cyrilzakka/clinical-trials huggingface dataset:
Newly Diagnosed With Inflammatory Arthritis - a Self-management Intervention (NISMA)

Even though medical treatment has improved within the last 10-15 years, patients with inflammatory arthritis (IA) still experience reduced quality of life, depression, anxiety, changes in family roles, work life, and social relationships. Particularly the newly diagnosed, require regular consultations and available support from health professionals, to be able to handle emotional, social, and physiological challenges.

The hypothesis is that a self-management intervention can improve patients' ability to monitor their arthritis and respond to symptoms, reduce the risk of co-morbidities, and improve adherence. And also, that they can develop cognitive, behavioral, and emotional strategies to manage life with arthritis. There is a lack of disease-specific evidence, in integrated interventions with multiple components targeting patients with a newly diagnosed IA. In a previous study, the investigators developed a self-management intervention, and now wish to test it in a randomized feasibility study.

RATIONALE FOR NISMA PROJECT

The hypothesis is that a self-management intervention can help patients develop behavioral and emotional strategies to manage life with arthritis. There a lack of disease-specific evidence, in integrated interventions with multiple components targeting patients with a newly diagnosed IA. Therefore, the investigators wish to develop a self-management intervention.

Aim

The overall aim of this study is to determine whether a full-scale randomized controlled trial, which aims to increase self-management in patients with newly diagnosed IA, is possible. The investigators wish to identify methodological, clinical, and procedural uncertainties in delivering a self-management intervention. Furthermore, to investigate outcomes related to recruitment, including adherence, retention, accrual rate, characteristics of the sample, and reliable recruitment methods.

Design

This feasibility study is designed as a randomized controlled feasibility trial (allocation ratio 1:1) to assess the proposed method in the definitive RCT.

Overall Setting

The intervention will take place at the Center for Rheumatology and Spine Diseases, Rigshospitalet, Denmark.

Eligibility Criteria:
Inclusion Criteria:

* Adult persons (≥18 years)
* Diagnosed with one of the following diagnoses: Rheumatoid arthritis (ICD10 diagnoses: M05.3, M05.9, M05.8, M06.9), Spondyloarthritis (ICD10 diagnoses: M45.9, M46.1, M46.8, M46.9) or Psoriatic arthritis (ICD10 diagnoses: M073.A, M073.B), within the last 6 months.

Exclusion Criteria:

* Insufficient language skills to discuss the topics in the intervention in Danish
* In chemotherapy treatment for malignancies
Volume Assessment of the Periapical Healing Following Regenerative Endodontic Procedures Using Cone- Bean Computed Tomography

3D volume assessment was done to evaluate the periapical healing following REPs in mature teeth.

REPs were done for 10 mature maxillary necrotic teeth with periapical lesions confirmed by digital periapical radiographs. Instrumentation was done using Protaper Next till size X3 (size 30). Pre-operative radiographs also included CBCT scans to measure the 3D volume and area of the periapical lesion to be used as baseline data. The postoperative radiographic examination included: a) digital periapical radiographs taken at 3,6,9, and 12 months to monitor the lesion through out the follow-up period. b)CBCT scan to measure quantitatively the volume and area of the periapical lesion after 12 months follow up

Eligibility Criteria:
Inclusion Criteria:

* Necrotic Mature Maxillary anterior teeth with periapical lesions.

Exclusion Criteria:

* Patients with mobile and fractured teeth
Pregnancy After Stem Cell Transplantation in Premature Ovarian Failure

Out of 112 high risk patients for Premature Ovarian Failure (POF), diagnosis was established in 10 cases.

ESS cut off point for menstruation and pregnancy was 6.

Out of 112 high risk patients for POF, diagnosis was established in 10 cases. Endometrial fractional biopsy was taken, stained with H\&E stain and by immubohistchemical (IH) staining by stem cell marker OCT4. IH expression of stem cell marker OCT4 was evaluated before and after transplantation according to Edessy Stem Cell Score (ESS).

After laparoscopic injection of stem cell sample in the ovaries, participants were followed up monthly for a period of one year by hormonal (FSH, LH and E2), clinical (resuming menstruation), US (folliculometry), histopathological (HP), and IH expression of stem cell (stem cell positivity and scoring according to ESS).

These cases were of ESS 5 and 6.

Eligibility Criteria:
Inclusion Criteria:

* Post-menarche female less than 40 years old.
* Normal karyotyping female.
* Primary ovarian failure females
* Follicle-stimulating hormone (FSH) more than or equal to 20 IU/L.
* Agree to sign the designed consent for the study.

Exclusion Criteria:

* Autoimmune diseases.
* Breast cancer, ovarian cancer.
* Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs.
* Those with major medical problems such as malignancy, hepatitis, etc.
A Phase 4 Study to Evaluate Response to Treatment and Safety of Paliperidone Extended-Release in Participants With Schizophrenia

The purpose of this study is to evaluate the response to treatment and safety of paliperidone extended-release (mechanism to dissolve a drug over time in order to be released slower and steadier into the blood stream) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

This is a non-randomized, single-arm, multi-center (conducted in more than one center) study to explore response to treatment and safety of flexible dose of paliperidone extended-release (ER) in participants with schizophrenia. During the study period, dose of paliperidone ER will remain within the range of 3 to 12 milligram per day and will be administered for 12 months. Both hospitalized and non-hospitalized participants may be included in the study. Participants may switch to any effective dose of paliperidone ER from any oral antipsychotic medication without dose adjustment or if required, cross-dose adjustment may be done. Maximum 4 weeks of switching period is allowed. Use of anticholinergic (opposing the actions of the acetylcholine, a neurotransmitter) drugs will not be restricted. Response to treatment will be evaluated primarily through total Personal and Social Performance (PSP) Scale. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
* Recent onset (less than 3 years after the first episode/hospitalization) schizophrenia but either not on antipsychotic medication for at least 3 months or in need of antipsychotic medication switches because of safety and/or lack of efficacy reasons
* To be considered physically healthy at Screening according to vital signs and physical examination findings. If there are abnormalities, they must be consistent with the underlying illness in the study population
* Women at postmenopausal state for at least 1 year; or undergone surgical sterilization, or for women with child-bearing status, should be willing to use an effective contraceptive method throughout the study
* Participants who are willing and capable to complete the questionnaires

Exclusion Criteria:

* Use of clozapine, depot neuroleptics or risperidone within the last 3 months
* Any unstable clinical condition including clinically important abnormal laboratory findings
* Previous and current tardive dyskinesia (abnormal involuntary movements which primarily affect the extremities, trunk, or jaw) symptoms
* History of malignant neuroleptic syndrome
* To be considered carrying high risk regarding adverse effects, homicide and/or suicide
Patient-reported Outcome and Patient-reported Experience After Status Epilepticus

Status epilepticus (SE) is a common life-threatening neurological emergency in which prolonged or multiple closely spaced seizures can result in long-term impairments. SE remains associated with considerable mortality and morbidity, with little progress over the last three decades. The proportion of patients who die in the hospital is about 20% overall and 40% in patients with refractory SE. Morbidity is more difficult to evaluate, as adverse effects of SE are often difficult to differentiate from those attributed to the cause of SE. Our experience suggests that nearly 50% of patients may experience long-term functional impairments. The precise description of the consequences of these functional impairments and their impact on quality of life after SE requiring intensive care management has been little studied. Indeed, if cognitive, physical and mental impairments are now identified in the populations of patients who required intensive care under the term postresuscitation syndrome (PICS), neuronal lesions consecutive to the SE itselfor to its cause could be responsible for these different functional alterations.

Thus, the following have been described: (i) cognitive disorders in the areas of attention, executive functions and verbal fluency, visual and working memory disorders, but also spatio-temporal disorders; (ii) physical disorders such as the so-called post-resuscitation polyneuromyopathy; and (iii) mental disorders such as anxiety disorders, depressive states or those related to post-traumatic stress.

Assessment and characterization of patient-reported outcomes is essential to complement the holistic assessment of clinically relevant outcomes from the patient's perspective. The POSEIDON study was a cross-sectional collection of PROs and HR-QOL components, and associated with patient functional outcomes, in those who required ICU management for status epilepticus. We propose here to continue the description of potential alterations after a subsequent ME, namely a longitudinal study (POSEIDON 2) which will also include the evaluation of patient-reported experience (PREMS) and the measurement of family burden.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years old or older
* Patients previously included in the ICTAL registry (Status Epilepticus cohort NCT03457831)
* Survivors after ICU management for Status Epilepticus More than 3 months and less than 5 years after ICU discharge

Exclusion Criteria:

* Legal guardianship
* Opposition to participate
* Unread and unwritten French language
* Patient not affiliated to a Social Security system
Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy

The purpose of this study is to determine the advantages of single trocar cholecystectomy over standard laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-60
* symptomatic cholelithiasis
* ASA 1-2

Exclusion Criteria:

* pregnancy
* morbid obesity with BMI\>35
* other gallbladder pathology like polyps or tumor
* history of upper abdomen laparotomy
* suspected choledocholithiasis
ECMO LEft Ventricle UNloading Strategy

The present study is an International multicentric prospective observational cohort study. This will be an international research campaign to prospectively collect and analyze clinical data of all VA ECLS patients admitted to participating ICUs with a focus on LV venting modalities. The aims of the study are:

* To investigate the meaning of LV overload during veno-arterial (VA) extracorporeal life support;
* To extensively describe the left ventricular (LV) unloading strategy during VA extracorporeal life support in a large prospective international cohort.
* To compare different strategies to unload the left ventricular in terms of efficacy and outcomes;

Cardiogenic shock and cardiac arrest are among the most lethal manifestations of acute cardiovascular disease, both burdened by extremely high in-hospital mortality rates. Extracorporeal life support is increasingly used either in adults or children with acutely impaired cardiac function refractory to conventional medical management, mainly in profound cardiogenic shock and refractory cardiac arrest. Veno-arterial extracorporeal life support works as a partial cardiopulmonary bypass draining the venous circulation directly into the systemic circulation. Veno-arterial extracorporeal life support provides biventricular support and provides respiratory gas exchange. One of the most important issues occurring during veno-arterial extracorporeal life support is the effect of the retrograde aortic flow which causes a marked increase in the left ventricular afterload with detrimental effects on myocardial performance. Left ventricular overload increases wall stress and myocardial oxygen consumption, jeopardizing ventricular recovery. Nowadays, different techniques are available for unloading the left chambers. However, despite the increasing worldwide experience with extracorporeal life support and the increased knowledge on the benefits of left ventricular unloading, the best veno-arterial extracorporeal life support configuration to achieve hemodynamic support, myocardial recovery, and left ventricular unloading, is still a matter of debate.

This is a prospective clinical study which is observational. The aims of the study are:

* To extensively describe the left ventricular unloading strategy during veno-arterial extracorporeal life support in a large prospective international cohort, providing detailed information on indications, timing, type and modality among a wide spectrum of clinical conditions
* To compare different strategies to unload the left ventricular in terms of efficacy and outcomes
* To provide a common definition of left ventricular overload by collecting clinical, hemodynamic data and radiological information before and after unloading.

Demographics, clinical, instrumental and laboratory data prior and post implantation of veno-arterial extracorporeal life support will be collected. No interventions on top on the ones necessary as a standard of care will be taken.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing VA ECLS will be enrolled.

Exclusion Criteria:

* Patients without VA ECMO will not be considered
The Mechanical,Physiological and Therapeutic Effects of Eccentric Exercise Combined With Extracorporeal Shockwave Therapy in Athletes With Patellar Tendinopathy

Patellar tendinopathy is one of the most common injuries in jumping athletes. Changes in mechanical and physiological properties of tendon are the two proposed forms of pathogenesis. The efficacy of eccentric exercise when applied alone and combined with extrocoporeal shockwave therapy had been reported; however, the underlying treatment mechanisms of pain and dysfunction are not clear. This project aimed to explore the mechanical, physiological and therapeutic effects of eccentric exercise when applied as a single treatment and as an adjunct to extracorporeal shockwave therapy.


Eligibility Criteria:
Inclusion Criteria:

* Competitive athletes
* Pain at the inferior pole of the patella with training for at least 3 months
* Tenderness at the inferior pole of the patella on palpation

Exclusion Criteria:

* Patellofemoral pain syndrome, fat pad irritations, meniscus injury, osteoarthritis, rheumatoid arthritis or infections
* History of fracture over lower limbs and inflammatory myopathies
* Cortisone injuection and other interventions within 3 months
* Contraindication to extracorporeal shockwave therapy
A Study of Islatravir (MK-8591) in Trans and Gender Diverse Participants (MK-8591-035)

The primary objective of this study is to evaluate the safety and tolerability of Islatravir (ISL) in trans and gender diverse (TGD) participants who are receiving gender-affirming hormone therapy (GAHT) and are at low-risk for human immunodeficiency virus 1 (HIV-1) infection.


Eligibility Criteria:
Inclusion Criteria:

* Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before allocation to study intervention.
* Is on stable GAHT and does not intend to change therapy through Week 4 of the study.
* Has a low-risk of HIV infection.
* Identifies with a gender that is different from that assigned at birth.
* A participant assigned female at birth is eligible if not pregnant or chest-feeding and is not of childbearing potential (POCBP) or: Is a POCBP and using an acceptable contraceptive method, or be abstinent from penile-vaginal intercourse with an individual capable of producing sperm (abstinent on a long term and persistent basis); a POCBP must have a negative highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) within 24 hours before the first dose of study intervention; If a urine test cannot be confirmed as negative (e.g, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive; the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a participant assigned female at birth with an early undetected pregnancy; contraceptive use by participant assigned female at birth should be consistent with local regulations.

Exclusion Criteria:

* Has known current or chronic history of liver disease (e.g, non-alcoholic or alcoholic steatohepatitis) or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome, asymptomatic gallstones, or cholecystectomy), unless the participant has stable liver function tests and no evidence of hepatic synthetic dysfunction.
* Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ anal cancers.
* Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time (past or current use).
* Is currently participating in or has participated in a clinical study with an investigational compound or device, within 30 days before Day 1 through the duration of the study.
* Is expecting to conceive or donate eggs at any time during the study.
A Study to Measure the Degree and Effectiveness of the Various vSculpt Operating Modes

A pilot study to determine the degree and effectiveness of the various modes of vSculpt, an over-the-counter "OTC" medical device, on enhanced genital blood flow and improvement in quality of life in menopausal women who suffer sexual dysfunction and stress incontinence

The primary aim of this study is to determine the degree and effectiveness of the various modes of vSculpt on enhanced genital blood flow with menopausal women who experience sexual dysfunction and stress incontinence as measured by temperature change in the genitalia immediately after initial and final treatment and an improvement in quality of life after using the vSculpt device over the course of four weeks. The secondary aim is to compare the differences in genital blood flow and improvement in quality of life of vSculpt's various modes against Intone, another over-the-counter "OTC" medical device that utilizes a different technology to treat stress incontinence and improve sexual dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Study participants will be female
* Female participants who are capable of giving informed consent
* Female participants who are menopausal who have not had a menses within one year, and are within the ages of 48 and 60
* Female participants who have had one or more vaginal births
* Female participants who are currently engaged in vaginal sexual intercourse with a partner
* Female participants who are presently experiencing bladder control issues either leakage, frequency or urgency
* Female participants who are presently experiencing pain during sexual intercourse

Exclusion Criteria:

* Female participants shall not have an active sexually transmitted disease and/or infection
* Female participants who are actively undergoing chemotherapy
* Female participants who are currently taking any cancer-related drugs
* Female participants who are breastfeeding or lactating
* Female participants who have a medical history of neurological disorders (e.g., multiple sclerosis, Parkinson's disease)
* Female participants with an active urinary tract infection (UTI)
* Female participants with active bladder stones
* Female participants with active bladder tumor(s)
* Females with prior laser or vaginal rejuvenation surgeries or treatments
* Females with a medical history of vaginal cancer or radiation or surgery with exception of related to childbirth
* Females with prior non-invasive treatments (estrogen cream) or pelvic floor physical therapy for the vaginal area/ pelvic floor in the past six month
* Females with a physical disability precluding her from holding a lithotomy for an hour
* Females who are homeless
Trial of Iloprost in Pulmonary Hypertension Secondary to Pulmonary Fibrosis

Idiopathic pulmonary fibrosis(IPF) is chronic progressive fibrosing lung disease of unknown cause. There is no effective therapy yet for this disease and the mean survival in most reports is about 3 years after the diagnosis. Because of the stiff fibrosis of the lung, pulmonary hypertension is the late complication of IPF and its development heralds a very poor outcome of the patients. For the primary pulmonary hypertension, recently the effective drugs have been available. However, there is no study about the efficacy of these drugs in the patients with pulmonary hypertension secondary to pulmnary fibrosis, and the aim of this trial is to study the safty and efficacy of "Iloprost," one of the safe and effective drugs in primary pulmonary hypertension.

* Prospective open labeled observational study
* Subjects: About 15 patients with secondary pulmonary hypertension due to IPF or pulmonary fibrosis associated with collagen vascular diseases.
* Method: 3 month trial of inhaled iloprost. Check the safty and measure the pulmonary arterial pressure by right heart catheterization, exercise capacity by 6 minute walking test, echocardiography, and quality of life questionnaires before and after the trial.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic pulmonary fibrosis or fibrotic NSIP according to American Thoracic Society and European Respiratory Society guidelines by biopsy and diagnosis of pulmonary fibrosis associated with connective tissue disease.
* Mean pulmonary artery pressure over 30mmHg.
* NYHA functional class II to IV

Exclusion Criteria:

* Suffering lung diseases other than pulmonary fibrosis (COPD, Pulmonary Thromboendarterectomy ).
* Administration of prostanoids, bosentan, beta- blocker or phosphodiesterase5 inhibitor.
* Dosage adjustment of calcium channel blockers within 6 weeks.
* Resting pulmonary capillary wedge pressure over 15mmHg.
* Bleeding tendency.
* Bilirubin level above 3mg/dl or creatinine clearance level below 30ml/min.
* Unstable angina pectoris, myocardial infarction or severe arrhythmia within 6 months.
* Cerebrovascular accident within 6 months.
* Present lung infection.