cyrilzakka/clinical-trials huggingface dataset:
Comparative Effectiveness Of Low Extra-Corporeal Shock Wave Versus Acetylcholine Iontophoresis On Type2 Diabetic Neuropathy

In our thesis, we will compare the effectiveness of low-intensity shock wave versus acetylcholine iontophoresis as a possible new therapy for microcirculation changes in type 2 diabetic neuropathy

Methods: A group of 80 patients (male and female) diagnosed with type 2 diabetes mellitus, was included in the study. Their age ranged from 40-60 years. Patients randomly will be divided into two groups: Study groups (A) 40 patients with type 2 diabetes mellitus with clinically proven peripheral neuropathy. And study group (B) 40 patients with type 2 diabetes mellitus with clinically proven peripheral neuropathy. They were selected from South Valley University Hospitals. Group A received low-intensity extracorporeal shock wave therapy Li-ESWT (3 Hz, 0.09 mJ/mm2, 300 pulses), for two sessions per week for six weeks. Study group (B) received iontophoresis by acetylcholine current intensity of 3 to 5 mA. Check skin every 3-5 minutes for signs of skin irritation with (15) min for three sessions per week for four weeks. Nitric oxide level and the electrophysiology (EMG) of peripheral nerves and muscles were measured pre and post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients have to be symptomatically stable with type 2 diabetes mellitus complicated with peripheral neuropathy.
* Optimized pharmacological treatment that will be remained unchanged throughout the study.

Exclusion Criteria:

* Implanted cardiac pacemakers.
* Patients with known skin allergies.
* Presence of skin inflammations.
* Peripheral vascular disease.
* Patients with unstable angina pectoris.
* Progressive ventricular dysrhythmia.
* Intermittent claudication.
Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety

Protocols for Oral Immunotherapy (OIT) for the main food allergens have been recently incorporated in clinical practice for food allergies and their clinical benefits have been acknowledged in European and Canadian official guidelines. There has been some reluctance in both clinicians and patients to implement these therapies, primarily because of the risk of allergic reactions during the desensitization process. This study will investigate if protocols using low doses of a food allergen or processed versions of the allergen can be both effective in conferring desensitization while inducing fewer allergic symptoms during the desensitization process.


Eligibility Criteria:
Inclusion Criteria:

* A history suggestive of immediate allergy to the food. A convincing clinical history of an IgE mediated reaction to a specific food will be defined as a minimum of 2 mild signs/symptoms or 1 moderate or 1 severe sign/symptom that was likely IgE mediated and occurred within 120 minutes after ingestion or contact
* The presence of at least one of the following confirmatory tests:

  * Positive SPT to the culprit food allergen (weal diameter 3 mm larger than that of the normal saline control). The allergens used will be commercial extracts of the foods (Omega Labs, Toronto, Ontario).
  * Detection of serum specific IgE (\>0.35 kU/L) to the culprit food or any of its proteins, measured by fluorescence enzyme immunoassay (Phadia, CAP System, Uppsala, Sweden).

Exclusion Criteria:

* Patients who have uncontrolled respiratory disease (asthma, cystic fibrosis, etc.)
* Patients who present with intercurrent disease active at the time of starting desensitization.
* Non IgE mediated or non-immunological adverse reactions to milk or peanuts.
* Malignant or immunopathological diseases and/or severe primary or secondary immune deficiencies.
* Patients receiving oral immunosuppressor therapy.
* Patients receiving β-blockers (including topical formulations), or who receive daily doses of NSAIDs, aspirin or ACE inhibitors for cardiac issues.
* Associated diseases contraindicating the use of epinephrine: cardiovascular disease, severe hypertension or hypotension.
* Patients diagnosed with eosinophilic gastrointestinal disorders, including patients with a history of antacid use for reflux related to food impaction or with a history of esophageal spasm.
* Patients already tolerating processed/cooked forms of the food (e.g.,baked goods with milk).
Self-management of Low Back Pain in Horticulture Workers

The primary purpose of this hybrid Type II comparative effectiveness and implementation study is to compare two self-management strategies in nursery and landscape workers. This randomized pragmatic study will compare interventions with different degrees of support to determine if self-management videos plus multimodal personalized support is more effective than self-management videos alone for improving LBP among horticulture workers. Both groups will review short self-management video modules to introduce general pain concepts and the importance of managing pain without medication, risks of opioid use, self-management of pain, and simple ergonomic strategies for both groups. Both groups will choose 1 self-management strategy to manage pain at home and 1 ergonomic workplace strategy to limit pain. The video+support group will receive 1) check-list guidance, 2) review videos of their work tasks, and 3) receive text reminders to support implementation. Surveys will include instruments reflecting low back pain disability, pain, work ability, and affective or cognitive characteristics (self-efficacy, pain anxiety, depression, coping), collected at baseline, pre- and post-intervention, with follow-ups at 3- and 6-months. Workers will be videoed pre- and post-intervention for calculation of work risk and to compare any changes after the intervention. Specific aim 2 will identify contextual factors impacting engagement, adoption, effectiveness, and implementation. Interviews, focus groups, and field notes will be used to explain results and establish patterns to inform future translation.

Primary dependent variables will be collected at all measurement points: pain severity, interference, and persistence, pain with specific work tasks, disability, work ability, and pain medication use. Affective or cognitive characteristics potentially impacting adoption and effectiveness (secondary dependent variables or confounders) such as coping, fear, anxiety, depression, will also be collected.The post- and follow-up survey questions will also reflect adoption, opinions of interventions, effectiveness, facilitators, and barriers.

Eligibility Criteria:
Inclusion Criteria:

Workers

1. working full time (30 hours or more per week) in physically demanding nursery or landscape work
2. currently employed or self-employed in small or medium size businesses
3. 18 years of age or older
4. English or Spanish speaking
5. experiencing continuous or intermittent LBP over the past 3 months

Owners, managers, supervisors

1. Owners, managers, or supervisors who meet the same inclusion criteria as workers will be eligible to participate in the training interventions as well as the supervisory roles.
2. All owners, managers, and supervisors who are willing to participate will be enrolled.

Exclusion Criteria:

Workers

1. history of major trauma, surgery, or spinal nerve blocks in the past year
2. seeking disability or workman's compensation
3. self-disclosed pregnancy
The Efficacy and Safety of Iron Supplementation

Each year, 5 million packs of iron tablets are dispensed in England and Wales to treat anaemia due to iron deficiency. Iron tablets are not always easy to take. The investigators think that there could be ways to reduce the number of iron tablets needed, by increasing the dietary intake of iron. In this study the investigators will assess the efficacy and safety of a dietary iron supplement compared to iron tablets using controls and new biomarkers.

18 healthy individuals will be randomised to one of three arms, and for two consecutive mornings, will receive either an iron tablet (ferrous sulphate 200mg), a dietary iron supplement, or no agent.

Blood and urine samples will be collected pre-dose, and at stated intervals 2.5, 4, 7, 24 and 48 hours post first dose.

The standard deviations of data obtained in this pilot study will be used to perform power calculations for our future studies in this field.

Eligibility Criteria:
Inclusion Criteria:

To be a healthy, consenting volunteer not currently receiving iron supplements.

Exclusion Criteria:

1. Needle phobia
2. Currently receiving iron supplements
3. Unable to provide informed consent
EXPLAIN -FragilE X Registry: An exPlorative Longitudinal Study for chAracterIzation, Treatment Pathways and patieNt-related Outcomes

This prospective observational study (registry) on Fragile X syndrome (FXS) is designed to evaluate characteristics, management and patient and caregiver-related outcomes the quality of life of Families and patients with FXS and to collect epidemiological and health economic data.

* EXPLAIN will report current and comprehensive data onEpidemiology data on fragile X syndrome
* Characterisation of the phenotype of FXS patients
* Description of patient characteristics (demographics, family history, comorbidity, education, working situations, care situations, insurance status)
* Documentation of therapeutic interventions
* Recording and assessment of psychosocial parameters (possibly also inclusion of family members, carers)
* quality of life of the carer and if possible the patient
* Health economic parameters and consumption of resources


Eligibility Criteria:
Inclusion Criteria:

* Patients with FXS as confirmed by genetic testing

Exclusion Criteria:

* none
* Other protocol-defined inclusion/exclusion criteria may apply
A Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS-NF1 Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects

The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.

GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech.

GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption by Extending the Absorption Site.

To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".

Basically, this system is a triple-layered tablet, comprised of upper and lower layers that swell and draw a sufficient amount of water, plus a highly water - soluble middle layer that rapidly draw water into the tablet core simultaneously.

The water drawn into the tablet (about 3 to 4 times the weight of the tablet itself) functions as an additional media which enables additional and later drug release out of the dosage form. This serves to overcome the shortage of surrounding media that has been reported to be one of the key reasons for mal-absorption of a drug in colon.

As the middle layer induces a rapid water draw into the tablet core, the penetrated water also diffuses to the upper and lower layers, which makes the tablet to rapidly swell and controls drug release.

At virtually the same time, the swollen upper and lower layers form to surround a lateral side of the middle layer, which can, in turn, further control drug release.

This relatively rigid swollen matrix structure makes drug release not affected by surrounding mechanical flux, which can provide relatively consistent in vivo drug release irrespective of degree of gastrointestinal motility.

Eligibility Criteria:
Inclusion Criteria:

* 20\~45 years old, Healthy Adult Male Subject
* 17.5\~30.5kg/m2(BMI) and ≥ 45kg

Exclusion Criteria:

* SBP ≥ 140mmHg or DBP ≥ 90mmHg
Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening

This research study is evaluating whether contrast enhanced mammography can be used as an alternative to breast Magnetic Resonance Imaging (MRI) for cancer screening

Mammography is the main way to help find breast cancers early so they can be treated. Unfortunately, mammography does not work as well in women who have dense breast tissue or who are at high-risk for breast cancer. In these women, breast MRI is also used to help find breast cancers.

Contrast enhanced mammography is a new type of mammogram. It uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone. This is similar to breast MRI.

For this study, participants who had both CEM and MRI evaluating a finding that initiated from a screening exam will be included. Radiologists will compare the images to see if the contrast enhanced mammograms and the breast MRI find the same number of breast cancers. If the investigators find they perform similarly, then contrast mammography may be used to aid in breast cancer screening in the future.

Eligibility Criteria:
Inclusion Criteria:

* CESM and MRI exam performed within 3 months of one another.
* CESM and breast MRI exams must be performed as part of imaging work-up based on a screening exam of any type (mammography, tomosynthesis, ultrasound, and MRI)
* CESM studies will include at least four low energy and four recombined images (LCC, LMLO, RCC, RMLO).
* MRI exams will include at least fluid sensitive sequence, multi-phase T1-weighted

Exclusion Criteria:

* Imaging sets with implants.
* Imaging sets in which a biopsy or surgical intervention was performed since the most recent screening exam, prior to acquisition of the study MRI or CESM.
* Imaging sets in which a biopsy was recommended, but biopsy was not performed and 2 year imaging follow-up is not available
Tablet-based Interactive Distraction Preoperative Anxiety in Children: A Randomized Controlled Trial

Children develop anxiety during the induction of anaesthesia and video-games might reduce or alleviate it. The investigators intend to conduct a clinical trial to study the effect of tablet-based interctive games on alleviating preoperative anxiety.

It is estimated that 50% of children may suffer preoperative anxiety. They have a higher risk of generating postanesthetic delirium and behavioral changes in the postoperative period up to 67% of cases.

For the management of preoperative anxiety there are pharmacological and non-pharmacological treatments. Within the first group there's the use of benzodiazepines of short half life like midazolam, however, the use of this medication is not exempt of risks such as paradox reactions, respiratory depression, among others. This is why the non pharmacological mesures have taken force and every day there is more evidence regarding its effectiveness.

There are no reports in Chile or latin america regarding the use of this tools, this is why the investigators designed this study to prove the effectiveness of audiovisual distraction measures in reducing preparatory anxiety compared to premeditation with midazolam.

Eligibility Criteria:
Inclusion Criteria:

Children aged 2-10 years, under major surgery ambulatory program at Hospital Carlos Van Buren, with no contraindication for the use of midazolam.

Exclusion Criteria:

Patients with cognitive impairment or sensory deficit Patients with previous history of major surgery will also be excluded Patients with myastenia "Hard airway" History of paroxystic reaction to benzodiazepines Attentional deficit hyperactivity disorder Sleep aphnea Full stomach Adenotonsillar hypertrophy Respiratory acute infections
A Multi-Site Study to Evaluate the Safety and Effect of Study Drug on Participants With Rheumatoid Arthritis

This study is a multicenter, double-blind, study to evaluate the safety and effectiveness of treatment with LY2127399 (in addition to the standard of care treatment, methotrexate) for participants with Rheumatoid Arthritis. Participants will receive three intravenous doses of LY2127399 or placebo. Participants will participate in 10 or more visits to the study site, over 6 months. Evaluation of safety and efficacy will be conducted throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of 18 and 75 years
* Have given written informed consent approval
* Women must not be at risk to become pregnant during study participation
* Diagnosis of Rheumatoid Arthritis according to the 1987 revised American Rheumatism Association (ARA) criteria for the classification of RA
* Serum C-reactive protein (CRP) measurement greater than the upper limit of normal (ULN, 0.574 mg/dL), or erythrocyte sedimentation rate (ESR) ≥28 mm/hr
* Current, regular use of Methotrexate, at a stable dose
* Biologic DMARD naïve, and have had an insufficient response (in the opinion of the investigator) to an adequate therapeutic dose of at least 1 oral DMARD

Exclusion Criteria:

* Use of excluded medications (reviewed by study doctor)
* Surgical treatment of a joint with 2 months of study enrollment that is to be assessed in the study
* Are unable to ambulate; that is, confined to bed or wheelchair bound
* Have medical findings which, in the opinion of the study doctor, put participant at an unacceptable risk for participation in the study
* Have had recent or ongoing infection which, in the opinion of the study doctor put participant at an unacceptable risk for participation.
Safety and Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma

The purpose of this study was to evaluate the safety and intraocular pressure (IOP)-lowering efficacy of anecortave acetate for treatment of elevated IOP in patients with open-angle glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of open-angle glaucoma;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Pseudoexfoliation;
* Pigment dispersion component;
* Other protocol-defined exclusion criteria may apply.
A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator

This is a Phase 2 clinical trial in adult hypogonadal males with baseline morning serum testosterone concentrations \<300 ng/dL. The purpose of this study is to evaluate the pharmacokinetics of FE 999303, delivered using an applicator in comparison to hand application


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-75
* History of hypogonadism
* In good health based on medical history, physical examination, and clinical laboratory tests
* Serum testosterone deficiency
* One or more symptom(s) of testosterone deficiency (i.e. fatigue, reduced libido, or reduced sexual functioning)
* Body mass index (BMI) between 18 and 35 kg/m\^2
* All screening lab tests within 20% of the normal range (exceptions are liver function tests)
* HIV, Hepatitis B and C negative

Exclusion Criteria:

* Previous use of FE 999303
* Prostate cancer
* Breast carcinoma, patient or partner
* Palpable prostatic mass(es)
* Serum PSA levels ≥3 ng/dL
* Chronic use of any drug of abuse
* Lower urinary tract obstruction
* Clinically significant anemia or renal dysfunction
* Cardiovascular disease
* Hyperparathyroidism or uncontrolled diabetes
* Generalized skin irritation or significant skin disease
* Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone (DHEA)) or could interfere with androgen metabolism (e.g. spironolactone, 5-alfa-reductase-inhibitors, ketoconazole, abiraterone)
* Use of estrogens, GnRH agonists/antagonist, antiandrogens, human GH (within previous 12 months of screening)
* Use of testosterone products (within 8 weeks of screening for parenteral products, or 6 weeks of screening for other preparations)
* Sleep apnea
* Untreated depression
* Subject with a partner who is pregnant or will not use contraception
VideoEndoscopic Radical Inguinal Lymphadenectomy for Penile Cancer

Assess the feasibility of performing a RCT comparing videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in men diagnosed with genital cancer requiring inguinal lymphadenectomy, and determine the design of such an RCT.

There is increasing interest in using videoendoscopic inguinal lymph node dissection (ILND) as an alternative to open ILND. Videoendoscopic inguinal lymphadenectomy (VEIL) may decrease complications compared to open ILND and provide equivalent short-term oncological outcomes.

As yet, there have been no randomised-controlled trials (RCTs) comparing these procedures.

VELRAD aims to assess the feasibility of performing a RCT comparing VEIL and open ILND. This will be measured by recruitment rate, the acceptability of the trial design and intervention to clinical stage and patients. Investigators will also collect qualitative data on why patients did or did not agree to be randomised

Eligibility Criteria:
Inclusion Criteria:

1. People requiring inguinal lymphadenectomy i.e.

   1. Patients with squamous cell carcinoma or mucosal melanoma of the penis \> T1bG2 or patients with male genital cancer requiring inguinal lymphadenectomy
   2. Patients unsuitable for dynamic sentinel node biopsy (DSNB) with impalpable nodes: previous penectomy or non-visualisation at previous DSNB
   3. Previous DSNB with metastatic inguinal nodes on histology or FNA positive nodes on cytology who require a completion radical inguinal lymphadenectomy
   4. Small volume palpable inguinal lymph nodes (\< 2 cm on CT) not fixed to skin
2. Age \> 18 years

Exclusion Criteria:

1. Unfit for surgery
2. People unlikely to benefit from lymphadenectomy because of advanced cancer
3. Those with palpable inguinal lymph nodes fixed to skin or adjacent structures
4. Does not want to participate in the trial or unable to provide informed consent