cyrilzakka/clinical-trials huggingface dataset:
Dynamic Contrast-Enhanced Fluorescence Arthroscopy of Meniscus Pilot

Single-center pilot prospective observational study to determine feasibility of assessing meniscal tissue vascularity using dynamic contrast-enhanced fluorescence arthroscopy

The purpose of this pilot study is to determine whether it is possible to translate the dynamic contrast-enhanced fluorescence imaging methods we have been using to assess bone perfusion in orthopaedic trauma patients to the field of arthroscopic surgery. In other words, it is the development of dynamic contrast-enhanced fluorescence arthroscopy.

While fluorescence arthroscopes are available, there are several challenges associated with minimally invasive procedures compared with wide field imaging, and this pilot study will help determine whether these can be overcome. They are mainly to do with motion artifacts caused by the non-fixed position of the scope during wash-in/wash-out of the dye, and the use of an arthroscopic pump to pressurize the fluid in the surgical cavity.

The long-term goal of this work is to use dynamic contrast-enhanced fluorescence arthroscopy for the assessment of vascularity of meniscal tissue arthroscopically to determine potential healing capacity using dynamic contrast-enhanced fluorescence imaging.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years of age or older.
2. Meniscal tear based on MRI or preoperative assessment
3. Provision of informed consent.

Exclusion Criteria:

1. Inability of patient to provide informed consent
2. Iodine allergy.
3. Evidence of septic arthritis of the proposed surgical joint.
4. Burns.
5. Incarceration.
6. Expected survival of less than 90 days.
7. Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
8. Pregnant or Breastfeeding Women
Efficacy and Safety of TenoMiR in Lateral Epicondylitis

This study is testing a drug called TenoMiR that is being developed for the treatment of tennis elbow (lateral epicondylitis). The study drug is a new compound that works by improving the quality of the collagen which helps repair damage to the elbow. The study drug is being developed in the hope of providing a more reliable treatment than those currently available and can be given at the time of first diagnosis, so that recovery can begin as soon as possible. The study drug has been tested in humans in an earlier study, and appeared to be safe and well-tolerated. This study aims to test the study drug in a larger number of participants.

TenoMiR a chemically synthesised mimic of microRNA-29a (miR29a) which has improved stability, activity and cellular uptake while being non-immunogenic, has been created to restore miR29a levels back to pre-injury levels. TenoMiR is unique in directly targeting the key changes in collagen production associated with tendinopathy. Unlike other therapies, TenoMiR has a well-defined mode-of-action that is supported by a wealth of scientific data.

Moreover, treatment with TenoMiR does not require invasive biopsies and can be delivered at the point of initial diagnosis initiating recovery at the very earliest time. This is a global multicentre study which will test TenoMiR in a larger population, to follow on from the previous Phase 1b study in which TenoMiR appeared to be both safe and well-tolerated.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following inclusion criteria.

1. Subject has a clinical diagnosis of lateral epicondylitis.
2. Aside from lateral epicondylitis, the subject is otherwise healthy as determined by a responsible physician, based on medical history, physical examinations, concomitant medication, vital signs, 12-lead ECGs and clinical laboratory evaluations. Laboratory values may be retested once at the discretion of the Investigator.
3. Subject's symptoms can be reproduced with resisted supination or wrist dorsiflexion (as confirmed by tenderness at lateral epicondyle and positive pick up back of chair sign).
4. Subject's symptoms have persisted for at least 6 weeks to 9 months, despite conservative treatment that includes 1 or combinations of:

   1. Physical therapy
   2. Splinting
   3. NSAIDs

Exclusion Criteria:

Subjects with any of the following will be excluded from study participation:

1. Subject has undergone previous corticosteroid injection therapy to the affected elbow in less than 6 months prior to enrolment.
2. Subjects unwilling or unable to discontinue use of pain medication (opiate or NSAID) from at least 1 week prior to Investigational Medicinal Product (IMP) administration.
3. Subject has received previous Platelet-Rich Plasma (PRP) injection to the affected elbow.
4. Subject uses or has recent use of medications known to affect the skeleton (e.g., glucocorticoid usage \>5 mg/day, fluoroquinolone antibiotics).
5. Subject has undergone surgical intervention to the affected elbow for the treatment of lateral epicondylitis.
Serial Changes in Micturition Symptoms, Urine Flow and Bladder Voiding Efficiency Following Transobturator Tape Surgery

The aim of this study was to identify the serial changes in lower urinary tract symptoms (LUTS), urine flow and bladder voiding efficiency after transobturator tape (TOT) surgery for treatment of female stress urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* women who underwent transobturator tape surgery for treatment of female stress urinary incontinence

Exclusion Criteria:

* any urinary tract infection
* pregnancy
* bladder malignancy
* postoperative follow-up of less than 12 months
Movicol in Childhood Constipation (ProMotion Study)

This was a single centre study comprised of two stages (Parts I and II). Part I was a 9-day open label evaluation of Movicol administered to patients in hospital. This study evaluated the safety and efficacy of Movicol in treating faecal impaction. Movicol was administered over 3 - 7 days to achieve disimpaction.

Patients received Movicol treatment until disimpaction was achieved according to the following regime:

Day 1: Ages 2 - 4 received 1 (one) sachet whilst 5 - 11 year olds received 2 (two).

Day 2: Ages 2 - 4 received 2 (two) sachets whilst 5 - 11 year olds received 3 (three).

Day 3: Ages 2 - 4 received 2 (two) sachets whilst 5 - 11 year olds received 4 (four).

Day 4: Ages 2 - 4 received 3 \*three) sachets whilst 5 - 11 year olds received 5 (five).

Day 5: Ages 2 - 4 received 3 (three) sachets whilst 5 - 11 year olds received 6 (six).

Day 6: Ages 2 - 4 received 4 (four) sachets whilst 5 - 11 year olds received 6 (six).

Day 7: Ages 2 - 4 received 4 (four) sachets whilst 5 - 11 year olds received 6 (six).

If on day 8 the patient was still impacted they were withdrawn from study and treated according to their individual needs. Disimpaction was assessed clinically (loss of faecal masses and passage of watery stools).

Two days following disimpaction patients were randomised (according to the randomisation list) to receive Movicol or Lactulose Dry. During bowel retraining the appropriate maintenance dose of Movicol or Lactulose Dry was determined. Patients were discharged once they were passing regular, painless, bowel actions.

Eligibility Criteria:
Inclusion Criteria:

* patients that, in the opinion of the investigator, are constipated/fecally impacted as to require hospital stay to treat and/or relieve the impaction
* children aged 2 - 11 years old inclusive
* patients of either sex

Exclusion Criteria:

Patients with

* intestinal perforation or obstruction
* severe inflammatory conditions of the intestinal tract
* uncontrolled renal/hepatic/cardiac diseases
* uncontrolled endocrine disorder(s)
* any neuromuscular condition affecting bowel function
* hypersensitivity to lactulose or PEG or other constituent of Movicol
* patients who have taken any investigational drug in the three months
* patients or patients whose parents would in the opinion of the investigator are unable to comply with requirements of the study
Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?

Transcatheter aortic valve implantation (TAVI) is a well known safe treatment for severe aortic stenosis. To perform TAVI safely, there is a need for two vascular entry (access) sites: the primary and secondary access sites. While the femoral approach remains the most common site for primary access, secondary access (which is needed for guidance during the procedure) has drawn little attention in trials of TAVI. The two secondary access sites most commonly used are the radial (through an artery in the wrist) and femoral (through an artery in the groin) access sites. Observational studies comparing the two have shown a lower risk of complications with radial access compared to femoral access, but there are no randomized controlled data to confirm these findings. Accordingly, investigators aim to undertake a multicenter, randomized controlled trial among patients who are undergoing transfemoral TAVI, to assess if radial access is superior to femoral access as a secondary access site.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Undergoing transfemoral TAVI with any commercially available transcatheter heart valve
* Suitable radial and secondary femoral access

Exclusion Criteria:

* Primary arterial access via surgical cut-down
* Inadequate contralateral femoral artery access and/or bilateral radial artery access as determined by the interventional cardiologist
* Previously failed attempt to access bilateral radial arteries.
* Patient on hemodialysis
Enhancing Functional Hand Recovery Through Nerve Reconstruction in Total Brachial Plexus Birth Injury

Interpreting the published outcomes of hand function in total BPBI is confounded by a lack of clear documentation regarding detailed surgical findings and management strategies. Investigators have followed a well-defined protocol for surgical reconstruction with the primary objective being reinnervation of the lower trunk using the best available root. In this paper, Investigators outline the details of the strategy and provide a comprehensive analysis of the nerve reconstruction techniques and the resulting functional outcomes.

Managing total BPBI cases is complex because surgical reconstruction must address the restoration of shoulder, elbow, and hand functions. In cases where multiple nerve root avulsions are present, prioritizing which functions to reinnervate shoulder, elbow, or hand becomes a critical decision. While attempts to restore hand function in adults with total brachial plexus lesions have yielded disappointing results, it has been shown that restoring hand function in infants with BPBI is more promising due to their enhanced neuro-regenerative capacities. Interpreting published outcomes of hand function in total BPBI is confounded by a lack of clear documentation regarding detailed surgical findings and management strategies. Various hand function scales that measure the individual joint movements or the global function of the hand and wrist have been used in the assessment of the outcomes, but none has quantitated the recovery of the intrinsic muscles of the digits or thumb. Furthermore, it is well-documented that the recovery of hand function can be a prolonged process, often extending up to eight years before reaching a plateau. The majority of the published studies have typically reported outcomes based on a minimum follow-up period of two years, which may not provide sufficient time to assess the full extent of hand function recovery.

Investigators have followed a well-defined protocol for the surgical reconstruction of total BPBI with the primary objective being restoration of hand function through reinnervation of the lower trunk followed by restoration of elbow and shoulder functions through innervation of the upper trunk. In this paper, Investigators outline the details of the surgical strategy and provide a comprehensive analysis of the nerve reconstruction techniques and the resulting functional outcomes. Furthermore, investigators explore and identify the factors that may significantly impact the recovery process.

Eligibility Criteria:
Inclusion Criteria:

* Patients Who underwent brachial plexus exploration and reconstruction for total OBPP.

who have reached at least four years of follow-up

Exclusion Criteria:

* Excluding children who had selective distal neurotization for restoration of specific functions without brachial plexus exploration or who had secondary procedures to the hand.
Lower Protein Intake and Long-term Risk of Obesity and Cardiovascular Disease

The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and cardiovascular disease.

Obesity and its cardiovascular consequences are the most important causes of morbidity and mortality worldwide. Breastfed infants have been shown to have less cardiovascular risk factors in adulthood, which can be partially explained by their slower growth compared to formula fed infants. The primary objective of this study is to investigate if consumption of lower protein formula can slow the rate of weight gain of formula-fed infants between 3 and 12 months of age. Secondary objectives include investigation into whether infant nutrition and growth have an impact on later risk of obesity and atherosclerotic cardiovascular disease (CVD), the critical windows for these programming effects, and the mechanisms of action.

Eligibility Criteria:
Inclusion Criteria:

* Healthy term infant
* Infant is aged 14 weeks (+/- 1 week)
* Infant is exclusively formula feeding or predominantly breast-feeding at age 14 weeks

Exclusion Criteria:

* Any adverse maternal, fetal or infant medical history that may have effects on growth and/or development
* Infant born with congenital disease or malformation affecting growth and/or development
* Food allergy to any trial products (e.g. milk, soy)
Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab

The purpose of this study is to evaluate the safety and effectiveness in the treatment of recurrent glioblastoma with Cadonilimab combined with fractionated radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. . Written and signed informed consent.
2. . Male or female, age≥ 18 and ≤ 75 years old on day of signing informed consent.
3. Epitentorial glioblastoma confirmed by pathology; Diagnosis of recurrence through clinical imaging evidence.
4. The maximum diameter of recurrent tumor is less than 6 cm.
5. Concurrent radiotherapy and chemotherapy with standard STUP treatment scheme in the past.
6. The interval from the last radiotherapy is more than 6 months.
7. KPS (Karnofsky function status score)\>60.

Exclusion Criteria:

1. Prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment.
2. Concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies.
3. Multiple malignant gliomas.
4. Subtentorial glioblastoma or Extracranial metastatic lesions.
5. Active autoimmune diseases.
6. Known history of primary immunodeficiency virus infection or known history of testing positive for human immunodeficiency virus (HIV).
Observation of the Efficacy and Tolerance of Motens® (Lacidipine) in Patients With Essential Hypertension

Study of the efficacy and tolerance of Motens® (lacidipine) in patients with essential hypertension. To obtain information on the dosage used in practice and the tolerance at the start of treatment (12 weeks)


Eligibility Criteria:
Inclusion Criteria:

Non-hospitalised patients of both sexes aged 18 years or more with essential hypertension requiring treatment according to the recommendations of the German League for Hypertension

Exclusion Criteria:

Patients who had the contraindications listed in the product information (the case report file contained a copy of the product information)
Remote Delivery of Weight Management by Phone and Social Media

The purpose of this study is to compare two different weight management delivery methods, social media versus a traditional care model.

Obesity is a major public health issue as 68% of the US population is either overweight or obese. Weight loss and weight loss maintenance is difficult. Traditionally, successful weight loss programs are weekly behaviorally-based clinics which utilize a combination of calorie restriction and physical activity. Traditional "face to face" weekly meetings may not be feasible for everyone.

An alternative to provide weight loss and weight maintenance created by KUMC researchers uses weekly group phone conference calls. While this method produced equal weight loss with fewer burdens to participants when compared to the traditional "face to face" format, weight regain during maintenance was still high.

This study will investigate a new delivery method (social media platform "Facebook") compared to the group phone conference calls. In the social media platform participants will be able to socialize with other participants in their group by commenting on posts from other participants or posting messages themselves. Social media delivered programs have potential to be a more a cost-effective approach to reach a large group of individuals.

Participants who are eligible and decided to be in this study will take part in study related activities for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 30 to 45 kg/m\^2
* Have access to a computer, smart phone, or tablet
* Give informed consent to participate

Exclusion Criteria:

* Unable to participate in moderate intensity PA (i.e., walking)
* Participation in a weight loss or physical activity program in the previous 6 mos.
* Greater than 3, 30-min bouts of planned exercise/week
* Not weight stable (±4.6 kg) for 3 mos. prior to intake
* Unwilling to be randomized to 1 of the 2 study groups
* Report being pregnant during the previous 6 mos., currently lactating, or planned pregnancy in the following 6 mos.
* Serious medical risk such as cancer, recent cardiac event (i.e. heart attack, stroke, angioplasty) as determined by the individual's PCP via the clearance to participate in the investigation
* Current use of antipsychotics or untreated depression
* Adherence to specialized diet regimens, i.e., multiple food allergies, vegetarian, macrobiotic
* Binge eating disorder as assessed by the Binge Eating Scale
* Living in the same household as another study participant
Improving the Assessment of Hypersomnolence

The overall purpose of this study is to employ a pragmatic, multidimensional assessment of hypersomnolence that "piggybacks" on routine clinical care in patients with suspected disorders of central nervous system (CNS) hypersomnia, to determine whether these additional objective and subjective assessments are useful in the diagnosis and management of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-89
* Referred for polysomnography/multiple sleep latency test at Wisconsin Sleep, the sleep medicine clinic and laboratory of the University of Wisconsin-Madison

Exclusion Criteria:

* unstable medical condition that, in the opinion of the investigators, would make it unsafe for the subject to participate
Traumatic Below-knee Amputees With Prosthetics: Health-related Quality of Life and Locomotor Capabilities

The present study assesses the health-related quality of life and the locomotor capabilities major traumatic lower limb amputees who use prosthesis.

A cross sectional study based on a retrospective review of prosthetic using major traumatic lower limb amputees' demographic and clinical details together with HRQoL and locomotor capabilities patient-reported outcome measures.

Eligibility Criteria:
Inclusion Criteria:

1. Below-knee prosthesis users with amputation due to trauma
2. age \>18

Exclusion Criteria:

1. Patients with no prosthesis
The Effects of Inhaled Aclidinium Bromide/Formoterol Fumarate on Inspiratory Pleural Pressures in Smokers

This short-term study aims to prove the potential cardio-protective physiological effect of inhaled aclidinium bromide/formoterol fumarate on inspiratory pleural pressures.

Smoking is associated with gas-trapping (hyperinflation), even in the absence of chronic obstructive pulmonary disease. Breathing in the presence of gas-trapping requires large negative inspiratory pleural pressures, which are transmitted to the surface of the heart and increase cardiac wall stress.

Inhaled aclidinium bromide and formoterol fumarate has been shown to reduce gas-trapping, but the impact on inspiratory pleural pressures and biomarkers of cardiac stress in smokers is unknown.


Eligibility Criteria:
Inclusion Criteria:

* Current and former smokers with ≥20 pack-years of smoking history
* Gas-trapping (residual volume \>110% predicted)

Exclusion Criteria:

Physician-diagnosis of chronic obstructive pulmonary disease in the past 1 year and regular use of long-acting antimuscarinic (LAMA) and/or long-acting beta-agonist (LABA) (i.e., at least 30 consecutive days)

* Physician-diagnosis of asthma in the past 5 years
* Regular inhaled corticosteroid (ICS) use in the past 5 years (i.e., at least 30 consecutive days)
* Physician-diagnosis of other lung diseases (sarcoidosis, tuberculosis, cystic fibrosis, pulmonary fibrosis, lung cancer), or long-term oxygen therapy
* Respiratory tract infection within 4-weeks
* Physician-diagnosis of arrhythmia, or significant valvular disease.
* Physician-diagnosis of myocardial infarction, unstable angina or heart failure requiring unscheduled outpatient or emergency department visit within 6-months.
* Arrhythmia or prolonged corrected QT (QTc) on electrocardiogram.
* Inability to use study inhaler
* Glaucoma
* Benign prostatic hypertrophy
* Pregnancy
* Allergy to the study treatment, salbutamol, lidocaine, or severe milk protein allergy (note: lactose intolerance is not an exclusion criteria)
* Contraindications to anti-cholinergic, beta-agonist, or cardiopulmonary exercise testing with manometry
* Inability to provide written informed consent
Double ABCX Theory Based Cognitive Psychotherapy Combined Progressive Muscle Relaxation Intervention on Women Undergoing IVF-ET

The in vitro fertilization and embryo transfer(IVF-ET) is a therapy to help the infertile couples. The mental health status of couple under IVF-ET, commonly seen in depression and anxiety, is found to be closely related to the success of IVF-ET. This study aims to develop a intervention program combing cognitive psychotherapy and progressive muscle relaxation to ease the negative emotion and promote the success rate among couples undergoing IVF-ET.


Eligibility Criteria:
Inclusion Criteria:

* The couple who are eligible for in vitro fertilization-embryo transfer (IVF-ET) treatment;
* Junior high school and above;
* voluntarily accepted for investigation and signed informed consent.

Exclusion Criteria:

* Suffering from physical diseases such as severe heart, liver and kidney, and mental disorders;
* Experiencing major traumatic events in the past 2 years.