study.
11. Patient has a planned surgical or interventional procedure within 30 days after the study procedure.
The Effect of Low Dose Aspirin on the Pharmacokinetics of Methotrexate

High dose aspirin have been shown to increase the level of Methotrexat in patients with Rheumatoid Arthritis. However, most of RA patients are not currently treated with high dose aspirin. On the other hand, they frequently receive treatment with low dose aspirin. The effect of low dose aspirin on the levels of Methotrexate is not well known. Therefore,the purpose of this study is to assess the effect of low dose aspirin on the levels of methotrexate.

Thirty Rheumatoid Arthritis patients currently treated with low dose methotrexate (MTX) will participate in this study. On the day of intake of methotrexate, the patients will receive 10 mg of MTX. Serum levels of MTX will be measured at time 0,30 ,90, 120 minutes, and after 12 and 24 hours.

Two weeks later, the patients will be recommended to take 100 mg aspirin/d during a week. The levels of MTX will be measured after a week of treatment in a way similar to a week before.

Eligibility Criteria:
Inclusion Criteria:

* RApatients treated with Methotrexate

Exclusion Criteria:

* Contraindication to aspirin
The Resistance Exercise Training for Worry Trial: Replication and Expansion

This protocol details the full methods of a ten-week moderate-to-high intensity, guidelines-based resistance exercise training intervention compared to a low intensity sham attention control among young adult women with analogue Generalized Anxiety Disorder.

A recent clinical trial supported the anxiolytic effects of regularly-performed resistance exercise training compared to a waitlist control among young adults with and without at least subclinical, or analogue, Generalized Anxiety Disorder. Although the evidence to date is promising, waitlist control conditions cannot control for potential social and psychological benefits of engaging with most interventions, including social contact, expectations for improvement, and mastery experiences, which could potentially be achieved from easier activities. Therefore, this trial aims to replicate the previously investigated World Health Organization and American College of Sports Medicine guidelines-based resistance exercise training program, and expand on this research by more rigorously examining the effects on anxiety and worry symptoms, independent of potential social and psychological benefits of engagement with the intervention. Consequently, this trial quantifies the acute and chronic effects of moderate-to-high intensity, guidelines-based resistance exercise training compared to a low intensity SHAM attention control on signs and symptoms of Generalized Anxiety Disorder among at-risk young adult women with Analogue Generalized Anxiety Disorder. This trial consists of a two-week familiarization protocol, eight weeks of formal resistance exercise training, and a one-month post-intervention follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 18-40y
* Met criteria for analogue Generalized Anxiety Disorder

Exclusion Criteria:

* Medical contraindications to doing resistance exercise training
* Currently involved in formal resistance exercise training
* Currently pregnant or post-partum
CART-19 Cells for R/R B-cell Lymphoma

Relapsed/Refractory B Cell Lymphoma is a challenge to be treated, however,CART-19 cells could be very promosing. This study aims to assess the safety and toxicity of CART-19 cells for patients with relapse or refractory B cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Aged between 1-65 years
* Patients with relapse/refractory B-cell lymphoma
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

* Pregnant or lactating females.
* Any co-morbidity precluding the administration of CART-19 cells.
Systemic Adverse Effects After Osteopathic Treatment and Vitamin C

The goal of this triple-blind randomized clinical trial is to learn about systemic adverse effects in first visit patients who attend an osteopathic medicine center in Barcelona. The main question it aims to answer are:

• Check if there is a relationship between taking vitamin C and the reduction in the appearance of systemic adverse effects after osteopathic treatment (24-72 hours) First-visit patients, at the end of treatment, are asked to enter the study. If they accept, they are administered 1g. of vitamin C, or 1g. placebo or nothing.

If there is a comparison group: Researchers will compare placebo group, control group and intervention group to see if there is a relationship between taking vitamin C and the appearance of systemic adverse effects\].

Introduction Systemic adverse effects (SAE) after osteopathic treatment are rarely reported in the scientific literature. There is a consensus in the scientific literature that these adverse effects occur with a certain frequency, without it being clear what the pathophysiology of such effects is. The relationship between free radicals and central sensitization to pain is increasingly evident. Vitamin C is known as a good electron receptor that is used by the body's antioxidant systems to reduce and also has anti-inflammatory properties. The brain has deficiencies in antioxidant systems and vitamin C has a very important role in the control of oxidative stress.

Objective Check if there is a relationship between taking vitamin C and the reduction in the appearance of systemic adverse effects after osteopathic treatment (24-72 hours).

Design Triple-blind randomized clinical trial, where one group was given 1g of vitamin C, another group was given 1g of placebo and the third group was given nothing. From April 1 to May 30, 2022, patients without food allergies or intolerances were recruited. The patients were randomly assigned to the study groups and neither the patient, nor the therapist, nor the person in charge of collecting the data was aware of which group each patient belonged to. Adverse reactions were classified in relation to pain and fatigue. Data collection was carried out through WhatsApp messages to the patients 72 hours after receiving the treatment.

Eligibility Criteria:
Inclusion Criteria:

* first-visit patients
* of legal age,
* without food allergies or intelorenacies
* the ability to receive and send messages via WhatsApp.

Exclusion Criteria:

-
Randomized Implementation of Primary HPV Testing in the Organized Screening for Cervical Cancer in Stockholm

The purpose is to evaluate whether implementation of primary human papillomavirus (HPV) screening in the screening programme for cervical cancer improves the programme in terms of better cancer protection and better cost efficiency.

Primary HPV screening is a method with higher sensitivity than cytology for detection of high-grade cervical intraepithelial neoplasia, which is the precursor of cervical cancer. In particular, HPV test is a better test for revealing adenocarcinomas, since these cancers often show a normal cytology.

Cytology is less effective in older women, and screening with cytology in women over 60 has no documented effect. Today a large part of cervical cancer develop in women older than 60, to whom no screening is offered. The prevalence of HPV is around 4% in this age group. Since we know that testing negative for HPV gives a better long-term protection against cervical cancer compared to cytology, primary screening for HPV in 60-year old women would give a longer lasting protection in this high-risk group compared with today.

HPV screening is most cost effective above 35 years of age. The reason for this is that HPV is less prevalent at age 35 than in younger women and also because cervical cancer seldom develops before this age. Since the HPV test has a negative predictive value (NPV) of almost 100% this could lead to longer screening intervals, which would be improve cost-effectiveness.

Eligibility Criteria:
Inclusion Criteria:

Women between the age 30 and 64 years resident in the Stockholm-Gotland region. No exclusion criteria.
Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064)

The study will evaluate the safety, tolerability, and efficacy of caspofungin as compared with amphotericin B deoxycholate in the treatment of invasive candidiasis in neonates and infants. The primary hypothesis to be tested in the study is that caspofungin will be superior to amphotericin B deoxycholate with regard to the proportion of participants with fungal-free survival at the 2-week post-therapy follow-up visit.


Eligibility Criteria:
Inclusion Criteria:

* Culture-confirmed invasive Candida infection

Exclusion Criteria:

* Candida disease limited to the oropharynx, esophagus, or other mucosal or superficial skin surfaces
* Positive culture for Candida only from sputum, broncho-alveolar lavage, catheter tip, or previously placed indwelling non-vascular catheters or drains
* Prosthetic device as the suspected site of Candida infection
* Active co-infection with a non-Candida fungal organism
* Received \>48 hours of systemic antifungal treatment since the positive Candida index culture was collected as therapy for the present episode of invasive candidiasis
* Failed prior systemic antifungal therapy for the present episode of invasive candidiasis
* Diagnosis of acute hepatitis or cirrhosis
* Scheduled or anticipated to receive rifampin or other systemic antifungal therapy while on study therapy
* History (including participant's mother) of allergy, hypersensitivity, or any serious reaction to caspofungin or other member of the echinocandin class, or to amphotericin B deoxycholate or other member of the polyene class
* Severe congenital disorder known to lower immune response
Informational Nudge to Improve Heart Failure Prescribing

This study addresses a critical gap of care for Veterans with heart failure (HF). Only 1/3 or fewer eligible Veterans are receiving recommended SGLT2 and MRA therapies that save lives and prevents HF hospitalizations. The investigators will compare the effect of clinician directed nudges as strategies to improve the health of Veterans with HF.

This study addresses a critical gap in quality of care for Veterans with heart failure (HF). Only 1/3 or fewer eligible Veterans are receiving SGLT2 inhibitors and mineralocorticoid receptor antagonists, both medications that save lives and prevents HF hospitalizations. The investigators will combine insights from behavioral science and quality improvement science to create two types of 'nudges' - informational alerts and peer comparison feedback - to increase prescribing of these medications. The investigators will create two types of 'nudges' - informational alerts and peer comparison feedback - to increase prescribing of these medications. The investigators will compare the effect of these two nudge strategies alone and in combination compared to usual care. This project will develop simple, scalable, and low-cost strategies to improve the health of Veterans with HF.

Eligibility Criteria:
Inclusion Criteria:

* Primary care and cardiology clinicians at Southern AZ VA Health Care System working in outpatient clinic setting

Exclusion Criteria:

* Clinicians who are in training status (resident, fellow) will be excluded.
Postoperative Pain After Conservative Root Canal Preparation

The goal of this clinical trial is to compare the pain experienced by healthy participants after root canal treatment with small versus large root canal sizes.

The main questions it aims to answer are:

1. Do small and large root canal sizes cause different pain levels?
2. What is the number of painkiller pills taken by each participant?
3. Does small root canal size cause severe pain and facial swelling?

The researcher will perform root canal treatment on lower molar teeth. The researcher will ask about the pain level, painkiller pill number, and swelling on the 6th,12th, 24th, 48th, 72nd hours, and 7th day after the treatment.

Root canal shaping is an essential step for root canal treatment. Necrotic tissues, debris, microorganisms, and organic matter should be removed to clean and disinfect the root canals. Previously, this conventional procedure involved removing excessive dentine from root canals, which weakened the tooth's structural integrity. Due to technological advances, excessive dentine removal is not always necessary. Root canals are claimed to be disinfected despite minimal dentine removal. This concept of treatment is called minimally invasive or conservative root canal treatment.

This study compares postoperative pain after conservative and conventional root canal preparation in healthy participants with necrotic mandibular molars.

Participants will be enrolled after clinical and radiographic examination by an independent endodontist and allocated randomly to conventional or conservative root canal treatment groups. After the root canal treatment, the researcher will send the participants an online questionnaire on the 6th,12th, 24th, 48th, and 72nd hours and 7th day and ask them to rate their pain score according to the Numerical Rating System and the number of painkillers they have taken. The flare-up rate will be determined according to the presence of swelling and severe pain.

An experienced endodontist not involved in the research will monitor eligible participants and clinical treatment protocol.

Eligibility Criteria:
Inclusion Criteria:

* mandibular molar tooth
* asymptomatic apical periodontitis
* pulp necrosis
* periapical lesion index 4 (visible and well-defined periapical lesion)
* absence of pretreatment pain

Exclusion Criteria:

* symptomatic apical periodontitis
* preoperative pain
* sinus tract
* pulpitis
* acute apical abscess
* tooth not being in occlusion
* external and internal root resorption
* open apices
* periodontal probing depth of more than 4 mm
* initial apical file larger than 15 and 20 K-File for mesial and distal canals respectively
* chronic illness, analgesic allergy, prior analgesic and antibiotics usage 12 hours and 3 months before treatment, respectively
Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug

The purpose of this study is to systematically and prospectively collect data from patients with partial-onset seizures in routine clinical practice setting receiving adjunctive Vimpat®. The observed population will be only patients with one baseline antiepileptic drug. Seizure control and tolerability data will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* The patient's treatment must be in accordance with the local marketing authorization (MA) for Vimpat®
* The decision to prescribe Vimpat® has to be made by the physician before and independently of his/her decision to include the patient in the study
* The Vimpat® treatment should have been started not longer than 2 weeks before study inclusion of the patient
* The patient must have a diagnosis of Epilepsy with Partial-Onset Seizures
* Based on the physician's clinical judgment, the patient's seizure activity is not controlled sufficiently on a current monotherapy and it is in the patient's best interest to be prescribed adjunctive Vimpat®

Exclusion Criteria:

In accordance with the Summary of Product Characteristics (SmPC)
An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination

To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients with essential hypertension who failed to control their BP with either monotherapy


Eligibility Criteria:
Inclusion Criteria:

1. Patients with essential hypertension
2. Outpatient

Exclusion Criteria:

* Patients whose SBP \>=180 mmHg or DBP \>=110 mmHg at the end of treatment visit of the double-blind treatment period in the "non-responder trials"
* Patients who have met any of the exclusion criteria defined in the "non-responder trials"
A Clinical Study to Compare the Efficacy and Safety of HLX10 in Combination With HLX04 Versus Sorafenib as the First-line Treatment in Patients With Locally Advanced or Metastatic HCC

This study is a randomized, double-blind, multicenter, phase III clinical study to compare the efficacy and safety of HLX10 + HLX04 vs Sorafenibas as the First-line Treatment in Patients with Locally Advanced or Metastatic HCC

Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows:

Arm A (treatment group): HLX10 + HLX04 Arm B (control group): sorafenib Randomization is stratified by: region (Asia (excluding Japan) vs. others), HBV infection vs. HCV infection vs. no HBV or HCV infection, portal vein invasion or/and extrahepatic spread (with vs.without), and ECOG (0 vs. 1).


Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate in the clinical study;
2. Aged ≥ 18 years and ≤ 75 years;
3. Patients with histopathologically or cytologically diagnosed locally advanced or metastatic and/or unresectable HCC , or patients with clinically diagnosed HCC according to the diagnostic criteria of the American Association for the Study of Liver Diseases (AASLD);
4. Barcelona Clinic Liver Cancer (BCLC) Stage C; or BCLC Stage B patients who are not candidates for radical surgery and/or locoregional therapy.
5. Received no prior systemic HCC treatment (including chemotherapy, treatment with sorafenib, regorafenib, lenvatinib, or other small-molecule antiangiogenic agents);
6. At least one measurable lesion by the IRRC (central radiography) as per RECIST v1.1
7. Normal major organ functions as defined

Exclusion Criteria:

1. Patients with known hepatobiliary cell carcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma;
2. History of hepatic encephalopathy;
3. Patients with portal hypertension complicated with upper gastrointestinal hemorrhage, or esophageal/gastric fundal varices with the red color sign, or high hemorrhage risk investigated by the investigator within 6 months before the randomization. Subjects must receive endoscopic examinations to rule out high hemorrhage risk (e.g. red color sign and severe varices) before enrollment.
4. Patients with portal vein invasion at the main portal branch (Vp4), inferior vena cava involvement, or right cardiac involvement of HCC based on imaging examination. Patients with portal vein invasion at the main portal branch but with unobstructed blood flow in the bilateral or unilateral branch can be enrolled;
5. Central nervous system (CNS) or leptomeningeal metastases;
6. Positive for both HBV-DNA and HCV-RNA;
Experience and Technology Acceptance of Older Adults Towards a Gamified Rehabilitative Device Prototype

Title: Older adults' experience and acceptance of a 'gamified' rehabilitative device for Total Knee Arthroplasty Background: Total Knee Arthroplasty (TKA) is a common surgical procedure. Good post-operative rehabilitation is needed for successful functional recovery. Patients in our institution demonstrated reduced exercise compliance and accuracy during early post-operative rehabilitation. Root cause analysis identified 'reduced feedback', 'reduced care continuity' and 'lack of engagement' to be key contributing factors. Yet, healthcare resource limitations necessitate new ways of care continuation and patient activation. In response, Fun-Knee™, an app-based innovation was created. Using 'gamification' of rehabilitative exercises, Fun-Knee™ guides and tracks rehabilitation from post-surgery to after hospital discharge, till outpatient physiotherapy review. The experience and opinions of older adults towards such 'gamified' rehabilitative technology is unknown.

Purpose: This feasibility study aims to evaluate and develop Fun-Knee™, a novel, app-based rehabilitation device that 'gamifies' post-TKA exercises to improve exercise compliance, effectiveness, and patient activation. Our prototype of Fun-Knee™ was introduced to two cohorts of healthy older adults. Users' experience with hardware and software components of Fun-Knee™, and their acceptance of Fun-Knee™ for rehabilitation were surveyed. Feedback from the first cohort guided prototype refinement. User experience was re-evaluated in the second cohort.

Methods: Community-dwelling adults with no knee pain, 50 years old and above were recruited if they met inclusion criteria. Participants were introduced to two 'gamified' exercises within Fun-Knee™ with standardised instructions. They were instructed to complete one round of the two games at their own time. Thereafter, a survey consisting of quantitative responses was administered. Statistical analysis were performed using Stata (version 13.1, College Station, TX: StataCorp LP), Fisher's exact tests were performed 2-sided at the 5% significance level. Qualitative feedback was obtained during individual interview. Suggestions for hardware or software refinements to Fun-Knee™ were collated and implemented. The above process was repeated for the second cohort of participants, using the latest version of Fun-Knee™.


Eligibility Criteria:
Inclusion Criteria:

* Cognitively intact (able to follow 3 step commands), community dwelling adults who are 50 years old and above. Not currently attending physiotherapy for knee pain.

Exclusion Criteria:

* Lower limb skin sensitivity, lower limb sensory impairment, open wounds or broken skin, severe vision or hearing impairment, presence of knee pain above 3/10 on numerical rating scale and being English/ Chinese illiterate.