cyrilzakka/clinical-trials huggingface dataset:
Bioimpedance Analysis in Perioperative Assessment in Thoracic Surgery

The assessment of surgical and postoperative risks in thoracic surgery is a field of significant interest because the surgical procedure causes substantial changes in the body's homeostasis.

The postoperative course is characterized by considerable clinical variability compared to the preoperative classification, which highlights more homogeneous data among various patient groups. This variability appears to result from individual differences in response to extensive pulmonary resections. Notably, the homogeneity of preoperative data does not correlate with the greater variability observed in the postoperative course.

The application of algorithms derived from BIVA in bioimpedance studies has proven particularly useful for prognostic assessments in oncology, as it can evaluate a patient's hydration status and muscle reserves at the time of diagnosis or the start of clinical/surgical treatment.

Understanding body composition, particularly the quantity and/or quality of muscle mass, is essential for diagnosing sarcopenia.

By passing a low-intensity alternating current (imperceptible to the patient) through the body, BIVA measures provide insights into body water distribution (both intracellular and extracellular), lean mass and skeletal muscle mass. Overall, the test offers a detailed picture of hydration status and skeletal muscle composition.

Another validated tool for assessing sarcopenia, which provides information on both muscle quantity (via cross-sectional area measurements) and muscle quality (via muscle density measurements), is computed tomography (CT). CT imaging is typically performed for diagnostic and staging purposes before surgery in thoracic surgery patients, either alone or in combination with positron emission tomography (PET).

Our study will focus on assessing correlations between clinical, imaging, and bioimpedance data and postoperative outcomes, with particular attention to the incidence of atrial fibrillation (AF), pulmonary atelectasis requiring treatment, and increased pleural drainage production.

Additionally, we will evaluate the relationship between the surgical approach (open surgery vs. video-assisted thoracoscopic surgery, or VATS) and short-term bioimpedance values.


Eligibility Criteria:
Inclusion Criteria:

- Patients undergoing pulmonary resection surgery for primary neoplasm within a one-year timeframe.

Exclusion Criteria:

* Patients with chronic atrial fibrillation (AF).
* Patients who have previously undergone major pulmonary resection.
* Patients with pacemakers or implantable devices, as the use of bioimpedance vector analysis (BIVA) may be contraindicated.
Research on Gut Microbiome and Metabolomics Alterations in C.Difficile Infected IBD Patients

The goal of this research is to compare alterations of gut microbiota and fecal metabolomics alterations between inflammatory bowel disease patients infected with or without Clostridioides difficile. The main questions it aim to answer are: which bacterial genus or fecal metabolites can discriminate IBD patients infected or more likely to be infected with Clostridioides difficile and their role in the pathogenesis of Clostridioides difficile.

type of study: observational study participant population/health conditions

1. population diagnosed with Ulcerative colitis or Crohn's disease
2. Having diarrhea Participants will be included in this research. If there is a comparison group: Researchers will compare healthy people without IBD or any diarrhea to see if disease or diarrhea would affect the gut microbiota and metabolites.


Eligibility Criteria:
Inclusion Criteria:

* inpatients diagnosed with ulcerative colitis or Crohn's disease in Renji hospital
* age from 18 to 75 years old

Exclusion Criteria:

* other infection caused diarrhea
* other metabolic diseases or inflammatory diseases
* patients who are not able to send back samples 4-6 weeks after therapy
Virtual Reality Therapy for Treatment-resistant Auditory Hallucinations in Schizophrenia

Treatment of verbal hallucinations in schizophrenia is clinically challenging for both the patient and the therapist. For the therapist, one of the main difficulties arises from the impossibility of directly communicating with the entity persecuting the patient. For the patient, the therapeutic process is challenging because it aims at getting to better cope with an entity that keeps repeating stereotyped and abusive sentences without having the emotional strength to reply to the persecutor. To help overcome these clinical challenges, virtual reality enable patients to recreate the face and the voice of their persecutor.The hypothesis is that the engagement of patients in a dialogue with an external representation of their persecutor, with the support of the therapist, would help them to gain better control over their voices.


Eligibility Criteria:
Inclusion Criteria:

* distressing auditory verbal hallucinations
* medication resistance relating to auditory verbal hallucinations (no response after 3 antipsychotics trials lasting at least 4 weeks each with a minimum of 400mg chlorpromazine equivalent)
* DSM-5 diagnosis of schizophrenia or schizoaffective disorder

Exclusion Criteria:

* any change in medication within the past 2 months;
* substance use disorder within the last 12 months
* neurological disorder or unstable and serious physical illness
* ongoing psychotic episode
* cognitive behavioural therapy for psychosis within the last 12 months
Comfort and Antimicrobial Efficacy of Chlorhexidine vs Betadine for Intravitreal Injections

The purpose of this prospective interventional study is to compare patient experience, ocular surface irritation, and bacterial colony counts and microbial spectrum between povidine iodine and aqueous chlorhexidine as ocular surface antiseptic prior to intravitreal injection

This is a single center prospective study comparing antiseptic efficacy and ocular surface irritation with PI (povidine iodine) and AC (aqueous chlorhexidine). Patients will be recruited in the clinical offices of the Retina Service of Wills and Hospital/Mid Atlantic Retina clinic offices. Patients who are determined to require bilateral intravitreal injections of an anti-VEGF (vascular endothelial growth factor) agents by a retina specialist at their regularly scheduled retina appointment will be evaluated for qualification by study personnel. Patients who meet inclusion criteria will be identified and informed consent will be obtained. Prior to injection, topical anesthetic (0.5% proparacaine, Alcon) will be instilled in both eyes. Study personnel will obtain four samples from the superior and inferior fornices of the upper and lower lids of both eyes using swabs (COPAN ESwab, ThermoFisher Scientific) for patients enrolled at Wills. Topical antisepsis will then be applied, the first eye will be randomized to one drop of either PI 5% or AC 0.1% and the second eye will receive the other agent. One minute after instillation of the eye drop to each eye, patients will rate their pain in each eye using the Wong-Baker (smiley face) rating scale. The injections will then be performed by the treating retina specialist. Following the injection, a second conjunctival culture will be taken in an identical manner to the first for patients enrolled at Wills. Study personnel will then instill fluorescein dye (fluorescein sodium ophthalmic, BioGlo) into each eye, and a brief slit lamp examination will be performed. Study personnel will record surface findings according to the Ocular Surface Score and a numerical score for each eye will be determined. On post-injection day one study personnel will call the patient and ask to rate the pain in each eye using the same verbal numerical rating scale. No additional clinic visits will be required as part of the study.

Eligibility Criteria:
Inclusion Criteria:

* Current patient of the Wills Eye Hospital Retina Service including all Mid Atlantic Retina offices
* Clinical indication of bilateral intravitreal injection as determined by the treating retina specialist for a diagnosis of age-related macular degeneration, diabetic macular edema, proliferative retinopathy or macular edema associated with retina vein occlusion.
* Age greater than 18.

Exclusion Criteria:

* Documented allergy to PI or AC
* Current diagnosis of infectious keratitis
* History of unilateral contact lens wear in the past 30 days
* Current unilateral use of prescription eye drops.
Comparing Efficacy and Safety Between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients

Multi-center Study to Compare Efficacy and Safety between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients during 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have ability to comprehend the contents of study and before participating in trial and have willingness to sign of informed consent in writing
* 20≤ age ≤60
* A patient has symptom of acute low back pain
* 4≤ VAS

Exclusion Criteria:

* Subjects who cannot prohibit anti-inflammatory drug, painkiller or muscle relaxants during clinical trial
* Chronic rheumatoid arthritis patients
* Patients having a medical history of hypersensitivity to Eperisone Hydrochloride
* Subject having a hereditary problem such as galactose intolerance, Lapp lactase deficiency, or glucose galatose malabsorption
* Participation in other studies before 60 days of first dosing
* Female patients having positive pregnancy test, lactating women,planning pregnancy during clinical trial
* Inadequate subject for the clinical trial by the investigator's decision
Clinical Effectiveness of iReadMore for People With Alexia

iReadMore will provide an app-based therapy for people with pure or central alexia.

This study aims to test the clinical effectiveness of iReadMore for improving reading accuracy and speed in real world users of the therapy.

iReadMore is a self-led therapy app for improving single word reading accuracy and speed in individuals with acquired reading impairments. iReadMore has been demonstrated to improve reading speed and accuracy in pure and central alexias (Woodhead et al., 2013, 2018). iReadMore therapy is not expected to improve reading for the remaining alexia subtypes.

iReadMore includes 590 of the most frequently written words from the SUBTLEX lexical database (Brysbaert and New, 2009). High frequency words were chosen to maximise the relevance (ecological utility) of the training to everyday life. The therapy mechanism relies on mass practice of cross-modal, paired associate learning (Holcomb and Anderson, 1993) based on the Triangle Model approach to reading. Untrained words will not be affected, and thus word reading improvements are not expected to generalise beyond trained items.

The therapy utilises gamification and is designed to be accessible in order to drive motivation and engagement for the user group. iReadMore is downloadable via the Google Play store on Android tablet devices. iReadMore is a CE-marked class 1 medical device that was developed by the Neurotherapeutics Group, University College London.

An online roll-out trial will be conducted to evaluate the clinical effectiveness of iReadMore with a study population of real world users. The therapy will be evaluated in a clinical population with a reading impairment of any acquired cause (such as stroke or brain injury). Participants will self-enrol in the study through the app, which has been co-designed to ensure accessibility to this user group.

A within-participant evaluation of trained versus untrained items will investigate the clinical effectiveness of the therapy for improving reading speed and accuracy. The primary outcomes are improvements in single word reading accuracy and speed. Interval testing will be conducted after every 5 hours of therapy. The secondary outcomes are self-reported Activities of Daily Living and a series of qualitative questions.

Further analyses will be conducted on alexia subtypes and the influence of therapy dose and intensity on the therapeutic outcomes.

Ethical approval for the iReadMore roll-out trial was obtained from the UCL Research Ethics Committee (ID: 7609/001).

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Diagnosed with stroke, dementia, brain injury or brain tumour
* Diagnosed or self-diagnosed with impaired reading ability
* Willing and able to give informed consent for participation in the study

Exclusion Criteria:

* History of developmental reading or speech and language disability
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250 mg/5 ml Oral Suspension Fed Conditions

To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250 mg/5 ml fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Study of Buprenorphine Maintenance Treatment for Opioid Dependence in Primary Care

The purpose of this treatment research study is to assess the effectiveness of buprenorphine maintenance treatment for opioid dependence delivered in a primary care clinic setting. This study will determine whether buprenorphine treatment in primary care is effective in reducing cravings, reducing illicit opioid use, reducing addiction severity, and retaining patients in primary care treatment for opioid dependence.

Buprenorphine maintenance treatment of opioid dependence in primary care may expand treatment access. Buprenorphine is a partial mu-opioid agonist approved for treatment of opioid dependence (dependence on heroin, prescription opioid pain medication, or methadone), which can be prescribed in primary care by authorized physicians. The purpose of this study is to assess the effectiveness of buprenorphine maintenance treatment in a primary care setting. Outcome measures include illicit opioid use during treatment, addiction severity scores from the Addiction Severity Index (ASI), patient craving ratings on a 100mm visual analog scale (VAS), and patient retention in treatment.

This is a 6-month, prospective cohort study of adults aged 18-65 who are seeking buprenorphine maintenance treatment for opioid dependence. This study is observational, not experimental, and patients will be treated in a naturalistic condition according to their individual treatment needs. Clinic visits will occur weekly for the first 4 weeks (Induction and Stabilization Phases), and monthly for the remaining 20 weeks (Maintenance Phase), at which time up to a month of medication may be prescribed. Participation in ancillary psychosocial treatment is recommended but not required. Urine toxicology and craving ratings will be collected at each visit. Additionally, research visits will occur monthly to collect data assessing addiction severity, risk factors, general health, and psychiatric symptoms.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for current opioid dependence
* Must be seeking treatment
* Must describe opioid medication or heroin as primary drug of abuse
* Must be financially able to receive treatment at the primary care clinic site and to receive medication (e.g., Medicaid)
* Able to give informed consent and comply with study procedures

Exclusion Criteria:

* Axis I psychiatric disorder(s) as defined by DSM-IV-TR that are unstable or would be disrupted by study participation
* Individuals at significant risk for suicide based on current mental state
* DSM-IV dependence with physiologic dependence other than opioid and nicotine
* Women must not be pregnant or lactating, and must agree to use a proven effective method of contraception and not become pregnant during the study
* Unstable physical disorder that might make participation hazardous
* Known allergy, sensitivity or adverse reaction to buprenorphine
* Current buprenorphine maintenance
* Inability to read or understand the self-report assessment forms unaided
Examining the Impact of Heated Yoga on Mindfulness and Rumination

This study will examine how doing heated yoga or non-heated yoga affects depression.

The purpose of this study is to investigate the effects of heated and non-heated yoga on depressive symptoms. Previous research trials using heated and non-heated yoga interventions have shown promising results for reducing depression and its related outcomes. However, no studies have directly compared the effects of heated vs. non-heated yoga for depression. The researchers aim to address this gap by conducting a non-inferiority trial comparing heated yoga and non-heated yoga interventions to improve depressive symptoms. Both the heated and non-heated yoga interventions will be conducted in-person by certified yoga instructors. Eligible participants will be adults who do not regularly practice yoga or meditation and are experiencing moderate levels of depression. Assessments will be conducted at baseline, mid-treatment, post-treatment, and follow-up using a secure data capture system.

Eligibility Criteria:
Inclusion Criteria:

1. adults (≥18 years old)
2. provide informed consent
3. are able to read and understand English
4. PHQ-9 score between 10-20, indicating moderate but not severe depressive symptom severity (27)

Exclusion Criteria:

1. older adults (\> 65 years old)
2. have had a bone fracture or joint surgery in the past 6 months
3. are unable to walk
4. have severe heart failure or lung disease
5. participants endorse an item on the revised Physical Activity Readiness Questionnaire (PAR-Q+) and do not have approval from their treating physician (we will check in with treating physician in the event that participants endorse any item on the PAR-Q+)
6. participants must have a physician responsible for their medical care
7. are pregnant or planning to become pregnant
8. no more than 6 yoga classes in the past 6 months
9. have active suicidal thinking (i.e., PHQ-9 item 9 ≥1)
10. report manic symptoms (Altman Self-Rating Mania Scale score ≥ 6 (28))
11. are on medications that make dehydration more likely (e.g., stimulants, lithium, antipsychotics)
12. active eating disorders or substance use disorders within the past 12 months
13. antidepressant or psychiatric medications that are initiated less than 8 weeks or a dose change less than 4 weeks prior to screening visit
14. psychotherapy that has been initiated within the past 3 months
15. willingness to keep psychiatric medications and psychotherapy stable throughout the course of the study
16. psychiatric hospitalization within the past year
17. diagnosed with any neurological disorders that would impact participation or make participation unsafe
18. are not currently in any active ketamine, ECT, or TMS
19. are unable to follow the study procedures (e.g., not able to travel to the heated or non-heated yoga studios)
Diagnosis and Management of Arterial Hypertension for Algerian Patients in Current Medical Practice

Blood pressure reduction and control are associated with reduced risk of stroke and cardiovascular disease. There is evidence that ambulatory blood pressure monitoring (ABPM) results more accurately reflect the risk of cardiovascular events than do office measurements of blood pressure. New international guidelines recognize the importance of ABPM which has an important and growing role in the diagnosis and in guiding antihypertensive therapy. In 2011 in the United Kingdom, the National Institute for Health and Care Excellence (NICE) recommended that ABPM be performed on all patients with suspected hypertension to confirm the diagnosis and reduce unnecessary treatment in people who do not have true hypertension. The aim of this observational study is to describe the utility of ABPM generally and specifically in the management of hypertension by Cardiologists in the Algerian context.

The primary Objective of this study is to assess the benefit of the ABPM in the diagnosis and management of arterial hypertension in by Cardiologists.

The Secondary Objectives are:

* To identify the conditions of usage of ABPM for the diagnosis of arterial hypertension,
* To evaluate the blood pressure during the ABPM assessment and at 6 weeks of follow up
* To describe the study population (socio-demography),
* To describe the therapeutic stratégies and the compliance to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are either hypertensive (defined as those with a clinic SBP ≥ 140 mmHg or DBP ≥ 90 mmHg \[7\]) or referred for the assessment of hypertension
* Informed consent obtained before any study-related activity

Exclusion Criteria:

* ABPM contraindication
* Patient with psychiatric disorder
* Patient not able to comply with study-related procedures based on clinical judgement of the investigator
Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions

The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* BMI ≥ 27 (no lower BMI limit for Type 2 diabetics)
* 70 years of age or less
* Have 2 or more of the following obesity-related co-morbid conditions:

  * Systolic blood pressure 140-160 mmHg (130-160 if diabetic);
  * Diastolic blood pressure 90-100 mmHg (85-100 if diabetic);
  * Requirement for 2 or more medications to achieve control (\<140/90 mmHg)
* Triglyceride level between 200-400 mg/dL or requirement for 2 or more medications to achieve control (\<200 mg/dL)
* At lease one of the following metabolic criteria:

  * Fasting blood glucose level \> 100 mg/dL
  * Glucose level \> 140 mg/dL
  * Diagnosis of type 2 diabetes
* Waist circumference ≥ 102 cm for men or ≥88 cm for women

Exclusion Criteria:

* Stroke/MI/unstable cardiovascular disease within 6 months
* Clinically significant renal, hepatic or psychiatric disease
* Unstable thyroid disease or replacement therapy
* Nephrolithiasis
* Obesity of known genetic or endocrine origin
* Participation in a formal weight loss program or lifestyle intervention
* Glaucoma or intraocular pressure
* Pregnancy or breastfeeding
* Drug or Alcohol abuse
* Smoking cessation within previous 3 months or plans to quit smoking during study
* Eating disorders
* Cholelithiasis within past 6 months
* Excluded medications
* Type 1 diabetes or use of any antidiabetic medication other than metformin
* Previous bariatric surgery
* Bipolar disorder or psychosis
* Steroid hormone therapy
* Systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg
* Creatinine clearance \< 60 mL/minute