cyrilzakka/clinical-trials huggingface dataset:
Stepped Care to Optimize Pain Care Effectiveness

Pain is the most common physical symptom in primary care, accounting for an enormous burden in terms of patient suffering, quality of life, work and social disability, and health care and societal costs. Pain is particularly prevalent among veterans. Four major barriers to optimal care include underdetection of pain, inadequate initial treatment, failure to monitor adherence and symptom response, and failure to adjust treatment in patients not responding or intolerant of initial therapy. Therefore, we propose to conduct the Stepped Care to Optimize Pain care Effectiveness (SCOPE) study, a randomized clinical effectiveness trial in primary care.

SCOPE will enroll 250 primary care veterans with persistent (3 months or longer) musculoskeletal pain of moderate severity, and randomize them to either the stepped care intervention or usual care control group. The intervention will be based upon the empirically-validated Three-Component Model which in SCOPE will involve collaboration between the primary care physician, a nurse pain care manager, and a supervising physician pain specialist. SCOPE will involve a telemedicine approach coupling automated home-based symptom monitoring with telephone-based nurse care management. The intervention will consist of optimized analgesic management using a stepped care approach to drug selection, symptom monitoring, dose adjustment, and switching or adding medications. All subjects will undergo comprehensive outcome assessment at baseline, 1, 3, 6 and 12 months by interviewers blinded to treatment group. Our principal aim is to test whether SCOPE is more effective than usual care in reducing pain as measured by the Brief Pain Inventory. Secondarily, we will test the impact on other pain outcomes (e.g., severity, self-efficacy, use of self-management strategies), emotional functioning, health-related quality of life, and treatment satisfaction.

Eligibility Criteria:
Inclusion Criteria:

SCOPE will enroll 250 primary care veterans with persistent (3 months or longer) musculoskeletal pain of moderate severity and randomize them to either the stepped care intervention or usual care control group.

Exclusion Criteria:

Individuals who:

* have filed a pain-related disability claim in the last 6 months;
* do not speak English;
* have moderately severe cognitive impairment;
* have schizophrenia, bipolar disorder, or other psychosis;
* are actively suicidal;
* have current illicit drug use; or
* have an anticipated life expectancy of less than 12 months.
Efficacy of the Use of Diaries in Intensive Care Units

Randomized clinical trial that aims to evaluate the impact of the use of a diary in patients and relatives of patients admitted to an ICU in relation to usual practice in terms of health-related quality of life, the post-traumatic stress and anxiety/depression at 2, 6 and 12 months after ICU discharge.

Randomized, parallel, open, non-blinded, multicenter clinical trial, with an experimental group (diary) and a control group (usual practice), to compare the effect produced on quality of life by post-traumatic stress and anxiety/depression of patients and relatives, whether or not they have access to a diary during the stay in the unit. Three validated scales will be used at three different times. 120 cases per group, carrying out a preliminary pilot test. Data analysis according to IBM SPSS v.24 to describe and compare both groups.

Eligibility Criteria:
Inclusion Criteria:

* admitted intensive care unit
* sedated and mechanically ventilated for 24hours
* signed consent
* not language barrier
* willingness to attend follow-up visits

Exclusion Criteria:

* verbal manifestation of psychiatric, mental or cognitive antecedents
* who do not coluntarily agree to participate
Effects of Non-nutritive Sweeteners on the Composition of the Gut Microbiome

This pilot study is being conducted to evaluate whether consumption of diet soda sweetened with sucralose and acesulfame-potassium leads to changes in the gut microbiota. Following a one week run-in period, healthy, young adults are randomized to consume either diet soda or carbonated water (control) three times per day for one week. Stool and urine samples are collected at baseline, following the run-in, and after the one-week intervention.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 18-35 years
* Consume less than 1 food/beverage with non-nutritive sweeteners per month
* Able and willing to consume diet soda three times daily for 1 week

Exclusion Criteria:

* Recent diet or significant weight change
* Antibiotic use in the past 3 months
* Diarrhea in the past two weeks
* Use of medications known to affect metabolism or weight
* Weight \< 50 kg (110 lbs.)
* History of metabolic complications including high blood sugar, elevated cholesterol, or liver disease
Prucalopride Versus Placebo in Gastroparesis

Controlled cross-over study of prucalopride 2 mg daily or placebo in gastroparesis (idiopathic or diabetic). Patients will be randomized to 4 week treatment with the first regimen (double-blind), followed by a 2-week washout and 4 week treatment with the second regimen in cross-over.

To assess the influence of prucalopride (Resolor®) 2mg daily, 30 patients with idiopathic and 30 patients with diabetic gastroparesis will undergo two gastric emptying breath tests with concomitant assessment of meal-related symptoms, at the conclusion of two consecutive, 4-week treatment periods of prucalopride or placebo. The order of prucalopride and placebo treatment will be randomised at the initiation of the study. Medication for both patient groups, 30 patients with idiopathic and 30 patients with diabetic gastroparesis, will be randomized separately. Half of the subjects will receive placebo first; the other half will receive prucalopride first. Treatment periods will be separated by a wash-out period of 2 weeks. All drugs potentially affecting gastrointestinal motility or sensitivity will be discontinued at least two weeks prior to the initiation of the study. Informed consent will be obtained from each participant.

In order to establish the gastrointestinal symptom and quality-of-life profile of this cohort, each patient will complete the following validated self-reported instruments at baseline and at each of the two testing visits (table 1): Patients assessment of Gastrointestinal symptoms (PAGISYM), Patients assessment of Gastrointestinal Quality of Life Impact (PAGIQoL) Gastrointestinal and Global Severity Score, Patient Health Questionnaire (PHQ-15), Appetite Questionnaire, Hospital Anxiety and Depression Scale, Visceral Sensitivity Index, Short Form Nepean Dyspepsia Index (SF-NDI). The PAGI-SYM is a comprehensive questionnaire of upper GI symptoms, and it includes a gastroparesis questionnaire module: the Gastroparesis Cardinal Symptom Index (GCSI), which has been validated in (idiopathic) gastroparesis.26 Furthermore, during the entire study duration patients will complete a daily symptom diary, incorporating a separate horizontal 100-mm visual analogue scale (VAS) for each of 9 upper abdominal symptoms. As prucalopride has a well-known therapeutic effect in chronic constipation, patients will also register information about their stool frequency and stool type in the daily diary (Bristol Stool Scale).

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with a previously established diagnosis of diabetes or functional dyspepsia according to Rome III criteria, and with delayed gastric emptying (t1/2 for solids ≥ 109 min) on a breath test

Exclusion Criteria:

* The presence of oesophagitis, gastric atrophy or erosive gastroduodenal lesions on endoscopy

  * the presence of lesions on small bowel X-ray
  * major abdominal surgery
  * underlying psychiatric illness
  * use of non-steroidal anti-inflammatory drugs, steroids, or drugs affecting gastric motility.
  * Major co-morbidities
Measurement of Forces Applied Using a Macintosh Direct Laryngoscope Compared to GlideScope Video Laryngoscope

During Anesthesia many patients require that a breathing be inserted into their windpipe. This is usually achieved using a direct laryngoscope, consisting of a retraction blade with a light near its end. When achieving a direct line-of-sight to the windpipe is difficult, more force is often applied, resulting in greater patient stress. A GlideScope video laryngoscope uses a camera and light source to see the windpipe. This enables the user to see objects that may not be in the direct line-of-sight. This likely results in less force being required, reducing patient stress. Because such stresses are often confounded by patient variables, we are comparing the forces required by the direct and video laryngoscopes on patients with at least one risk factor for difficulty, by directly measuring these with special sensors attached to the laryngoscope blades.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18years
* elective surgery
* single lumen endotracheal intubation required
* signed informed consent
* one risk factor for a difficult laryngoscopy ( Mallampati score \>3, inter-incisor gap \< 3.5cm, thyromental distance \< 6.5cm, sternomental distance \< 12.5cm, reduced neck extension and flexion)

Exclusion Criteria:

* lack of patient consent
* anesthesiologist declines to consent
* contraindication to neuromuscular blockade
* ASA 4
* rapid sequence intubation
* previous failed intubation
* other method of intubation indicated eg fiberoptic intubation, awake tracheostomy
* symptomatic gastro-esophageal reflux
* cervical spine instability
* unstable hypertension and symptomatic coronary artery disease
* cerebrovascular disease or raised intracranial pressure
* oral/pharyngeal/laryngeal carcinoma
* loose teeth/poor dentition
Cohort Study Investigating the Association Between Antichlamydial Antibody Positivity and ART Outcomes in Women With TFI

In a prospective cohort study investigators will examine characteristics and clinical outcomes of treatment with ART in women with tubal factor infertility (TFI) with regard to seropositivity to antichlamydial antibodies.

At the first day of stimulation blood analyses for immunoglobulin G (IgG), immunoglobulin A (IgA) and immunoglobulin M (IgM) to major chlamydial antigens (anti-C.trachomatis), major outer membrane protein (MOMP) and plasmid-encoded protein (pgp3) will be performed for patients found eligible for the study.

According to the result of chlamydial antibody test (CAT) participants will be divided into two groups: group A - women with at least one of antibodies detected (CAT+); Group B - seronegative subjects (CAT-).

Women of both groups will undergo a conventional ovarian stimulation (COS) with GnRH antagonist and daily gonadotropin administration at the dose of 150-300 international unit (IU).

Retrieved oocytes following fertilization (conventional IVF or ICSI) will be cultured to Day 3-5 in vitro; ultrasound guided single or double embryo transfer will be performed; remaining embryos of eligible quality will be vitrified.

Patients will be followed up to live birth. Frozen/thawed embryo transfers (FET) will be performed until at least one live birth (≥20 weeks of gestation) occurred or all embryos resulting from the mentioned assisted ovarian stimulation were used.

Eligibility Criteria:
Inclusion Criteria:

* Tubal factor infertility diagnosed by laparoscopy;
* Female age between 20-41 years;
* BMI 17,5-35 kg/m2;
* Early follicular phase follicle stimulating hormone (FSH) ≤15 IU/L
* Presence of viable spermatozoa in partner's sperm;
* Signed informed consent.

Exclusion Criteria:

* previous ovarian surgery;
* endometriosis;
* antimullerian hormone (AMH) level ≤0,3 ng/ml;
* hyper- or hypogonadotropic ovarian failure;
* severe male factor infertility;
* Pre-existing medical condition preventing or interfering with IVF treatment: any clinically significant systemic disease; inherited or acquires thrombophilia and thromboembolism; endocrine or metabolic abnormalities; moderate or severe impairment of renal or hepatic function; any oncological diseases in anamnesis; known history of recurrent miscarriage, abnormal karyotype of both partners; currently active pelvic inflammatory disease;
* Abnormal IVF screening tests: Papanicolaou (PAP) smear, Syphilis, HIV 1\&2, Hepatitis B, Hepatitis C, Chlamydia, and Gonorrhea;
* Presence of uterine pathology: Asherman's Syndrome, endometrial polyps, nodus form of adenomyosis or uterine fibroids ≥3 mm in diameter;
* Visualization of ovarian cysts ≥25 mm, endometriomas or hydrosalpinx;
* One or more follicles ≥8 mm at the start of the COS protocol.
Nurses' Level of Knowledge on Skin Tears: A Cross-Sectional Study

Skin tears (ST) are one of the skin integrity problems encountered in healthcare settings with rates equal to or greater than pressure injuries. However, the importance of this problem has been emphasized in the literature in recent years. This study was conducted to determine the knowledge level of nurses about ST.

The population of the study consisted of all nurses working in acute care hospitals in Turkey.

The sample size of the study was calculated as 384 nurses. The data of the study were collected in the form of online and paper-based surveys (an introductory information form and the Skin Tear Knowledge Assessment Instrumen)

Eligibility Criteria:
Inclusion Criteria:

* were employed as a nurse for at least 1 year
* cared for patients aged 65 and over
* agreed to participate in the study

Exclusion Criteria:

• nurses who filled in the data collection tools incompletely
The Effect of Ischemic Pre-Conditioning on the Rate of Recovery Following Exercise-Induced Muscle Damage

Strenuous exercise or exercise involving eccentric muscle contractions can lead to muscle damage and changes in muscle function; this is known as exercise-induced muscle damage (EIMD). It is known that brief, repeated periods of ischemia followed by reperfusion, known as Ischemic Preconditioning (IPC) cause a delay in cell injury in cardiac muscle as well as in various other organs.

Therefore the purpose of this study is to:

1. Quantify the use of IPC in recovery following EIMD.
2. Identify any effect of IPC during recovery on muscle function


Eligibility Criteria:
Inclusion Criteria:

* Physically Active Males

Exclusion Criteria:

* Muscular skeletal disorders
Altered Respiratory Compliance Under Invasive Mechanical Ventilation in SARS-CoV-2 & Development of Respiratory Sequels

The goal is to study the association between the value of the compliance of the respiratory system at the first day of the initiation of invasive mechanical ventilation and the presence of respiratory sequelae at a distance from the COVID-19 infection with the hypothesis that patients who have presented an alteration of the compliance of the respiratory system are at greater risk of developing respiratory sequelae.

Studying the altered compliance of the respiratory system in ARDS secondary to COVID-19 and its relationship to the development of respiratory sequelae would help us to improve the management of patients with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in intensive care medicine between 01/03/2030 and 01/09/2022 (with invasive mechanical ventilation for at least 48 hours for a SARS-CoV-2 infection documented by RT-PCR) who were followed in pulmonary outpatient medicine at least 3 months after their hospitalization in intensive care medicine and before 01/12/2022 and who had respiratory sequelae during this period.
* Hospitalized in intensive care medicine between 01/03/2020 and 01/12/2021 (with invasive mechanical ventilation for at least 48 hours for SARS-CoV-2 infection documented by RT-PCR) who were followed up in pulmonary outpatient medicine but did not have respiratory sequelae between 01/06/2020 and 01/12/2022.

Exclusion Criteria:

* Documented underlying respiratory pathology.
* Pneumothorax within the first 10 days.
* Patient requiring extracorporeal circulatory support.
* Refusal to participate
* Persons referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code: Pregnant woman, parturient or breastfeeding mother / Minor (not emancipated) / Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice) / Adult unable to express his consent
* Persons deprived of liberty by a judicial or administrative decision, persons under psychiatric care under articles L. 3212-1 and L. 3213-1.
* Respiratory system compliance data not available on the computer software
Rivaroxaban Evaluation in Real Life Settings

To discover outcomes of patients treated with Rivaroxaban with atrial fibrillation with at least one additional investigator-determined risk factor for stroke in real-life practice.

This large global registry focuses on studying Atrial Fibrillation (AF) and evaluating characteristics, management and outcomes of patients treated with Rivaroxaban. The RIVER registry is observational, decisions on patient management are determined by the health care professional and the patient and not by the protocol. Patients are therefore treated according to normal local practice and the drug label/relevant product information of any drugs administered to them.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age 18 years and over
* New diagnosis of non-valvular atrial fibrillation (diagnosed within the last 6 weeks) with at least one additional investigator-determined risk factor for stroke
* Initial treatment with Rivaroxaban following AF diagnosis

Exclusion Criteria:

* No further follow-up envisaged or possible within enrolling hospital or with associated primary care physician.
* Patients with transient AF secondary to a reversible cause.
* Patients participating in an interventional study that dictates treatments, visit frequency or diagnostic procedures
* Not treated with Rivaroxaban as first treatment
NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test

The objective of this study is to investigate the potential of NeoMatriXTM Wound Matrix to cause an allergic response to healthy volunteers using a skin prick test.

Using a minimally invasive skin prick test, the test material, positive control, and negative control are applied to the forearm using a prick test. The test area is observed after 15 minutes, 6 hours, and again at 1-2 days after the initial prick test. The skin will be examined for a reaction such as a wheal and/or a flare, a flare alone is not clinically significant.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged at least 18 years.
* Completed written informed consent and receive a copy of their executed ICF.
* Volunteers must be capable of understanding and following directions in English.

Exclusion Criteria:

* Pregnancy or lactation;
* Inadequate or non-existent contraception (women of child bearing potential only);
* A current skin disease;
* Heavy alcohol consumption;
* Current use or history of repeated use of recreational drugs;
* Recent illness prior to test;
* Significant past medical history of diseases to potentially effect study results;
* Current treatment of allergy;
* A history of multiple drug hypersensitivity;
* Concurrent medication likely to affect the response to the test articles or confuse the results of the study;
* Known sensitivity to the test articles;
* Participation in a repeat insult patch test (RIPT), skin prick test (SPT) or follow-up work within the last month;
* Sensitization or questionable sensitization in a skin test;
* Recent immunization.
Right Ventricular Damage in Cardiovascular Magnetic Resonance

The purpose of this study is to determine the predictors of right ventricular damage (RVD) assessed by wall motion abnormalities, edema, myocardial salvage and delayed enhancement (DE)cardiac magnetic resonance imaging in acute ST-elevation myocardial infarction (STEMI) and its prognostic significance.

The investigators hypothesize that ischemia related changes of the myocardium are also visible in the right ventricle and that they have an impact on patient outcome.


Eligibility Criteria:
Inclusion Criteria:

* Onset of symptoms \<12 h before angioplasty.
* ST-segment elevation of at least 0.1 mV in ≥2 extremity leads or at least 0.2 mV in ≥2 precordial leads.

Exclusion Criteria:

* Contraindications to CMR as implanted defibrillators, pacemakers, ferromagnetic intracranial metallic implants or pulmonary metallic splints and claustrophobia. A further exclusion criterion was prior fibrinolysis.
To Compare the Efficacy of Intralesional Saline Versus 35% Trichloracetic Acid (TCA) Peel in the Treatment of Atrophic Acne Scars

This study aimed to compare the efficacy of intradermal normal saline versus trichloroacetic acid (TCA) in treating atrophic acne scars. Atrophic acne scars are a common and disfiguring complication, with limited research on the use of normal saline.

Acne vulgaris is a common skin problem affecting adolescents and adults. It is the eighth most common skin disease globally, having a prevalence ranging from 35%-85%, with notable variations across different regions and age groups.A randomized controlled trial was conducted at the Dermatology Department, Sheikh Zayed Hospital, Rahim Yar Khan, from 1st April 2023 to 31st October 2023. 126 patients were enrolled. Scar grading was based on Goodman and Baron's Qualitative Scar Classification. The Observer Scar Assessment Scale (OSAS) was used by dermatologists. Patients rated their acne scars using the Visual Disease Severity Scale. Photographs were taken for comparison. Efficacy was defined as ≥50% improvement in the OSAS.

Eligibility Criteria:
Inclusion Criteria:

* Age: 13-50 years
* Clinically diagnosed patients of atrophic acne scars on face
* duration of more than 6 months
* no history of any procedural intervention in past 3 months

Exclusion Criteria:

* history of keloid, active acne, local infection, skin allergies, hypertrophic scarring, photosensitivity, or history of any comorbidities
* history of use of oral isotretinoin, OCPs, steroids or immunosuppressants
* pregnant or lactating females
The Effect of Probiotics on Response to Therapy and on Adverse Effect in Patients Treated With Colchicine for Familial Mediterranean Fever.

Colchicine is the drug of choice to treat patients with Familial Mediterranean Fever (FMF ), some of the patients treated with colchicine may suffer from gastrointestinal (GIT) adverse effect such as diarrhea and abdominal pain especially in the higher dose.

5-10% of the patients with FMF that have been treated with colchicine may have partial or no response to this therapy.

Aim of our study: the aim of our study is :.1to evaluate the efficacy of probiotics in reducing the number of adverse effect in patients with FMF that are being treated with colchicine and suffering from GIT adverse effect.

.2 To evaluate the efficacy of probiotics in reducing the number of FMF attacks in children with FMF that has been treated with colchicine with only partial response.

Methods: the study will be done among children (5-17 years old) with FMF that are currently followed in the pediatric rheumatology clinic at Mayer children hospital Israel Haifa that are being treated with colchicine and suffering from either GIT adverse effect or partial response to colchicine.

The study is design to be double blind placebo control, in the first 3 month patients will be with no therapy and will be required to record all there FMF episodes and their GIT adverse effect, in the second period the patients will be randomly divided into two groups 1.patients that will received placebo (group 1) and the 2. Probiotics group - patients will received probiotics (Bio -25 including 11 types of bacteria L.acidophilus, B.bifidum , L.rhamnosus, L.lactis, L.casei, B.breve, B.thermophilus, B.longum, L.paracseis, L.plantarum, B.infantis), both for three month, during this period patient will be required to record their gastrointestinal symptoms and other symptoms that may be related to FMF.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of FMF
* Age 5-18 years
* Colchicine therapy
* Gastrointestinal adverse effect or recurrent FMF attacks on colchicine

Exclusion Criteria:

• Severe immune deficiency