cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Efficacy of Phenol Block and Corticosteroid-Local Anesthetic Block Applied to the Genicular Nerve

There are different neurolysis methods. Aim of this study is to compare two different methods, phenol block and corticosteroid local anesthetic block.

Knee osteoarthritis is one of most frequent reason of knee pain. There are different treatment methods such as analgesic drug treatment, physical therapy techniques, intraarticular injections and neurolysis techniques. In this study, we will compare neurolysis techniques these are phenol block and corticosteroid local anesthetic block.

Eligibility Criteria:
Inclusion Criteria:

* Patients with knee osteoarthritis must have pain at least 6 months
* NRS score of knee pain equal or more than 5
* At least grade 3 in Kellgren-Lawrence grading scale
* Non responsive to life style change, weight control, exercises program, medical treatment and the other conservative treatments (physical therapy, intraarticular injections)
* Decreasing at NRS score more than %50 after diagnostic block
* Those who accept the consent form

Exclusion Criteria:

* Patients who have acute knee injury
* Surgery history in knee
* Connective tissue disease that affect knee
* Sciatica
* Injection story in last 3 months
* Psychiatric or neurologic diseases that affect study
* Septic arthritis, active local or systemic infection
* Coagulopathy
* Pregnancy
* Allergic reaction
Very Low Calorie Diet for Diabetic Kidney Disease

The purpose of this study is to determine whether a very low calorie diet will stabilize or improve diabetic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* Age \> 18
* Body mass index ≥ 30
* Presumed or biopsy-proven diabetic nephropathy
* Estimated GFR \< 40 ml/min/1.73 meters squared
* Proteinuria \> 0.5 gm/day
* Motivated to lose weight
* Stable medical co-morbidities
* Using an ACE inhibitor or angiotensin receptor blocker agent (unless contraindicated)

Exclusion Criteria:

* Inability to sign informed consent
* Life expectancy of \< 1 year
* Expected need for initiation of dialysis within 9 months
* Type 1 Diabetes
* Recent myocardial infarction or stroke (past 3 months)
* Unstable angina
* Active cancer
* Pregnancy/lactation
* Serious psychiatric diseases
* Substance abuse
* Uncontrolled hypertension (\> 180/110)
* Ineligible for VLCD based on laboratory data
Parks & Pediatrics Fit Together

The proposed project will test an implementation strategy (the "TrailGuide") for delivering an existing model of pediatric obesity treatment ("Fit Together") that has demonstrated ability to meet published recommendations for improving health outcomes of children with obesity.

Evidence-based treatment for childhood obesity exists, yet a fundamental knowledge-to-action gap has significantly limited the uptake of recommendations into clinical practice, particularly in low-income settings. Persistence of this gap represents a large-scale public health threat, as the earliest generation of children living through the obesity epidemic now enters adulthood, they are the first in US history to have a shorter life expectancy than their parents, mainly due to rising rates of obesity-related cancers and cardiovascular disease. A central challenge in delivering recommended treatment is the intensity; ≥26 hours of face-to-face contact are necessary to achieve health benefits and risk reduction. The objective of the proposed project is to develop and test an implementation strategy that pairs primary care pediatric clinics with the municipal Parks and Recreation (P\&R) centers to deliver the current treatment recommendations with high fidelity, while allowing

Eligibility Criteria:
Inclusion Criteria:

* Child receives primary care at one of the participating clinics
* Child age 6-11 years old at the time of enrollment in the study
* BMI greater than or equal to 95th percentile for age and sex
* English- or Spanish-speaking

Exclusion Criteria:

* Injuries or disabilities preventing physical activity.

Inclusion criteria for caregivers:

* Age 18 or older
* English or Spanish-speaking
* Caregiver has smartphone and is willing to download app(s) used in the study
* Anticipates bringing the child to the program the majority of the time and spends significant time with the child outside of program hours (necessary in order to accurately answer survey questions about child behavior and child participation in the program, and provide feedback about the program)
* Does not have plans to leave the area during the next 12 months
Study on Normal Ranges of Lipids in Breast Milk of Healthy Mothers

This trial is undertaken to better understand the ranges of functional components normally found in human milk. This will strengthen the scientific knowledge on breast-milk composition as a "gold standard".


Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 37 and not above 42 weeks
* 18 years old ≤ Mother ≤ 40 years old
* 18.5 ≤ pre-pregnancy BMI ≤ 29
* Mothers willing to breastfeed for the first 4 months

Exclusion Criteria:

* Gestational diabetes
* HTA \< 140/90
* Mothers who are smokers while breast-feeding
Surgery vs. Casting for Displaced Articular Radius Fractures in Elderly

Objective: to compare the functional outcome after open reduction and internal fixation with non-operative cast treatment for elderly patients with displaced intra-articular distal radius fractures.

Rationale: there is no consensus about the optimal treatment of displaced intra-articular distal radius fractures in elderly patients. To ensure optimal functional outcome there is a tendency to operate. However, there is no evidence that supports the surgical treatment of patients aged 65 years or older and in the absence of clinical trials it stays unclear how elderly patients with intra-articular fractures should be treated.

Study design: multi-center randomized controlled trial with a non-inferiority design. Economic evaluation alongside a randomized controlled multi-center trial.

Study population: all consecutive patients aged between 65 years and older with displaced intra-articular (AO Type C) distal radius fractures, with a not acceptable reduction within 3 weeks following trauma.

Intervention: patients will be randomized between open reduction and internal fixation (intervention group) and plaster immobilization (control group).

Main study parameters: the primary outcome will be evaluated after 1 year with the Patient-Rated Wrist Evaluation score (PRWE). Secondary outcomes comprise other patient reported outcome measures (PROM) including the Disability of the Arm, Shoulder and Hand (DASH), Quality of life (EQ-5D) and Pain Catastrophizing Scale (PCS). Further outcome measurements comprise a costs evaluation questionnaire, range of motion (ROM), grip strength, radiographic parameters and Complications.

Eligibility Criteria:
Inclusion Criteria:

* \> 65 years at time of trauma
* Intra-articular distal radius fracture (AO type C\*)
* One or more of the following fracture characteristics within 3 weeks post-trauma (including secondary dislocation):

  ≤15° inclination \<5 mm radial length \>15° dorsal tilt \>20° volar tilt intra-articular gap or step-off \>2 mm
* \< 3 weeks post trauma
* Living independent
* Fit for surgery
* Mentally competent
* Dutch fluency and literacy
* Informed consent

Exclusion Criteria:

* Open fractures
* Neurovascular damage
* Multiple-trauma patients (ISS \>16)
* Other fractures in the injured extremity other than ulnar styloid process fractures
Optimal Multimodal Analgesia in Abdominal Hysterectomy

The purpose of this study is to test the current standard of care (SOC) treatment for abdominal hysterectomy with a group receiving SOC minus epidural analgesia plus additional perioperative analgesics in terms of postoperative abilities, postoperative nausea and vomiting (PONV), pain and discharge time from the PACU (post-anaesthesia care unit).

Aim of the study: to compare postoperative complaints (PONV, pain, etc) and PACU discharge time between two groups, for patients admitted for planned abdominal hysterectomy with or without BSO:

* A: standard of care (SOC) receiving paracetamol, celecoxib, epidural analgesia, dexamethasone, ondansetron and droperidol, and general anaesthesia with propofol, remifentanil and cisatracurium
* B: SOC with sham epidural analgesia, preoperative gabapentin, intraoperative lidocaine, s-ketamine and sufentanil

Eligibility Criteria:
Inclusion Criteria:

* Planned abdominal hysterectomy with or without BSO
* Age above 18 years
* Written informed consent
* American Society of Anesthesiologists (ASA) class I-III

Exclusion Criteria:

* Planned vaginal or laparoscopic hysterectomy
* Hysterectomy as part of other surgery
* Allergy to part of the treatment regimen
* Previous reactions to opioids (nausea, cognition)
* Previous inability to place correct epidural catheter
* Severe state anxiety according to the OCAP or STAI
* ASA class IV
* Dependency on alcohol, opioids or central stimulants
* Chronic pain condition
* Hemorrhagic diathesis
* Participation in another study
Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects ≥40 years and ≤85 years of age at the time of consent.
* Subject must have a primary diagnosis of mild or moderate COPD defined as post-bronchodilator FEV1/FVC ratio of \<70% and FEV1 of ≥50% of predicted normal value as per the NHANES III predicted normal values at screening.
* Willing to stop all other COPD medications or other medications which will interfere with the study results for the entire duration of the study, except albuterol/salbutamol as needed.
* Current or ex-smoker with ≥10 pack-year smoking history.

Exclusion Criteria:

* Subjects with a chest x-ray/CT scan that suggests a diagnosis other than COPD (eg, pneumonia, other infection, atelectasis, or pneumothorax or other active/ongoing pulmonary conditions) and taken within 6 months prior to study start. If there is no chest x-ray or CT scan taken within 6 months prior to study start, or if recent results are unavailable for review, a chest x-ray must be performed.
* Use of oral/parenteral corticosteroids or antibiotics for COPD within 6 weeks or depot corticosteroids within 3 months prior to screening or subject has had a change in dose or type of any medications for COPD within 14 days before screening.
* Hospitalization for COPD exacerbation or pneumonia within 3 months prior to screening.
* Subjects with a history of asthma, with the exception of outgrown childhood asthma, defined as transient wheezers outgrown by 5 years of age.
* Subject has a known history of alpha 1 antitrypsin deficiency-related emphysema.
* Subject requires nocturnal oxygen or continuous supplemental oxygen therapy.
* Subject with history of a positive result for HBsAg or HCV antibody.
* Subject is known to be seropositive for human immunodeficiency virus.
* Female subject is pregnant or lactating.
* Subject has a history of allergic reaction to the anti-cholinergic or any components of the study medications.
Large-Scale Metabolomic Profiling for the Diagnosis of Inborn Errors of Metabolism

Researchers are trying to determine the efficacy of a global metabolomic approach in testing for and diagnosing inborn errors of metabolism as opposed to traditional testing methods.

Residual samples will be tested for a variety of biomarkers that may lead to better understanding of these disorders and help develop treatment options.

Eligibility Criteria:
Inclusion Criteria:

* All individuals with specimens in Biochemical Genetics Laboratory and from patients collected under another IRB who have agreed to share samples/data

Exclusion Criteria:

* None
Impact of Hypnosis During Invasive Procedure in Intensive Care Unit

Pain during ICU stay remains one of the major complaints for patients. Beside pain intensity, well described by patients' self reports, pain distress, which is an emotional experience, cannot be treated with usual analgesia. The aim of the study is to analyze the impact of hypnosis on pain intensity and distress on short and long term outcomes in non-sedated ICU patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years and older
* ICU hospitalisation
* Non-sedated patients who need an invasive procedure (Invasive procedures are defined as chest tube (insert or remove), fibroscopy, catheter insert, lumbar punction and bone marrow aspiration)
* Physician experienced in hypnosis available
* written informed consent
* health insurance

Exclusion Criteria:

* sedation and intubation, delirium, end-of-life decision,
* deaf patient,
* patient who does not understand French language,
* pregnancy
* patient under guardianship or curatorship
* lack of health insurance
Prevalence and Impact of Diabetes Mellitus in Hospitalized COVID-19 Patients in a Tunisian Center

Objective: The objective of this study was to evaluate the prevalence and impact of diabetes mellitus on the severity and mortality of COVID-19.

Methods: Data of laboratory-confirmed hospitalized patients at the COVID-19 unit of Ibn El Jazzar University Hospital in Kairouan between September 2020 and August 2021 were analysed, in a cross-sectional study. The population was classified into two groups (COVID-19 patients with versus without diabetes). Primary outcomes were the overall length of hospital stay, the admission to the intensive care unit (ICU), and death.

The outbreak of the coronavirus disease 2019 (Covid-19) has become an evolving worldwide health crisis. With the rising prevalence of diabetes mellitus has come an increasing awareness of their impacts on infectious diseases, and the risk for post-infection complications and mortality from critical infections.

Objective: The objective of this study was to evaluate the prevalence and impact of diabetes mellitus on the severity and mortality of COVID-19.

Methods: Data of laboratory-confirmed hospitalized patients at the COVID-19 unit of Ibn El Jazzar University Hospital in Kairouan between September 2020 and August 2021 were analysed, in a cross-sectional study. The population was classified into two groups (COVID-19 patients with versus without diabetes). Primary outcomes were the overall length of hospital stay, the admission to the intensive care unit (ICU), and death. Association between diabetes and death was assessed in a Cox proportional hazards model.

Eligibility Criteria:
Inclusion Criteria:

Confirmed cases indicated the patients whose real-time reverse transcriptase-polymerase chain reaction (RT-PCR) analysis results for nasal swab specimens were positive.

Exclusion Criteria:

* the investigators didn't included patients who were suspected cases, and whose the result of PCR test was negative ; Covid-19 patients admitted in other departments (Cardiology, pediatrics, obstetrics, intensive care unit, medicine, surgery department...) ; and patients with missing medical records. -
Invasive Techniques in Trigger Points

Myofascial pain syndrome (MPS) is present in up to 87% of the patients that present pain. MPS usually presents painful myofascial trigger points (MTrPs).

One methodology used to quantify the pain in MPS is the algometry, which measures the pressure pain threshold (PPT).

Invasive techniques in physiotherapy have become popular in the last years due to their clinical efficacy and evidence. Percutaneous Microelectrolysis (MEP®) and dry needling are techniques that are already in use for this syndrome.

MEP® is a technique that employs a galvanic current up to 990 microAmperes, which is applied percutaneously with an acupuncture needle connected to the cathode. It is also known as low intensity percutaneous electrolysis.

The aim of this study is to compare the effects in pain and muscle tone (measured with algometry and surface electromyography) of invasive techniques. Healthy subjects between 18 to 48 years old, both sex, presenting MTrPs in upper trapezius will be recruited.

The secondary objectives are to determine the discomfort degree of each technique and if it is better to use MEP® with a fixed dose or with an algorithm in which the dose varies.

The hypothesis, according to our previous studies, is that MEP® generates higher changes in PPT.


Eligibility Criteria:
Inclusion Criteria:

1. Neck pain during the last 6 months
2. Presence of a palpable taut band in the upper trapezius
3. Presence of a hypersensitive tender spot in the taut band, with local or referred pain elicitation in response to compression
4. PPT less than 3 Kg/cm2

Exclusion Criteria:

1. Previous cervical and/or shoulder surgical intervention.
2. Phobia to needles.
3. Temporomandibular disorders.
4. Medicated with anticoagulants
5. Still receiving a treatment for the myofascial trigger points (Physical therapy, NSAIDs, etc.)
6. Diagnosis of fibromyalgia.
7. Radiculopathies and/or radicular pain
8. Whiplash related neck pain
9. Migraines
10. Dizziness
11. Endocrinal diseases
12. Being pregnant
13. Cancer
The Effect of High-intensity Laser Therapy on the Supraspinatus Tendon Using Shear Wave Elastography

Subacromial impingement syndrome, one of the most common causes of shoulder pain. In studies investigating the effectiveness of high-intensity laser in patients with subacromial impingement syndrome, it was stated that high-intensity laser reduced the complaints of patients in the early and late periods. However, there is no research examining the effect of high-intensity laser on the supraspinatus tendon. Therefore, the investigators aimed to investigate the effect of high-intensity laser on the supraspinatus tendon using shear wave elastography.

Subacromial impingement syndrome, one of the most common causes of shoulder pain, occurs when the supraspinatus tendon, subacromial bursa or bicipital tendon becomes compressed between the acromion, coracoacromial ligament, coracoid process and/or acromioclavicular joint during shoulder movements. Several factors contribute to subacromial impingement syndrome, including weakening of the rotator cuff, capsular tension, poor scapulohumeral rhythm, and muscular imbalance in the upward rotation force of the scapula. Steroid and non-steroidal anti-inflammatory agents, physiotherapy applications, laser therapy, manual therapy, ESWT and active and passive normal joint movements involving the shoulder joint are frequently applied treatments in the treatment of subacromial impingement syndrome.

It is stated that high-intensity laser treatment can quickly produce photochemical and photothermic effects in deep tissue. Therefore, collagen production in tendons is promoted and blood flow, vascular permeability and cell metabolism can be increased. As a result of all these processes, tissue healing begins and painful stimuli decrease. In studies investigating the effectiveness of high-intensity laser in patients with subacromial impingement syndrome, it was stated that high-intensity laser reduced the complaints of patients in the early and late periods. However, there is no research examining the effect of high-intensity laser on the supraspinatus tendon. Therefore, in this study, the investigators aimed to investigate the effect of high-intensity laser on the supraspinatus tendon using shear wave elastography.

Eligibility Criteria:
Inclusion Criteria:

* Shoulder pain lasting more than 6 weeks.
* Diagnosed with subacromial impingement
* Being between the ages of 30-60
* Volunteering to participate in the study

Exclusion Criteria:

* Acute inflammatory disease affecting the shoulder area
* Presence of cervical radiculopathy
* Surgical intervention involving the shoulder and neck area
* Soft tissue or bone problems affecting the shoulder
* had any neurologic problems
* Patients who wish to withdraw from the study at any stage after volunteering
Couples-Based Yoga Program in Improving Quality of Life in Patients With High-Grade Glioma Undergoing Radiation Therapy and Their Partners

This randomized clinical trial studies couples-based yoga program in improving quality of life in patients with high-grade glioma undergoing radiation therapy and their partners. A couple-based Hatha yoga program may improve fatigue, distress, sleep quality, and overall quality of life in patients with glioma and their partners.

PRIMARY OBJECTIVES:

I. Examine the feasibility of a couple-based and a caregiver yoga program in glioma patients undergoing radiotherapy (RT) and their partners.

SECONDARY OBJECTIVES:

I. Establish the initial efficacy of the yoga program in patients and their partners regarding quality of life (QOL) outcomes (i.e., fatigue, sleep disturbance, depressive symptoms, and overall QOL and health care utilization).

EXPLORATORY OBJECTIVES:

I. Explore potential moderation (e.g., baseline psychological distress, patients' tumor grade, performance status and class attendance) of the intervention effects.

OUTLINE: The first five couples are assigned to arm I. All subsequent couples are randomized to 1 of 2 arms.

ARM I: Patients and their partners attend up to 15, 45-60 minute sessions of Hatha yoga over the course of radiation therapy 5 times a week for 5-6 weeks. The program comprises four main components: joint loosening with breath synchronization; postures with deep relaxation techniques; breath energization with sound resonance; and meditation. At the fifth session, patients and their partners receive a digital video disc (DVD) and are encouraged to practice on their own (individually and/or together) on the days when they do not meet with the instructor.

ARM II: Patients receive standard of care provided by the health care team and complete questionnaires before and after radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Able to read and speak English
* Able to provide informed consent
* PATIENTS ONLY: Diagnosed with a primary glioma and going to receive at least 4 weeks of radiotherapy with at least 20 fractions
* PATIENTS ONLY: Karnofsky performance status (KPS) of 80 or above
* PATIENTS ONLY: Having an informal caregiver (spouse, romantic partner, adult child, sibling, or friend) who is willing to participate; for phase 1 only, if patients do not have one consistent primary caregiver for the duration of the study, they may be accompanied to the yoga sessions by an alternate caregiver who meets eligibility criteria

Exclusion Criteria:

* PATIENTS ONLY: for phase 1 only, regularly (self-defined) participated in a yoga practice in the year prior to diagnosis
* PATIENTS ONLY: for phase 1 only, physician-rated life expectancy of less than 6 months
* PATIENTS ONLY: for phase 1 and 2, cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team