cyrilzakka/clinical-trials huggingface dataset:
Patient Reported Experience in Endoscopic Ultrasound

The evaluation of the patient's experience is becoming increasingly important as a better patient experience can improve the quality of the delivered health service. Patient-reported experience measures (PREMs) are self-reported assessment tools provided by patients about their experience during any health event. There are few PREMs's instruments in the field of gastrointestinal endoscopy, and none is specific for Endoscopic Ultrasound (EUS). The aim of this study is to develop a questionnaire to evaluate the experience of patients undergoing EUS, identifying and prioritizing the factors related to the patient's experience. In order of it, expected results are developing a valid tool of question to value patients experience during EUS and, for ranking, it is iphotized that will be more correlation with patients's and nurses's answer that clinicians's one. In literature is described that nurse's view and patient's view are more similar especially in those aspects concerning empatics and psychological aspects.

The study will consist of several phases: 1) Tool creation: a "patient reported measure of EUS" (PREUS) questionnaire will be created based on literature review; 2) Face and Content Validity: The PREUS tool will be submitted to 7 experts in the field (physicians, nurses, psychologist, communication expert, patients' advocacy representative) for a two-round evaluation and to "expert" patients who had already undergone EUS at least once. Content Validity Index (CVI) will be calculated and questions with a CVI \< 0.70 will be excluded; 3) Questionnaire Creation: Based on the results of phase 2, a modified "PREUS" tool will be then evaluated by ranking the relevance of the identified questions in the previous phase (from 0 to 10) by 50 outpatients undergoing EUS and Cronbach's alpha will be calculated to determine reliability; 4) Ranking: tool of phase 3 will be also evaluated by 6 physicians and 13 nurses working in IRCCS Ospedale San Raffaele endoscopy Unit to measure the agreement between patients and health care professionals (HCPs) by the Spearman-Brown coefficients.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years;
* Outpatients undergoing EUS in I.R.C.C.S. San Raffaele Hospital (Milan, Lombardy, Italy);
* Written informed consent signed

Exclusion Criteria:

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Phase IIb Clinical Trial With TGF-β2 Antisense Compound AP 12009 for Recurrent or Refractory High-grade Glioma

In this multinational dose finding Phase IIb study the efficacy and safety of two doses of AP 12009 compared to standard chemotherapy (temozolomide or PCV) is investigated in adult patients with confirmed recurrent high-grade glioma.

The purpose of this study is to compare the safety and efficacy of two doses of AP 12009 and standard chemotherapy in adult patients with recurrent high-grade glioma (anaplastic astrocytoma \[AA\], WHO grade III; or glioblastoma \[GBM\], WHO grade IV). AP 12009 is a phosphorothioate antisense oligodeoxynucleotide specific for the mRNA of human transforming growth factor-beta2 (TGF-beta2). The growth factor TGF-beta plays a key role in malignant progression of various tumors by inducing proliferation, invasion, metastasis, angiogenesis and escape from immunosurveillance. It has been shown that in a number of tumor types the degree of TGF-beta production strongly correlates with tumor grade and stage. In patients with high-grade glioma, the TGF-beta2 overexpression is associated with disease stage, clinical prognosis and the immunodeficient state of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed diagnosis of recurrent or refractory high-grade glioma (anaplastic astrocytoma, WHO grade III; or glioblastoma, WHO grade IV)
* Supratentorial localization
* No more than two chemotherapy regimens including radiochemotherapy since primary diagnosis
* Eligible for either TMZ or PCV treatment
* Recovery from acute toxicity caused by any previous therapy
* Adequate organ functions
* KPS at least 70%

Exclusion Criteria:

* Tumor surgery within 2 weeks prior to study entry
* Radiation therapy within 8 weeks prior to study entry
* Chemotherapy within 4 weeks prior to study entry (nitrosureas: 6 weeks)
* No more than 3 mg/day dexamethasone (or equivalent) at baseline
* Prior TGF-beta targeted therapy or tumor vaccination
* Baseline MRI shows mass effect
* Known active infection with HIV, HBV, or HCV; acute viral, bacterial, or fungal infection
* Significant psychiatric disorders/legal incapacity or a limited legal capacity
Effects of a Squatting With Hip Adduction in Patients With Patellofemoral Pain Syndrome

An imbalance in the activation and onset time of the vastus medialis oblique (VMO) and vastus lateralis (VL) muscles may be one of the primary causes of PFPS. Several studies have discussed various exercise methods believed to selectively contract the (VMO) muscle for treating patellofemoral pain syndrome. VMO activity is higher during static closed-chain tasks combined with hip adduction, indicating that performing hip adduction exercises may selectively strengthen the VMO muscle.

Patellofemoral pain syndrome (PFPS) poses challenges in motor control and pain management, especially regarding balanced muscle activation of the vastus medialis oblique (VMO) and vastus lateralis (VL). This study introduces a home-based PFPS rehabilitation approach involving a squat exercise program with hip adduction, examining its effects on motor control and clinical outcomes. Thirty PFPS participants were randomly assigned to conventional squatting (SQU) or squatting with hip adduction (SQU-HA) groups. Participants performed exercises five days a week for 8 weeks, with pre- and post-assessments capturing clinical measures and motor control indicators using electromyography (EMG). This home-based program, integrating hip adduction into squats, enhances motor control, reduces knee stress, and improves daily function, ensuring continued care post-pandemic.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-50 years.
* Pain around the patella at least two of the following activities¬-standing up after prolonged sitting, going up and down the stairs, running, jumping, squatting, kneeling, and high-angle knee flexion for a long time.
* Knee joint pain for ≥3 months.
* Pain level of ≥ 30 mm on a 100-mm visual analog scale (VAS).

Exclusion Criteria:

* Had a history of patellar subluxation, dislocation, or knee surgery.
* Had central or peripheral neurological pathology.
* Had an obvious knee joint deformity or lower extremity malalignment.
* Experienced severe knee joint pain (VAS) score \> 80 mm), or received nonsteroidal anti-inflammatory drugs, injections, or physical therapy within the past 3 months.
Examination of Low Wattage and High Wattage E-Cigarettes

The overall aim of the proposed study is to evaluate the effect of switching from conventional cigarettes to either a LWe or HWe on smoking behavior, product use patterns and continued use, as well as biomarkers of toxicant exposure and effects.


Eligibility Criteria:
Inclusion Criteria:

1. smoke ≥5 cigarettes per day for the past year;
2. no quit attempt in the prior 3 months and no plan to quit in the next 3 months;
3. read, write, and speak in English;
4. report at least minimal interest in switching to an alternative product (\> "not at all" on a Likert scale);
5. never purchased or regularly used a tank system, mechanical mod, or advanced personal vaporizer EC, though previous use of cig-a-like devices will be allowed but not in the last 3 months;
6. plan to live in the local area for next year; and
7. have reliable means of transport. -

Exclusion Criteria:

1. \<18 years old;
2. unstable or significant medical condition such as respiratory, kidney, or liver disease that could potentially affect biomarker data;
3. unstable or significant psychiatric conditions (past and stable conditions will be allowed);
4. history of cardiac event or distress within the past 3 months; and
5. currently pregnant, planning to become pregnant, or breastfeeding (n.b: pregnancy status will continue to be evaluated throughout the study at each visit).

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Trial of Transcranial Direct Current Stimulation (tDCS)

Among antidepressant treatments, ECT stands as the most effective in treating acute depression. However, patient concerns with the cognitive side effects of ECT have encouraged the development of new and more focal forms of brain stimulation such as transcranial Direct Current Stimulation (tDCS). However, not all patients may respond to this treatment in the way that it is currently administered and this has raised interest in finding alternative, possibly more optimal ways of administering tDCS. This study will investigate whether tDCS stimulation using an alternative electrode montage has antidepressant effects. Further sessions of tDCS, spaced less frequently, will be trialed for maintenance treatment. Mood, cognitive test performance and biomarkers will be measured periodically in the duration of the trial.


Eligibility Criteria:
Inclusion Criteria:

* Subject meets criteria for a DSM-IV Major Depressive Episode.
* Total MADRS score ≥20.

Exclusion Criteria:

* Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation.
* History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
* Inadequate response to ECT in the current episode of depression.
* Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
* Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
* Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk of seizure or neuronal damage with tDCS.
* Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
* Female subject who is pregnant.
* Participants who are not fluent in English will not be included in the trial for safety reasons: a) It is usually not possible to have an interpreter reliably available every weekday for up to 4 weeks and it is not safe to give tDCS to a subject who cannot tell us immediately of any side effects; b) As this is a novel treatment, the study involves detailed neuropsychological testing for safety reasons. This testing cannot be effectively or validly completed by someone who is not fluent in English. Note that translation of the proposed tests into English has not been validated and that we cannot be confident that neuropsychological impairment would be detected using this method.
Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis

The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who present with a diagnosis of active, mild to moderate, ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible participants will be allowed to maintain previously established oral 5-aminosalicylic acid (5-ASA) treatment at doses up to 4.8 grams/day (g/day).


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily sign written informed consent.
* Male or non-pregnant and non-lactating females.
* Confirmed diagnosis (by endoscopy procedure) of active, mild to moderate UP or UPS, with disease extending at least 5 centimeters (cm) but no further than 40 cm from the anal verge.
* Must possess a baseline MMDAI score between 5 and 10.

Exclusion Criteria:

* History or current diagnosis of Crohn's disease and indeterminate colitis.
* Prior gastrointestinal surgery except appendectomy and hernia.
* Concomitant active gastrointestinal disease or distortion of intestinal anatomy.
* History of diverticulitis, collagenous colitis, celiac disease, recurrent pancreatic or known gallbladder disease.
* Uncontrolled, previously diagnosed type 1 or 2 diabetes mellitus.
* Uncontrolled abnormal thyroid function.
* Unstable significant cardiovascular, endocrine, neurologic or pulmonary disease.
* Hemoglobin levels less than (\<) 7.5 grams /deciliter (g/dL).
* History of sclerosing cholangitis, cirrhosis, or hepatic impairment.
* Renal disease manifested by greater than (\>) 2.0 milligrams/deciliter (mg/dL) serum creatinine.
* History of avascular hip necrosis, active tuberculosis, ocular herpes simplex or ocular varicella zoster, malignant disease, and HIV or hepatitis B or C.
* Adrenal insufficiency.
* Active systemic or cutaneous infection or toxic megacolon, fistula, perforation or abscess.
* History of uncontrolled psychiatric disorders or seizure disorders.
* History of asthma requiring ongoing use of inhaled steroids.
* Recent history of drug or alcohol abuse.
* Positive stool test for bacterial pathogens, Clostridium difficile toxin, or ovum and parasites.
* Vaccination within 28 days prior to randomization.
* Allergies to budesonide or to any other items used in its preparation.
* Participation in another clinical trial in the past 30 days.
* Pregnant or at risk of pregnancy.
* Taking a prohibited medication. Some medications to treat UP/UPS are prohibited during participation in the study, including laxatives and anti-diarrhea medications; however, oral 5-ASA agents at doses up to 4.8 g/day and daily fiber supplements are allowed. Other medications (e.g., antibiotics, anti-seizure and anti-coagulant medicines) are also prohibited.
Ventilatory Functions, Oxygen Saturation, and Quality of Life Response to Long Time Cement Dust Exposure

Thousands of people are working daily in a dusty environment. Many studied reported respiratory symptoms and ventilatory disorders among Factory workers who exposed to cement dust. But the evidence for respiratory effect and daily activities over a long time of cement dust exposure has not been conclusive

A total of 49 subjects working in a cement production factory were assessed and divided into three groups according to the total period of work exposure. Groupe A (18 subjects) with work period \< 10 years, group B (13 subjects) with work period 10-15 years, group C (18 subjects) with work period \> 15 years. The ventilatory functions, oxygen saturation, and quality of life were assessed in the three groups. RESULTS: The study results revealed a statistically significant difference between the three groups in the mean values of FVC (%), FEV1/FVC (%), SPO2.

Eligibility Criteria:
Inclusion Criteria:

* The ages were between 25 to 50 years old.
* the body mass index ranged from (18,5 - 29,9) kg/m2.

Exclusion Criteria:

* Age less than 25 or more 50.
* Any chronic diseases
* severe musculoskeletal and cardiopulmonary disorders and
* Class III Obesity (35-39.9 kg/m 2) or more
Effectiveness of SMS Reminders on Influenza Vaccination Coverage in Patients With RA in the ART Registry

Biotherapies have significantly improved the prognosis of rheumatoid arthritis (RA), particularly anti-TNF. However, these molecules are associated with a well-demonstrated increase in infectious risk, including an over-risk of pneumococcal and influenza infection.. Therefore, when initiating anti-TNF treatments, it is recommended to update the vaccination schedule of these patients, to vaccinate them against pneumococcus and carry out an annual anti influenza vaccination.. However, vaccination coverage remains sub-optimal. The means to improve this vaccination coverage are multiple but often require human resources. Medical teams often lack time, nursing interventions are effective but again requires the availability of the health care team. The use of modern digital means (automatic reminders) is an attractive alternative to increase immunization coverage without the use of medical or paramedical time.

The objective of the study is to evaluate the effectiveness, in terms of immunization coverage, of SMS and/or email reminders reminding the need to vaccinate against seasonal influenza compared to usual care, in patients with RA on biotherapies participating in the e-cohort of the French ART Registry (NCT03062865).

This study will be based on the ART Registry e-cohort. This will be a randomized controlled trial in patients in the ART e-cohort. The patients will be allocated in one of the 2 arms : one arm receiving reminders by email and SMS of the influenza vaccination, the other arm with absence of reminders. This study will be conducted during the annual French National communication campaign to encourage influenza vaccination.

The main evaluation criterion will be the influenza vaccination coverage rate at the end of the vaccination campaign. It will be compared between the two arms.

Design :

Randomised, controlled trial within the e-cohort population of the French ART registry (observational study)

Target population :

All participants to the e-cohort of the French ART Registry (Rheumatoid Arthritis and anti-TNF)

Eligibility Criteria:
All patients included in the French ART Registry (rheumatoid arthritis and anti-TNF) and participating to the e-cohort.

Inclusion Criteria:

* Adult patients with RA,
* Patient in whom the specialist physician decides to start treatment with an anti-TNF drug, regardless of the treatment line and regardless of the anti-TNF, including infliximab, adalimumab, etanercept, certolizumab and golimumab, and their respective biosimilar according to their arrival on the market
* Clinicians (hospital-based and private practice) who agree to adhere to the yearly renewal of the hospital prescription

Exclusion Criteria:

* Patient already treated by the same anti-TNF in the past (same drug)
Association Between Serum and Neuroimaging Measurements of the GABAergic System

The goal of this study is to better understand the relationship between peripheral and central nervous system measurements of the gamma-aminobutyric acid (GABA) system in otherwise healthy individuals. the main questions it aims to answer are:

1. Does GABA cross the blood-brain barrier?
2. Can peripheral measurements of the GABAergic system be used to study GABA in the brain?

Participants will receive oral GABA and Placebo and undergo blood draws, MRI scans and transcranial magnetic stimulation sessions.

Although gamma-aminobutyric acid (GABA) is the main inhibitory neurotransmitter in the central nervous system in humans, and various pharmacological compounds and natural products aim to modulate it, it is still unknown whether GABA can cross the blood-brain barrier. The present project aims to clarify this issue by comparing measurements obtained in the central nervous system (the brain) with peripheral measurements (serum) following oral administration of the amino acid GABA. This will help determine if peripheral concentrations of GABA in the blood reflect levels in the brain. This would facility studying the GABAergic system in vulnerable clinical populations (such as children or patients with intellectual disabilities) to participate in without resorting to expensive neuroimaging exams and the inclusion of individuals who cannot undergo neuroimaging exams (e.g., claustrophobia, presence of metal in the body). To achieve this, GABA measurements (serum and neuroimaging) will be obtained before and after the oral intake of 1800mg of GABA or a placebo in 30 healthy adults participating in a cross-over, single-blind study with repeated measures.

Eligibility Criteria:
Inclusion Criteria:

* Be between 18 and 35 years old
* Be of right manual dominance
* In good health

Exclusion Criteria:

* Have an implant or pacemaker,
* Having tinnitus,
* Have a history of fainting,
* Have already had an epileptic seizure or have a family history of epilepsy,
* Have a known neurological disease,
* Have a diagnosis of diabetes
* Be under psychotropic medication,
* Have suffered from substance abuse or dependence in the last 6 months,
* Have a neurostimulator,
* Have a splinter or metallic implant in the head or the rest of the body,
* Have a cochlear implant,
* Have an automated injection system implanted (insulin pump),
* Have a transdermal patch,
* Have tattoos in the area to be studied,
* Be pregnant or breastfeeding,
* Being claustrophobic or having other reasons that would prevent the volunteer from tolerating the imaging exam.
May Preoperative Waist to Height Ratio Predict Postoperative Weight Loss in Bariatric Patients?

Bariatric surgery is an effective method for treatment of obesity. Sleeve gastrectomy is one of surgical methods and became popular in recent years. Weight loss rates after bariatric surgery differs among patients. The exact reason of this difference stays unclear. age, nationality, difference between body composition and type of surgery may be in concern. waist to height ratio has become popular recent years as an indicator of cardiomethabolic status. in this study, investigation of the effect of waist to height ratio differences of patients on weight loss following laparoscopic sleeve gastrectomy as a bariatric surgery.

Waist to height raito is the major determinator of patients and will be noted in every patient who will fulfil the eligibility criteras defined below and undergo laparoscopic sleeve gastrectomy. demographic data, BMI, body lipid composition, lean body weight also will be noted. all patients will undergo standardized laparoscopic sleeve gastrectomy operation. patients will be follow up during first, third, sixth and one year periods. all parameters noted preoperatively will be measured and noted again. possible statistical difference will be calculated statistically and a cut off value will be seeked.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* BMI\>40 kg/m2
* Sleeve gastrectomy operation planned patients

Exclusion Criteria:

* Type 1 or 2 diabetes mellitus
* osteoarticular pathology that may restrict postoperative regular physical activity.
* apparent mental or psychological disorder that may affect postoperative recommendations
* refusal of informed consent for this study
An Evaluation of Web Based Pulmonary Rehabilitation

The purpose of this pilot study is to compare a six week web-based pulmonary rehabilitation programme with traditional hospital-based pulmonary rehabilitation classes for people affected by COPD.

Chronic Obstructive Pulmonary Disease (COPD) is a term used to describe a number of lung conditions characterised by irreversible damage to the airways causing airflow obstruction. Pulmonary Rehabilitation (PR) is a broad programme that helps improve the health and well-being of people with breathing difficulties, most commonly COPD. Participation in PR leads to improvements in exercise tolerance and functional ability, as well as a reducing breathlessness in everyday activities. It is traditionally an outpatient programme based in a hospital or community setting run by a multidisciplinary team, and usually lead by physiotherapy and nursing staff. Typically it includes a physical exercise programme, and advice and education on managing a chronic lung condition. The purpose of this pilot study is to compare a six week web-based pulmonary rehabilitation programme with traditional hospital-based pulmonary rehabilitation classes for people affected by COPD.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of COPD
* Suitable for participation in the NHS Lanarkshire PR programme
* Independently mobile
* Access to the internet in their own home

Exclusion Criteria:

* Unstable cardiac or other health problems which may prevent participation in study
* Under the age of 18
* Pregnant
* Unable to read/understand English
* Unwilling to be randomised into PR delivered via the hospital or internet