cyrilzakka/clinical-trials huggingface dataset:
Vitamin B6 and Magnesium- A Clinical Trial on ASD Patients

To determine whether Vitamin B6 and Magnesium improve neurobehavioral status in terms of General observation, Cognitive working, Socialization, Communication and Sensory Dysfunction in patient with Autism Spectrum Disorder.


Eligibility Criteria:
Inclusion Criteria:

1. Children between 2 to 12 years of age suspected ASD assessed by DSM-5 and ADCL tool
2. Each patient will be free of psychoactive medication for atleast 3 months prior to the entry into the trial
3. Newly diagnosed patient
4. Co-morbid neurological disorder like hyperactivity

Exclusion Criteria:

1. Patients with chronic diseases or any known metabolic or hormonal diseases
2. Patients with any known chromosomal or genetic syndromes
3. Patients unable to give informed consent
4. Patients unable to travel to clinical visits or non co-operative
Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty

The investigator's study aims to see if an enhanced recovery regimen of pain medications before and during surgery will decrease the use and risk of opioid pain medications as well as improve pain control in anterior urethroplasty patients. Participants will be randomized to one of two pain regimens (enhanced recovery regimen vs standard regimen).

The purpose of this study is to assess the difference in narcotics usage between two different pain management protocols after urethroplasty. Management at the current time varies between giving intraoperative painkillers along with peripheral nerve blocks in some patients, while others do not receive this protocol. In this study, one group will continue the historical standard of care of the hospital, receiving postoperative nonsteroidal anti-inflammatory drugs (NSAIDs) and narcotics for pain control. The other group will utilize a protocol to lower narcotics usage, including acetaminophen, gabapentin, Celebrex, and local anesthetic (bupivacaine) in an attempt to reduce the usage of narcotics postoperatively. Given the heightened concern over narcotic usage by postoperative patients, including the risk of chronic usage by even young patients, the objective will be to assess if using this protocol as a new standard can limit the need for postoperative narcotics prescriptions.

In related urological procedures, bupivacaine injections given before surgeries have been shown to significantly lower pain scores after surgery for patients undergoing penile prosthesis. The University of Alabama at Birmingham has also been using an Enhanced Recovery After Surgery (ERAS) protocol, a multimodal presurgical care pathway designed to achieve early recovery after surgical procedures, for cystectomy and seen reduced narcotic usage among those patients.

This study would potentially help determine a new pain management protocol for urology patients undergoing anterior urethroplasty that is both more effective and less risky.

Eligibility Criteria:
Inclusion Criteria:

* Men greater than 18 years of age who are scheduled for anterior urethroplasty surgery

Exclusion Criteria:

* Any patient not classified as a II or III on the American Society of Anesthesiologists (ASA) physical status classification system.
* General anesthesia or neuraxial anesthesia with epidural used as anesthetic techniques
* Allergy/intolerance to local anesthetic or steroids
* Pre-existing neurological and/or anatomical deficit that would preclude regional block
* Coexisting coagulopathy such as hemophilia or von Willebrand Disease
* BMI greater than 40 or less then 20
* History of intravenous drug or opioid abuse
* History of opioid use within a week prior to urethroplasty
* History of any chronic pain syndrome
* Posterior urethroplasty
* Patients with chronic kidney disease
* Patients allergic to NSAIDs
* Patients requiring more than one buccal graft harvest
* Patients with graft urethroplasty with site other than buccal
* Patients with a history of previous urethroplasty
Faith-Based Initiative to Promote Health in Appalachia

The project will target two behavioral causes of obesity: a sedentary lifestyle and an unhealthy diet. The goal is to test a faith-based intervention among men and women who are members of participating Appalachian churches.

The primary hypothesis being tested in this project is: The change in body mass index from baseline to one year follow-up in intervention churches will be greater than among comparison churches, such that the differential change will be negative on average.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Member of the participating church who has attended services at least 4 times in the past 2 months
* resident of an Appalachia county
* Able bodied (no contraindications to physical activity and no dietary restrictions that are part of a medically prescribed diet for weight loss or formal weight loss program)
* Able to read and write in English
* Have a BMI indicating that they are overweight (BMI \> or = 25.0, assessed during biometric measurement)
* Under 400 pounds (per self-report and confirmed during biometric measurement)
* Not planning to move out of the area within the next year
* Does not reside in nursing facility or residential home
* If female, is not pregnant, breastfeeding or less than 9 months post-partum and does not intend to become pregnant during the study
* Able to provide informed consent.

Exclusion Criteria:

* Does not meet Inclusion criteria
Comparison of Biphasic Insulin Aspart 30 Individually Adjusted by the Subject and the Trial Physician, Both Combined With Metformin in Subjects With Type 2 Diabetes

This trial was conducted in Asia, Europe and South America. The aim of this trial was to confirm efficacy of subject driven titration (individually adjusted) of biphasic insulin aspart 30 (BIAsp 30) twice daily in terms of glycaemic control assessed by change in glycosylated haemoglobin (HbA1c).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes for a minimum of 12 months prior to Visit 1 (screening)
* Currently treated with a basal insulin analogue for at least 3 months prior to Visit 1 (screening)
* Stable treatment (no change in dose or regimen) with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) ± additional OAD treatment. The metformin treatment must have been stable for at least 2 months prior to Visit 1 (screening)
* HbA1c higher or equal to 7.0% and below or equal to 10.0% (one re-test within one week of screening visit was allowed. The last sample was to be conclusive)
* Body Mass Index (BMI) below or equal to 40.0 kg/m\^2
* Able and willing to eat at least 2 main meals each day during the trial
* Able and willing to adhere to the protocol including compliance with performance of self measured plasma glucose (SMPG), injection regimen and titrating themselves according to the protocol
* Experience in performing self measured plasma glucose (SMPG)

Exclusion Criteria:

* Treatment with any thiazolidinedione (TZD) and glucagon-like peptide-1 (GLP-1) receptor agonists or pramlintide within the last 3 months prior to Visit 1 (screening)
* Impaired hepatic function defined as alanine aminotransferase (ALAT) above or equal to 2.5 times upper referenced limit (one re-test within one week of screening visit was allowed. The last sample was to be conclusive)
* Impaired kidney function with serum creatinine above or equal to 133 micromol/L (1.5 mg/dL) for males and above or equal to 124 micromol/L (1.4 mg/dL) for females (one re-test within one week of screening visit was allowed. The last sample was to be conclusive)
* Cardiac problems or uncontrolled treated/untreated severe hypertension (defined as systolic blood pressure higher or equal to 180 mmHg and/or diastolic blood pressure higher or equal to 100 mmHg)
* Previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations) or bolus insulin. Previous use of pre-mixed or bolus insulin products was allowed only in case of hospitalisation or a severe condition requiring intermittent use of pre-mixed or bolus insulin products for less than 14 consecutive days, but not during the last 3 months prior to screening visit (Visit 1)
3D Printing for Pre-Surgical Planning

3D printing is emerging as a new diagnostic tool for pre-surgical planning. 3D printed models are extremely advantageous to surgeons in their preoperative planning. Handling these physical replicas engages active spatial perception skills, enabling a more comprehensive understanding of the presented information in an inherently intuitive manner that cannot be achieved with conventional methods of imaging review that use screen based 2D and volume rendered representations. The investigators are developing a novel technique to create 3D models derived directly from extremely high-resolution medical images that are superior in spatial and contrast resolution to current 3D modelling methods. This produces patient specific models that contain previously unachievable special fidelity and soft tissue differentiation.

Investigators hypothesize that the preoperative use of these new diagnostic quality models will reduce surgical time and improve post-surgical outcomes in the near future. This prospective project will optimize the quality of these 3D models to create highly useful pre-surgical models. Investigators will target those subspecialist areas of the multidisciplinary surgical and imaging team where it is believed these models will have the most impact. The proposed prospective study has two major goals: 1) Investigate the use of uncompressed, ultrahigh resolution CT/MR datasets to produce diagnostic 3D models with identical spatial/contrast resolution to the acquired datasets in the target areas of congenital cardiothoracic surgery, neurosurgical tumor resection and nephrectomy. 2) Compare the accuracy of this innovative method for 3D printing to radiological images and pathological data when available.

The tangible outcome of this research will be measured in a comparative study. The investigators will compare the 3D printed models, resulting from the development of this iterative process of generating models from ultra-high resolution medical images and review by all parties, to radiological images and pathological data. The study team will employ non-biased methods to quantify the results of this comparative study. There will be no randomization and all subjects will receive the same treatments and all outcomes are data focused. Models will not be used for patient treatment and will be used only as to aid preparation and will not be used as a therapeutic device. For this reason, the study team will not prospectively consent subjects.

Eligibility Criteria:
Inclusion Criteria:

* - Patients seen at UCHealth/CHCO and NOC sites between 6/1/2021 - 6/1/2026
* Pregnant women and their fetuses

Exclusion Criteria:

* - Patients 65 and older
Diacerein on Insulin Secretion in Diabetes

Aim. To assess the effect of interleukin 1β (IL-1β) and tumor necrosis factor α (TNFα) inhibition with diacerein administration on insulin secretion and metabolic control of drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity.

Hypothesis. Diacerein administration improves insulin secretion and metabolic control of drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity.

Materials and methods. Design: Randomized, double-blind, placebo-controlled clinical trial. Population: 40 drug-naïve adult patients with T2DM and overweight or obesity. Measurements: A metabolic profile including IL-1β, TNFα, interleukin 6, and fasting insulin levels, as well as, hyperglycemic-hyperinsulinemic clamp technique; to assess the phases of insulin secretion and insulin sensitivity. Intervention for 2 mo: diacerein (50 mg once daily) for the first 15 days and twice daily for 45 additional days or placebo. Statistical analyses: Wilcoxon signed rank and Mann-Whitney U test.


Eligibility Criteria:
Inclusion Criteria:

* Fasting glucose levels between 7.0 and 11.1 mmol/L
* A1C levels between 7 and 9%
* Same residential area and socioeconomic status
* Excessively sedentary or participated in heavy physical activity
* Nonsmokers
* Body weight was stable for at least 3 months before the study
* Blood pressure was \<130/80 mm Hg

Exclusion Criteria:

* Personal history of hepatic, renal or coronary artery disease
* Medications known to affect metabolism during the previous 6 months.
Complete Decongestive Therapy in Breast Cancer-Related Lymphedema

The purpose of this study is to investigate which number of lymphedema therapy treatments/week best reduces upper extremity swelling, increased arm function, and reduces the most lymphedema symptoms.

Complete Decongestive Therapy (CDT) is the "gold standard" in lymphedema care and has been found to be efficacious in numerous studies. These studies have varying treatment protocols of intensive phase I CDT with dosing ranging from 2x/wk for a mean of 7.5 wks to 6x/wk until a plateau in arm volumes were achieved. This variability in research does not lend itself to recommendations of evidence-based protocol use of CDT in an outpatient setting.

Although CDT is backed by efficacy studies, the daily dosing given to patients is based on anecdotal rather than evidence-based practice. Because the traditional protocol was developed from "longstanding experience," research is necessary to determine the best dosing of the intensive phase of CDT. The purpose of this study is to investigate what level of dosing in the intensive CDT phase promotes best volume reduction and increased upper extremity function in the breast cancer-related lymphedema patient population. This particular study will answer: What dosing produces best volumetric reduction and upper extremity function in the intensive phase of complete decongestive therapy for outpatients with breast cancer-related lymphedema 2x/wk for 4wks or 4x/wk for 4 wks?

Eligibility Criteria:
Inclusion Criteria:

1. Have active unilateral breast cancer-related lymphedema
2. Medically stable
3. Have not participated in lymphedema therapy the past 3 months
4. An affected limb volume measurement of \>10% excess volume
5. Ages 18-95 years old

   * Patients undergoing any medical treatment for their breast cancer diagnosis will be included in this study.
   * Patients with any stage breast cancer will be included in this study.
   * Patients with a prior diagnosis of breast cancer, other cancer will be included in this study. There is no minimum time requirement that has prolapsed between their diagnosis and this study.

All subjects must have given signed, informed consent prior to registration on study.

Exclusion Criteria:

1. Prophylactic treatment indicated
2. A presence of upper extremity wounds present
3. Active signs of infection or deep vein thrombosis (DVT)
4. Bilateral lymphedema present
5. Evidence of contraindications to CDT: uncontrolled hypertension, heart disease including congestive heart failure, and renal insufficiency
6. Severe lymphedema present as defined by \> 30% increase in limb volume
Wiser Choices in Osteoporosis Choice II: A Decision Aid for Patients and Clinicians

Emphasis in treating osteoporosis has been on T-scores rather than overall fracture risk. Fracture Risk Assessment Tool (FRAX) supports a risk sensitive approach to osteoporosis treatment by providing an absolute fracture risk. FRAX combined with a decision aid may promote a shared decision making approach with patients, allowing the clinician and patient to weigh potential fracture risk (without treatment), versus risk reduction with medication (including side effects and costs). OSTEOPOROSIS CHOICE II will test the effectiveness of:

* FRAX
* FRAX + decision aid
* Usual care (no decision aid and no FRAX given to clinician)


Eligibility Criteria:
Inclusion Criteria:

* Peri and Postmenopausal Caucasian, Black, Hispanic and Asian women, aged 50-90
* Bone mineral density (BMD) T-Score \< 1.0
* Have appointment with clinician to discuss test results and treatment options
* Patients with FRAX \<20% risk who have taken a bisphosphonate for \< 5 years.

Exclusion Criteria:

* Unable to speak or read English
Efficacy and Safety of Runzao Zhiyang Capsule to Treat Chronic Eczema

The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in treating chronic eczema.

Polygoni multiflori Preparata, dried rehmannia root, mulberry leaf, sophora flavescens, Honghuoma, for skin itching, acne, constipation due to blood vacuity and wind-dryness, also used in clinical treatment of eczema.

The purpose of this study is to evaluate the efficacy and safety of Runzao zhiyang capsule in treating chronic eczema.

Eligibility Criteria:
Inclusion Criteria:

* Consistent with diagnostic criteria for chronic eczema(Referring to "the Chinese eczema diagnosis and treatment guidelines" in 2011);
* Investigator Global Assessment (IGA) score was 2 or 3;
* The skin lesions were localized, hypertrophy and dry, and the affected skin area was 3%\~10% of body surface area (estimated by palm method); the diameter of target lesions was 2\~10cm and located in the limbs or trunk.
* The course of chronic eczema is more than 6 months;
* Age 18 to 70, males or females;
* The Subjects obtain informed consent, participated the trial voluntarily. Procedure to obtain informed consent is in accordance with the provisions of Good Clinical Practise(GCP).

Exclusion Criteria:

* Subjects with acute eczema, subacute eczema, universal eczema, special type of eczema;
* Subjects used corticosteroids, immunosuppressive agents and ultraviolet irradiation in 4 weeks prior to the enrollment;
* Subjects were treated with antihistamine and topical drugs in 2 weeks;
* Women in Pregnancy, Lactation, or Planned pregnancy during the test;
* Comorbid with severe primary heart, liver, lung, kidney, blood disease, diabetes, thyroid disease or a serious disease affecting survival, such as cancer or HIV / AIDS;
* Subjects were allergic to test drug ingredients;
* Subjects could not give full informed consent because of mental and behavioral disorders;
* Suspected or identified with a history of alcohol or drug abuse;
* Have other diseases or conditions which may reduce the possibility of enrollment or complicate the recruiting process based on the investigator judgment. For example, working environment changed frequently led to easily lost follow-up;
* Have been or currently enrolled in other clinical trials within 3 months.
Reducing INfection at the Surgical SitE With Antibiotic Irrigation During Ventral Hernia Repair (RINSE Trial)

This is a study to determine if the incidence of infection at the Surgical SitE is impacted if with Antibiotic Irrigation is used during Ventral Hernia Repair (RINSE Trial)

Surgical site infection (SSI) is common after open ventral hernia repair. Numerous factors contribute, including patient comorbidities, operative technique, and degree of contamination of the case. SSI often requires prolonged hospital length of stay (LOS), readmission, or other procedural intervention. One potential intervention to reduce SSI is the use of antibiotic irrigation, which has been shown to reduce SSI in colorectal surgery in a recent randomized control trial. We retrospectively evaluated our use of dual antibiotic irrigation at the time of mesh placement during open ventral hernia repair (OVHR), demonstrating a significant reduction in SSI (16.5 vs 5.4%) using a combination of gentamicin and clindamycin irrigation when compared to saline alone.

We plan to complete a registry-based, randomized clinical trial (RCT) through the Americas Hernia Society Quality Collaborative (AHSQC) to further assess the impact of dual antibiotic irrigation on SSI after OVHR with mesh. This will include patients undergoing open retromuscular (RM) repair with or without transversus abdominis myofascial advancement flap (TAR) with placement of permanent synthetic mesh (mid-weight, large-pore polypropylene). Power analysis based on only this subset of patients from our initial study indicates a total of 210 patients are needed to demonstrate a significant reduction in SSI using antibiotic irrigation vs saline irrigation alone.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 y/o.
* Elective, open ventral hernia repair in a retromuscular fashion, with or without TAR.
* Clean, clean-contaminated, or contaminated wounds.

Exclusion Criteria:

* Age \<18 y/o.
* Pregnancy.
* Emergency hernia repair.
* Laparoscopic, robotic, or hybrid approach.
* Dirty wounds.
* Use of biologic or absorbable synthetic mesh.
* Onlay, intraperitoneal or preperitoneal mesh placement.
KAP for Use of SDF Among Dental Interns Before vs After Educational Intervention

This study is a KAP questionnaire to assess Egyptian intern dentists' knowledge, attitudes and practices regarding use of SDF before and after an educational intervention.

The questionnaires will be distributed and filled out under the supervision of the primary investigator.

Each intern will be allowed to fill out the questionnaire. An educational lecture about SDF will follow. The questionnaires will be distributed and filled under the supervision of the primary investigator again.

Eligibility Criteria:
Inclusion Criteria:

Dental Interns who are enrolled in the pediatric dental department, Faculty of Dentistry, Cairo University who are willing to participate.

Exclusion Criteria:

Dental Interns who are enrolled in the pediatric dental department , Faculty of Dentistry, Cairo University who are unwilling to participate.
Hydratation Status at Initiation of Peritoneal Dialysis: Study of the Role of Peritoneal Permeability

Bioimpedance is recently known to be a reliable, reproducible and validated technic allowing determination of hydratation status in patients with chronic kidney disease treated with peritoneal dialysis (PD). Overhydratation attested by bioimpedance is strongly associated with cardio-vascular morbidity and mortality in patients with PD. Overhydratation might concern more than half of patients at PD initiation, though the underlying mechanism remains unknown.

High peritoneal permeability (HPP) might concern about a third of patients starting a PD, although only a few datas are published on this condition. HPP at initiation of PD is associated with a decrease in both technical and patient survival and might be responsible of ultrafiltration failure. The underlying mechanisms of HPP at initiation of PD also remains unknown.

To our knowledge, the correlation between hydratation status and peritoneal permeability at initiation of peritoneal dialysis remains unknown. Moreover, there is no datas concerning the cinetic evolution of peritoneal permeability; demographic or biologic factors associated with HPP in days and months following PD start.

The aim of the present study is to correlate hydratation status (attested by bioimpedance) and peritoneal permeability at early start of peritoneal dialysis. Thus, we investigated early cinetic of peritoneal permeability at different time point during the first year of peritoneal dialysis and we analyzed the demographical and biological factors associated with HPP and overhydratation during this period.

This study is a prospective, multicentric cohort study. Fourty patients recruited in a two years' period in five centers of nephrology will be included. Hydratation status will be determined with Fluid Overload measurement by bioimpedance technic thanks to BCM system (Fresenius Medical Care®). Peritoneal permeability will be determined by modified Peritoneal Equilibration Test with complete drainage at sixty minutes. Datas will prospectively be collected, including: weight, blood pressure, diuretic posology, diuresis, PD modality, dialysate prescribed.


Eligibility Criteria:
Inclusion criteria:

* End stage chronic kidney disease
* Ambulatory
* Starting a peritoneal dialysis in one of the participant centers
* Accepting the study protocol
* Age \> 18yo

Exclusion criteria:

* Age \<18yo
* Protected by the law