cyrilzakka/clinical-trials huggingface dataset:
Erector Spinae Versus Paravertebral in Pediatric PCNL

To compare the efficacy of ultrasound-guided erector spinae plane block versus ultrasound-guided paravertebral block in pediatric patients undergoing percutaneous nephrolithotomy

Percutaneous Nephrolithotomy (PCNL) is a commonly performed surgical procedure for complex upper renal tract calculi. Although the skin incision for PCNL appears small, the intensity of intraoperative and postoperative pain is significant owing to soft tissue injury.

Erector spinae plane (ESP) block is an interfascial block that was first described by Forero et al. in 2016. It can be performed by injecting the local anesthetic in the deep interfascial plane of the erector spinae muscle to provide both visceral and somatic analgesia with a sensory level from T2-4 to L1-2.

. Paravertebral block is the technique of injecting local anesthetics in a space immediately lateral to where the spinal nerves emerge from the intervertebral foramina. This technique is used increasingly for intra-operative and post-operative.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing percutaneous nephrolithotomy

Exclusion Criteria:

* Coagulation disorders
* Infection at the site of injection
* Allergy to the local anesthetics used
* Spinal cord abnormalities or neurological deficits
Noble Meta Alloy Coated Catheters in Patients With Long Term Catheterization

Eighty percent of nosocomial UTI caused by indwelling urinary catheters and so known-as catheter-associated UTI. CAUTI leads to multiple local and systemic derangements such as suprapubic pain, dysuria, cystitis, pyelonephritis, septicemia, and even septic shock.

This study will be conducted up on 100 patients (50 per each group) with long term catheterization to assess efficacy of noble metal alloy coated catheter in reducing CAUTI.

This prospective controlled randomized study conducted upon 100 patients at Alexandria University hospital from 21 May 2020 to 21 December 2020. Patients enrolled will be divided into two equal groups according to the urethral catheter inserted

The institutional ethics committee for research approved the study. Written informed consent was obtained from all participants. In addition to taking the patients' medical history and completing general and physical examinations, physicians will choose proper catheter size all perform catheterization using aseptic technique according to guidelines of proper aseptic catheterization. Urologist ensures comparable catheter size and amount of balloon inflation.

An aseptic non-touch technique (ANTT) must be used to obtain catheter specimen urine following these steps:

* After catheterization apply clamp 10 cm distal to meatus then after few minutes clean the drainage port with alcohol and allow to dry then insert the syringe tip into the drainage port.
* Three to five ml of urine collected in sterile disposable plastic cup at day zero (within 2 hours of catheterization), day ten and day twenty post catheterization.
* The urine subjected to routine urine analysis, urine culture and sensitivity.

Appropriate statistical tests will be used to indicate the frequency and type of CAUTI as well as to assess catheter tolerance in each arm, followed by a comparison to conclude the results.

Eligibility Criteria:
Inclusion Criteria:

- Patient under age of 80 years old who need prolonged urethral catheterization (more than 2 weeks) as a method of bladder drainage.

Exclusion Criteria:

* Patients with current or recent symptomatic urinary tract infection.
* Antibiotic use currently or within 7 days prior to inclusion.
* Known hypersensitivity to latex, silver salts or hydrogel.
* Patients with recent surgical intervention in the urinary tract.
* Patients with anatomic or functional upper urinary tract issues (e.g reflux, stones, etc.)
* Uncontrolled DM. Patients on corticosteroid treatment. Immunosuppressed patients. Patients received pelvic irradiation.
The Effects of Losartan on Emotion Processing

The aim of the study is to investigate the effect of losartan (50mg, single dose) on salience processing

In a double-blind, between-subject, placebo-controlled design the effects of a single dose of losartan (50mg) on salience processing in healthy participants will be examined. The study will adopt a previously validated visual Oddball fMRI paradigm, starting 90 minutes after subjects receive 50mg losartan or placebo. The task requires participants to respond to emotional and novelty oddballs. Neural activity will be assessed by the acquisition of functional magnetic resonance imaging (fMRI) data.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury
* medical or psychiatric illness
* hypertension
Impact of Physiological, Lifestyle and Genetic Factors on Body Composition

Research has shown that body composition is a key component of health and future disease risk. Being overweight and obese is associated with a higher body fat composition, and a greater risk of developing type II diabetes and heart disease. The location where fat is stored in the body is becoming increasingly recognised an important predictor of risk, with extra fat around the abdomen and waist (referred to as the android pattern of fat distribution or 'apple' shape) thought to increase your disease risk than storing fat around the thighs and buttocks (gynoid pattern of fat distribution or 'pear' shape). As a result, there is significant interest in techniques to accurately monitor and detect changes in body composition, and also physiological and lifestyle factors which influence body fat, lean tissue mass and bone mineral density. This cross sectional human study will look at how physiological, behavioural and genetic factors relate to total body composition in 1,196 healthy men and women aged between 18 and 70 years. Interested applicants will be invited to attend for a single visit at the Hugh Sinclair Unit of Human Nutrition at the University of Reading. This visit lasts around two hours and includes noninvasive measures of body composition (bio-electrical impedance and dual energy x-ray absorptiometry), arterial stiffness and fasting measures of metabolic health. Diet and physical activity will then be monitored over a four day period using diet and activity diaries, and an activity monitor. The findings from this study will contribute to the evidence base on how subject characteristics influence body composition and inform on the design of future human studies on body composition methodology.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5-39.9 kg/m2
* Not having suffered a myocardial infarction/stroke in the past 12 months
* Not hyperlipidaemic (total cholesterol level \< 7.8 mmol/l and triacylglycerol \< 2.3 mmol/l).
* Not diabetic (diagnosed as fasting blood glucose \> 7 mmol/l) or suffer from other endocrine disorders
* Not suffering from renal or bowel disease or have a history of cholestatic liver disease or pancreatitis
* Not diagnosed with cancer
* Not suffering from arthritis or fracture deformity of the spine or femur
* Not undergone bone related surgeries such as hip replacement or fusion(s)
* Not on drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
* No history of alcohol abuse
* Not anaemic (Haemoglobin \>115 g/l for women and 125 g/l for men)

Exclusion Criteria:

Due to the use of ionising radiation by the dual energy x-ray absorptiometry (DXA) scanner to assess total body composition and bone mineral density, the following exclusion criteria apply:

* Females who are breastfeeding, may be pregnant, or if of childbearing potential and are not using effective contraceptive precautions.
* Individuals with other radio-opaque implants (such as a knee or other joint replacement) or medical devices (such as a pacemaker).
The Effect of Remote Ischemic Preconditioning on Myocardial Injury After Noncardiac Surgery

This is a multicentre, parallel-group, randomised, sham-controlled, observer blinded trial, assessing the efficacy of remote ischemic preconditioning on preventing myocardial injury after noncardiac surgery.

This is a multicentre, randomised, sham-controlled, observer blinded trial. Patients at high clinical risk for cardiovascular events and scheduled to undergo major abdominal surgery will be enrolled. A total of 766 patients are randomised (1:1 ratio) to receive RIPC or no RIPC (control) before anaesthesia induction. RIPC will comprise four alternating cycles of cuff inflation for 5 min to 200 mm Hg and deflation for 5 min. In controls, the identical looking cuff will be placed around the arm but not actually inflated for 40 minutes. The primary outcome was myocardial injury after surgery within three days of surgery. The secondary outcomes were peak plasma hs-cTnT and total hs-cTnT release during the first three days after surgery, hs-cTnT above the prognostically important thresholds, length of hospital stay after surgery, and length of stay in the intensive care unit, myocardial infarction, major adverse cardiovascular events, cardiac-related death and all cause death within 30 days, 6 months, 1 year and 2 years after surgery, postoperative morbidity and adverse events within 30 days after surgery. Besides, blood samples were stored for the other ancillary studies.

Eligibility Criteria:
Inclusion criteria

1. Patients at high clinical risk for cardiovascular events;
2. Patients scheduled to undergo major abdominal surgery.

Exclusion criteria

1. Immediate or urgent surgery or surgery where there is insufficient time to perform RIPC.
2. Abdominal vascular surgery, such as surgery for abdominal aortic aneurysm
3. Experience of conditions precluding the use of RIPC in both arms
4. Patients who are being treated with drugs, such as sulphonamide or nicorandil
5. With contraindications for anaesthetic regimes required in this trial.
Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients

To evaluate the efficacy, safety and tolerability at 8 weeks (2-months), 52 weeks (12-months), and 104 Weeks (24-months) post the start of the following treatment regimens in participants with: Drug Sensitive TB (DS-TB) patients given BPaMZ for 17 Weeks ( or 4 months) vs. Standard HRZE/HR treatment given for 26 weeks (or 6 months) and Drug Resistant TB (DR-TB) patients given BPaMZ for 26 Weeks (or 6 months)

Phase 2c multi-center, open-label, partially randomized clinical trial in DS-TB and DR-TB participants.

All participants in the below arms will have follow-up for a period of 104 weeks (24 months) from the start of therapy.

Participants with Drug Sensitive TB (DS-TB):

Participants with DS-TB will be randomized to one of two treatment arms. These participants will receive either BPaMZ daily for 17 weeks (4 months), or HRZE/HR combination tablets daily for 26 weeks (6 months). participants will be stratified for co-infection with human immunodeficiency virus (HIV) and cavitation.

Participants with Drug Resistant TB (DR-TB):

Participants with DR-TB will be assigned to receive BPaMZ daily for 26 weeks (6 months).

Eligibility Criteria:
Inclusion Criteria:

* Sputum positive for tubercule bacilli (at least 1+ on the International Union Against Tuberculosis and Lung Disease \[IUATLD\]/WHO scale (Appendix 1) on smear microscopy) at the trial laboratory.
* Participants with one of the following pulmonary TB conditions:

DS-TB treatment arm participants should be:

* sensitive to rifampicin and isoniazid by rapid sputum based test AND
* either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB.

DR-TB treatment arm participants should be Resistant to rifampicin and/or isoniazid.

* Of non-childbearing potential or willing to practice effective methods of birth control
* Body weight (in light clothing and no shoes) ≥ 30 kg.
* Completed informed consent form

Exclusion Criteria:

* Karnofsky score \<60%
* Any risk factor for QT prolongation
* Any planned contraindicated medicines
* Resistant to fluoroquinolones (rapid, sputum-based molecular screening tests).

Any of the following lab toxicities/abnormalities:

* CD4+ count \< 100 cells/µL (HIV infected participants)
* platelets \<75,000/mm³
* creatinine \>1.5 times upper limit of normal (ULN)
* eGFR ≤ 60 mL/min
* haemoglobin \<8.0 g/dL
* serum potassium less than the lower limit of normal for the laboratory.
* GGT: greater than 3 x ULN
* AST: ≥3.0 x ULN to be excluded;
* ALT: ≥3.0 x ULN to be excluded
* ALP: ≥3.0 x ULN to be excluded
* Total bilirubin: \>1.5 x ULN to be excluded;
* Direct bilirubin: greater than 1x ULN to be excluded
Astigmatism in Keratoconus Patients

Keratoconus is a bilateral (but usually asymmetrical) non-inflammatory progressive thinning process of the cornea. It manifests as characteristic cone-like ectasia of the cornea associated with irregular stromal thinning, resulting in a cone-like bulge , which causing irregular astigmatism and vision impairment.

Keratoconus is the most common form of corneal ectasia, with an incidence of 50-230 per 100,000 persons.Pentacam used diagnose \& detect the progression in patients with keratoconus and also provide a detailed information about corneal tomography and topography.

In the last few years, it has been shown that in healthy individuals the posterior corneal surface has not only a different amount of astigmatism but also a different alignment of the steep meridian.

The aim of this research is to compare the amount and axis alignment of anterior and posterior corneal astigmatism in keratoconus with a healthy controlled group .

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with keratoconus using the following criteria:

Specific diagnostic signs is asymmetric refractive errors with high progressive or irregular astigmatism, and elevated keratometry values, scissoring of the red reflex, Vogt striae, Fleischer rings, inferior or central steepening on topography with abnormal localized steepening .

Exclusion Criteria:

* Unwillingness to participate in the study .
* Corneal scarring.
* Any ectatic conditions that were not explicitly keratoconus such as keratoglobus and pellucid marginal degeneration .
* Previous ocular surgery.
Effects of Drospirenone-containing or -Not Containing Combined Oral Contraceptives on General and Sexual Well-being

The purpose of this study is to evaluate the symptoms and satisfaction for women taking drospirenone (DRSP)-containing combined oral contraceptives in comparison with women taking other kind of combined oral contraceptives.


Eligibility Criteria:
Inclusion Criteria:

* According to the label of the prescribed Combined Oral Contraceptive (COC)
* first Combined Oral Contraceptive use or previous Combined Oral Contraceptive use
* intention to use current COC for 1 year at least

Exclusion Criteria:

* Contraindications listed in the label of the prescribed Combined Oral Contraceptive (COC)
EUS-RFA for Unresectable Pancreatic Cancer

The clinical application of intraoperative or percutaneous radiofrequency ablation (RFA) for pancreatic ductal adenocarcinoma (PDAC) is limited due to higher mortality and incidence of adverse events. The aim of this study was to evaluate the efficacy and safety of endoscopic ultrasonography-guided RFA (EUS-RFA) for locally advanced, unresectable PDAC. Patients with unresectable PDAC who underwent EUS-RFA were included from September 2013 to June 2016. Pre- and post-procedural clinical data was retrospective collected.

evaluate the efficacy and safety of endoscopic ultrasonography-guided RFA (EUS-RFA) for locally advanced, unresectable PDAC.

Eligibility Criteria:
Inclusion Criteria:

* age 20 to 80 years old. ② unresectable PDAC based on review of abdominal cross-sectional imaging (CT or MRI) and cytology/ histology results. ③Intolerance to chemotherapy due to side effects or patient's comorbidities.

Exclusion Criteria:

* Pregnancy or breast-feeding；②ECOG performance status 3 or 4；③Patients with distant metastases or malignant ascites, life expectancy less than 3 months.
Radiofrequency Treatments for Lumbar Facet Joint Pain Management

In this study, investigators compared the effectiveness of medial branch conventional radiofrequency application and combined radiofrequency application in patients with lumbar facet joint disease , focusing on pain scores. The combined radiofrequency application, a sequence of pulsed radiofrequency and conventional radiofrequency , has been shown to be successful in treating neck pain and headache. These findings are of significant importance in the field of pain management and spinal disorders.

The treatment of chronic pain using pulsed radiofrequency (RF) has not shown any significant side effects. As a result, a combined approach of using both pulsed and conventional RF treatment in the same session has been assumed since the 2010s. This combined RF method is still widely used for pain management. The aim of this study is to compare the effectiveness of conventional RF with the combined RF method as a medial branch RF method for the management of lumbar facet joint pain.The study involved patients who had undergone medial branch denervation for lumbar facet joint pain and had medical records available. This study was conducted retrospectively by examining the study data. Patients with missing data were excluded from the study.

Patients underwent a fluoroscopy-guided selective medial branch nerve block using 2% lidocaine 0.5ml before treatment. After 30 minutes, they were asked if there was a 50% reduction in pain intensity.The conventional RF group consists of patients who received medial branch RF with a duration of 2 minutes, at 80̊ C temperature, and 7 Volts. In the combined RF group, treatment was initiated first with a conventional RF duration of 2 minutes at a temperature of 80̊ C at 7 Volts. Then, pulsed RF duration was applied for 6 minutes at a temperature of 42 C at 45 Volts, with a pulse frequency of 2 Hz and a width of 20 ms.After procedure In the outpatient clinic, experienced pain specialists recorded NRS (Numeric Rating Scale) and DN4 (Douleur Neuropathic 4 Questions) scores at the 6th and 12th-month follow-up appointments after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* 40 - 90 years of age
* Patients with low back pain for more than three months and did not respond to conservative treatment

Exclusion Criteria:

* Patients who underwent facet joint medial branch RF treatment previously
* Patients had additional interventional pain treatment or lumbar surgery within one year of the procedure
* Patients had radicular and significant disc pathology, psychiatric diseases or mental problems, malignancies
* Patients of one year follow-up could not be assessed entirely in the system
A Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate

It is hypothesized that Idoform plus will recuce the occurence of gastrointestinal side effects related to the use of antibiotics


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers 18-70 years of age
* Subjects with normal gastrointestinal function
* Subjects willing to provide written informed consent

Exclusion Criteria:

* Subjects receiving antibiotic treatment within three months prior to inclusion in the study
* Pregnancy or planned pregnancy
* Breast feeding
* Subjects who are allergic to beta-lactam antibiotics, amoxicillin / clavulanate or its components
* Subjects with known renal insufficiency
* Subjects using products containing probiotics, fibers and/or prebiotics
* Subjects using proton pump inhibitors
* Subjects using H2 antagonists
* Subjects using antacids frequently
Vinorelbine/Gemcitabine Versus Vinorelbine/Carboplatin in Advanced Non-small Cell Lung Cancer

The purpose of this study is to explore if the combination of vinorelbine and gemcitabine is better than vinorelbine and carboplatin in the treatment of advanced non-small cell lung cancer, in terms of survival, quality of life and need for palliative radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Non-small cell lung cancer stage IIIB or IV
* Not eligible for radical radiotherapy or surgery
* WHO performance status 0-2

Exclusion Criteria:

* Pregnancy
* Other clinical active cancer disease
* ALAT/ALP more than 3 times upper normal limit, bilirubin \>1.5 upper limit
* Bowel disease that causes malabsorption
Immediate Effects of Kinesio Taping on Pain and Postural Stability in Persons With Discogenic Low Back Pain.

Discogenic LBP is the leading cause of disability worldwide. Eventhough other types of Chronic LBP are more common, 63% of all patients reporting to tertiary care hospital with LBP are discogenic in nature. However, immediate effects of kinesio-taping on pain and postural stability in discogenic low back pain has not been well documented in existing literature. This study is focused on immediate effects of kinesiotaping on pain and postural stability in persons with discogenic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Participants in an age range of 20-65 years will be considered for this study.
* Participants with disc bulge, herniation or prolapse indicate by MRI.
* Positive straight leg raise (SLR) Positive centralization and peripheralization phenomenon.
* Participants with MRI findings conclusive of disc pathology will be included.

Exclusion Criteria:

-
The Effects of Changing Light Levels on Contrast Sensitivity in Patients With Glaucoma

The study is a prospective observational study where participants will be recruited from the Ophthalmology department (Outpatient department, Eye Casualty). Only one research visit will be required. Participants will be asked to fill in a set of questionnaires (Visual Functioning Questionnaire-15(61), Low Luminance Questionnaire(62)) assessing their quality of life and vision and their full medical history will be collected. Then they will have their contrast sensitivity tested under various light conditions. If a recent visual field test is not available, that might be performed as part of the study.

The purpose of our, real world study is to explore contrast sensitivity differences after changes in ambient light setting in patients with glaucoma compared with controls (patients with ocular hypertension). Participants will be asked to read a Pelli- Robson chart under photopic (bright light conditions) and mesopic (intermediate light conditions); followed by scotopic conditions (dim light conditions). This chart is a fast, easy, and effective way to measure spatial contrast sensitivity with reliable and reproducible results(60). This study will therefore help clinicians gain more insight into glaucoma related disability and provide a possible additional tool to visual field testing in patients with advanced glaucoma where VF testing may be hampered by floor effects.

Eligibility Criteria:
Inclusion Criteria:

* • Male or Female, aged 40 years or above.

  * Diagnosis of glaucoma (including primary open angle glaucoma, pigment dispersion syndrome, pseudoexfoliation, normal tension glaucoma, chronic angle closure glaucoma, narrow angle glaucoma) or ocular hypertension
  * Willing and able to give informed consent for participation in the study.
  * Best Corrected Visual Acuity equal or better than 6/12 as measured with the Snellen Chart

Exclusion Criteria:

* • Neovascular, uveitic, acute angle closure glaucoma

  * Non-glaucomatous ocular disease such as AMD, Diabetic retinopathy, Inherited eye diseases
  * Visually significant cataracts (Distance VA ≤ 6/12 (0.30 LogMAR) and grade ≥ grade 2 nuclear sclerosis.)
  * Current use of miotic glaucoma medication
  * Incisional or laser eye surgery within 3 months of enrolment
  * Severely impaired cognition
  * Self-reported physical ability limiting function (e.g. stroke)
  * Unreliable visual fields (SITA Standard or SITA Fast: fixation losses \>20% or false-positive errors \>33% or false-negative errors \>33%)