cyrilzakka/clinical-trials huggingface dataset:
Ankle Proprioceptive Training In Patients With Diabetic Peripheral Neuropathy

Diabetes being a very prevalent condition results in various complications including neuropathy, which can impair various functional outcomes in patients including balance. Ankle proprioceptive training (APT) is an intervention that is used to tackle this problem. The study will compare APT with standard balance training in subjects with diabetic neuropathy.

The study will include the diagnosed diabetic subjects with score of 4 or more on Douleur neuropathique 4 questionnaire (DN4Q). The subjects will be randomly divided into 2 groups; interventional group and control group. Interventional group will receive APT 3 days a week for 8 weeks. Balance training exercises will be given to both groups 3 days a week for 8 weeks. The assessments will be done at baseline, after 4 weeks and after 8 weeks of interventions.

Eligibility Criteria:
Inclusion Criteria:

* Known case of diabetic peripheral neuropathy (DPN),
* Patients who met the criteria of DN4 scored equal or greater than 4.
* Patients who have positive SHARPEND ROMBERG TEST

Exclusion Criteria:

* Patients with DVT
* orthostatic hypotension
* Any recent surgery of lower limb
* Amputies
* Patients with crutches or walking aids
* Patients with gangrene
* Lower BMI
* Acute systemic illness
* Vestibular impairment
Dual Task Performance in Community Dwelling Older Adults

Dual task performances may be impaired with the impairment in motor performance and cognitive functions due to aging. The aim of the present study is to investigate the gender differences in dual task performance. A total of 82 community dwelling older adults (41 males and 41 females) aged between 65 and 75 years were included in the study. Motor performance was evaluated with sit-to-stand test, the timed up and go test, 10 m walking test and cognitive functions were evaluated with Montreal Cognitive Assessment Test. Dual task performances were evaluated as motor-motor and cognitive-motor performance.


Eligibility Criteria:
Inclusion Criteria:

* The individuals aged between 65 and 75 years, who agreed for participation, who received 8 or higher points from Hodkinson Mental test, who had no neurologic/orthopedic problems that could affect balance and walking, or communication problem were included in the study.

Exclusion Criteria:

* The individuals who were using 3 or more medications that could affect motor and cognitive functions, and the ones who could not complete the tests were excluded.
Effects of Balance Exercises With and Without Clamshell Exercises After Menopause

Exercise-based balance intervention is structured program of physical exercises intended to enhance balance, stability, and clamshell exercises are known as an exercise-based balance intervention. A crucial component of physical therapy and fitness regimens targeted at enhancing stability, reducing the risk of falls, and promoting general physical health is exercise-based balance therapies. Women's ability to function both physically and mentally can be significantly impacted by menopause. To find out the effects of an exercise based balance intervention on physical and clamshell exercises after menopause Certain consequences can be lessened by address these alterations with focused interventions.These will be a randomized clinical trial and will be conducted in Bhawalpur Victoria Hospital and Mehran Rehab Clinic. This study will be completed in the time duration of 10 months after the approval of Synopsis. Non probability convenience sampling technique will be used and participants will be recruited in study after the randomization.80 participants with age between 50-65 years will be included in the study according to the inclusion criteria. Group A will receive balance exercises and clamshell exercises Group B will be recieve only balance exercises the tool that will be used are the sit and raised test , y balance test, Romberg test for check the balance. Timed raised chair task for check the strength . timed up and go for check the mobility . heel shin touch test for check the coordination. Time shuttle runs for check the speed. Step test for check the power after data collection, data will be analyzed by using SPPSS 26.


Eligibility Criteria:
Inclusion Criteria:

* age 65 years or older;
* having significant concerns about their balance
* participants to be living independently in the community
* Berg's Balance Scale scores more than 41/56 indicating minimal fall risk were included in the study

Exclusion Criteria:

* Participants were excluded from the study if their vision was compromised so that they were unable to see objects on the floor or recognize the instructor's movements

  * progressive neurologic disease which could impair balance
  * hypertensive
* unable to understand, speak, or hear
Gastrointestinal Transit and Motility in Renal Transplant Recipients

Gastrointestinal (GI) complications after renal transplantation are commonly reported as side effects of immunosuppressive agents. Despite this, motility disorders have been scantily studied. Alternating Current Biosusceptometry (ACB) are biomagnetic sensors designed for a wide range of applications. In clinical practice, their non-invasive and radiation free features provide an excellent approach for monitoring of GI transit as alternative to scintigraphy and breath tests. The aim of this study is to examine GI transit and motility of solids in stable renal transplant recipients to determine the potential influence of immunosuppressive therapy on gastrointestinal parameters.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteer or Renal Transplant Patients
* Signed informed consent obtained
* Fasted since midnight

Exclusion Criteria:

* Subject has known GI related symptoms complaints or GI diseases
* Subject has cancer or other life threatening diseases or conditions
* Subject is pregnant
* Subject has undergone abdominal surgery
* Drug abuse or alcoholism
* Subject has cardiac pacemaker
* Subject takes any medication affecting GI motility
Frontal Bone Window in ICUF (FBW-ICU)

Transcranial doppler (TCD) is an established tool for monitoring flows in intracranial cerebral arteries. Its use is recommanded in the last guidelines on traumatic brain injury. The temporal bone window (TBW) is limited in evaluating flow in the anterior cerebral arteries (ACA) because of an unfavorable insonation angle. Thereby TCD could be unfit to detect a segmental lesion on the anterior cerebral arteries (ACA).

The frontal bone window (FBW) is a promising approach in evaluating flows in the ACA. However, the utility of the FBW for patients with acute brain injury (ABI) in ICU has not been yet determined.

The goal of the present study is to determine the rate of detection of the ACA by using the FBW in patients with ABI in ICU.


Eligibility Criteria:
Inclusion Criteria:

* Membership in a health insurance scheme
* Patients with an acute cerebral pathology
* Hospitalized patients in a supportive care unit of Montpellier University Hospital
* Be able to benefit from transcranial doppler within 3 days of admission

Exclusion Criteria:

* Clinical suspicion of encephalic death
* Known allergy to ultrasound gel
Simplified Isoniazid Preventive Therapy Strategy to Reduce TB Burden

The overall objective of this study is to determine if a multi-component implementation intervention (SPIRIT) and additional leadership and management training that targets District Health Officers (DHOs) can increase IPT initiation among HIV-infected persons, as compared to country standard practices, in a cluster randomized trial in Uganda.

The failure to use isoniazid (INH) preventative therapy (IPT) in HIV-infected individuals in Sub-Saharan Africa represents one of the single biggest implementation gaps between evidence and practice in today's response to the HIV epidemic. The proposed study will evaluate the effectiveness of a multi-component intervention to improve IPT uptake in two regions of Uganda. The study design is a randomized controlled trial (RCT) where the unit of randomization is clusters of districts in Uganda. The clusters consist of 5-7 districts and the District Health Officer (DHO) and District TB and Leprosy Supervisor (DTLS) from each district is invited to participate. The SPIRIT intervention is based on the PRECEDE framework which outlines the importance of social networks, social influence, and behavior change.

The SEARCH-IPT multi-component intervention includes:

* A teaching collaborative which will be formed within the randomized clusters of district DHOs and DTLSs to create a mini-collaborative, which will be led by an opinion leader with HIV and TB expertise, to spread new scientific knowledge about IPT and the clinical ability to rule out TB, and to facilitate discussion between DHOs.
* A "toolkit" of options to ease IPT implementation will support DHOs to scale up IPT through the study of the comparative effectiveness of material contributions to their day-to-day function of managing front line providers and clinics.
* A reporting collaborative comprised of the teaching collaborative groups, will define targets as a group, and reconvening every 6 months for 3 years (with the additional option of 36 months for a final report back), where each collaborative has an opportunity to share progress and results.

In addition, an enhanced business training \& 'training-of-trainers' curriculum will be conducted to evaluate the effect of enhanced business training among intervention group DHOs from Phase 1 (Years 1-3 of trial follow-up) in the southwestern Uganda region on IPT initiation during years 4-5 of trial follow-up (Phase 2).

Eligibility Criteria:
AIM 1 - Spirit Intervention:

Inclusion Criteria:

* District Health Officer or TB District Supervisor (or other DHO-appointed TB focal person) in Uganda.
* By definition, the DHO or TB District Supervisor are all ≥18 years of age.

Exclusion Criteria:

* Planned departure from position as DHO or TB District Supervisor prior to randomization.
* DHOs from Kampala and Wakiso districts, Uganda.
The Spine PROMCO Study

Our primary objective is to design a cohort to determine the treatment outcome of different surgical interventions of the degenerative lumbar spine highlighting the expediency and value of the current surgical treatment program.

This observational prospective unicenter cohort study includes patients who are eligible for elective lumbar spine surgery due to a degenerative spine disease (e.g. herniated disk, spinal canal stenosis, discopathy and spondylolisthesis). An enrolment rate of at least 80% is pursued within minimal 1.5 years of inclusion. A digital survey is used including self-reporting questionnaires that pertain to outcomes as pain, functionality and disability (COMI Back), health status (EQ-5D-5L), re-operations and complications, and satisfaction. The survey is sent at given time-intervals (e.g. baseline 2 weeks prior to surgery, 6 weeks post surgery and 6, 12, 36 months post surgery). Besides descriptive statistics and multivariate analysis, an economic evaluation will be performed from a societal perspective.

Eligibility Criteria:
Inclusion Criteria:

* All patients who are eligible for elective surgery of the lumbar spine.
* All patients with degenerative disorder of the lumbar spine including: herniated disk, stenosis, discopathy and spondylolisthesis.
* Patients must be able to fill in the questionnaire online
* Patients with imaging (Magnetic resonance imaging (MRI)) confirmed lumbar disc herniation, stenosis, discopathy, or listhesis.
* Elective cases
* Patients operated with laminectomy, microscopic discectomy, percutaneous transforaminal endoscopic discectomy, and spondylodesis.

Exclusion Criteria:

* Patients who cannot speak nor read the Dutch language
* Patients who are not able to complete the digital questionnaires, according to the including doctor
* Patients with fractures, primary infections of the spine, or with spinal malignant- cies.
* Patients in a traumatic setting.
A Lifestyle Investigation With Spectacles and Daily Disposable Contact Lenses in Young Patients

The purpose of this study was to evaluate the relative benefits of daily disposable contact lenses versus spectacles in young adults.


Eligibility Criteria:
Inclusion Criteria:

* Understands rights as a research subject and willing and able to sign a Statement of Informed Consent, or if under 18, parent or guardian understands rights and is willing and able to sign a Statement of Informed Consent.
* Willing and able to follow the protocol.
* Currently wearing spectacles full-time (at least five days per week, eight hours per day).
* Has never worn contact lenses (more than one day) before.
* Agrees to not participate in other clinical research for the duration of this study.
* Can attain at least 6/9 in each eye with the study optical correction.
* Can be fitted with study lenses in the available power range (contact lens group) or can select a satisfactory spectacle lens frame and lenses (spectacle group).
* Willing and able to wear the study lenses or spectacles for a minimum of five days per week, eight hours per day.
* Owns or has regular access to a mobile phone and is familiar with SMS text messaging.
* Has an up-to-date and functional pair of spectacles at time of enrollment.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Has an ocular or systemic disorder that would normally contraindicate contact lens wear.
* Is using any topical medication such as eye drops or ointment.
* Has had corneal refractive surgery.
* Has had cataract surgery.
* Has diabetes.
* Has taken part in other clinical research within two weeks of starting the study.
* Other protocol-defined exclusion criteria may apply.
Comparative Safety and Efficacy of Vaginal Dinoprostone Versus Lidocaine-prilocaine Cream in Copper IUD Insertion

the aim of the present study is to Compare Safety and Efficacy of Vaginal dinoprostone Versus Lidocaine-prilocaine Cream in copper IUD Insertion in nulliparous women: a randomized controlled trial


Eligibility Criteria:
Inclusion Criteria:

* nulliparous women requesting copper IUD insertion

Exclusion Criteria:

* multiparous women, active vaginal or cervical infections and contraindications to IUD Insertion.
Randomized Study of PH-10 for Psoriasis

PH-10 is an aqueous hydrogel formulation of rose bengal disodium (RB) for topical administration to the skin, and is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. This multicenter phase 2 study of subjects randomized sequentially by center to one of four treatment cohorts will assess efficacy and safety of topical PH-10 applied once daily to areas of mild to moderate plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Men or women, age 18 or older.
* Presence of mild to moderate plaque psoriasis on the trunk or extremities (excluding palms, soles, scalp, and facial or intertriginous areas).
* Fitzpatrick skin type I-VI.
* Written informed consent by the subject or legal guardian.

Exclusion Criteria:

* Female subjects of childbearing potential who are pregnant, attempting to conceive, not using effective contraception, or who are nursing an infant.
* Subjects who have received psoralen plus ultraviolet A (PUVA) therapy or systemic antipsoriatic therapy (immunosuppressants, cytostatics, corticosteroids) within 28 days of study initiation (two weeks for methotrexate).
* Subjects who have received ultraviolet B (UVB) light therapy within 14 days of study initiation.
* Subjects who have received topical antipsoriatic therapy (including corticosteroids, tar, anthralin or Vitamin D analogs) to the study plaque areas within 14 days of study initiation.
* Subjects who have received agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of study initiation.
* Subjects who have received any approved or investigational biologic drug therapy for psoriasis within 90 days or 5 half-lives of study initiation.
* Subjects who have participated in a clinical research study within 28 days of study initiation.
* Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
* Subjects with clinical conditions that, in the opinion of the Investigator may pose a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.
Ocular Function in Autism Spectrum Disorder

This study will investigate the visual function in individuals with ASD, with a particular focus on the ocular surface condition and visual function assessment.

Anomalies in visual information processing can have a major effect on the life quality of individuals with autism spectrum disorders (ASD), including eye gaze abnormality, higher frequency of refractive errors (e.g., astigmatism, hypermetropia, and anisometropia), strabismus, abnormal blinking rate, disturbed eye movements that may be associated with or aggravated social communication deficits of ASD. However, little is known about the ocular surface conditions. This study will investigate the visual function in individuals with ASD, with a particular focus on the ocular surface condition. We plan to recruit 50 adults with ASD and 50 age-/sex-matched typically developing controls in this project, and perform visual function assessment.

Eligibility Criteria:
ASD group:

Inclusion Criteria:

1. Having a clinical diagnosis of autism spectrum disorder
2. Aged over 20 years; able to read and sign an informed consent form.
3. Clear conscious and can follow the instruction of opening eyes and movement toward all direction.

Exclusion Criteria:

1. Unable to cooperate with the examinations.
2. Younger than 20 years old.

TD group:

Inclusion Criteria:

1. Aged over 20 years; able to read and sign an informed consent form.
2. Clear conscious and can follow the instruction of opening eyes and movement toward all direction.

Exclusion Criteria:

1. Unable to cooperate with the examinations.
2. Younger than 20 years old.
3. Having a clinical diagnosis of autism spectrum disorder
Diabetes Nutrition Algorithms in Patients With Overt Diabetes Mellitus

Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable.

The researchers therefore investigate dietary strategies such as low-carb and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients.

Basic treatment of type 2 diabetes should focus on diet, physical activity and lifestyle. Nevertheless, in early and late stage of T2DM, lifestyle intervention is mostly substituted by pharmacological intervention, although lifestyle modification and dietary treatment would be favourable.

The researchers therefore investigate dietary strategies such as low-carb diets and very-low calory diets regarding their potential to improve metabolism and body weight in (mostly) long-term T2DM patients.

An intensive intervention of 3 weeks is followed by an 11-month maintenance phase to consolidate metabolic improvements.

Eligibility Criteria:
Inclusion Criteria:

* male and female subjects
* 18-79 years old
* type 2 diabetes

Exclusion Criteria:

* renal insufficiency
* anaemia
* immunosuppression
* previous symptomatic cancer diagnosis
* acute cardiovascular disease (stroke, coronary syndrome)
* pregnancy and lactation
* severe psychiatric disorders
* corticoid or other immunosuppressive therapy
Novel Endoscopic Resection of Upper Gastrointestinal Subepithelial Tumors Originating From the Muscularis Propria

Endoscopic submucosal tumor resection using biopsy forceps was performed for 11 consecutive patients who had clinical indications for lesion removal. Following the injection around a submucosal tumor, the adjacent mucosa or submucosa was grasped with the forceps and pulled away to form a "tent". The tissue was dissected using an electrocoagulating current. In brief, the tumor was dissected from the muscularis propria layer and then carefully removed using forceps. Demographic data, indication for intervention, safety of the procedure and follow-up will be assessed.

After the target lesion was identified, several marking dots were made around the lesion, using the hot biopsy forcep. A 0.9% saline solution mixed with epinephrine (1:10,000) and indigo carmine dye was injected along the border of the tumor to raise the gastric mucosa. Then, a circumferential incision was made along the margin of the targeted lesion, using the hot biopsy forceps, and the superficial mucosa was removed. Repeated injection was performed into the submucosal layer. The surrounding tissue was then carefully dissected using the hot biopsy forceps to the level of the deepest submucosal layer. The adjacent tissue was grasped using the forceps and pulled away, forming a "tent". To ensure complete resection, the muscular fibers and stalks that connected the tumor to the propria layer were shelled along the capsule of the tumor, using the coagulating forceps. The investigators used a coagulating forceps when strip the tissue of the outer longitudinal layer. Visible blood vessels in the submucosal layer were directly coagulated using coagulating forceps. After the lesion was removed, further visible blood vessels were coagulated. The hot biopsy forcep was used to apply a forced coagulation current (80 W, Effect 2, VIO300D; Erbe, Germany). However, coagulating forceps with a soft coagulation current (60 W, Effect 6, VIO300D; Erbe, Germany) were used to cut muscle fibers adjacent to the tumor or hemostasis.

Eligibility Criteria:
Inclusion Criteria:

1. the tumor size had increased on the follow up gastroscopy,
2. the EUS showed a well demarcated GI SET, or
3. they requested an endoscopic excision because the tumor was causing them anxiety.

Exclusion Criteria:

1. they had predominantly extraluminal growth,
2. they were ill demarcated, or
3. the EUS showed adjacent lymph nodes with a malignant appearance.
Intratumoral Bromelain + Acetylcysteine in Relapsed and Unresectable Pseudomyxoma Peritonei

This trial pursues studying a compassionate treatment option for patients with inoperable pseudomyxoma peritonei through percutaneous administration of bromelain + N-acetylcysteine (NAC) in order to decrease tumoral volume. Secondary endpoints are the decrease of ascites, compressive symptoms and pain through the dilution of mucins, which would better intestinal blockage.


Eligibility Criteria:
Inclusion Criteria:

* Pseudomyxoma peritonei diagnosis through imaging tests and/or histological studies
* Pseudomyxoma peritonei relapse in abdominal area in patients who comply inoperability criteria, which are:

At least two HIPEC operations or major abdominal surgery (PSS \> 3). Patients with acute morbidities (ASA score IV)

* ECOG 0-2
* Age ≥ 18
* Signs informed consent

Exclusion Criteria:

* Candidates to other potentially healing treatments
* Allergy to bromelains (pineapple), N-Acetylcysteine or possible cross-reactive allergy (eggs, sulphate. latex, carrots, celery, wheat...)
* Non-manageable coagulation alterations
* No possibility of intraabdominal drainage catheter
* Acute respiratory pathology (asthma, COPD), acute hepatic, cardiopathic or kidney pathology
* Allergy to any substance that might cause crossed reactivity to bromelain
* Unwillingness to participate in this clinical trial