cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Acupuncture as an Adjunct to Methadone Treatment Services for Heroin Addicts

This is an open-label, randomized, 2-sequence, cross-over study evaluating the difference of efficacy between ear acupressure alone and ear acupressure plus electroacupuncture therapy both combined with methadone treatment services for heroin addicts.

Methadone substitution therapy has been the treatment of first choice for opiate dependence, but patient on Methadone substitution therapy report a wide side effects, and relapse rate is up to two third of methadone treatment patients between one to two years. Therefore, adjuvant therapeutic interventions for heroin addiction patients are needed. Since 1996, the World Health Organization (WHO) has classified acupuncture treatment indications, including drug abuse. The purpose of this study is to compare the difference of efficacy between ear acupressure alone and ear acupressure plus electrical acupuncture therapy both combined with standard methadone maintenance therapy to the heroin addicts.

Patients who receive methadone were randomly assigned to sequence A and B. Sequence A(n=20) receive ear Acupressure combined with electroacupuncture for four weeks, followed by one week wash-out period. Then ear acupressure alone for another four weeks.

Sequence B(n=20) receive EAR acupressure alone for four weeks first, and followed by one week wash-out period, then ear acupressure combined with electroacupuncture for another four weeks. Measures of methadone dosage and using the craving visual analog scale (VAS) to assess the craving severity for 8 weeks. Using the Short Form Health Survey (SF-36) and the Pittsburgh Sleep Quality Index (PSQI) to assess improvement of life quality and sleep quality. Using Beck anxiety and Depression inventory to evaluate emotional problems. Urine opiate screenings are provided after 4 weeks , 8 weeks treatment and 1 month after end of treatment, to screen opiate reuse.

The study hypothesis was acupuncture had more clinical efficacy than ear acupressure upon craving severity, life quality, mood stability ,reduced methadone dosage and sleep quality when provided as an adjunct to a standard methadone maintenance treatment.

Eligibility Criteria:
Inclusion Criteria:

Fulfilled Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria for Opioid Use Disorder and had been received methadone maintenance treatment for more then one month.

Exclusion Criteria:

1. had taking acupuncture treatment in past 30 days
2. had severe adverse effects or events history from receiving acupuncture treatment
3. had any serious physical illness
4. had a significant risk of suicide
5. ear infection
6. were pregnant or or a woman plan to pregnant
7. had bleeding disorders or were taking anticoagulant drugs
8. had epilepsy, cerebral vascular disease and brain injured history.
Effect of High-Flow Tracheal Oxygen on EELI

The goal of this analytical experimental study is to evaluate whether high-flow tracheal oxygen therapy at flow rates above 60 L/min increases end-expiratory lung impedance in tracheostomized patients in the intensive care unit. The main question it aims to answer is whether high-flow tracheal oxygen therapy improves end-expiratory lung impedance in tracheostomized patients.

This study will be conducted in the Intensive Care Unit of Sanatorio Parque in Rosario, Santa Fe, Argentina, between December 1, 2024, and March 31, 2025. The participant population consists of adult ICU patients (≥18 years old) who are tracheostomized, have undergone at least 10 days of mechanical ventilation, and can tolerate spontaneous breathing for at least 12 hours.

By analyzing the effects of high-flow tracheal oxygen therapy on lung function, this study aims to generate valuable insights into its physiological impact, potentially influencing clinical management strategies for tracheostomized patients in intensive care settings.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent; ability to tolerate spontaneous breathing for at least 12 hours; arterial oxygen pressure (PaO2) ≥ 60 mm hg or pulse oxygen saturation (SpO2) \> 90%; corrected metabolic disorders ph ≥ 7.32; hemodynamically stable.

Exclusion Criteria:

* neuromuscular or neurodegenerative pathology; contraindication for the use of Electrical Impedance Tomography, RASS \> +1.
The Effect of Yoga on Mindfulness and Perceived Stress

This study aimed to examine the effect of yoga on mindfulness and perceived stress levels in nursing students. A randomized controlled study was conducted in a nursing department in western Turkey between September 2019 and January 2020. The required institutional permission and ethics committee approval was received. The study participants were 56 nursing students with (intervention group (n:29), control group (n:27). The intervention group received the yoga program for 15 weeks delivered once a week. The control group did not practice yoga.

This study aimed to examine the effect of yoga on mindfulness and perceived stress levels in nursing students in a parallel-group pretest-posttest randomized controlled study design. The required institutional permission and ethics committee approval was received.

The study was conducted in a nursing department in western Turkey between September 2019 and January 2020. The study consisted of 56 nursing students with (intervention group (n:29), control group (n:27). The intervention group received the yoga program for 15 weeks delivered once a week face to face. The control group did not practice yoga. The data were collected using "Personnel data form", "Mindful Attention Awareness Scale", "Perceived Stress Scale". The data were collected from the students using the online survey. For data analysis, descriptive statistics, paired sample t test, independent t, Pearson chi-square test were used. At the end of the study, the same yoga session was held with the students in the control group.

Eligibility Criteria:
Inclusion Criteria:

* being a first-year class nursing student
* older than 18 ages
* volunteering to participate
* giving consent

Exclusion Criteria:

* with a disability to practice yoga, hearing, and visual impairment
* unwillingness to continue participating in the study and school absenteeism
PredIcting SterOid DepeNdEnt LivEr InjuRy with Polyreactive Immunoglobulin G

The investigators identified polyreactive immunoglobulin G (pIgG) in adults (published in Hepatology: https://doi.org/10.1002/hep.32134) and children (in preparation). Quantification of these pIgG using a "home-made" ELISA facilitates the diagnosis of autoimmune hepatitis (AIH) as compared to non-AIH liver diseases and healthy controls. Positivity for pIgG was independent from ANA/SMA positivity and equally diagnostic for AIH even when conventional autoantibodies (ANA/SMA/SLA/LKM) were negative.

Additionally, the frequency of pIgG was lower than conventional autoantibodies (ANA, SMA) in vaccinia/drug associated severe liver injury in a retrospective multicenter study after Covid-19 vaccination (https://doi.org/10.1016/j.jhepr.2022.100605).

Aims of the study The study aims to evaluate the diagnostic capacity of pIgG to predict AIH in comparison to other liver diseases prospectively. To avoid diagnostic inaccuracy between AIH with long-term need for an immunosuppression and drug induced liver injury with autoimmune features, which can be indistinguishable from AIH at baseline and which has a very low relapse rate after a short steroid course, a follow-up after six months is obligatory for inclusion.

Therefore, the investigators will collect one serum sample from every patient (without immunosuppressive treatment) that presents to the respective hospital for evaluation of liver disease by liver biopsy within one year after initiation of the study and that provided written informed consent. Follow-up for evaluation of steroid dependency at six months after diagnosis is obligatory.


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic liver biopsy for the work-up of any liver disease
* Informed consent
* Definition of any liver disease according to current societal guidelines

Exclusion Criteria:

* No ongoing immunosuppression at the liver biopsy or prior to the liver biopsy
* Liver biopsies for the grading or staging of an already known liver disease (e.g. non-alcoholic fatty liver disease (NAFLD), Hepatitis B/D Virus Infections (HBV/HDV Infection), ...)
Radiofrequency Ablation Versus I-131 for Solitary Autonomous Thyroid Nodules

The purpose of this study is to compare treatment of hyperthyroidism with radiofrequency ablation or I-131 for solitary autonomous thyroid nodules.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Hyperthyroidism or subclinical hyperthyroidism caused by a solitary hyperactive thyroid nodule (HTN), either located in an otherwise normal thyroid gland, or in a multinodular goitre (MNG), with a diagnosis based on the following characteristics:

  * Blood TSH level below the lower limit of normal, and associated with either normal or elevated FT4 and FT3 levels
  * Anti-TSH antibody negative
  * Solitary HTN confirmed by a diagnostic I-123 scintigraphy, corresponding with a well demarcated thyroid node on ultrasound, cystic degeneration \< 75%, nodule size \<50 mm.
* Treatment with RAI indicated, and eligible for RFA treatment
* Signed informed consent Patients who are ineligible for randomization due to unsuitability for RFA, may be eligible for the RAI cohort group.

Exclusion Criteria:

* Multifocal HTN
* HTN \> 50 mm
* Presence of a medical device susceptible to disturbances caused by RFA generated currents
* Patients with physical or behavioural disorders that preclude safe isolation in radiation protection rooms, or safe RFA procedure under local anesthesia
* Patients with dysphagia, oesophageal stenosis, active gastritis, gastric erosion, a peptic ulcer or impaired gastro-intestinal motility
* Uncorrectable haemorrhagic diathesis
* Pregnant or breastfeeding women
The Effect of Proton Pump Inhibition on Palpitations

Feeling of palpitations with no clear arrhythmia is frequently encountered in clinical practice. The majority of these patients have documented sinus rhythm even while having symptoms. Gastrointestinal association with such symptoms was first described by Ludwig von Roemheld (1871-1938).The investigators thought to investigate the effect of proton pump inhibition in patients with feeling of palpitations but no clear cause.

One hundred and fifty patients with palpitations and no clear cause for their symptoms will be randomized to receive either proton pump inhibitor (PPI) (lanzoprazole 30 mg) or placebo for one month. At base line they will be investigated to rule out arrhythmia by documenting normal heart rate (less than 110 beat per minute) or ECG showing normal sinus rhythm or mild sinus tachycardia (Less than 110 per minute) during symptoms. Obvious causes such as anxiety due to a stressful event or organic causes such anemia or thyroid disorders should be also ruled out.

Patient who agree to participate in the study will be asked to sign an informed consent. A baseline questionnaire with symptoms will be filled. They will then be randomized for treatment with either PPI or placebo once at night time. After 10 days of treatment they will be contacted and questioned regarding their symptoms. The two groups will be compared to see if there is any improvement of symptoms with treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Persons with palpitations and no clear cause who are above the age of 16 years and who consent to the study will be included
2. Clear causes that should be excluded are true arrhythmia such SVT or VT or frequent premature atrial or ventricular contractions or any organic cause such as thyroid disorder, anemia (hg less than 11 g/dl) and obvious anxiety disorder
3. Arrhythmia can be excluded by an ECG showing sinus rhythm or sinus tachycardia during episodes or measurement of heart rate by a reliable method during symptoms showing regular heart rate less than 120 beats per minute.

Exclusion Criteria:

1. Refusal to sign consent form
2. Already taking PPI or H2 blocker
3. Frequency of symptoms less than 2 times per week
Drug Compliance and Quality of Life in Patients With Heart Failure Dosed With Either Once-daily or Twice-daily Coreg

The purpose of this study is to compare dosing compliance between study patients taking controlled release carvedilol once a day, and study patients taking immediate release carvedilol (Coreg) twice a day.

Study Further Study Details:

Primary outcome: pill-taking compliance (total doses taken versus total doses prescribed)

Expected Total Enrollment: 400 subjects at 56 study sites in the U.S.

Study Start: October 2005

This is a 5-month double-blind treatment study of male and female subjects with stable mild-to-severe chronic heart failure and with left ventricular dysfunction with symptoms of heart failure.

Eligibility:

Must be stable on treatment with Coreg IR at a standard dose: 6.25, 12.5, 25 mg twice a day.

Eligibility Criteria:
Inclusion Criteria:

* Ability to read English
* Stable symptoms of mild to severe heart failure
* Stable medical regimen for heart failure
* On a stable dose of Coreg for at least 2 months
* LVEF ≤40% within the previous 24 months

Exclusion Criteria:

* Uncorrected obstructive or regurgitant valve disease
* Complex congenital heart disease
* Recent ICD or pacemaker placement
* Recent coronary artery bypass surgery or stroke
* Candidate for heart transplanct within 5 months of study start
* Present or planned use of MAO inhibitors, alfpha-blockers, combined alpha-beta blockers, any Class I/II anti-arrythmnic agents, (amiodarone may be used if ≤ 200mg/day). Use of intravenous vasodilator/inotropic agents.
Feasibility of a Vocational Rehabilitation Intervention for Job Retention in Workers with MS-RiaLSM Intervention Project

Multiple sclerosis (MS) is an autoimmune demyelinating disease of the central nervous system with both inflammatory and degenerative characteristics that affects approximately 136,000 people in Italy. The highest incidence of disease onset occurs between the ages of 20 and 40, which corresponds to the most productive period of a person's life. For this reason, one of the main social consequences of MS is the reduction or abandonment of work activity, which often begins in the early stages of the disease. Vocational Rehabilitation (VR) interventions, as reported in the literature, are used to manage and reduce work-related difficulties. The goal of VR is to enable individuals who experience difficulties in performing work activities to access, find, and maintain employment. This approach is characterized by its multi-professional and multidimensional nature, involving different types of interventions carried out by various professionals in diverse settings.

The overall aim of the project is to define a Vocational Rehabilitation (VR) protocol to reduce work-related challenges and promote job retention for workers with MS within the Italian healthcare and social context. The intervention will be organised into three different areas: rehabilitation, reasonable accommodation and education. Participants will receive any of the three interventions or a combination of these. The study will involve a multidisciplinary team of doctors (e.g. neurologist, physiatrist), psychologists, occupational therapists, physiotherapists, social workers, and labour law experts who will be involved according to the subject's specific needs.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed MS diagnosis
* Age ≥18 years
* Currently employed at the beginning of the study entry
* Have worked at least one day in the last 12 months
* MSQ-Job \>=15
* Written informed consent

Exclusion Criteria:

* Presence of other pathologies impacting on work productivity
Effects of Oxygen After Abdominal Oncological Surgery

The aims of the research is to determine whether a Hyperoxic intermittent stimuli protocol can increase reticulocyte counts, signififying a rise in EPO production, in patients undergoing abdominal surgery

For anemia treatment in cancer patients, human recombinant erythropoietin is often used. However, its application is constrained due to high costs, side effects, and limited availability in some regions. This research and clinical exploration aim to identify an tool alternative to transfusion.

Randomization was conducted post-surgery in a 1:1 ratio across groups: Normobaric Oxygen Paradox (NOP) group, and a control (CTR) group. The NOP group received 60% oxygen for two hours on days 1, 3, and 5 post-surgery using a venti-mask. The CTR group did not receive oxygen therapy during the post-operatory period starting from day 1. All patients could receive oxygen during the surgery and the first 24 hours post-surgery (day 0) as needed. The belonging to one group or the other was blinded to the laboratory staff.

Pre-surgery, all patients were administered an oral benzodiazepine. General anesthesia was employed, potentially combined with epidural techniques and standard anesthesia monitors were used. The choice of anesthesia technique was at the discretion of the anesthetist. During surgery, patients received 40-50% FiO2 ventilation and were extubated at the surgery's end. Post-surgery, patients were admitted to the ICU for at least 24 hours, receiving oxygen if saturation dropped below 98%. The oxygen protocol commenced 24 hours after ICU admission (day 1). The transfusion threshold was set at 8 g/dl with clinical signs.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing abdominal oncological surgery

Exclusion Criteria:

* GFR\<60 ml/minute and/ or creatinine serum level \> 2mg/dl
* Transfusion of red blood cells per or postoperatively
* Bleeding requiring repeated transfusions during or after surgery
* Severe respiratory syndrome necessitating continuous oxygen
* Intolerance to oxygen mask
TOtal Skin Electron Beam Therapy (Low-dose) for Tumor Clone Eradication in Early-stage Mycosis Fungoides

Primary cutaneous T-cell lymphomas are a group of peripheral T-cell lymphomas that primarily involve the skin. Mycosis fungoides (MF) is the most frequent subtype. Most patients with early-stage MF (i.e., patches and plaques of the skin without extracutaneous involvement) have a good prognosis but a subset of patients progress to incurable advanced-stage disease with an overall survival (OS) less than 5 years and an impaired quality of life.

We have recently identified the tumor clone frequency in lesional skin (measured by high-throughput sequencing of the TCRB locus) as the most important prognostic factor of progression-free survival (PFS) and OS in a retrospective analysis on 210 patients with early-stage MF (p\<0.001).

Phototherapy is a standard therapeutic option in early-stage MF but fails to eradicate the tumor clone from the skin.

Low-dose total-skin electron-beam therapy (LDTSEBT, 12 Gy over a 3-week period) has been shown to be safe and highly effective in MF with an 88% overall response rate and a better safety profile compared to standard-dose total-skin electron-beam therapy, in a pooled analysis from 3 phase II trials on 33 patients and a retrospective analysis of 12 patients treated with LDTSEBT.

We hypothesize that the use of LDTSEBT is associated with a significantly higher 1-year PFS compared to conventional treatment with phototherapy. Our secondary hypotheses are that LDTSEBT is associated with a higher tumor T-cell clone eradication compared to phototherapy, and improves OS and quality of life in patients with skin-limited MF.

The main objective of this study is therefore to prospectively determine if LDTSEBT is associated with a higher 1-year progression-free survival in patients with early-stage mycosis fungoides, compared to conventional treatment with phototherapy.

The primary endpoint is PFS at 12 months after study inclusion.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Histopathologically confirmed diagnosis of International Society for Cutaneous Lymphomas (ISCL) / European Organisation for Research and Treatment of Cancer (EORTC) mycosis fungoides stage IB or IIA

Exclusion Criteria:

* Poor performance status: WHO performance status score \> 2
* Physically unable to maintain the posture
* Patient with no health coverage
* Patient under guardianship or curatorship
* Previous history of dose-limiting radiation therapy in the field
* Previous history of dose-limiting phototherapy
* Previous history of melanoma, skin squamous cell carcinoma or basal cell carcinoma or other absolute contraindication to phototherapy (including a history of lupus, xeroderma pigmentosum, or porphyria)
* Pregnant or breastfeeding woman
* Contraindication to methoxsalen (severe liver, renal or heart failure)
A Radiopharmacokinetic and Radiodosimetric Phase I Imaging Study of 18F-FAZA

Hypoxia (little of no oxygen) is considered to be an important characteristic of a patient's tumour that may help predict patient outcomes and/or help inform patient management decisions. 18F-FAZA Positron Emission Tomography (PET) can detect hypoxic tumours because 18F-FAZA accumulates in hypoxic tissues. This study is being done to learn more about the processes by which 18F-FAZA is absorbed, distributed, metabolized (built-up and broken down) and eliminated by the body.

A Phase I Radiopharmacokinetic and Radiodosimetric study of 18F-FAZA. Prior to treatment, subjects will receive a single injection of 18F-FAZA. Subjects will undergo a series of 5-5 PET scans, and will have 8-13 blood samples and 2 urine samples taken at specified time points over a 4.5-5.5 hour period. 18F-FAZA PET images will be reviewed to develop a dynamic uptake model, and blood and urine samples will be analyzed for unchanged 18F-FAZA and its metabolites.

Eligibility Criteria:
Inclusion Criteria:

* Male of Female \> or = to 18 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test required
* Subjects with known primary or suspected metastatic SCC head and neck; NSCLC; SCLC; GBM; lymphoma, or NET with at least one lesion \> 1 cm in diameter
* Able and willing to follow instructions and comply with the protocol
* Provide written informed consent prior to participation in the study
* Karnofsky Performance Scale Score of 70-100

Exclusion Criteria:

* Previous treatment for their primary or metastatic SCC head and neck, NSCLC, SCLC, GBM, Lymphoma, or NET
* Bilirubin \> or = to 200 umol/L
* Creatinine \> or - to 150 umol/L
* AST or ALT \> or = to 5 times the upper limits of normal
* Serious medical conditions such as: congestive heart failure, unstable angina, unstable ventricular arrhythmia, uncontrolled psychiatric conditions, serious infections, uncontrolled diabetes
* Nursing or pregnant females
Comparative Study Between Retained and Non-retained Urinary Catheter in Total Knee Arthorplasty With Epidural Anesthesia

The purpose of this study is to compare the prevalence of postoperative urinary retention between retained and non-retained urinary catheter in total knee arthorplasty with epidural anesthesia


Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty

Exclusion Criteria:

* History of renal disease
* History of urinary tract infection
* History of previous urinary tract surgery
* Benign prostatic hypertrophy
* Bilateral total knee arthroplasty
* Revision total knee arthroplasty
* Patients who need intraoperative monitoring of urine output