cyrilzakka/clinical-trials huggingface dataset:
Short Leg Walking Plaster Cast Versus Walking Foot Cast for Jones Fracture

This study is an open-label, randomized controlled trial comparing the effectiveness of two plaster cast methods-Short Leg Walking Plaster Cast and Walking Foot Plaster Cast-for treating Jones fractures, a common fracture at the base of the fifth metatarsal in the foot. This trial will be conducted at Lady Reading Hospital Peshawar. The study will evaluate differences in fracture healing and functional outcomes between these two treatment approaches. Findings from this trial may guide more evidence-based treatment protocols for Jones fractures, potentially improving patient mobility and recovery without requiring surgical intervention.

Jones fractures represent 26.3% of fractures at the base of the fifth metatarsal and are commonly treated conservatively through various weight-bearing casts. The lack of consensus on the optimal casting method for Jones fractures necessitates further study, particularly given the absence of published guidelines. This trial, unique in its randomized and prospective approach within Pakistan, aims to compare Short Leg Walking Plaster Casts and Walking Foot Plaster Casts specifically for Jones fractures.

Patients meeting the inclusion criteria will be randomly assigned to one of the two treatment groups, with the primary endpoints being fracture healing (union) and functional outcomes at six weeks, assessed via radiographs and the American Orthopaedic Foot and Ankle Score (AOFAS). This study seeks to produce robust evidence to inform treatment guidelines, allowing patients, especially in low- and middle-income settings, to continue daily activities with minimal disruption during recovery.

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* 18 years and above
* Jones fractures that are un-displaced or minimally displaced (less than 2 mm)
* Fractures presented within 7 days of injury

Exclusion Criteria:

* Significant foot swelling
* Open fractures
* Ipsilateral foot, ankle, or lower limb soft tissue pathology or fractures
* Pathological fractures
GB34 Acupuncture in Acute Cholecystitis

The purpose of this pilot study is to investigate the effects of GB34 acupuncture, performed as adjuvant to standard medical treatment, on clinical response and laboratory parameters of patients with a diagnosis of acute cholecystitis.

Acute cholecystitis is a frequent complication of gallbladder stones. The prevalence of gallbladder stone is 10-15% and in 35% of patients complications and recurrent symptoms develop in their lifetime. Acute cholecystitis is one of the most frequently encountered acute surgical conditions. It is manifested in 3-10% of patients referred to emergency departments with complaints of abdominal pain.

Although the gold standard of therapy is laparoscopic cholecystectomy in symptomatic cholecystitis and related complications, more than 70% of patients respond well to medical treatment at first place. Actually, timing of cholecystectomy was studied extensively, yet is still debatable. Early cholecystectomy is the operation performed within 72 hours of the beginning of the symptoms. Delayed cholecystectomy is the operation performed 6 weeks after the suppression of the inflammation. Investigators perform early cholecystectomy is in cases with perforation and complication like gangrenous or emphysematous acute cholecystitis whereas delayed cholecystectomy is preferred in the remaining patients.

In fact it is known for some time that ear and body acupuncture have modulatory effects on motor functions of gallbladder and even provide some improvement in acute cholecystitis. Previously, studies demonstrating that GB34 has specific effects on the motility of bile ducts were published. More recently, researchers were able to demonstrate that GB34 electro acupuncture have positive effects on gall bladder wall thickness and on WBC levels, by using an experimental rabbit model of acute cholecystitis. Additional functional MR studies were used to distinguish the neural specificity of the acupuncture points. GB34 were found to induce a specific response pattern which is more significant in motor functions in brain. Furthermore it is known for decades that acupuncture other than point specific effects, triggers self-healing mechanisms of the body via endogen pathways.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed and hospitalised patients with mild acute cholecystitis

Exclusion Criteria:

* Pregnant women
* Immunosuppressive patients
* Patients with intermediate and severe acute cholecystitis
* Patients with acalculous acute cholecystitis
* Patients with uncontrolled diabetes mellitus
* Patients with collegen tissue diseases
* Patients with malignancies
* Patients who are using anti-coagulant or anti-aggregant medications
* Patients with blood diseases
* Patients with BMI\>35
The Impact of Routine Measurement of Cardiac Troponin (hsTnT) on Outcome in Elderly Patients Undergoing Major Surgery

To document levels of cardiac troponin hsTnT in patients above 75y undergoing high risk surgery and the relationship between elevated levels and outcome in terms of hospital stay and 30 day mortality.

Elevated troponin (Tn) hsTnT levels occur as a result of myocardial damage and are used in the diagnosis of myocardial infarction (MI). However, there are multiple different causes that also result in abnormal Tn levels, such as direct myocardial-cell injury, impaired renal excretion and sepsis. Because of this, elevated Tn level is a common finding in hospitalized patients.

Several studies on patients admitted to the intensive care unit (ICU) without MI show that Tn elevation is a mortality risk factor and an independent predictor of hospital mortality.

Up till now it is not yet known if the routine measurement of Tn in elderly patients undergoing surgery can significantly improve their outcome and that is the primary aim of this study. In addition, it is not known what the impact could be if a diastolic function assessment could be performed peri-operatively.

This study will examine the correlation between elevated Tn levels in elderly patients undergoing major surgery and their short-term outcome (in-hospital). Before and immediately after surgery, diastolic function will be assessed by means of transthoracic echocardiography (TTE).

Eligibility Criteria:
Inclusion Criteria:

* All patients ≥75 y undergoing elective and major surgery till we have collected an entire dataset of 100 patients.
* Only those patients will be included who are planned for elective and major surgery.

Exclusion Criteria:

* Patients under the age of 75
* Intraoperative mortality
* Eye surgery
* Cardiac or thoracic surgery
* Patients undergoing surgery which is not withheld as major surgery
* For patients undergoing multiple surgeries for the same indication and during the same hospitalization, only the first surgery will be included
Liver and the Spleen Stifness in Adult Patients With Gaucher's Disease Using Ultrasound Shear Wave Elastography

The investigated cohort will examine liver and spleen fibrosis in patients with Gaucher Disease(GD) by using Shear Wave Elastography- SWE to evaluation fibrosis of the tissue and to check the correlation of fibrosis with the biomarkers of disease severity.

To assess liver and spleen stiffness measurement using Shear Wave Elastography-SWE and evaluate liver and spleen fibrosis in patients with Gaucher Disease. To compare the elastography with the biomarkers that taken at the GD haematology clinic and to check the correlation with severity of liver and spleen fibrosis.

SWE is a safe with diagnostic accuracy regarding the liver (\& Spleen) fibrosis. Estimating spleen fibrosis is an innovative approach in liver disease and Gaucher.

The evaluation of fibrosis with this relatively new and safe method could avoid complications and invasive procedure in GD patients .

Eligibility Criteria:
Inclusion Criteria:

1. Patients with Gaucher disease over the age of 18 years.
2. Patients able to sign informed consent form.
3. Women are not pregnant.
4. Patients who read and understood the contents of the consent form and gave their written consent to participate in the study.

Exclusion Criteria:

1. Participants under the age of 18.
2. Pregnant women.
3. Participants are unable to sign an informed consent form.
4. Participants with known liver disease not associated with Gaucher disease such as liver cirrhosis, patients with HBV, HBC or liver cirrhosis.
Real-World Experience of Patients Treated for Musculoskeletal Injuries With SAM in Routine Care

The purpose of this study is to evaluate continuous ultrasound treatment with diclofenac coupling patch during routine care of musculoskeletal injuries which failed conservative treatment to better understand clinical utilization of the treatment on types of injuries, how the treatment helps patients (pain, function and quality of life), and information on healthcare provider ordering the therapy and general workflow.

Low-intensity continuous ultrasound (LICUS) is a bio regenerative technology used when normal rehabilitation is insufficient, applied with a wearable device (SAM, Zetroz Systems LLC) for daily use. The treatment provides long-duration ultrasound for approximately four hours. The objective of this study is to examine the real-world outcome data on symptoms improvement and return to function using SAM during routine care.

ZetrOZ's SAM Ultrasound Device is a portable and wearable medical device which, when applied to various areas of the body, applies Low Intensity Therapeutic Ultrasound to deep tissues. The SAM device is currently used by a broad range of Athletic Trainers (ATs) in the United States to assist in the rehabilitation of injured athletes.

The purpose of this this study is to examine the real-world outcome data on symptoms improvement and return to function using SAM during routine care. This includes understanding utilization of the treatment (how often and how much time), how the treatment helps patients (rehabilitation and recovery), and information on SAM treatment augmenting conservative therapies.

Eligibility Criteria:
Inclusion Criteria:

* Work-related musculoskeletal injuries with limited improvement under traditional therapies

Exclusion Criteria:

* Healthy participant
Use of Corifolitropin Alfa in Oocyte Donors

The purpose of this study is to determine if corifollitropin alfa (long-term gonadotropin administration) is effective in a controlled ovarian stimulation protocol in oocyte donors compared to daily gonadotropin administration (recombinant FSH or HP-hMG)

In recent years, increasingly advances have been developed in terms of controlled ovarian stimulation protocols. These improvements have also moved into the way of administration of the different treatments, and at present, with subcutaneous devices, it is possible to offer advantages such as the ability to ensure administration of the correct dose or modify the dose before charging.

Simplification of ovarian stimulation protocols can help to reduce physical stress of the donors and the cancellation rate. The need for daily injection does not worsen the degree of compliance, but it generates some anxiety related to the administration of the right dose and / or the possibility of making a unconsciously mistake . Innovations in delivery devices could help reduce the stress associated with the stimulation itself and improve the welfare of the donor. Given these considerations, the need to develop a stimulation protocol that reduces the physical and emotional burden of reproduction treatment is established.

Corifollitropin alfa molecule is a full-length recombinant FSH generating a sustained effect of stimulation; a single subcutaneous injection of this drug is able to replace the first seven injections of any daily FSH preparation, so finally, the result would be an overall decrease in the number of injections needed for the whole cycle. Pharmacological and pharmacodynamic characteristics of corifollitropin alfa could facilitate the design of simple stimulation protocols and the need for fewer resources when monitoring the donor, including fewer clinic visits.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-35 years who meet the entry criteria for the IVI Donor Program:
* Weight \< 60 Kg
* Women with at least 6 antral follicles per ovary
* Women who will fit the protocoo during the period of the study
* Women who give written consent to participate in the test

Exclusion Criteria:

* Women with basal antral follicle count above 20 or below 6.
* Women with comorbidities, in the judgement of the investigator, that may interfere with the trearment of ovarian stimulation.
Efficacy and Safety of COMBIGAN® in Korean Patients With Primary Open Angle Glaucoma (POAG) and Normal Tension Glaucoma (NTG)

The objective of this study is to evaluate the long-term efficacy and safety of COMBIGAN® (brimonidine tartrate/timolol malate) in patients only using COMBIGAN® (brimonidine tartrate/timolol malate) and also in patients who require additional IOP lowering with LUMIGAN® (bimatoprost) 0.01%.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Primary open angle glaucoma (Regardless of Intraocular pressure)
* Previous history of topical beta-blocker use and insufficiently controlled IOP

Exclusion Criteria:

* Pigmentary or exfoliative glaucoma
* History of angle-closure or an occludable angle by gonioscopy
* Prior filtration or laser iridotomy
* Argon laser trabeculoplasty or Selective laser trabeculoplasty performed less than 6 months
* History or signs of chronic inflammatory eye disease, ocular trauma, or potentially progressive retinal disease
Applying the Spanish Version of the UP-A as a Universal School-based Anxiety and Depression Prevention Program

The current study proposes to extend transdiagnostic treatment research to adolescents by establishing initial pre to post-treatment and follow-up outcomes associated with the use of the Spanish Version of the Unified Protocol for the Treatment of Emotional Disorders in Adolescents (UP-A; Ehrenreich-May, Bilek, Buzzella, Kennedy, Mash, \& Bennett, 2016) as a universal school-based preventive intervention.

The study has the primary aim to examine whether a transdiagnostic CBT intervention adapted as a school-based universal preventive intervention and delivered by professionals is more effective than the usual school curriculum in: (1) reducing symptoms of anxiety and depression and (2) preventing high levels of anxiety and depression from developing in 13-18 years old adolescents.

The study has the following secondary aims: (1) Examine the reduction in negative affect, anxiety sensitivity, emotional avoidance and emotional symptoms' interference levels at post-treatment as compared to pre-treatment levels; (3) Examine the improvement in positive affect, self-esteem, satisfaction with life, quality of life, school adjustment, and general indiscipline at post-treatment as compared to pre-treatment levels; (4) Examine the moderating role of gender, age, social economic status, personality traits, conduct problems, hyperactivity/inattention, and peer problems on the effectiveness of the UP-A program; (5) Assess the moderating role of home practice, understanding of basic concepts of the program, number of sessions attended, practice of specific strategies and behavior during sessions (6) Examine if the effects at post-treatment are maintained at the 3 month follow up; (7) Assess the feasibility and acceptability of implementing UP-A in a group format and in a school setting.

Eligibility Criteria:
Inclusion Criteria:

* Providing written, informed consent (both the adolescent and at least one of the parents or legal tutors)
* Being able to understand, write and read Spanish

Exclusion Criteria:

* No other exclusion criteria because of being an universal prevention study
Combination Osteogenic Therapy in Established Osteoporosis

This study is designed to determine if combining parathyroid (PTH 1-34) with fluoride (MFPSR) therapy in a cyclic treatment regimen will: (1) produce a greater increase in bone density of the spine than would be produced by either treatment alone; (2) prevent the resistance (i.e., decreased bone formation and no further increase in bone density) that is observed within 18-24 months of PTH therapy; (3) eliminate the calcium deficiency and osteomalacia that can occur with fluoride; (4) prevent excessive bone fluoride content; and (5) result in an increase in bone density which is maintained after treatment is discontinued.

This is a 3-yr, single center, open label, active controlled, randomized study of approximately 99 postmenopausal females with osteoporosis of spine or femoral neck. Patients will be assigned to 1 of 3 groups: 1) PTH 1-34; 2) Fluoride; 3) PTH and fluoride. The treatment period is 3 years with 3-month cycles of therapy. PTH will be administered subcutaneously by injection 600 units daily for 28 days the first month of each 3-month cycle. Fluoride will be administered orally one 76mg tablet twice daily (providing 20 mg fluoride/day), during the last 2 months of each cycle. Calcium will be provided 800mg/day during month 1 and 1500-2000mg for months 2 and 3 of each cycle.

Eligibility Criteria:
* Female, aged 60-80,
* Postmenopausal greater than or equal to 5 years,
* BMD -2.5 to -4.0 at lumbar spine or femoral neck and one standard deviation below young adult mean in the other site, or -2.0 with fracture.
* Vertebral fracture 0-1.

Exclusion Criteria:

* More than 1 vertebral fracture in lumbar spine or more than 4 fracture in the T-L spine.
* Weight less than 45 kg or more than 80 kg, or more than 25% above ideal body weight.
* Present cardiac disease present.
* Diseases or conditions known to affect bone metabolism.
* Therapies with drugs that affect bone metabolism within 6 months.
* Fluoride or Biophosphonates at any time.
Anesthesia Consent Process

Currently at University of Chicago Medical Center (UCMC) consent for anesthesia is obtained verbally by qualified anesthesia providers. Later this year, the investigators will be moving to a written informed consent form for anesthesia that must be signed by patients before proceeding with elective surgery. The department's aim is to study patient satisfaction and retention of information presented before and after this change is made.

After consent for anesthesia is obtained, study personnel will approach patients \>= 18 years of age scheduled for elective surgery and, after seeking verbal consent for this study, will administer a questionnaire which will assess patient satisfaction and retention of the risks that were presented.

Currently at UCMC consent for anesthesia is obtained verbally by qualified anesthesia providers. Later this year, the investigators will be moving to a written informed consent form for anesthesia that must be signed by patients before proceeded with elective surgery. The aim is to study patient satisfaction and retention of information presented before and after this change is made.

Study Procedures After consent for anesthesia is obtained, study personnel will approach patients \>= 18 years of age scheduled for elective surgery and, after seeking verbal consent for this study, will administer a questionnaire which will assess patient satisfaction and retention of the risks that were presented.

Demographic data will be recorded, including age, sex, classification of surgery (by service), urgency of case, as well as role of person obtaining anesthesia consent (resident vs. CRNA/APN vs. attending anesthesiologist). Method of obtaining anesthesia consent will also be recorded. Patient identifiers, including name, MRN and date of birth will NOT be recorded as part of this study.

Patients will be approached for participation in this study preoperatively, in the pre-op holding area, immediately after anesthesia consent is obtained by the appropriate anesthesia provider. The patient's electronic medical record will NOT be accessed in order to pre-screen for participation no PHI will be collected in this study.

Eligibility Criteria:
Inclusion Criteria:

* English speaking Age\> 18 years old

Exclusion Criteria:

* Emergency cases Pt unable to consent for themselves Age \<18 yo Pregnant women for delivery
Hemodynamic Monitoring in Hepatopancreaticobiliary (HPB) Surgery

This is a pilot study with the primary objective to validate the use of advanced minimally invasive hemodynamic monitoring with the PreSep™ Central Venous Oximetry Catheter, the Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management in Hepatobiliary and Pancreas Surgery. All of these devices and monitors are FDA approved devices and routinely used in the perioperative setting for these cases.

Surgical procedures involving the liver and pancreas are complex and involve paying close attention to hemodynamics to keep the patient stable through the duration of the case. Volume overload in liver and pancreas surgery leads to more intraoperative blood loss and rapid volume shifts make the patient unstable and more difficult to manage. Traditional methods of invasive monitoring to determine cardiac output and stroke volume include the placement of a pulmonary artery catheter and an arterial line. With the addition of the FloTrac™ Sensor to the arterial line and the Vigileo™ monitor; a pulmonary artery catheter would be no longer required. The minimally invasive cardiac output monitor connected to the central venous catheter will generate detailed information of cardiac function and fluid status and thereby help monitor and manage the hemodynamics of the patient intraoperatively. The information obtained from the Vigileo™ will be compared to the regular data normally available in patients undergoing hepatobiliary surgery to determine the advantages of using the system to aid in fluid management of the patient.

Eligibility Criteria:
Inclusion Criteria:

1. Adult male and female patients admitted to Carolinas Medical Center (CMC) with the need for the following surgical procedures: liver resection, distal pancreatectomy and splenectomy, and pancreaticoduodenectomy.

Exclusion Criteria:

1. Indication for emergency surgery, including pancreatic debridement in an acute setting; ruptured hepatic adenomas/hepatocellular carcinomas
2. Suspected inability to comply with trial procedures or understand consent
3. Employee at the investigational center, relative or spouse of the investigators
4. Patients incarcerated at the time of surgery
5. Females who are pregnant or breastfeeding
6. Planned use of Cell Saver during surgical procedure
Level of Iliopsoas Tenotomy in DDH Surgery

The goal of this clinical trial is to compare the postoperative clinical outcome of iliopsoas tenotomy in open reduction operation for developmental dysplasia of the hip. The main aim is to compare the postoperative clinical outcome of division of iliopsoas tendon at two levels, proximally at the pelvic brim and distally just above the lesser trochanter.

All the patients with DDH included in the current study underwent open reduction of their dislocated hip through the anterior approach. None of the included patients underwent hip surgery through the medial approach.

For the proximal level of psoas tenotomy at the pelvic brim, the hip was slightly flexed to relax the iliopsoas muscle; the iliacus muscle fibers were retracted anteriorly until the deeply seated posteromedially psoas tendon was isolated and transected. For the distal level of iliopsoas tenotomy just above the lesser trochanter, the thigh was put in the position of FABER (flexion, abduction, and external rotation). A curved right-angle hemostatic clamp was used to retract and bring the iliopsoas tendon into the field. Then, the tendinous fibers were transected.

Eligibility Criteria:
Inclusion Criteria:

* Children with DDH.
* Required open reduction of their hip problem.

Exclusion Criteria:

* Patients who underwent hip surgery without the need for sectioning the iliopsoas tendon.
* Children with mental retardation who were not cooperative in the assessment of the hip flexion strength.