cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Evaluation of Remission in Rheumatoid Arthritis

Evaluate correlations between the validated 12 joints-Naredo ultrasound score (B-mode (0-3), PD (0-3) or PDUS (0-3, max between B-mode or PD)) and the DAS28-ESR, DAS28-CRP, CDAI, SDAI and ACR-EULAR criteria for remission in routine care.

Clinical remission is now a realistic goal in managing rheumatoid arthritis (RA) with treat to target strategy assessed according to different composite scores (DAS28, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), ACR-EULAR 2011 for remission). There are, however, no validated ultrasound remission criteria because of continuing uncertainty on the signification of persistent synovial hypertrophy in B-mode or Power Doppler (PD) mode in RA patients in clinical remission.

The objective was to evaluate correlations between the validated 12 joints-Naredo ultrasound score (B-mode (0-3), PD (0-3) or PDUS (0-3, max between B-mode or PD)) and the DAS28-ESR, DAS28-CRP, CDAI, SDAI and ACR-EULAR criteria for remission in routine care.

This french multicenter cross-sectional study took place in 11 rheumatology departments. The inter and intra-observer reproducibility for the ultrasound scoring was good to excellent. Inclusion criteria were as follows: RA meeting ACR-EULAR criteria, \<15 years of progression, DAS-28-ESR\<2.6 for at least 3 months, with a stable treatment including corticoids if necessary (equivalent prednisone\<0.1 mg/kg) for 6 months. A standardized US examination was performed by an experience ultrasonographist blinded to clinical data. Spearman's correlation coefficients were determined between the Naredo12 B-mode (min-max,0-36), PD mode (0-36) and PDUS (0-36) scores and the different clinical remission scores. The impact of disease duration or duration of the clinical remission on ultrasound scores was also assessed (Kruskall-Wallis's test).

Eligibility Criteria:
Inclusion Criteria:

* Adults (âged of 18 or more),
* Rheumatoid arthritis according to ACR-EULAR 2010 criteria, during less than 10 years at least
* Remission according to DAS28-VS (\<2.6) since 3 months at least,
* Disease modifying anti-rheumatic drugs and/or biotherapy stable dose since 6 months at least
* Steroids ≤0.1 mg/kg/day without high dose during the last 3 months
* Oral and written information and consent

Exclusion Criteria:

* Patient participating to a clinical trial about rheumatoid arthritis treatment
* Patient under administrative supervision
Type I Diabetes and Non-surgical Periodontal Treatment

Current evidence suggests a bidirectional association between periodontitis and diabetes. Periodontal therapy improves short term HbA1c levels and is safe to perform. Most studies are focused on type 2 Diabetes. Literature about the correlation between periodontitis and type 1 diabetes is scarce, since no randomized clinical trials have been performed.

The objective of the present clinical investigation is to evaluate the effects of nonsurgical treatment of periodontal disease on glycemic variability in patients with type 1 diabetes (T1DM). The hypothesis is that nonsurgical periodontal therapy affects glycemic variability in terms of time spent in hyperglycemia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 1 diabetes
* Patients under treatment in the department of Diabetology of AOU Careggi having a microinfusor for continuous subcutaneous insulin infusion (CSII) and a Flash Glucose Monitoring (FGM) device
* Diagnosis of periodontitis (all stages and grades)

Exclusion Criteria:

* Contraindications for non-surgical periodontal therapy
* Pregnancy
* History of other systemic disease (cancer, HIV, bone metabolic dysease, Head and Neck Radiotherapy, Immunosuppressive/modulating therapy)
Effectiveness of the GumChucks® Flossing System Compared to String Floss for Interdental Plaque Removal in Children

This study evaluates the interdental plaque removal efficacy, flossing speed, and reduction in gingival inflammation of a new flossing system (GumChucks®) compared to string floss, and to assess preference between the two flossing products in children, parents, and dentists.


Eligibility Criteria:
Inclusion Criteria:

* healthy children aged 4-15 years, who were not on any type of medication
* presence of at least 4 posterior interdental contacts
* ability to follow verbal and/or written instruction
* availability for a 4-week study period
* one parent or legal guardian of each included child participant.

Exclusion Criteria:

* had antibiotics within the last 6 months
* are pregnant.
Technology-Enhanced Quitline Services to Prevent Smoking Relapse

The purpose of this study is to see if automated telephone monitoring will enhance existing quitline services, such as Alere Wellbeing's Quit For Life program, and help people quit smoking. If successful, this intervention could be incorporated into existing quitline protocols and delivered to millions of people who are trying to quit smoking.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Enrolled in Free \& Clear, Inc. services
* Self-reported abstinence for at least 24 hours at the quit date call
* Able to read and speak English
* Personal access to a touch-tone telephone or cellular telephone

Exclusion Criteria:

* Have not stopped smoking for 24 hours
* Currently incarcerated
* Currently participating in any other smoking cessation research
* Live in same household as another study participant
* Participated in the Alere Wellbeing Quit for Life Program within the last 6 months
* Were previously enrolled in this study even if they repeat the smoking cessation program during the accrual period
* Hearing impaired enrollees receiving Free \& Clear services via telecommunications devices for the deaf (TDD) will be excluded from the study as the IVR technology currently does not have this capability
Pre-operative Rehabilitation Exercise Program for Total Knee Arthroplasty

The purpose of this study is to determine whether a pre-operative home rehabilitation exercise program designed for knee replacements is more effective than pre-operative usual care.

Patients with lower levels of function prior to total knee arthroplasty (TKA) attain lower functional endpoints after surgery. Therapeutic exercise improves function in patients with arthritis of the knee, yet little evidence has examined the impact of pre-operative exercise for TKA.

Single blinded randomized clinical trial comparing a pre-operative home exercise program to pre-operative usual care for patients who are waiting for TKA.Comparison group is usual care within the health region which does not include pre-operative rehabilitation program.

Primary outcome: WOMAC function subscale. Secondary outcomes: 1) quality of life; 2) ambulation; 3) self-efficacy; 4) anxiety; 5) patient satisfaction; 6) cost-effectiveness of this intervention.

Total Enrollment: 230 patients

If the intervention improves function prior to surgery, results will be clinically applicable for patients waiting for surgery

Eligibility Criteria:
Inclusion Criteria:

* primary unilateral total knee arthroplasty
* poor functional status (WOMAC=50 or greater)
* 50 yrs or older
* reside within health region
* understands English

Exclusion Criteria:

* unicompartmental total knee arthroplasty
* revision surgery
Pelvic Floor Disorders in Multiple Sclerosis Patients

Primary objective

1. Clinical assessment of bowel, bladder, and sexual dysfunction in patients with MS
2. Impact of sphincter disorders on quality of life in patients with MS by using correlation between Extended Disability Status Scale (EDSS)and The Incontinence Quality of Life Questionnaire (IQOL)

Secondary objectives

-Studying the effect of low frequency rTMS on bladder symptoms in patients with MS.

2.4.1- Type of the study: This study will be a cross-section observational study. 2.4. 2- Study Setting: neuology unit assuit university hospital 2.4. 3- Study subjects: From the neurologic outpatient clinic in Assiut University and patients referred from our staff members in Neuropsychiatry department.

1. Inclusion criteria:

   Adult patient with definite Multiple sclerosis according to Mcdonald's Criteria (revised criteria 2017), Age \> 18 years both sexes patient with subjective complaint of any of pelvic floor dysfunction (bladder, sexual or bowel)
2. Exclusion criteria:

Patients with other systemic or neurological disorder affecting sphincter (Diabetes Mellitus, Renal diseases, Urinary tract infection, epilepsy, peripheral neuropathy, irritable bowel syndrome.....) Patients taking drugs affecting sphincter as psychotropic drugs

2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ...): Step I Patients will be assessed through full neurological history and examination with

All of them will be subjected to the following scales:

* Extended Disability Status Scale (EDSS)
* Multiple Sclerosis Quality of Life Inventory (MSQLI)
* Actionable Bladder Symptom Screening Tool (ABSST)
* Neurogenic Bladder Symptom Score (NBSS)
* The Incontinence Quality of Life Questionnaire (IQOL)
* Neurogenic Bowel Dysfunction Score (NBD)
* Multiple sclerosis intimacy and sexuality questionnaire 19-item version (MSISQ-19) Step II All patients will have the paraclinical assessment in form of neuroimaging (recent MRI brain and spine within last year) evoked potentials (visual, auditory brainstem) Motor evoked potential using TMS with parameters gained using single pulse paradigm Step III as a fulfillment for our secondary objective regarding the study of the effect of rTMS on urinary dysfunction we will recruit 20 patients with significant urinary dysfunction according to assessment results with EDSS ≤ 6 and they will be randomized in two arms for active and sham application of rTMS. by using high intensity low frequency protocol for rTMS application\[39\] for 10 sessions over two weeks with using voiding diary, specific selected scales and selected cortical excitability measures as assessment tools, we will follow up the patients immediately and for one month post sessions.

Eligibility Criteria:
Inclusion Criteria:

1.Adult patient with definite Multiple sclerosis 2-Age \> 18 years 3-both sexes 4-patient with complaint of any of pelvic floor dysfunction (bladder, sexual or bowel)

Exclusion Criteria:

1. Patients with other systemic or neurological disorder affecting sphincter.
2. Patients taking drugs affecting sphincter.
The TARANG Intervention

The mixed methods pilot study aims to evaluate the acceptability, feasibility, and implementation challenges of the TARANG intervention in villages in rural/tribal Rajasthan to inform the study design and operational details for a larger cluster-randomized controlled trial.

Participants will participate in the single group in the TARANG intervention arm and receive the sessions that will enable them to navigate newly formed relationships (e.g. spousal communication, healthy relationships with in-laws, establishing peer network, and negotiation skills), improve participants awareness of sexual reproductive health, enable participants to challenge inequitable gender norms to reduce unintended pregnancies.

Newly married women (daughters-in-law) received 17 sessions; husbands received 4 sessions and mothers-in-law received 4 sessions. The sessions are implemented by NGO partner, Vikalp Sansthan via trained facilitators/moderators who are supervised by NGO staff.

In this mixed methods pilot study, we aimed to qualitatively understand the participants' acceptability, feasibility of the TARANG intervention delivery, content, modules, etc. We also aimed to capture the qualitative impact of the TARANG intervention and pilot activities in communities/villages as well as to understand the operational challenges of delivery from participants and NGO moderators (key informants) delivering the intervention. Quantitative pre- and post-surveys were conducted to understand implementation outcomes such as feasibility, acceptability, and satisfaction, among other outcomes.

Eligibility Criteria:
Inclusion Criteria:

Newly married women:

* Age 18-25 years at the time of wedding
* Does not plan to move out of the area for the period of the intervention
* Mother-in-law has agreed to support daughter-in-law's participation in the study
* Mother-in-law and husband are eligible for the study participation

Husbands:

* 18 years or more at the time of the wedding
* Does not plan to move out of the village during period of the intervention
* Mother and wife are eligible for study participation

Mothers-in-law:

* Has a daughter-in-law who is eligible and willing to participate in the study
* Provides individual consent to participate in the study
* Assents for daughter-in-law to participate in the study
* Does not plan to move out of the village during period of the intervention
* The son and the daughter-in-law are eligible for study participation

Exclusion Criteria:

Newly married women:

* Wanting to have a child in the next 12 months at the time of baseline
* Cognitive ability to participate in surveys
Aesthetic Performance of "Profhilo®" Injective Intradermal Treatment for the Neck

The objective of this study is to investigate the aesthetic performance of the Hyaluronic acid (HA)-based dermal filler Profhilo® injected by a novel bio aesthetic point technique ("BAP" techinique ) in woman aged 40-65 years with skin flaccidity and roughness of the neck.


Eligibility Criteria:
Inclusion Criteria:

* female sex,
* 40-65 years,
* 3-4 neck roughness/laxity grade according to a clinical reference scale;
* asking for neck laxity and roughness restoration;
* available and able to return to the study site for the post-procedural follow-up examinations;
* accepting to not change their habits regarding food, physical activity, cosmetic and cleansing products for the neck;
* accepting to not expose their neck to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study, without appropriate sun protection;
* accepting to sign the informed consent form.

Exclusion Criteria:

* Pregnancy;
* lactation;
* smokers;
* alcohol abuse and/or drug use;
* subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
* subjects not in menopause who do not accept to perform the pregnancy test at T0 (before the 1st aesthetic procedure) and at T1 (1 month after the 1st injection treatment execution, before the 2nd aesthetic procedure);
* Body Mass Index (BMI) variation (± 1) during the study period;
* performing skin treatments for neck aesthetic correction (biomaterials implants, neck lifting, botox injections, laser, chemical peeling) in the 6 months prior to the study start;
* performing permanent filler in the past;
* change in the normal habits regarding food, physical activity, neck cosmetic and cleansing use during the month preceding the test;
* sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit);
* subjects whose insufficient adhesion to the study protocol is foreseeable;
* participation in a similar study currently or during the previous 9 months;
* dermatitis;
* presence of cutaneous disease on the tested area, as lesions, scars, malformations;
* recurrent facial/labial herpes;
* clinical and significant skin condition on the test area (e.g. active eczema, psoriasis, severe rosacea, scleroderma, local infections and severe acne);
* diabetes;
* endocrine disease;
* hepatic disorder;
* renal disorder;
* cardiac disorder;
* pulmonary disease;
* cancer;
* neurological or psychological disease;
* inflammatory/immunosuppressive disease;
* drug allergy;
* Anticoagulants and antiplatelet drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago);
* using of drugs able to influence the test results in the investigator opinion.
A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids

The objective of this study is to determine the safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to premenopausal subjects with symptomatic uterine leiomyomata.

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids. Asoprisnil (10 mg and 25mg) is being evaluated in a Phase 3 program to establish long term safety and effectiveness and therefore provide women with a medical alternative to surgery.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women
* History of regular menstrual cycles (21-42 days)
* Diagnosis of uterine fibroid(s)
* Abnormal vaginal bleeding associated with uterine fibroids
* Otherwise in good health
* Subject must have at least one fibroid with a diameter ≥ 2 cm or multiple small fibroids with a uterine volume of ≥ 200 cm3

Exclusion Criteria:

* Less than 3 months postpartum and post-lactation
* Previous myomectomy within 1 year
* Any abnormal lab or procedure result the study-doctor considers important
* Severe reaction(s) to or are currently using any hormone therapy
* History of osteoporosis or other bone disease
Exploratory Study in the Relief of Drug-induced Xerostomia Associated With Hyposialia

The purpose of this study is to evaluate the clinical efficacy, the safety and acceptability of three new oral sprays with a reference oral spray in the relief of drug-induced xerostomia associated with hyposialia, i.e. dryness of the mouth induced by a decrease of salivation (hyposialia) induced by chronic drug intake.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects,
* Adult subjects (≥18 years) taking drug(s) causing salivary hypofunction / xerostomia, for at least 1 week prior to study initiation and expected to continue without change during study
* Subjects with a complaint of dry mouth as assessed by a response of 40mm or greater on item "Rate the dryness of your mouth" of the Dry Mouth Visual Analogue Scale (VAS) questions. (The VAS limits will be 0 representing normal \[i.e. no dry mouth symptoms\] and 100 representing "the worst imaginable" dry mouth symptoms). This score should also be met before the 1st product application, on P1 D1.
* Documented hyposalivation with test of resting saliva weight absorbed ≤ 0.5g/5 min at baseline

Exclusion Criteria:

* Presence of disorders (bucco-dental disease, history of major medical/psychiatric illness or surgery, ... ) which, in the judgement of the investigator, may interfere with study implementation and/or study parameter assessment(s).
* Sjögren syndrome and related autoimmune diseases,
* Other medical causes of xerostomia (oral candidiasis).
* History of head and neck irradiation and cancer chemotherapy
* History of hypersensitivity to any of the components of the investigational products,
* History or current excessive use of alcohol,
* History of drug addiction,
* Presence of treatments for their dry mouth within 7 days prior to inclusion into the study
Development of Real-time Image-guided Radiotherapy

The goal is to achieve the maximal radiotherapy tumor dose while sparing the health tissue and critical structures. On-board cone-beam CT (CBCT) scans are routinely acquired prior to dose delivery and matched with simulation CT at the planned treatment positions. Thus, setup or motion errors can be detected and corrected. However, CBCT is not available for situations with gantry collisions such as WBI and TSEB. More importantly, CBCT cannot reveal any irregular respiration or body movement during beam-on time. Thus, it is essential to develop a real-time image system that can detect organ/body motion during beam-on time, and correlate simulation-planning images with prior treatment CBCT images.In this proposed clinical trial, we will cooperate with a 3D camera company (Xigen LLC) to develop novel 4D video imaging techniques and validate the feasibility and accuracy of 4D video image guidance in correlation with 4D CT/CBCT useful for advanced IGRT.


Eligibility Criteria:
Inclusion Criteria:

* All patients benefit from advanced IGRT can participate to the study except for those emergent and pediatric patients (age \<18 years) who require special care or there is no time for the setup the 4D video systems
* The patient population would be selected according to the technical progress and clinical needs

Exclusion Criteria:

* None
BIO|MASTER.CSP Study

The goal of this clinical study is to test the clinical safety and performance of the Amvia pacemakers and the Solia CSP S lead when used for left bundle branch area pacing (LBBAP). The patient population consist of patients with cardiac pacemaker indication or cardiac resynchronization therapy indication and intended for implantation of a system with left bundle branch area stimulation. Participants will visit sites at enrollment in the study, at implantation and pre-hospital discharge, 1-, 6- and 12-month follow-up visits. Additional annual follow-up(s) may apply until study termination after regulatory approval of Solia CSP S. The total duration of the clinical investigation is expected to be until September 2027, with last patient out (LPO). During the visits the regular pacemaker and lead measurement are performed. A 12-lead ECG is recorded to document intrinsic and ventricularly paced heart rhythm to assess left bundle branch area pacing. Programming of the pacemakers will be done according to the participant´s therapeutical needs.

The study will be conducted in approximately 18 sites in Europe, Australia and New Zealand where more than one physician per site are expected to participate.


Eligibility Criteria:
Inclusion Criteria:

For patient enrollment in the study all of the following inclusion criteria have to be fulfilled at the time of enrollment:

* Standard indication for de novo pacemaker implantation or cardiac resynchronization therapy (CRT)
* Patient is intended for implantation of a pacemaker or CRT-P system with left bundle branch area stimulation
* Ability to understand the nature of the study
* Ability and willingness to perform all follow-up visits at the study site
* Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept

Exclusion Criteria:

Enrollment of a patient is not permitted if at least one of the following criteria is fulfilled:

* Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
* Expected to receive heart transplantation or ventricular assist device within 12 months
* Life-expectancy less than 12 months
* Pregnant or breast feeding
* Age less than 18 years
* Participation in another interventional clinical investigation (according to the definition given in the CIP)
IntellaTip MiFi XP Ablation Catheter Trial

A study to assess the performance of a new catheter design for the treatment of Atrial Flutter.

A prospective, non-blinded, single arm, single center study designed to assess the performance of the IntellaTip MiFi XP Ablation Catheter for the treatment of recurrent or sustained type I atrial Flutter.

Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* indicated for ablation for Atrial Flutter

Exclusion Criteria:

* Thrombus
* Recent MI/cardiac revascularization
* Prosthetic Valves
* recent ablation for atrial flutter
* atrial flutter with reversible cause
* Class IV HF