cyrilzakka/clinical-trials huggingface dataset:
Assessment of Efficacy of Sacral Erector Spinae Plane Block for Postoperative Analgesia in Pediatric Rectal Biopsies

The purpose of this study is to evaluate how sacral erector spinae block changed the postoperative analgesia requirements in pediatric patients undergoing rectal biopsies under general anesthesia.

Rectal biopsies in pediatric patients are performed under general anesthesia to obtain adequate tissue samples and optimize for patient comfort, well-being and safety. Post-operative pain can persist for longer than a day and requires analgesics. This study aimed to evaluate the effectiveness of sacral erector spinae block in decreasing post-operative pain scores and analgesic requirements.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing only rectal biopsy
* ASA class I-II

Exclusion Criteria:

* ASA class III or more
* Coagulation disorders
* Sacral or spinal anatomical abnormalities
* Infection around the block site
* Local anesthesia allergy
Effect of Posture and Breathing Exercises in Forward Head Posture

This study aims to compare the effects of postural exercises with and without breathing exercises in the subjects having forward head posture.

Forward head posture (FHP) is a prevalent postural deviation that can occur in individuals of various age groups, spanning from childhood to old age. It manifests as an anterior positioning of the head in relation to the neck in the sagittal plane. . FHP is commonly associated with the excessive extension of the upper cervical spine (C1-C3) and flexion of the lower cervical spine (C4-C7). A common method to diagnose forward head posture is by measuring craniovertebral angle i.e. if CVA\<49 than FHP is positive. In many cases faulty postures are linked with different musculoskeletal conditions as well as breathing difficulties. Forward head posture specifically impairs the mobility and functionality of the diaphragm, resulting in inefficient contraction of abdominal muscles and reduced lung capacity. A randomized clinical trial will be conducted so that we can rule out proper treatment protocol for forward head posture.

For this randomized clinical trial, 36 participants having forward head posture will be recruited from Sehat medical complex and shalamar hospitals Lahore by nonprobability convenient sampling. Participants will divide in two groups A and B by randomization. Group A will be given both exercise regimes of postural exercises and breathing exercises while group B will be given with only postural exercise protocol. Pain, ROM and craniovertebral angle will be assessment before the treatment start, after 5 weeks and at the end of treatment after 10 weeks. After the collection of data in 8 months, Statistical analysis using SPSS version 21, will be done to summarize the results.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with 20 to 35 years of age, both male and female
* Individuals with CVA \<49.

Exclusion Criteria:

* History of Surgery of thorax or spine or both.
* Traumatic neck injury.
* Acute or chronic neuro-muscular pain.
* Clinical deformity present in thoracic cage or spine
Protective Ventilation Strategy

The purpose of this study is to find a proper ventilation strategy for one-lung ventilation to prevent postoperative pulmonary complications


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective thoracic surgery
* ASA I, II, III
* scheduled \> 2 hours of surgery

Exclusion Criteria:

* denied patients
* age under 18 years
* FEV1/FVC or FEV1\<70% in preoperative pulmonary function test
Treatment of Unilateral Complicated Zygomatic Complex Fractures Using Computer-Assisted Navigation System

Many studies show that computer-assisted navigation system have been available to treat zygomatic-complex fractures. However, most of them are case reports or clinical experiences lacking multiple variables and controlled design. The aim of this study was to evaluate the accuracy of the computer-assisted navigation system by a randomized controlled trial with multiple variables.

In this prospective randomized controlled trial, twenty patients with unilateral complicated zygomatic fractures were divided into experimental and control groups. Patients in the experimental group were treated with open reduction and internal fixation with the assistance of surgical navigation technology, and patients in the control group without it. Preoperative and postoperative CT data were obtained to measure surgical landmarks discrepancy between the 2 groups. The Chi-square Test and t-test were conducted to test whether there was significant difference in the accuracy between the two groups. Evaluating the effect of fixation by the data and clinical symptoms.

Twenty patients with unilateral complicated zygomatic-complex fractures received operation. All patients healed and their function and facial contour were improved obviously. Postoperative clinical symptoms were not significantly different between the two groups (P\>0.05). Compared with the control group, discrepancy of surgical landmarks measured by software Geomagic studio 11, Brainlabiplan CMF 3.0 were significantly low in the experimental group (P\<0.05). Software measurement showed the symmetry of zygomatic area and the effect of the fixation in the experimental group were more satisfactory than the control group.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral ZMC fractures including complete monofragment zygomatic or tetrapod fracture, multifragment or comminuted fracture
* Patients were sane and the age were between 18 to 60 years
* Patients suffered facial deformity and dysfunction which need be treated by operation
* There is no contraindication in patients
* The study were conducted after patient's informed consent

Exclusion Criteria:

* Cases in which technical problems or registration fails occur and patients who were lost to follow-up within 1 year are excluded from this study.
Incidence of HIV Infection in Screening Indian Men Who Have Sex With Men

This research trial studies the incidence of human immunodeficiency virus (HIV) infection in screening Indian men who have sex with men (MSM). Gathering health information over time from Indian MSM may help doctors determine how many Indian MSM develop new cases of HIV infection.

PRIMARY OBJECTIVES:

I. To determine the one-year incidence of HIV among high-risk MSM in India.

SECONDARY OBJECTIVES:

I. To test the feasibility and acceptability of recruiting a sample of 150 high-risk HIV-uninfected MSM using respondent-driven sampling (RDS) and following them every six months for one year.

II. To produce preliminary descriptive data on the prevalence and incidence of human papillomavirus (HPV) infection and HPV-associated disease and sexually transmitted infections (STIs) other than HPV in HIV-seronegative MSM in India.

III. To produce preliminary descriptive data on sexual risk behaviors with men and women, as well as data on other potential confounders.

OUTLINE:

Participants receive a questionnaire, undergo a targeted physical and anal clinical exam, undergo blood collection and urethral swab for STIs, and a penile skin cell and anal swab for cytology and HPV deoxyribonucleic acid (DNA) at months 0, 6, and 12. Participants also undergo high-resolution anoscopy (HRA) and penile clinical exam at month 12.

Eligibility Criteria:
Inclusion Criteria:

* HIV seronegative, as documented by any licensed HIV test according to National Acquired Immunodeficiency Syndrome (AIDS) Control Organization (NACO) guidelines
* Participants report any sex with a man in the past 6 months
* Participants must speak Hindi, Marathi, or English
* Participant should not have any plans to move out of the area in the next 12 months and commit to attending two additional visits one at 6 months and one at 12 months

Exclusion Criteria:

* Active drug or alcohol use or dependence, or other impairment that, in the opinion of the site investigator, would interfere with adherence to study requirements

  * Participants with impairments that, in the opinion of the site Investigator, are temporary, will be asked to return another day for enrollment
* Inability to provide informed consent
* History of a sex change operation that would preclude collection of penile or scrotal specimens
Establish the Caring Model of Children With Chronic Kidney Disease and End-stage Renal Disease: To Set up Childhood Glomerular Filtration Rate (GFR) Formula in Taiwan

Inulin's usefulness as a diagnostic agent is based on the method of its elimination from the body. Inulin is biologically inert, unbound by plasma proteins, freely filtered at the glomerulus, and is neither reabsorbed, metabolized nor secreted by the kidneys. It is excreted almost entirely by glomerular filtration. Inulin clearance is considered to be identical to glomerular filtration rate (GFR).


Eligibility Criteria:
1. Main inclusion criteria: Pediatric OPD, age \< 18 y/o.
2. Main exclusion criteria: Acute renal failure, edema, muscular dystrophy, pleural effusion, ascites, malnutrition, neurogenic bladder, heart failure and ketoacidosis. And taken cimetidine or trimethoprim, and accepted renal replacement therapy.
Project CASA in Promoting Smoke-Free Indoor Air Policy in Mexican American Households

This trial studies the effect of an intervention program, Project CASA, on smoking cessation and reducing secondhand smoke exposure in Mexican American households. Project CASA, comprising pamphlets and fotonovelas (illustrated storybooks), may provide valuable information to participants on how to improve the air quality in their homes.

PRIMARY OBJECTIVES:

I. Reduction in secondhand smoke exposure: The study will distinguish if a tailored intervention designed to address the needs of the target group will reduce objectively and subjectively measured secondhand smoke exposure of nonsmokers in Mexican American (MA) households.

Ia. Develop tailored fotonovelas for intervention implementation. II. Smoking cessation: The study will identify if a tailored intervention designed to address the needs of the target group will help the primary smokers in the household quit smoking.

III. Stages of change: The study will identify if the proposed intervention will have a significant impact on the primary smoker(s) progression through the stages of smoking cessation.

IV. Knowledge and attitudes: The study will identify if the proposed intervention will result in better knowledge and changed attitudes towards secondhand smoke exposure among members of MA households (smokers and nonsmokers) compared to standard care.

V. Perceived health: The study will distinguish whether reduced exposure to secondhand smoke would improve perceived health.

OUTLINE: Participants are assigned to 1 of 2 groups based on smoking status.

GROUP I (SMOKERS): Participants receive smoking cessation intervention materials based on transtheoretical model of change (TTM).

GROUP II (NON-SMOKERS): Participants receive fotonovelas and other materials on secondhand smoking and how to assist the smoker in quitting.

Participants are followed up at 6 and 12 months to assess for home air quality.

Eligibility Criteria:
Inclusion Criteria:

* Live in the targeted Mexican American neighborhoods.
* Can read Fotonovelas in English and Spanish.
* Access to telephone.
* Smoker in household (adult \[18+\] person living in the household who smokes INSIDE at least one cigarette a week).
Monitoring Parameters Beyond Glycemic Control: Impact of Sitagliptin on Quality of Life in Type 2 Diabetes Patients

Scarcity of local patients' quality of life data assessing diabetes treatment led us design a protocol to assess improvement in the quality of life of patients with Type II Diabetes mellitus. Quality of life measures are designed to enable patients' perspectives on the impact of health \& healthcare interventions on their lives to be assessed \& taken into account in clinical decision making \& research. Its an open label experimental study where participants are assessed for quality of life impact over 6 months duration on Metformin + Sitagliptin therapy. Their safety and efficacy profiles will also be monitored

Study Objective: To assess the changes in quality of life (QOL) in patients with type 2 diabetes mellitus receiving sitagliptin plus metformin therapy in routine care.

Study design: Open label, prospective, multicenter, experimental study.

Sample size: The sample size is 157. To overcome loss to follow-ups, total n=300 will be recruited where each site will enroll 30 patients.

Number of Site: There will be 10 sites.

Duration of study: 12 months (data lock point will be the completion of 6 months of follow-up from the time of last patient's enrollment date)

Study Treatment: Dose of Sitagliptin + Metformin (Treviamet® pharmaceutical brand used locally) :

For Sitagliptin + metformin: \[50mg+500mg, 50mg+850mg, 50mg+1000mg\] For Sitagliptin + metformin Extended Release (XR): \[50mg+500mg, 50mg+1000mg\].

Safety Assessment: Patient will be monitored for Hypoglycemia, Nausea, Vomiting, Diarrhea, Abdominal Discomfort, Flatulence, Asthenia, Indigestion Other adverse events and serious adverse events.

Follow up visits: After recruitment, patient is supposed to have three visits for follow-ups.

Visit 1: 4 to 6 weeks of initiation of therapy. Visit 02: At 12 weeks of initiation of therapy. Visit 03: At 24 weeks of initiation of therapy.

Study outcomes:

Primary (QoL outcomes): Diabetes Quality of Life assessment using DQOL-13 questionnaire.

Secondary (Safety and Efficacy outcomes): Frequency of adverse events and serious adverse events during the course of study follow-up. Change from baseline in HbA1c % and FBS (mg/dl) to the last-observation on treatment.

Ethical consideration: The ethical approval of study is taken from Pakistan Medical Association. The study will be conducted in compliance with the protocol, good clinical practices (GCP), the ethical principles that have their origin in the Declaration of Helsinki and the applicable regulatory requirements.

Eligibility Criteria:
Inclusion Criteria:

* Patient with Type 2 Diabetes mellitus between 18 to 65 years
* HbA1C 7% - 10%
* who can give informed consent.
* Patient uncontrolled on metformin and lifestyle modification from at least 3 months or who are metformin resistant

Exclusion Criteria:

* type 1 diabetes
* ≥1 episode of Diabetic Ketoacidosis and/or hyperosmolar hyperglycemic state,
* ≥1 episode of severe hypoglycaemia,
* Pregnant or lactating women,
* Pancreatitis,
* any serious complications or hypersensitivity
Predictors of Poor Outcomes in 1038 Sigma Knees

The aim of the project is to ascertain the pre and intra operative predictors of poor outcomes in total knee replacement.

It is known that surgical outcomes are good in the majority following a Sigma knee at 5 years. 3% have persistent pain. Is it possible to predict these patients? Is it possible to make a determination as to which of the 3 outcome measures ((1) American Knee Society Score; (2) SF12 Oxford 12 and (3) Complications) is most appropriate to use and when is the most appropriate time to use it

Eligibility Criteria:
Inclusion Criteria:

All patients undergoing total knee replacement in Fife
Standardized Criteria to Judge Diagnostic Urethrocystoscopy Skills

Develop a tool to objectively quantify technical skills necessary to perform diagnostic cystoscopy (using Objective Structured Assessment of Technical Skills- OSATS).

Develop criteria by which surgeons skills in diagnostic cystoscopy can be evaluated or judged.

Develop an intervention (1.5 hour workshop) which can be replicated by other residency programs in order to enhance learning of diagnostic cystoscopy. The workshop should be adequate for practicing Gynecologists as well as they already have experience with diagnostic hysteroscopy which uses many of the same concepts.

The OSATS and a written examination will be used to assess residents skills and knowledge pertinent to diagnostic urethrocystoscopy. All residents will be tested on anatomic replica of human bladder for baseline competency using the above tools. Then approximately half will be randomly selected to undergo an educational intervention (a workshop teaching diagnostic urethrocystoscopy). As we are interested in short-term acquisition, about a week later all residents will be retested using the same methods. Grades on the exam will be kept confidential.

Eligibility Criteria:
Inclusion Criteria:

* All Obstetrics \& Gynecology and Urology resident physicians training at the University of Cincinnati

Exclusion Criteria:

* Any above resident with extensive training in cystoscopy
DreamKit Respiratory Effort Signal Validation

This study has been developed in order to demonstrate the validity of the DreamKit respiratory effort signal.

The rationale for undertaking this study is to demonstrate the agreement between the respiratory effort signal amplitude derived from DreamKit vs. the gold-standard esophageal manometry. Data collection will be completed within a single visit, in which participants will undergo simultaneous measurement using the DreamKit device and esophageal manometry. Data collection will be completed during wakefulness, while participants undergo a series of breathing maneuvers.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years;
* Fluent in English;
* Able to provide informed consent.

Exclusion Criteria:

* Contraindication to esophageal pressure monitoring, including a sensitive gag reflex (determined by a positive response to the screening question "do you sometimes or often gag while brushing your teeth?"), dysphagia, nasal obstruction, and/or esophageal disorder likely to impact placement of the balloon;
* Pregnancy or planned pregnancy during the study (self-reported);
* History of allergic reactions to medical adhesives;
* Known allergy to lidocaine;
* Known seizure disorder;
* Severe medical condition (controlled or uncontrolled) impacting breathing including neuromuscular disease, chronic obstructive pulmonary disease, respiratory failure or insufficiency, or requirement for oxygen therapy;
* Chronic cardiopulmonary or renal disease, including a history of irregular heart rhythms or dyspnea;
* At risk for excessive bleeding including use of anticoagulants;
* An employee, or spouse of an employee, of a company that designs, sells, or manufactures sleep related products (including Philips);
* An employee, or spouse of an employee, of Pulmonary \& Critical Care Associates of Baltimore.
Reducing the Incidence of PostOperative Residual Curarization

The NMB (Neuromuscular Blockade) is the most frequent complication in anesthesiology associated with an increase in adverse respiratory events in the postoperative period. Its appearance depends on multiple factors. The introduction of a comprehensive educational strategy aimed at promoting the proper management of NMB in the intraoperative period and a package of measures that must be performed (intraoperative neuromuscular monitoring and reversal of the effect of neuromuscular blockers) may contribute to a decrease in the incidence of NMB, Increase safety in the surgical patient and decrease associated costs.

Multicenter, epidemiological, prospective, randomized, sequential study. The introduction of an educational program and a package of clinical measures (specific monitoring and pharmacological reversion) in the incidence of NMB will be evaluated by evaluating variations in this incidence of NMB, the rate of compliance with the preventive measures and the perception of the Safety in the perioperative, through pre and postoperative survey.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years.
* Classification of the American Society of Anesthesiologists (ASA I-III).
* Patients with absence of cognitive deficit.
* Informed informed consent prior to surgery

Exclusion Criteria:

* Negative of the patient to participate in the study
* Patients under the age of 18 or incapable of giving their consent
* ASA IV-V
* Pregnancy or breastfeeding
* Associated neuromuscular disorders
* Diabetes mellitus with diagnosed neuropathy
Comparison of Postoperative Delirium in Patients Anaesthetised With Isoflurane and Desflurane During Spinal Surgery

Postoperative delirium (POD) is a known complication of inhalational agents used to anaesthetise patients for surgery with potential long term implications.The incidence of postoperative delirium in spine surgery is 3.3% to 3.8%.The purpose of this study is to compare the occurrence of postoperative delirium with inhalational anaesthetics namely isoflurane and desflurane in spine surgery patients.

The patient will be randomized to receive isoflurane or desflurane anaesthesia prior to surgery. All the patients involved in the study will be blinded to group allocation. Screening for preoperative cognitive dysfunction will be done using the mini-cog test which includes a three word recall test and clock drawing test.The primary outcome variable will be assessment of delirium at day one and day three following surgery. Post operative delirium will be diagnosed using the 3D- CAM(Confusion Assessment Method) which tests for four features with a series of questions. The features include 1) acute onset and fluctuating course,2) inattention,3) disorganized thinking and 4) altered level of consciousness. Diagnosis of delirium is made if features 1 and 2 and either 3 or 4 are present. Similarly the severity of postoperative delirium will be assessed on day one and day three following surgery. Severity of postoperative delirium will be assessed using the CAM-S(Confusion Assessment Method-severity)long form delirium severity score.It assesses ten features including 1) acute onset and fluctuating course,2)inattention,3)disorganized thinking , 4)altered level of consciousness, 5) disorientation, 6)memory impairment ,7)perceptual disturbances ,8)psychomotor agitation, 9)psychomotor retardation and 10) altered sleep-wake cycle. The scores range from 0 to 19.

The demographic data of the patients,type and site of surgery will be noted. Preoperative hemoglobin, serum electrolytes and blood urea will be recorded. The intraoperative factors like duration of surgery and anaesthesia,use of intravenous fluids ,blood loss, number blood units transfused and opioid use will be studied at the time of surgery. The time to emergence and extubation following the completion of surgery will be noted.

The postoperative factors like postoperative pain, nausea and vomiting, fever,hemoglobin,serum electrolytes and blood urea will be noted.

Preoperative and postoperative pain will be assessed using the numerical rating score on a scale of one to ten.

The association of various preoperative,intraoperative and postoperative factors with POD will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for spine surgery.
* Age between 18-65 years
* American Society of Anaesthesiologists (ASA) Grade I and II patients
* Patients with Glasgow Coma Scale (GCS) of 15
* Postoperative Aldrette score \> 9

Exclusion Criteria:

* Cardiorespiratory disorders
* Associated cerebral disease
* Psychiatric illness
* Electrolyte and hormonal imbalance
* History of drug abuse
* Postoperative meningitis
* Administration of high dose steroids