cyrilzakka/clinical-trials huggingface dataset:
The Effect and Safety of Recombinant Fibroblast Growth Factor-1 for Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is a common peripheral entrapment mononeuropathy of the upper limb, which results from compression of median nerve at level of wrist. In recent years, regenerative medicine has gradually been applied in the treatment of various degenerative conditions such as bones, muscles, and nerves. Human fibroblast growth factor 1 is a single-chain protein , which has been shown to play a crucial regulatory role in the brain and spinal cord and can facilitate nerve cell differentiation and growth. ES135 is a recombinant human fibroblast growth factor 1 (rhFGF1) which is composed of 135 amino acids with a molecular weight of approximately 15.2 kilodalton. Several studies have shown that significant improvement of Functional Independence Measure, motor and sensory function of spinal cord injury patients after ES135 treatment. One study also revealed the muscle strength have significant improvement in brachial plexus injury patients after ES135 therapy. According to above studies, the investigators hypothesized that ES135 may have benefits to CTS patients. Hence, the purpose of this study aim to demonstrate the therapeutic effects and safety of ES135 for CTS.

Participants established with diagnosis of mild-to-moderate CTS will been randomly assigned to ES135 or Placebo groups. With ultrasound guidance, injection with ES135 or Placebo was performed between median nerve and transcarpal ligament. The Boston Carpal Tunnel Syndrome Questionnaire is assigned as primary outcome. The secondary outcomes encompass visual analog scale, electrophysiological studies and cross-sectional area of the median nerve. The assessment is performed prior injection and at 1, 2, 3, 4 and 6 months post-injection.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-80 year-old.
* Diagnosis was confirmed by using an electrophysiological study
* CTS symptoms for more than 3 months.

Exclusion Criteria:

* Severe CTS
* Allergy to ES135
* Pregnancy
* Inflammation status
* Cervical radiculopathy
* Polyneuropathy, brachial plexopathy
* Thoracic outlet syndrome
* Previously undergone wrist surgery or steroid/platelet-rich plasma injection for CTS within 12 months
Using Allopurinol to Relieve Symptoms in Patients With Heart Failure and High Uric Acid Levels

The purpose of this study is to determine whether allopurinol is effective in relieving symptoms of patients with heart failure and high blood uric acid levels.


Eligibility Criteria:
Inclusion Criteria:

* NYHA class II-IV heart failure due to ischemic or non-ischemic cardiomyopathy.
* Left ventricular ejection fraction ≤ 40% by echocardiography- Heart failure symptoms for 3 months despite standard treatment.
* Serum uric acid level ≥ 9.5 mg/dl.
* At least one of the following additional markers of increased risk: Hospitalization, ER visit or urgent clinic visit for heart failure requiring IV diuretics within the previous 12 months; Left ventricular ejection fraction ≤ 25; B-type natriuretic peptide level \> 250 pg/ml

Exclusion Criteria:

* Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis, biopsy-proven myocarditis, severe stenotic valvular disease, or complex congenital heart disease.
* Acute coronary syndrome, PCI or CABG within 3 months.
* Current ventricular assist device or ventricular assist device or heart transplant likely within the next 6 months.
* Uncontrolled hypertension (i.e., SBP \> 170 mm Hg or DBP \> 110 mm Hg)
* Serum creatinine \> 3 mg/dL or estimated GFR \< 20 ml/min.
* Evidence of active hepatitis with ALT and AST greater than 3x normal.
* Any condition other than HF which could limit the ability to perform a 6-minute walk test
* Any diseases other than HF which are likely to alter the patient's global perception of status or quality of life over a period of 6 months.
* Receiving treatment with allopurinol currently or within 30 days, or having symptomatic hyperuricemia which requires treatment with allopurinol.
SupraScapular Cuff Study: Assessing the Effects of Size and Type of Rotator Cuff Tear on Suprascapular Nerve Function

The primary objective of the study is to determine in adult patients with a rotator cuff tear, what size and pattern of rotator cuff tear would result in damage to the suprascapular nerve.

The secondary objectives are

1. To determine if an injured suprascapular nerve can recover if the rotator cuff tear is surgically repaired.
2. To determine if there is a limit of retraction before the suprascapular nerve is irreversibly damaged.
3. To determine factors that are protective against SSN injury.
4. Can the patient data gathered be used to optimise operative procedures.


Eligibility Criteria:
Inclusion Criteria:

• All patients age ≥18 years presenting to a UHNM shoulder clinic with a confirmed diagnosis of a rotator cuff tear (affecting one or both shoulders).

Exclusion Criteria:

* Bony pathology (such as significant shoulder arthritis that would exclude isolated rotator cuff repair)
* Grossly abnormal shoulder anatomy
* Motor Neurone Disease
* Cervical cord disease affecting the SSN nerve roots
* Patients unable to undergo MRI scan
* Previous surgery at the affected glenohumeral joint
* Patients unable to tolerate NCS
* Acute fracture affecting the glenohumeral joint
* Recent glenohumeral joint dislocation (past 12 months)
* Patients unable or unwilling to give full informed consent
* Patients unable or unwilling to comply with the study procedures
HPV Vaccination in Women With Cystic Fibrosis

The main risk factor for the development of cervical lesions is human papillomavirus (HPV) infection. Vaccination against human papillomavirus, which is offered to all girls aged 11 to 14, and catching up to girls aged 15 to 19, is an effective method of preventing cervical pathology. Despite this, human papillomavirus vaccination coverage remains low in France.

Some women with cystic fibrosis might need a transplantation, which is a factor associated with increased risk of human papillomavirus carriage and cervical pathology. An over-risk of cervical pathology would also be present in non-transplanted women with cystic fibrosis. Particular attention should therefore be paid to vaccination in this population.

The objective is to estimate the frequency of human papillomavirus vaccination in young patients with cystic fibrosis, and to evaluate the reasons for non-vaccination.


Eligibility Criteria:
Inclusion Criteria:

* girls with Cystic Fibrosis
* followed in a pediatric or mixed Cystic Fibrosis center of the region Auvergne Rhône Alpes (AuRA)
* aged 11 years or older

Exclusion Criteria:

- Refusal to respond to the questionnaire
Stimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery

This study examines whether a permanent stimulation of the diaphragm improves left ventricular function in patients with severe heart failure following heart surgery.

Previous studies have shown that temporary stimulation of the diaphragm using an electrode to the phrenic nerve reduces electrical mechanical activation time (EMAT) and improves left ventricular function. This study examines whether patients with severe heart failure, who require permanent biventricular pacing after heart surgery, may benefit from an additional permanent electrode that stimulates the diaphragm. Heart function is assessed by echocardiography and acoustic cardiography (Audicor, Inovise Medical Inc., Portland, USA).

Eligibility Criteria:
Inclusion Criteria:

* Patients following open heart surgery who need permanent pacing

Exclusion Criteria:

* Patients with fast changing need of vasopressors
Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds

Comparison of the safety and effectiveness of Juvederm Ultra with lidocaine compared with Restylane in the correction of nasolabial folds.


Eligibility Criteria:
Inclusion Criteria:

* Desires correction of moderate to severe nasolabial folds (NLFs)
* Both NLFs have the same pre-treatment NLF severity score (either moderate or severe)
* Females of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study

Exclusion Criteria:

* Cosmetic facial procedures \[e.g., facelift, resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel or other ablative or non-ablative procedures), tissue augmentation with dermal fillers or fat injections, BOTOX Cosmetic injections, or mesotherapy\] in the lower 2/3 of the face, including the neck, within 1 month prior to study entry or be planning to undergo any of these procedures at any time during the study
* Initiating use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products in the NLF area within 1 month prior to enrollment or during the study
* Previous hyaluronic acid (HA)-based dermal filler treatment(s) injected within the last 12 months prior to enrollment is within 5mL of the recommended annual maximum volume for HA dermal fillers
* Previous injection of semi-permanent fillers or placement of facial implants anywhere in the head and neck or implantation of any of these products during the study
* Allergy or sensitivity to lidocaine, hyaluronic acid products, or Streptococcal protein
* Active inflammation, infection, cancerous or pre-cancerous lesion or unhealed wound in the NLF region
* Current treatment with anti-coagulation therapy or use of non-steroidal anti-inflammatory drugs or other substances known to increase coagulation time within 10 days of undergoing study injections
Effectiveness of Manual Manipulation With EPAT on Ankle Dorsiflexion and Dynamic Plantar Pressure

Diabetic foot complications are a common and costly problem. Excessive plantar pressures due to foot deformities and/or limited ankle dorsiflexion, especially in the presence of peripheral neuropathy, can predispose subjects with diabetes for diabetic foot ulcers. Achilles tendon lengthening surgery has shown to delay or prevent recurrence of diabetic foot ulcers.

Studies have shown that Shockwave Therapy (EPAT - Extracorporeal Pulse Activation Technology) was effective in treating subjects with chronic heel pain and Achilles tendonitis with no serious side effects. EPAT, therefore, may allow diabetic patients with ankle equinus to perform more effective stretching exercises and may prevent recurrence of diabetic foot ulcers.

The purposed of this RCT is to compare effectiveness of manual manipulation with EPAT versus manual manipulation alone on ankle dorsiflexion and dynamic plantar pressure in at-risk subjects with a history of diabetic foot ulcer.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 21 to 65, inclusive
* Diabetes, either type 1 or 2
* Ankle equinus (\< 0º passive ankle dorsiflexion with knee extended)
* Forefoot plantar hyperkeratosis (callus)
* Able to walk independently without the use of walking aids (cane, crutches, or walker)
* Able to understand the information in the informed consent form and willing and able to comply with study-related procedures

Exclusion Criteria:

* Previous history of ankle-foot surgery or amputation
* no active lower extremity skin ulcers
* Peripheral vascular disease (non-palpable pedal pulses or ankle brachial index \<0.8)
* Not willing or able to make required visits
* Nursing or pregnant
* Not willing or able to follow procedures specified by protocol and/or instructions of the study personnel, including discontinuation of icing, NSAIDs and natural anti-inflammatory agents (such as Arnica)
Multidrug Resistance After Trabeculectomy With Mitomycin C

We investigate whether mitomycin C treatment during previous filtration surgery induces P-glycoprotein expression.

Despite the adjuvant use of mitomycin C during trabeculectomy, short-term and long-term failures still occur. We investigate whether mitomycin C treatment during previous trabeculectomy induces P-glycoprotein expression. Expression of P-glycoprotein is analysed in surgically removed Tenon tissue using immunohistochemistry.

Eligibility Criteria:
Inclusion Criteria:

* patients with planned trabeculectomy for elevated eye pressure
* one third of patients without previous trabeculectomy
* two thirds of patients with previous trabeculectomy (one third with and one third without the use of mitomycin C)

Exclusion Criteria:

* patients not requiring surgery
* patients with planned surgery for elevated eye pressure other than trabeculectomy
Trial Comparing Outpatient Flexible to Rigid Cystoscopy in Females

The primary purpose of this study to assess patient pain scores comparing rigid to flexible cystoscopy in females; to assess post procedural complications, including frequency, urgency, infection and time to resolution of these symptoms between the two procedures; to assess physician perception of patient pain or discomfort with flexible or rigid cystoscopy.

This will be a prospective randomized trial study in order to determine to compare rigid and flexible cystoscopy in female patients. Patients will be recruited from OU Physicians Pelvic and Bladder Health clinic. Patients receive an information leaflet describing the procedure prior to their appointment. All procedures are performed by the attending physician. Procedures performed by residents and/or fellows are excluded from this study. The vulva is cleaned with antiseptic solution and 10 ml of Xylocaine 2% is be instilled into the urethra before the endoscope was introduced. A 16 F flexible cysto urethroscope (Storz, Culver city, CA) is used for flexible cystoscopy. When rigid cystoscopy is performed, a 17F, 70° scope (Storz, Culver city, CA) is used to enable optimal visualization of the lateral bladder wall in those with previous continence surgeries. The investigator may choose to use a 30° scope when appropriate. Cystoscopy is commenced by recording a postvoid residual ensuring appropriate bladder emptying prior to filling. Filling is performed with continuous saline infusion until the maximum tolerated capacity or 300 ml. (whichever was reached first). A standard systematic approach was adopted to ensure global assessment of the vesical surface. This included the bladder dome, the bladder neck, bladder trigone, sidewalls and ureteral orifices. The urethroscopy portion of the procedure is performed last. When performing rigid cystoscopy, a 0° degree lens is used for this portion of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the following indications for outpatient cystourethroscopy:

  1. Microscopic hematuria or
  2. Voiding dysfunction, or recurrence of urinary incontinence, or
  3. History of recurrent bacterial cystitis
* Age \>18
* Patient willingness to enroll
* Patient able to read and understand an English language self- administered questionnaire.

Exclusion Criteria:

* Severe detrussor overactivity
* Interstitial cystitis or chronic urethral or bladder pain
* Acute urinary tract infection
* Urinary retention defined as a post void residual \>120cc
* Pregnancy or planning pregnancy within the next 3 months
* Prior urethral surgery
* Dementia or inability to complete questionnaires
Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess

This study will test whether short-term suppression of ovarian function can ameliorate androgen (male hormone) overproduction in overweight girls with androgen excess. The investigators hypothesize that one dose of depot leuprolide agonist administration will improve androgen levels in girls with ovarian androgen overproduction. Specifically, this intervention will improve androgen levels after ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG).


Eligibility Criteria:
Inclusion Criteria:

* overweight (\>85th BMI%) females
* Early to late puberty (expected age range 7-18)
* Hyperandrogenemic (free testosterone greater than 2.5 standard deviations above the mean for normal control subjects of the same Tanner Stage)
* Screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated luteinizing hormone (LH), lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin and decreased follicle-stimulating hormone (FSH) and/or sex hormone-binding globulin (SHBG)

Exclusion Criteria:

* Screening labs outside of age-appropriate normal range
* Hemoglobin \<12 mg/dL and hematocrit\<36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. If still \<36%, they will be excluded.)
* Morning Cortisol \<5 g/dL
* 17-hydroxyprogesterone \>295 ng/dL
* History of Cushing's syndrome or adrenal insufficiency
* Pregnant
Investigation of the Timely-coordinated Therapy of Patients With Metastatic Cancer by Radiotherapy Together With Immune Checkpoint Inhibition

Immunotherapy for the treatment of several cancer entities steadily increased during the last years. The data from the finalized and ongoing studies show the tremendous impact of immune checkpoint inhibition (ICI) also for advanced metastatic patients. Especially the ICI with pembrolizumab and nivolumab have an increasing number of first line treatment approvals. However, in particular metastatic patients which receive ICI therapy are often irradiated for immediate palliation of several metastases. Preclinical work revealed that radiotherapy (RT) is capable to modulate the tumor phenotype, its microenvironment in a way that systemic anti-tumor immune responses are induced. However, radiation has also immune suppressive properties as e.g. the expression of immune checkpoint molecules is increased following radiotherapy. So the ICI therapy in combination with the RT has the potential to overcome the immunotolerance of the tumor and the metastases. More and more reports therefore describe a so-called systemic immune-modulating effect of radiotherapy (former and still often named as abscopal effect). However the timely application of ICI and RT is often randomly and depends on the clinical need for the palliative RT. The aim of this trial is therefore to standardize the chronology of RT in combination with ICI, to evaluate the effects of radio-immunotherapy with a stratified and comparable patient cohort. The ST-ICI study is a prospective and observational study not influencing the standard therapeutic scheme and will provide hints how the radio-immune therapy drives systemic anti tumor responses.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering and diagnosed for: metastatic cancer of several entities
* Clinical indicated therapy with PD-1/PD-L1 inhibitors or CTLA-4 antagonists
* Optionally radiotherapy if clinically indicated
* Age at least 18 years

Exclusion Criteria:

* fertile patients who refuse effective contraception during study treatment
* persistent drug and/or alcohol abuse
* patients not able or willing to behave according to study protocol
* patients in care
* patients that are not able to speak German
* patients which are imprisoned according to legal or governmental order
Ultrasound Measurement of RIJV in Patients Between 0-2 Years

After obtaining parental consent ultrasonographic evaluation of right internal jugular vein will be performed in pediatric patients undergoing elective surgeries between 0-2 years of age. The patients for whom central venous catheterization is indicated will be included. The success rates and outcomes of catheterization will be recorded.


Eligibility Criteria:
Inclusion Criteria:

0-2 years Elective surgery Requirement for central venous cannulation

Exclusion Criteria:

Congenital cardiovascular anomalies Emergency surgeries Previous cannulation or any intervention on the neck
Buikwe Electronic Community Health Information System Impact Study

The purpose of the study is to investigate the impact of the eCHIS intervention on key child health outcomes.

Following national guidelines, 2 VHTs per village will be supported to provide the full eCHIS community health package. In total 856 VHTs in Buikwe district will have been trained and equipped with the national strategy and operational guidelines on eCHIS as well as the VHT full package (iCCM+ and VHT basic package (reproductive health, immunization, nutrition) guidelines. The VHTs will be equipped with mobile devices and iCCM supplies to start the management of community-based health among children aged five years within their respective communities. A cross-sectional cluster randomized controlled trial (cRCT) will be used to establish study outcomes in children under 5 years in the intervention and control areas using mixed methods (qualitative and quantitative) of data collection.

A total sample size of 1,140 children under five: 570 children under five, per arm, was scientifically determined for the study. During data collection, several quality control measures will be applied to ensure the data recorded reflect the facts, responses, observations, and events. A standard operating procedure (SOP) with roles and responsibilities of the data collectors will be prepared to ensure standardized methods for capturing data. After endline data collection, difference-in-differences (DID) analysis will be done to derive an estimate of the intervention effect on odds of the study outcomes.

Results will be disseminated through agreed peer-review publications and international conferences. Malaria Consortium Uganda will work with relevant stakeholders at the Ministry of Health and Medic Mobile to disseminate findings nationally and throughout the study district.

Eligibility Criteria:
Inclusion Criteria:

* · Children between 3-59 months,

  * Being resident in the study area,
  * Consent to participate in the study obtained,
  * Willingness and ability of the child's guardians to comply with the study protocol for the duration of the study including attending a designated health centre if their child has malaria symptoms during the data collection period.

Exclusion Criteria:

* Children aged below 3 months and above 59 months
* Children resident outside the study areas
* Those who have not consented to participate in the study
Optimizing OR Simulation in MEDI 045: Bias Reduction and Strategic Improvements (OPTIMIST)

This study explores the evolving landscape of operating room (OR) simulation by identifying key trends, addressing potential biases, and providing actionable recommendations for improvement. Using data-driven analysis, the research uncovers patterns in skill development and decision-making, offering insights into the effectiveness of current OR simulation programs. The study also tackles biases in data collection, including selection and response bias, ensuring the reliability of findings.

The effectiveness of simulation training is crucial in medical education, particularly for skills retention and perceived effectiveness. This section evaluates the overall effectiveness of SimMan3G sessions in enhancing clinical skills among participants.

Objectives

* To analyze the correlation between the number of SimMan3G sessions and skill retention.
* To assess the perceived effectiveness of simulation training.
* To provide actionable recommendations for improving simulation training effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Participants enrolled in the MEDI 045 anesthesia program at King Saud Medical City.
* Medical students or trainees with prior exposure to basic clinical simulation.
* Aged 18 years or older.
* Willingness to participate in simulation-based training sessions.
* Ability to provide informed consent.

Exclusion Criteria:

* Participants with prior advanced simulation training in anesthesia.
* Individuals with documented cognitive impairments or learning disabilities that may interfere with the study tasks.
* Refuse to participate in post-simulation assessments or follow-ups.
* Lack of fluency in the language of instruction used in the simulation.