cyrilzakka/clinical-trials huggingface dataset:
Feasibility RCT of ACT Self-help for Depression in Haemodialysis

The purpose of this study is to assess the feasibility of conducting a trial to evaluate a self-help treatment for depression in people with end-stage renal disease.

Chronic Kidney Disease (CKD) is a long-term condition in which the function of the kidneys - to filter out waste products from the blood - slowly declines. When renal function becomes sufficiently low it is described as End Stage Renal Disease (ESRD) and renal replacement therapy (RRT) is likely to be needed to prolong life. The most common type of RRT is haemodialysis, in which the patient's blood is filtered through a machine.

It is estimated that depression is experienced by 20-40% of people with ESRD. Depression not only affects the quality of life of individuals with ESRD but is also associated with higher rates of hospitalisation and poorer physical health outcomes.

Acceptance and Commitment Therapy (ACT) has been found to be an effective treatment for depression and has been used successfully as a self-help treatment. However, no study has examined the effectiveness of an ACT self-help treatment for depression in ESRD. This study aims to assess the feasibility of conducting such a study and will look at suitability of recruitment, assessment methods and the acceptability of the self-help treatment, as well as helping to calculate the number of people needed for a definitive study.

Haemodialysis patients receiving dialysis through an NHS renal service will be invited to participate. To participate they will be consenting, over 18 years of age and experiencing depressive symptoms at a clinical level. Those eligible will be randomly assigned into one of two conditions; a control condition receiving treatment as usual (TAU), and an intervention condition receiving TAU alongside an ACT self-help manual with weekly telephone support. The manual will be completed over six weeks. Both groups will be asked to complete questionnaires prior to intervention and 2 and 4 months post-intervention. Participants from each condition will be asked to participate in interviews to explore their experiences of taking part.

Eligibility Criteria:
Inclusion Criteria:

* undergoing haemodialysis treatment at one of three identified units
* receiving haemodialysis treatment for more than 6 months
* moderate depression (as indicated by the PHQ-9)

Exclusion Criteria:

* receiving concurrent psychological treatment
* lacking mental capacity to consent due to cognitive impairment
* inadequate reading ability (indicated by inability to complete PHQ-9 screening measure)
* visual or hearing impairment that would prevent completion of the self-help book or engagement in telephone calls
Analgesic Efficacy of Genicular Nerve Block Versus (IPack Block ) in Patients Undergoing (ACL) Repair

One of the most common injuries to the knee is an anterior cruciate ligament (ACL) sprain or tear due to trauma ACL damage is crippling and often requires repair with an arthroscopic method, which is an outpatient surgery. Nevertheless, patients experience severe postoperative pain on the first day after the ACL reconstruction.Efficient postsurgery pain management is an important part of patient recovery that is also crucial for their satisfaction.

The optimum role of peripheral nerve blocks in ACL reconstruction continue to be debated as a component of multi-modal analgesia . As such ,an ideal block for ACLR would target sensation but not motor function,have minimal complication risk,and be easily reproducible The genicular nerves include branches from the femoral, common peroneal, saphenous, tibial, and obturator nerves which innervate the knee capsule . The superolateral, superomedial, and inferomedial On the other hand, the interspace between the Popliteal Artery and Capsule of the Knee (IPACK) block provides analgesia on the posterior knee joint, and the application of a genicular or IPACK block has been be associated with promising outcomes following the ACLR surgery

Eligibility Criteria:
Inclusion Criteria:

- Patient age from 18 to 45 years old Patient status ASA I - II Patient body mass index (BMI) \<40 kg/m2

Exclusion Criteria:

* -Patients were excluded if they refused consent.
* Patients who are Not cooperative.
* BMI \>40 kg/m2.
* Allergy to local anesthetics.
* Patients with anticoagulation or bleeding problems.
* Previous nerve dysfunction.
* Physical status ASA class IV.
Effects of Telmisartan by Ambulatory Blood Pressure Monitoring (ABPM) in Chinese Patients With Mild to Moderate Essential Hypertension

To assess the trough/peak ratio of 40 mg Telmisartan tablet by ambulatory blood pressure monitoring in Chinese patients with mild to moderate essential hypertension


Eligibility Criteria:
Inclusion Criteria:

* Chinese male or female aged 18 to 75 years
* Mild to moderate hypertension defined as a morning DBP _95 and \<110 mm Hg at visit1 and visit 2. Mean sitting systolic pressure (SBP) must be \<180 mm Hg
* Ability to provide written informed consent

Exclusion Criteria:

* Women who are pregnant or breast-feeding, or of childbearing potential without an effective method of birth control (effective birth control methods are: uterine device, surgical sterilisation, progestogens alone)
* Known or suspected secondary hypertension
* Known history of any chronic hepatic disease
* Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant
* New York Heart Association (NYHA) functional class congestive heart failure (CHF) III-IV
* Unstable angina pectoris
* Myocardial infarction or percutaneous transluminal coronary angiography (PTCA) or cardiac surgery within the preceding three months
* Clinical relevant cardiac arrhythmias as determined by the clinical investigator
* Hypertrophic obstructive cardiomyopathy or clinically significant valvular disease
* Evidence of retinal hemorrhages/exudates
* Clinical significant hyperkalemia as defined by serum potassium level \>6.0 milliequivalents (mEq)/L
* Insulin-dependent diabetes mellitus
* Non-insulin-dependent diabetes mellitus with poor glucose control as defined by persistent fasting blood sugar \>200 mg/dl, peripheral neuropathy or autonomic neuropathy
* Known drug or alcohol dependency
* Administration of any diuretic, ACE inhibitor or angiotensin II receptor antagonist within two weeks before run-in period
* Administration of medication known to affect blood pressure during trial period
* Patients receiving any investigational therapy within one month of signing the informed consent form
* Known hypersensitivity to any component of the formulation
* Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of trial medication
Psychosocial/Behavioral Intervention in Post-Stroke Depression

The primary aim of this study is to determine the effect of a nurse-delivered psychosocial/behavioral intervention on reduction of depression in community dwelling post-stroke patients. We expect the combined behavioral and pharmacologic intervention to be more effective than pharmacotherapy alone in sustaining the improvement in depression for the experimental group. Secondary aims are to examine the effect of the psychosocial/behavioral intervention time course and sustainability of response to treatment, effect on limitations in ability, limitation in participation and overall stroke impact in community-dwelling post-stroke patients, and to compare ischemic stroke survivors who are and are not depressed within the first four months following stroke by their 5-HTTLPR genotypes (s/s, s/l, or l/l).

150 patients at University of Washington affiliated hospitals who are found to be depressed by DSMIV criteria within the first four months following ischemic stroke will be invited to join the study, and randomly assigned to a problem-solving/pleasant events intervention provided by an advanced practice nurse, or to regular clinic follow-up. Both groups will receive standard antidepressant treatment and written materials from the American Stroke Association, and will be assessed for up to two years following the study. The primary outcome is reduction in depression at 12 months following stroke. Secondary outcomes are reductions in limitations in activity (Barthel Index), reduction in limitation in participation (Stroke Impact Scale) and overall stroke impact (Stroke Impact Scale) at 6, 12, and 24 months post- stroke. We hypothesize that all patients will improve their mood and functional ability related to their post-stroke standard treatment, but that those who receive the psychosocial intervention will have significantly greater improvement in mood, functional ability, social participation, and less overall stroke impact at all follow-up measurement. A supplemental aim is to expand aim 4 of the parent study, adding SERT genotype to our list of factors that might influence treatment outcome for PSD. Further, since we are screening both depressed and not depressed stroke survivors for this study, we will add a fifth aim: to compare ischemic stroke survivors who are and are not depressed within the first four months following stroke by their 5-HTTLPR genotypes (s/s, s/l, or l/l).

Eligibility Criteria:
Inclusion Criteria:

Ischemic stroke within previous 4 months Screens positive for depressive symptoms by Geriatric Depression Scale Able to provide informed consent -

Exclusion Criteria:

Subarachnoid or intracranial hemorrhagic stroke Global aphasia Reduced level of consciousness (GCS \<15)
Retrolaminar Block Versus Erector Spinae Plane Block as Opioid-Free Anesthesia for Enhanced Recovery After Posterior Lumbar Discectomy

The aim of this study is to compare retrolaminar block and erector spine plane block as opioid-free anesthesia for enhanced recovery after posterior lumbar discectomy.

Lumbar discectomy is a common procedure for patients who experience leg and back pain due to disc problems. Effective pain management is crucial for timely discharge and successful rehabilitation.

Opioid-free anesthesia is a technique that avoids the use of opioids during surgery. Enhanced recovery after surgery (ERAS) pathways are helpful strategies for incorporating opioid-free pain management techniques into clinical practice.

Erector spine plane block (ESPB) and retrolaminar block (RLB) are considered to be compartment blocks or interfacial plane blocks. In these approaches, local anesthetics are assumed to penetrate the superior costotransverse ligament and reach the paravertebral space, although the needle tip is not advanced into the paravertebral space.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Undergoing elective posterior lumbar discectomy under general anesthesia.

Exclusion Criteria:

* Body mass index (BMI) \>35 kg/m2.
* Patients with disturbed mental status.
* Allergies to the drugs used in the study.
* Local infection at the puncture site.
* Cardiac insufficiency.
* Renal insufficiency.
* Coagulopathy.
* Chronic opioid use.
Oral (Hypo-)function, General Function and Nutritional Status in Elderly Hospitalized Patients

The goal of this observational study is to learn about the effects of a reduced oral function on the nutritional status of non-acute hospitalized elders and on their oral health quality of life.

Malnutrition is highly prevalent among the elderly, many authors reported on the relationship between oral health and nutrition. However the the relationship between the dental state and the nutritional status was always limited to anatomical criteria such as number of teeth and the presence of prosthetic reconstructions.

The oral function is classified into 4 stages healthy state, oral frailty, oral hypofunction and oral dysfunction. The classification into the different stages result from an examination of 7 parameters: the oral hygiene, the oral dryness, the occlusal force, the tongue-lip motor function, the tongue pressure, the chewing function and the swallowing function.

This study aims to correlate the oral function with the nutritional status of non-acute hospitalized elders. And to further investigate the correlation between the different parameters defining the oral function and the oral health related quality of life (OHRQoL) as measured by theGeneral Oral Health Assessment Index.

A total 60 participants will be recruited in the University Hospital of Geneva, Loëx rehabilitation center. The investigators will see the patient for 2 visits after informed consent. The first visit will be 45 minutes long and will include a dental examination and an examination of the oral hygiene, the oral dryness, the tongue lip motor function, the tongue pressure, the occlusal force and the swallowing function. Diagnosis for nutrition according to the Glim criteria will be done. Furthermore, the participants will be asked to fill an oral health quality of life questionnaire comprising 12 questions.

Oral hypo function will be defined as a state when 3 or more signs were present from the 7 parameters examined.

Linear multiple regression analysis is used to examine the relationship between the nutritional status and oral function. Spearman's rank correlation coefficient will be used to correlate the oral function score and oral health related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* • Aged 70 years or over

  * Hospitalized in Geneva University Hospitals, in rehabilitation or in long term care (Loëx)
  * Able to follow simple instructions and perform the tests
  * Understand French and complete or answer the questionnaire
  * Give written informed consent
  * Consent can be obtained from their next of kin or legal representative if necessary
  * Have been admitted into the hospital no longer 15 days before inclusion

Exclusion Criteria:

* Patients with tube/intravenous feeding
* Poorly-controlled diabetes (Liu et al., 2015)
* Patients with gastro-intestinal diseases or symptoms (nausea, vomiting, diarrhea, constipation) affecting oral intake
* If the patient is taking an antimicrobial treatment at this time.
Clinical Application of Super-resolution Ultrasound(SR-US) Imaging in Solid Tumors

It has well accepted that tumor angiogenesis present aberrant vascular architecture and functional abnormalities, which is associated with tumorigenesis, tumor propagation and progression. By locating, separating and tracking microbubbles, the recently introduced and upgraded Ultrasound Localization Microscopy (ULM) surpassed classical wave diffraction limit. However, the acquisition of structural and functional parameters of microcirculation in vivo for ULM is still confined by the compromise between the resolution and penetration depth. The relatively long acquisition time induced the difficulty of motion correction potentially, which hampers the preclinical to clinical application in organs with distinct tissue motion such as the liver. Therefore, we take the lead in studying human liver lesion microvasculature, which remains a challenge for noninvasive, quantitative and functional intravital imaging especially due to its deep-seated location and strong motion. We developed a Super-resolution Ultrasound (SR-US) imaging technique based on ULM to assess its feasibility of visualizing and quantifying microvasculature in human organs.

In this study, 7 indexes were obtained by ultrasonic acquisition. These 7 indicators are used to describe and evaluate the microvessels in the tumor, so as to achieve the early identification and diagnosis of the tumor, and to monitor the growth of the tumor for a long time and evaluate the treatment of the tumor. This is not available with other ultrasound devices.

Based on contrast-enhanced ultrasound, this technology can provide information of smaller blood vessels, which will certainly contribute to the early diagnosis and real-time evaluation of solid tumors during treatment, and play an important role in clinical application.

Eligibility Criteria:
Inclusion Criteria:

1. Age over 18 years old, gender unlimited;
2. Patients with solid organ tumors with a maximum diameter \> 1cm;
3. No contraindications with contrast ultrasound agents;
4. It can improve the pathological results of the tumor or the diagnostic results supported by other relevant imaging tests.
5. Patients can understand the purpose of the examination, voluntarily participate and sign the informed consent.

Exclusion Criteria:

1. The subject is known to be allergic to any component of the contrast agent Sonovue;
2. Lesions were diffuse or borderless on contrast ultrasound;
3. Patients who underwent previous anti-angiogenesis and chemotherapy, or other local treatment of the tumor;
4. Poor image display or deep position in conventional ultrasound evaluation (\<10 cm from skin),
5. The researchers determined that there were any other factors that were not suitable for inclusion or affected participants' participation in the study
6. Patients with severe heart disease or lung disease;
7. Patients who are pregnant, may be pregnant or breastfeeding;
8. No enhanced MRI or enhanced CT results can be obtained;
9. The investigator considers the subjects unfit to participate in this study.
Senyo Health with Substance Use Disorder (SUD) in Primary Care

The purpose of this study is to examine the barriers, facilitators, and optimal processes for implementing a digitally enhanced screening, brief intervention, and referral to treatment (SBIRT) model for Substance Use Disorder SUD treatment among Mayo primary care clinics.


Eligibility Criteria:
Inclusion Criteria:

* Ability to read, write, and understand English
* Minimum DAST (1+), audit-C score (3+)
* Access and willingness to use a mobile device for asynchronous (text) and synchronous (video) engagement with care.

Exclusion Criteria:

* Diagnosed personality pathology as the primary presenting concern based on clinical judgment, severe cognitive impairment (e.g., intellectual disability or dementia), or psychosis
* Inability to actively participate in and learn from psychotherapeutic interaction based on clinical evaluation and clinical judgment
* Needing a higher level of mental health care as demonstrated by ASAM32 assessment.
* Decline to answer suicidality questions.
Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis

Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-1)

This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU-838 in adult patients with RMS. The study will consist of the following periods:

Screening Period: Approximately 28 days Main Treatment Period: Up to 72 weeks (approximately 15 months) Open Label Extension Period: Up to approximately 8 years

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient (age ≥18 to ≤55 years).
* Patients with an established diagnosis of MS according to 2017 McDonald Criteria.
* Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondary progressive MS, both defined according to Lublin criteria 1996 and 2014.
* Active disease as defined by Lublin 2014 evidenced prior to Screening by:

  1. At least 2 relapses in the last 24 months before randomization, or
  2. At least 1 relapse in the last 12 months before randomization, or
  3. A positive Gd+ MRI scan (brain and/or spine) in the last 12 months prior to randomization.
* Willingness and ability to comply with the protocol.
* Written informed consent given prior to any study-related procedure.

Exclusion Criteria:

* Patients with non-active secondary progressive MS and primary progressive MS.
* Any disease other than MS that may better explain the signs and symptoms, including history of complete transverse myelitis.
* Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-IgG-associated encephalomyelitis
* Any active and uncontrolled coexisting autoimmune disease, other than MS (except for type 1 diabetes mellitus and inflammatory bowel disease)
* Use of experimental/investigational drug (with the exception ofCOVID-19 vaccines approved by emergency use authorization) and/or participation in drug clinical studies within 6 months prior to Screening
* Previous or current use of MS treatments lifelong, or within a pre-specified time period.
* Use of the pre-specified concomitant medications.
* Clinically significantly abnormal and pre-specified lab values.
* History of chronic systemic infections within 6 months before the date of informed consent.
* Diagnosis or suspected liver function impairment, which may cause fluctuating liver function tests during this study.
* Known history of nephrolithiasis or underlying condition with a strong association of nephrolithiasis.
* History or clinical diagnosis of gout.
* History or presence of any major medical or psychiatric illness
* Substantial medical condition that could create undue risk to the patient, could affect adherence with the study protocol or could undesirably affect study outcomes
Assessment of the Number of Missing Tooth Surfaces and the Molecular Findings on the Outcomes of Vital Pulp Therapy Using Two Calcium Silicate Materials

The present study aimed to evaluate and compare the clinical and radiographic outcomes of full pulpotomy in mandibular molar teeth with symptomatic irreversible pulpitis according to:

A. Number of tooth surfaces defects:

* Class I cavity defect.
* Class II cavity defect.

B. Using two types of pulpotomy dressing materials:

* MTA+ (Cerkamed, Stalowa, Poland).
* Well-Root PT (Vericom, Gangwon-Do, Korea). And.,

To correlate this outcome to the quantification of two biomolecules:

* Tumor necrosis factor-alpha (TNF-⍺).
* Matrix metalloproteinases-9 (MMP-9).

Based on the results of the present study, it was concluded that:

1. Full pulpotomy using calcium silicate cements (CSCs) is considered a conservative, economical, and simple treatment option with a favorable prognosis for teeth with symptomatic irreversible pulpitis.
2. Class I and class II cavity defects do not adversely affect pulpotomy prognosis taking into consideration good aseptic condition, magnification, and proper seal of filling materials.
3. Although MTA+ and Well-Root PT yielded similar outcomes for pulpotomy in terms of success rates. Well-root PT is easier to handle compared to MTA+ and doesn't have a discoloration effect which is considered one of the drawbacks associated with MTA+.
4. Neither the preoperative pain nor the intraoperative bleeding time within 10 minutes influenced the pulpotomy outcome.
5. The concentration of TNF-α and MMP-9 biomarkers directly impact the outcome of pulpotomy.

The current study addresses an important gap in research, as the impact of cavity configuration on the outcomes of full pulpotomy has not been well explored. Comparing Class I and Class II cavity defects in this context can provide valuable insights, especially given the differences in structural integrity, bacterial infiltration risks, and restorative challenges associated with these defects.

Eligibility Criteria:
Inclusion Criteria:

* Mandibular molar teeth with signs and symptoms of symptomatic irreversible pulpitis without radiographic evidence of apical periodontitis.
* Age range of 21-45 years old.
* Males or females.
* No disabilities.
* Class I and/or class II cavity defects.
* Teeth reveal positive response to cold tests.

Exclusion Criteria:

* Presence of open apices.
* Non-restorable teeth.
* Teeth in which the pulpal bleeding time is more than 10 minutes.
* Presence of large carious lesions approaching the root.
* Presence of calcification or resorption.
* Periodontally affected teeth.
* Patients who are taking antibiotics within one week before treatment.
* Patients consumed taking analgesics within 24 hours before treatment.
* Systemically compromised patients.
* Pregnant females.