cyrilzakka/clinical-trials huggingface dataset:
Quadratus Lumborum Block vs Tranversus Abdominis Plane Block for Cesarean Section

The Quadratus Lumborum block (QLB) was first described by Blanco in 2007. The main advantage of QLB compared to the Transversus Abdominis Plane block (TAP) is the extension of local anesthetic agent beyond the TAP plane to the thoracic paravertebral space. The wider spread of the local anesthetic agents may produce extensive analgesia and prolonged action of the injected local anesthetic solution.

Previous studies showed that both TAP block and QLB may reduce morphine requirements in the postoperative period in patients who had cesarean section under spinal anaesthesia. However there are no published reports comparing the 2 techniques.

The aim of this randomised controlled, double blinded study is to compare the analgesic efficacy of QLB compared to TAP block in patients who had cesarean section under spinal anesthesia.

After ethical committee approval, informed written consent will be obtained from all patients. A Sample size of 72 patients (36 per group) was calculated based on 15% reduction in morphine consumption with 0.05% significance and a power of 0.8.

Consenting patients scheduled to have elective cesarean section under spinal anesthesia will be randomised to receive bilateral QLB or TAP at the end of surgery.The dose of local anaesthetic in both groups will be 0.2 ml/kg 0.125% Bupivacaine. Allocation to either group will be done using closed envelope technique.

All the blocks will be performed in operation theatre after the end of cesarean section with intravenous access, ECG, BP, oxygen saturation by pulse oximetry monitoring and full resuscitation equipment and medication ready.

All patients will be in the supine position . Under ultrasound guidance a 22 Gauge, two inch Pajunk Sonoplex needle will be used for both techniques. The calculated dose of local anaeshetic will be injected bilateraly with intermittent aspiration. The spread of injectate will be seed on ultrasound.

All patients will receive the routine postoperative analgesia, comprising patient-controlled IV morphine analgesia and regular diclofenac and paracetamol.

All patients will be assessed postoperatively by a blinded investigator: in the postanesthesia care unit and at 2, 4, 6, 12, 24, 36, and 48 h postoperatively.

Eligibility Criteria:
Inclusion Criteria:

Elective caesarean sections ASA 1 to 3 Written informed consent.

Exclusion Criteria:

Patient refusal Local infection at the site of injection Allergy to study medications Sepsis Anatomic abnormalities Systemic anticoagulation or coagulopathy Inability to comprehend or participate in pain scoring system Inability to use intravenous patient controlled analgesia
The Effect of the Role Performance Strengthening Program on the Adaptive Performance and Competence of Nurses

The "Role Performance Strenghthening Program (RPSP)" based on the Roy Adaptation Model was structured to increase the competence and adaptive performance levels of nurses working in pandemic units and to strenghthen role performance of nurses. In the measurements made after the completion of the program, it was determined that the competence and adaptive performance level of the nurses increased. It was found that the Roy Adaptation Model was suitable for use in research to be conducted on a nurse sample regarding coping with the challenges caused by coronavirus pandemic. It is recommended that the RPSP be included in institutional training programs.

It has been understood that supporting the mental health and resilience of nurses who are vulnerable to the difficulties experienced during the pandemic process is of great importance. In this context, it has been revealed that there is a need for supportive psychiatric nursing practices; that psychiatric nurses need to help their colleagues cope with difficulties during difficult processes such as the pandemic. Based on this need, a psychoeducation program was written in this doctoral thesis to support and strengthen nurses during the pandemic process. This program, called "Role Performance Strengthening Program", is shaped within the framework of cognitive behavioral approach elements and is based on the Roy Adaptation Model. It is thought that the competence and adaptive performance level of nurses will increase through this structured psychoeducation program; therefore, the competence and adaptive performance level of nurses will be maintained and even increased during difficult processes such as the pandemic.

Eligibility Criteria:
Inclusion Criteria:

* Working as a nurse in pandemic clinics, pandemic intensive care units or the orange area of the emergency room,
* Having a competency score average below 26 as a result of measurements made with the Nursing Competency Scale,
* Accepting to participate in the research in writing and verbally,
* Accepting to participate in all sessions of the Role Performance Strenghthening Program. -

Exclusion Criteria:

• It has been determined that the person is continuing a therapy program to cope with the problems he/she experiences due to working during the pandemic. -
Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa

According to WHO, about 40% of the incident TB cases in 2020 are either under-reported or under-diagnosed causing on one hand major health risks and on the other hand catastrophic financial consequences. In particular, indigent people in hard-to-reach communities with high TB/HIV burden are at high risk of missed or delayed diagnoses. Hence, active case finding for TB remains an integral part of tuberculosis control in high-risk groups, such as people living with HIV (PLHIV) or diabetes mellitus, people living in specific geographical locations associated with a high burden of TB and poor access to health care, miners, or prisoners. CAD4TB (Delft Imaging, NL), a digital chest X-ray analysis software, and point-of care C-reactive protein assay (POC-CRP; e.g. LumiraDx, UK), which detects a cytokine induced acute phase protein, are two tests which have great potential of becoming a screening and triage test for TB as outlined in the WHO target product profiles. Data on CAD4TB and CRP suggest that accuracy can be improved if thresholds are stratified by patient characteristics, such as HIV status, history of TB and TB symptoms. TB TRIAGE+ Trial takes place in the communities of Lesotho and South Africa, which present high prevalence of subclinical TB, where a symptom-based screening would miss almost half of all infectious TB cases. TB TRIAGE+ Trials conducts a direct (in the same individual) comparison of the two screening/triaging approaches which are not based on symptoms: CAD4TB screening alone (approach 1) versus CAD4TB screening with POC-CRP triage testing (approach 2), and followed by confirmatory Xpert MTB/RIF Ultra testing in both approaches. TB TRIAGE TRIAL is investigates the hypothesis that a community-based active case finding strategy with CAD4TB screening with POC-CRP triage testing (approach 2) will be non-inferior compared to CAD4TB screening alone (approach 1) with regard to yield of detected TB cases and superior with regard to cost effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide signed written consent or witnessed oral consent in the case of illiteracy, prior to undertaking any study-related procedure
* Adults (≥18 years)

Exclusion Criteria:

* Any condition for which participation in the study, as judged by the investigator or a designated staff member, could compromise the well-being of the subject or prevent, limit or confound protocol specified assessments
* Seriously ill person who needs immediate medical care
* Current anti-TB treatment (preventive TB treatment permitted)
* Lesotho only: Pregnancy (self-reported)
Effect of High-intensity Laser Therapy on Patients With Myogenic Temporomandibular Joint Dysfunction

This study will be conducted to investigate the effect of high-intensity laser therapy on the temporalis and masseter muscles activity in patients with myogenic temporomandibular joint dysfunction.

Temporomandibular joint dysfunction (TMD) is one of the problems that affect the quality of lifestyle through the presence of pain around the joint radiated in the face, neck, or shoulders muscles and a decrease in function of the temporomandibular joint that leads to difficulty in mastication, swallowing, earaches, dizziness, and hearing problems may sometimes be associated with TMD.

High-intensity laser therapy (HILT) is a laser with a wavelength of 1064 nm and has recently been used in the treatment of musculoskeletal diseases. Its primary effect is the analgesic effect and reactive vasodilation by affecting the cutaneous nerve endings. Another mechanism of action is based on tissue stimulation. This stimulation occurs at the level of cells, vascular tissue, interstitial tissue, and the immune system. It increases regeneration and beta-endorphin release by inducing protein synthesis in synovial fluid, thus exerting analgesic and anti-inflammatory effects.

Since there is a lack of literature studying the effect of HILT on masseter and temporalis muscles activity in patients with myogenic TMD so, this study may provide a baseline for a new technique in rehabilitation intervention in patients with myogenic TMD.

Eligibility Criteria:
Inclusion Criteria:

* Patients from both gender with unilateral myogenic temporomandibular dysfunction (TMD) with trismus diagnosed and referred from maxillofacial specialist.
* Aged between 20 to 45 years old .
* Visual analogue scale (VAS) score \>3 for unilateral myogenic pain of the temporomandibular joint (TMJ).
* Pain lasting at least 3 months.
* Patients were diagnosed as unilateral myogenic pain.

Exclusion Criteria:

* Previous TMJ surgery.
* History of jaw dislocation.
* History of jaw fracture.
* Previous therapy with occlusal splint.
* Concomitant therapy of bruxism.
* Presence of removable oral prosthesis.
* Metal implants in the skull.
* Presence of hearing aids.
* Malignancy.
* Pregnancy.
* Diabetic patients.
* Hypertensive patients.
* Systemic rheumatologic disease
* Systemic infection.
* Inserted cardiac pacemaker.
* Presence of coagulation disorders.
* Trigeminal neuritis.
* Cognitive dysfunction.
* Bilateral TMD.
Comparitive Study Between Uvb Alone and Uvb With Topical Tacrolimus 0.03% for the Treatment of Vitiligo

Vitiligo is a skin disorder that causes substantial social and psychological distress due to multiple patches of depigmentation.Disease can target at any age, but it appears to affect various parts of body due to loss of melanin. Although the exact cause of the disease is unknown, several theories suggest that genetic predisposition, autoimmunity, and increased vulnerability of melanocytes to the deleterious effects of harmful metabolites all play a role in disease causation. It impacts 0.1%-2% of the general population, with a 30% familial prevalence rate.

Vitiligo treatment still presents a therapeutic challenge for dermatologists despite a variety of therapeutic modalities. Topical steroids, ultraviolet B phototherapy (UVB 280nm-320nm), and photochemotherapy (PUVA i.e., psoralen plus UVA 329nm-400nm) are traditional treatment options. Topical calcipotriol and excimer laser are also used. According to research, narrowband UVB (NB-UVB) is effective when used alone.

Few studies, however also, have reported more than 75% re-pigmentation in patients treated with NB-UVB in conjunction with other modalities. Topical immunomodulators (tacrolimus, pimecrolimus) are considered safe and effective long-term treatments for vitiligo because they do not cause skin atrophy, which is associated with long-term use of topical corticosteroids. Tacrolimus is an effective treatment for vitiligo when used alone; in one study, 61% of patients showed more than 75% repigmentation when treated with tacrolimus alone. Another study found that when tacrolimus was combined with NB-UVB, 73% of patients experienced more than 50% repigmentation.

The objective of this research was to present a comparatively new mode of treatment that may be beneficial to vitiligo patients.


Eligibility Criteria:
Inclusion Criteria:

* patients having 20-60 years of age
* non pregnant
* no history of photosensitivity
* no history of immunosuppression or immunosuppressive drugs
* no histry of steroids use oral or topical in last four weeks

Exclusion Criteria:

* pregnancy
* lactation
* history of photosensitivity
* photo-aggravated dermatoses
* history of any immunosuppressive disorder or use of immunosuppressive medicine
* history of using steroids either oral or injectable within the previous one month
* history of skin malignancy
Surgical Treatment of a Chronic Anal Fissure

This study is aimed at studying the effectiveness and safety of surgical treatment of chronic anal fissure.

A chronic anal fissure is a rupture of the mucous membrane of the anal canal, lasting more than 2 months and resistant to non-surgical treatment. This condition is accompanied by a strong pain syndrome during and after defecation (defecation). This condition is most often found in young and able-bodied adults, so the issue of treatment is of particular relevance.

The main cause of the development of a chronic anal fissure is a spasm of the internal sphincter. It should be eliminated first of all to ensure effective therapy.The investigators plan to treat a chronic anal fissure by performing a lateral subcutaneous sphincterotomy, without excision of the fissure.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic anal fissure

Exclusion Criteria:

* Inflammatory diseases of the colon
* Pectenosis
* Previous surgical interventions on the anal canal
* IV grade internal and external hemorrhoids
* Rectal fistula
* Severe somatic diseases at the decompensation stage
* Pregnancy and lactation
* Anal sphincter insufficiency
Clinical Analysis of Ocular Parameters Contributing to Intraoperative Pain During Standard Phacoemulsification

Charts of 142 patients who underwent standard phacoemulsification under topical anesthesia between March and August 2016 were reviewed. The pain during phacoemulsification and 1 h after surgery was assessed and compared using a visual analog scale.

Patients scheduled for elective phacoemulsification and intraocular lens implantation with the Infiniti Vision System (Alcon, Fort Worth, USA) were included. All operations were performed in Kyungpook National University Hospital by the same surgeon between March and August 2016.

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent phacoemulsification with topical anesthesia

Exclusion Criteria:

* Patients who needed general anesthesia or were taking medications capable of affecting perceived pain
* Patients who had traumatic cataract and/or conditions likely to require vitrectomy and trans-scleral fixation of posterior chamber intraocular lens
Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids

The long-term use of calcineurin inhibitors (CNI) in patients who have received a kidney transplantation is associated with renal dysfunction and hypertension. The study will evaluate the safety and efficacy of replacing the calcineurin inhibitors by using basiliximab at monthly doses.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a first kidney transplant from a living or deceased donor at least 12 months after transplantation.
* Patients receiving CNI, mycophenolic acid (MPA) and oral corticosteroids.
* Patients who are able to tolerate full dose MPA.
* Patients with glomerular filtration rate (GFR) \> 30 mL/min.
* Patients without an acute rejection episode during the preceding 6 months.
* Patients with signs or symptoms of CNI intolerance (renal dysfunction, poor blood pressure control, diabetes, poor lipid control, hyperuricemia and gout, significant hypophosphatemia or hypomagnesemia, gingival hyperplasia, hypertrichosis, etc.) in whom CNI interruption is justified.

Exclusion Criteria:

* Patients with preformed positive skin test against basiliximab
* Patients with preformed panel reactive antibody (PRA) \> 10%.
* Signs of active immune process on graft biopsy.
* Patients with multi-organ or second kidney transplant

Other protocol-defined inclusion/exclusion criteria may apply.
Promoting Postpartum Weight Loss in Overweight Women

The purpose of this study is to evaluate, in a five-year randomized controlled trial, the efficacy of an intervention (AMP - ACTIVE MOTHERS POSTPARTUM) to increase physical activity and promote a healthy diet (decreased calorie and fat intake) for weight loss among postpartum women who were overweight or obese prior to pregnancy. The hypothesis is that the proportion of women losing at least 10% of BMI from baseline to 12 months post-intervention will be significantly greater in the AMP intervention arm than in the minimal care arm.

Retention of weight gained in pregnancy contributes to the development of overweight and obesity in middle age, now at epidemic proportions in America. While interventions to reduce weight retention specifically targeting the postpartum period have been few, interventions that promote modest weight loss starting in early postpartum are safe and could be efficacious, particularly for women who were overweight prior to pregnancy. Moreover, postpartum-related changes in cognitive factors (risk perceptions), behavioral factors (physical activity, diet), self concept (self-esteem) and social role (work, food preparation, child care) may make this time a "teachable moment" that could be capitalized upon by formal interventions. Interventions could leverage natural weight changes to encourage adoption of a healthy diet and increase physical activity, which together could accelerate and/or increase natural weight loss in postpartum. Whether the postpartum period is a teachable moment for weight loss interventions can be investigated empirically.

Eligibility Criteria:
Inclusion Criteria:

* pre-pregnancy BMI\>24
* over 18
* delivered baby in past 6 weeks
* English speaking
* driving distance to Duke University Medical Center

Exclusion Criteria:

* Hemodynamically significant heart disease
* Restrictive lung disease
* Severe anemia
* Unevaluated maternal cardiac arrythmia
* Chronic bronchitis
* Poorly controlled Type 1 diabetes
* Poorly controlled hypertension
* Orthopedic limitations
* Poorly controlled seizure disorder
* Poorly controlled hyperthyroidism
Saliva and Dried Blood Spot Therapeutic Drug Monitoring for MDR-TB in Tanzania

Dried blood spot and saliva samples are collected during multidrug resistant tuberculosis (MDR-TB) treatment to measure the drug concentration of levofloxacin. Feasibility of both analytical procedures in a high burdened setting is explored.

Background:

Measuring pharmacokinetic variability of anti-tuberculosis (TB) drugs and responding by dose correction will allow individualized treatment to improve microbiological response, curb acquired drug-resistance, protect and extend the efficacy of novel drugs rolled-out to endemic areas (pharmacovigilance), reduce toxicity to patients and lead to treatment duration shortening.

Aims and Objectives:

Implement Dried Blood Spot (DBS) collection for performance of high-performance liquid chromatography (HPLC) to optimize multidrug resistant TB (MDR-TB) treatment in Tanzania. Simultaneously, provide a proof-of-principle-demonstration that the developed saliva point of care drug assay for measurement of fluoroquinolone concentration works in a field setting.

Methods:

This will be a phase II prospective diagnostic study among patients from a national referral of MDR-TB in Tanzania. The investigators anticipate recruiting a minimum of 50 study participants to power for the primary aim. Subjects will have a minimum amount of blood and saliva collected for therapeutic drug monitoring and the investigational drug assays respectively. Expected results include agreement of saliva point-of-care and DBS for measurement of fluoroquinolone concentrations in HPLC. Other important findings related to field-testing include the best time for sample collection within the dosing interval and the algorithmic use of DBS and saliva, and clinical - demographic factors such as HIV coinfection, concomitant drugs, and diabetes mellitus that may influence the saliva drug assay results. Performance characteristics (sensitivity, specificity, negative and positive predictive values) of the saliva point-of care (PoC) and DBS will be calculated as a measurement of accuracy with reference to the gold standard.

Eligibility Criteria:
Inclusion Criteria:

* Participant is receiving care at Kibong'oto hospital
* Age of 18 years or above

Exclusion Criteria:

* Pregnancy at any gestation
* Co-morbid conditions such as generalized severe ulcers, Kaposi sarcoma,
* Hemophilia
* Participants with medical conditions like malignancy, dementia or those who will be critically ill and unable to consent and provide DBS and Saliva.
* Patients with Karnofsky score less than 40% or moribund
Effects of Pelvic Tilt Exercises Along With Hip and Knee Focused Exercises on Patients With Patellofemoral Pain Syndrome

This study is designed as a Randomized Controlled Trial to be conducted at the CRC Department of Chaudhary Muhammad Akram Teaching and research Hospital, Lahore.

A total of 48 participants will be recruited accounting for a 10% dropout rate (42+6=48) and equally divided into two groups 24 participants in each group: Group A(Intervention) and Group B(Control). Participants will be selected based on inclusion criteria which includes individuals aged 35-55 years with a clinical diagnosis of Patellofemoral Pain Syndrome (positive Patellar Compression Test) symptoms persisting for at least 6 weeks to 6 months and moderate-to-severe knee pain (NPRS ≥ 4). They must also be willing to comply with study protocols. Exclusion criteria include recent knee surgery, other knee conditions (e.g., ligament injuries or severe osteoarthritis), and neurological disorders affecting movement or cognition.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have a clinical diagnosis of Patellofemoral Pain Syndrome.
* Participants should be aged between 35 and 55 years, as this is the typical age group affected by PFPS and will help standardize the sample.
* Individuals with a BMI ranging from 18 to 25 kg/m2.
* Participants should have had symptoms of PFPS for at least 6 weeks to 6 months, ensuring the condition is subacute and chronic.
* Knee Pain Severity: Patients must report moderate to severe knee pain (e.g., pain score ≥ 4 on a 0-10 pain scale) to assess the effectiveness of rehabilitation interventions.
* Participants must be willing to engage in the prescribed exercise program and comply with study protocols including follow-up assessments.

Exclusion Criteria:

* Individuals who have undergone knee surgery within the last 6 months, as post-surgical rehabilitation could interfere with the study outcomes and confound results. Patients with other knee conditions, such as ligament injuries (e.g., ACL or MCL tears), meniscal tears or osteoarthritis, which could significantly affect rehabilitation or complicate the assessment of PFPS.
* Individuals with severe knee osteoarthritis (e.g., Kellgren-Lawrence grade 3 or 4) as it may impact the treatment response and differ from the typical PFPS rehabilitation approach.
* Individuals with neurological conditions (e.g., stroke, multiple sclerosis or peripheral neuropathy) that affect movement, balance or cognition making participation in rehabilitation exercises unsafe or difficult.