cyrilzakka/clinical-trials huggingface dataset:
InterFlex Plate Versus Conventional Miniplates in the Management of Anterior Mandibular Fractures.

the study aims to compare InterFlex plate with conventional miniplates in management of symphyseal mandibular fracture clinically regarding pain, wound healing and postoperative occlusion, and radiographically regrading bone density.

A total of 18 patients with recent symphyseal mandibular fractures were allocated into two groups. Group A, comprising 9 patients, underwent treatment with the InterFlex plate, while Group B, also consisting of 9 patients, was treated with conventional two miniplates. Clinical evaluations were carried at multiple intervals up to 12 weeks postoperatively, with radiographic assessments performed immediately after surgery and at 12 weeks to measure mean bone density at the fracture line.

Eligibility Criteria:
Inclusion Criteria:

* patients with recent anterior mandibular fracture located between the mental foramina.
* adults without gender predilection who agreed to follow-up,
* fractures requiring open reduction and internal fixation, and
* those medically fit for general anesthesia were included

Exclusion Criteria:

* medically compromised patients,
* fractures with infection,
* pathological or old fractures,
* completely edentulous patients,
* comminuted fractures
Pecs II Block as Alternative for Paravertebral Block in Modified Radical Mastectomy

Breast surgeries are usually associated with significant postoperative pain. Suitability of analgesic technique after breast surgery is always questionable. The aim of this study is to compare US guided Pecs II block versus thoracic paravertebral block performed by US guidance as regards to potential complications and analgesic efficacy of both techniques in the first 24 h after modified radical mastectomy.

Various modalities have been used for perioperative pain management in relevance to breast surgery. Thoracic epidural and paravertebral blocks (PVB) became the gold standard techniques to achieve this goal. However, both techniques may be associated with devastating complications such as spinal cord injury, total spinal anesthesia, inadvertent intravascular injection and pneumothorax.

On the other hand, the advancement of ultrasound (US) technology and our ability to visualize the pleura and other structures in and around the paravertebral space has increased interest in performing thoracic paravertebral blocks guided by US.

"Pecs" block is a less invasive procedure involving US guided interfascial injections has been suggested as potential alternative analgesic technique. The Pecs I block was initially described by Blanco for minor breast surgery. A year later, on 2012, he described a Pecs II block or "modified Pecs block" for breast surgery involving the axilla.

The Pecs I block targets the medial pectoral nerve (MPN) from C8 and T1 and the lateral pectoral nerve (LPN) from C5, C6, and C7. These nerves arise from the medial and lateral cords of the brachial plexus, respectively, and innervate the pectoralis muscles.

The Pecs II block targets the T2-6 intercostal nerves, the long thoracic nerve which supplies the serratus anterior, and the thoracodorsal nerve which supplies the latissimus dorsi. Potential complications include accidental intravascular injection and pneumothorax.

The easily identifiable landmarks allow this block to provide a simple alternative to paravertebral and neuraxial blocks for breast surgery. The block produces excellent analgesia and can be used as a rescue block in cases with patchy or ineffective paravertebral or epidural block.

Eligibility Criteria:
Inclusion Criteria:

* American Association for Anesthesiologists physical status I or II
* Body mass index \> 40 kg/m2

Exclusion Criteria:

* Patient refusal
* Severe or uncompensated cardiovascular disease.
* Significant renal disease.
* Significant hepatic disease.
* Significant endocrinal disease.
* Pregnancy.
* Postpartum period.
* Lactating females.
* Allergy to any of the study medication.
* Coagulation disorders.
* Infection at the site of needle insertion.
Examining the Impact of a Mobile Nutrition Education App for Child Nutrition Education in Canada

This trial will test the hypothesis that a digital curriculum-based nutrition education intervention using the Foodbot Factory serious game (i.e., a game designed for learning) leads to greater student engagement and learning about nutrition, compared to conventional nutrition education (e.g., worksheets), among students in Grades 4 and 5 in Ontario, Canada. This hypothesis is based on existing research suggesting that digital serious games, when well-integrated into the classroom setting, promote greater student engagement, learning and knowledge retention.

This two-arm parallel cluster randomized controlled efficacy trial will determine if a digital curriculum-based nutrition education intervention (intervention group) leads to greater increases in overall nutrition knowledge compared to conventional nutrition education (control group) in Grade 4 and 4/5 classrooms after 1 week, and that it facilitates greater retention at 4 weeks and 3 months following the intervention period. Secondary outcomes include sub-scores of nutrition knowledge (i.e., knowledge of specific food groupings), nutrition attitudes, general child nutrition behaviours and dietary intakes. Due to the enhanced engagement serious games can provide, it is hypothesized that participants in the intervention group will show greater changes in and retention of their nutrition knowledge and nutrition behaviours. Twenty-eight Grade 4 and 4/5 classrooms in Ontario, Canada will be randomized to the intervention or control group. Participants in both groups will receive nutrition education lessons for 35-40 minutes a day for five consecutive days. Participants in the intervention group will use the Foodbot Factory serious game while participants in the control group will use conventional learning materials (e.g., worksheets, teacher-led instruction). Both interventions will have these learning materials integrated into standardized nutrition education lesson plans. Overall and sub-scores of nutrition knowledge, and nutrition attitudes will be assessed using the Nutrition Attitudes and Knowledge questionnaire. General child nutrition behaviours (e.g., frequency of eating meals outside the home) will be assessed using a modified version of the Family Nutrition and Physical Activity Screening Tool and dietary intake will be assessed using the Block Food Screener for Ages 2-17. At baseline, parents and classroom teachers will respectively complete demographic questionnaires to measure co-variates that may impact outcomes of interest (e.g., household food security, presence of school food programs).

Eligibility Criteria:
Inclusion Criteria:

* Grade 4 or 4/5 classroom
* Classroom is located in a participating school board in Ontario

Exclusion Criteria:

* Classroom has already covered the "Healthy Eating" component of the Ontario Physical Health Education curriculum
Imatinib Mesylate and Mycophenolate Mofetil for Steroid-Refractory Sclerotic/Fibrotic cGVHD in Children

In this study we will combine mycophenolate mofetil and imatinib mesylate to treat steroid-refractory sclerotic/fibrotic type chronic graft-versus-host disease (GVHD) to see the response rate and to find the safety of combination.

Sclerotic/fibrotic type chronic GVHD is one of the most severe forms of the disease and is frequently refractory to standard treatment approaches. Imatinib mesylate, a tyrosine kinase inhibitor, has been shown to be effective in patients with sclerotic/fibrotic type chronic GVHD by strongly inhibiting both PDGF (Platelet-derived growth factor) and TGF-β (transforming growth factor-β) intracellular signaling, which is responsible for the expression of extracellular matrix genes.

Mycophenolate mofetil (MMF) is one of effective agent for the treatment of chronic graft-versus-host disease. MMF is rapidly absorbed after oral administration and hydrolyzed to the active metabolite, MPA (mycophenolic acid). MPA selectively inhibits inosine monophosphate dehydrogenase, blocking the pathway of purine synthesis in T and B lymphocytes. In this study we will combine MMF and imatinib mesylate to treat steroid-refractory sclerotic/fibrotic type chronic GVHD to see the response rate and to find the safety of combination.

Eligibility Criteria:
Inclusion criteria

* Patients must have a diagnosis of chronic GVHD with fibrotic/scleroderma-like features. This diagnosis can be made clinically or by histopathology.
* Patients must have active disease with at least one of the following manifestations: skin sclerosis, symptomatic bronchiolitis obliterans, extensive lung fibrosis, pathologically demonstrated visceral fibrotic involvement of the gut.
* Patients with corticosteroid refractory or dependant cGVHD are eligible. Steroid-refractory chronic GVHD is defined as chronic GVHD of sustained severity during the last full month during which the patients received the equivalent of prednisone 0.5 mg/kg or more per day or 1 mg/kg or more every other day.
* Age under 21 years old

Exclusion criteria

* Patients who have had chemotherapy, radiotherapy within 4 weeks prior to entering the study.
* Patients who have not recovered from adverse events.
* Prior treatment with imatinib mesylate or other tyrosine kinase inhibitor after the date of transplant.
* Patients on pregnancy or lactating
Clinical Evaluation of Composite Restorations Using Two-steps Universal Adhesive in Non-carious Cervical Lesion (NCCL)

The goal of this clinical study is to compare the clinical performance of a new 2-steps universal adhesive in patients with non-carious cervical lesions. The main question it aims to answer is: Is there any difference in clinical performance of a new 2-steps universal adhesives bonded with different etching strategies.

Participants will have restorations using a new 2-steps universal adhesives in different etching strategies.

* etch-and-rinse
* selective enamel etching
* self-etch


Eligibility Criteria:
Inclusion Criteria:

* Available for follow-up visits
* Have at least 28 teeth/ 20 teeth under occlusion
* Have at least 3 non-carious cervical lesions without peri-apical lesion. The lesion is not nearly exposed pulp and no history of previous restoration.

Exclusion Criteria:

* Rampant / uncontrolled caries
* Advanced untreated periodontal disease
* \>2 cigarette packs/day
* Systemic or local disorders that could not undergo dental procedures
* Xerostomia
* Severe bruxism, clenching, TMD
* Pregnancy at the time of screening
* Known history of sensitivity to resin or related materials
* Fixed orthodontic appliance or planning to have orthodontic treatment within 3 years
Sensitization Study of ATx201 in Healthy Volunteers

This is a Phase I, single-site study to evaluate the sensitization potential of topically applied ATx201 GEL, 2% and 4%, along with a placebo control, in healthy human subjects.


Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Body Mass Index no less than 19.0 and no greater than 36.0 kg/m² (inclusive).
* Demonstrates a Fitzpatrick skin score of I - IV
* Female subjects must agree to use acceptable contraceptive methods from the Screening Visit through 90 days after the End of Study (EOS) Visit; or postmenopausal status with no menses for at least 1 year prior to the Screening Visit.
* Willing to refrain from excessive consumption of sodium in food or beverage 48 hours prior to Day 1 through EOS Visit.
* Willing to shower using the same non-medicated soap/cleansers, and abstain from excessive sun exposure (including tanning salons) from the Screening Visit through EOS Visit.

Exclusion Criteria:

* Reports a history of diabetes mellitus, clinically significant asthma (acceptable if no episode within 5 years prior to Day 1), or currently diagnosed with hypertension or circulatory disease.
* Reports use of any oral, nasal or topical corticosteroids, or oral or topical retinoids (other than Vitamin A at normal dietary amounts)
* Reports a significant history of allergy to soaps, lotions, emollients, ointments, creams, cosmetics, adhesives, or latex.
* Reports a history of significant skin conditions or disorders such as psoriasis, atopic dermatitis, etc.
* Reports a history of significant dermatologic cancers.
* Displays an obvious difference in skin color between upper arms or upper back or the presence of a skin anomaly
* Reports smoking or use of tobacco or nicotine delivery products within 14 days prior to Day 1 through EOS Visit.
* Presence of any clinically significant results from laboratory tests and vital signs assessments, as judged by the Investigator.
* A female who is pregnant, lactating, breastfeeding, or intends to become pregnant over the course of the study.
* Reports a history of drug or alcohol addiction or abuse within the past year.
* Reports having donated blood or plasma within 48 hours prior to Day 1 through EOS Visit.
* Subject exhibits excessive hair density on the upper arms or back such that patch adhesion could be compromised.
* Subject reports undergoing hair depilation (e.g. chemical, laser, physical) within 30 days prior to Day 1 through EOS Visit.
Comparison of 2 NovoFine® Needles on the Reflux of Insulin

This trial is conducted in Europe. This trial aims to ensure that there is no substantial clinically relevant difference between the two Novo Nordisk needles NovoFine® 6 x 0.30 mm and NovoFine® 8 x 0.30 mm on reflux of insulin back to the surface of cutis.


Eligibility Criteria:
Inclusion Criteria:

* Children/adolescents with type 1 diabetes mellitus
* Usage of NovoPen® 1.5 for at least 3 months
* Duration of insulin treatment more than 1 year
* Normal weight according to Tanner scales
* The means of the last 2 HbA1c measurements taken within the last 6 months must be less than 10.5%

Exclusion Criteria:

* Pregnancy or desire to become pregnant
* Clinical relevant peripheral neuropathy as judged by the investigators
* Pronounced lipodystrophy in accordance with investigator's evaluation
* Use of drugs that can influence the trial
* Coagulation disorders (use of anti-coagulants)
* Serious, chronic diseases, making it highly unlikely that the subject can complete the trial
Thrombophilia and Thyroid Autoimmunity in Implantation Failure and Recurrent Miscarriage

This study was designed to evaluate the incidence of both, inherited and adquired thrombophilia, and thyroid autoinmunity in unknown infertility (UI), implantation failure (IF) and recurrent miscarriage (RM). To focus on these particular disorders and to rule out another potential confounding variables, 4 particular groups of women were created. Only young women (\< 38 years old), patients whose previous preimplantation genetic screening (PGS) cycles displayed an acceptable rate of aneploidies, and women without organic uterine abnormality, autoimmune disease or endocrine disorder were included in the study.


Eligibility Criteria:
Inclusion Criteria:

1. The control group included 32 oocyte donors, 18-35 years old, white caucasian, with normal karyotype, no miscarriages, and previous healthy live born infants without pregnancy complications.
2. The UI group consisted of 31 couples with \> 1 year infertility , \< 38 years of age, normal ovarian function, normal hysterosalpingography and transvaginal ultrasound scan of the uterus and ovaries, normal karyotype in both parents, and normozoospermia.
3. The IF group included 26 couples with 3.9±1.1 IVF failures with embryo transfer of at least 2 good quality embryos. They were \< 38 years old, white caucasian, and had normal uterus by vaginal ultrasound and/or hysterosalpingography/ hysteroscopy. Moreover, endocrine disorders or autoimmune diseases were ruled out, a normal karyotype was found in both parents. The male had a sperm concentration \> 5 mill/ml.They also had a PGS cycle with ≥ 60% of normal embryos.
4. The group of women with RM (n = 30) had 3.2±1.3 (range: 2-9) previous miscarriages. They were \< 38 years old, white caucasian, with normal uterus by vaginal ultrasound and/or hysterosalpingography/ hysteroscopy. Also, no endocrine anomalies or autoimmune diseases were found, and both parents had normal karyotype. Sperm concentration was \> 5 mill/ml. Only 6 women had 2 miscarriages (20%) and the remaining 24 women at least 3. They also had a PGS cycle with ≥ 60% of normal embryos.
ASP 8825 - Study in Patients With Painful Diabetic Polyneuropathy

To demonstrate the superiority of ASP8825 over placebo and dose response in patients with painful diabetic polyneuropathy.

Three doses of ASP8825 are compared to placebo in efficacy and safety point of view in patients with painful diabetic polyneuropathy.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 20 - 79 years
* Diabetes mellitus patients with diabetic polyneuropathy who have pain symptom for 26 weeks prior to the study
* Subjects who are compliant with diary completion

Exclusion Criteria:

* Subjects who have pain from other diseases at the evaluating site
* Subjects who have nerve diseases at the evaluating site
* Subjects with foot ulcer or gangrene
Laparoscopic Assisted Pull-through Versus Other Surgical Procedures for Treatment of Hirschsprung Disease

To evaluate the outcomes of laparoscopic pull-through concerning constipation, incontinence and enterocolitis in comparison of other surgical procedures for treatment of Hirschsprung disease.

Hirschsprung,s disease (HD) is a relatively common cause of intestinal obstruction in the newborn\[1,2\], The main goal in the treatment of patients with Hirschsprung,s disease is to resect the aganglionic segment and pull down the Normo-ganglionic bowel\[3\]. With the introduction of minimally invasive surgery, classic pull-through techniques were modified and improved with laparoscopy, because of the obvious advantages of laparoscopic-assisted pull-through operations in form of reduced pain and improved cosmoses this approach has gained much popularity\[4,5\].

Eligibility Criteria:
Inclusion Criteria:

1. Age from 6months to 3 years.
2. Both sexes.
3. Classic and long segment Hirshsprung.
4. Total a ganglionic colon.
5. Hirshsprung disease with leveling colostomy

Exclusion Criteria:

1. Patients \<6 months and \>3 years.
2. Short and Ultra-short Hirshsprung.
3. Recurrent cases of Hirshsprung.
4. Other contraindication of laparoscopy
Adherence to Secondary Prevention Guidelines for Cardiovascular Risk

The present observational study aims to determine the degree of adherence to the recommendations of clinical guidelines regarding the prevention of cardiovascular complications in patients hospitalized due to a cardiovascular event.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to the cardiology, neurology, or general surgery departments
* With any of the following admission diagnoses:

Non-ST-segment elevation acute coronary syndrome (NSTEACS) ST-segment elevation acute coronary syndrome (STEACS) Stable angina Unstable angina Non-ST-segment elevation myocardial infarction (NSTEMI) ST-segment elevation myocardial infarction (STEMI) Atherothrombotic ischemic stroke Lacunar stroke Peripheral artery disease Chronic ischemia of lower limbs Vascular ulcer due to arterial cause

Exclusion Criteria:

* Patients for whom lipid-lowering treatment is ruled out due to limited life expectancy
* Patients likely to die during hospitalization
* Patients who died during hospitalization
Point of Care Test to Diagnosed Colorectal Cancer and Polyps in Low Middle Income Countries

This is a-two phase study. Phase 1 will adapt a 3-metabolite biosensor that identifies patients with colorectal cancer (CRC) and precancerous polyps to Nigerian patients. Phase 2 will pilot test and evaluate the point-of-care (POC) biosensor device in Nigeria.

In Phase 1, urine will be collected from 450 Nigerian patients (150 with CRC, 150 with polyps, and 150 patients with no colon premalignant or malignant pathology. These samples will be used to refine a handheld biosensor. This handheld biosensor is intended to be a cost-effective POC diagnostic test highly sensitive for CRC in Nigerian patients.

In Phase 2, the biosensor device will be piloted in Nigeria with 75 patients that are high-risk for CRC.. After the pilot, POC test in real-time analysis on urine from 645 patients who are in one of three groups: 1.\> 40 years of age with rectal bleeding; 2.a family history of CRC; 3. have a diagnosis of CRC. All patients will receive a colonoscopy. Beliefs and barriers related to urine testing for CRC will be investigated. Study will be completed within 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 40 years of age with LGI bleeding OR
* Patients who are high risk due to family history of CRC

  o Must be at most 10 years younger than when relative presented with CRC (for example, a patient with a relative diagnosed at age 40 with CRC will be eligible after age 30) OR
* Patients with a diagnosis of stage I-III CRC who have no evidence of disease

Exclusion Criteria:

* Patients who are unable to provide written informed consent;
* Previous diagnosis, treatment, or surgery for any cancer other than CRC
* Age younger than 40 years with no family history of CRC
* Any significant medical comorbidities
* Inability to provide a urine sample no fewer than 3 days before colonoscopy
* Inability to fully complete the patient satisfaction survey tool
* Diagnosis of or suspected inflammatory bowel disease.
A Clinical Trial to Evaluate the Blood Pressure Lowering Effect of a Candemore Plus Tab Versus Cantabell Tab in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy

Phase 4 clinical trial to Evaluate the blood pressure lowering effect of a Candesartan/Hydrochlorothiazide(Candemore Plus Tab) versus Candesartan/Amlodipine(Cantabell Tab) in Hypertensive Patients


Eligibility Criteria:
Inclusion Criteria:

* over 19 years old
* Agreement with written informed consent
* Hypertensive Patients

Exclusion Criteria:

* Patients with secondary hypertension
* Participated in other trial within 30 days
* In investigator's judgement
Technical Performance Assessment of Tc-99m Tetrofosmin for Differentiation of Recurrence vs Radiation Necrosis in Patients With Glioma

This study aims to assess the technical performance of Tc-99m tetrofosmin SPECT as compared to F-18 FDG PET for the differentiation of radiation necrosis from glioma relapse and to obtain estimates of diagnostic accuracy for Tc-99m tetrofosmin SPECT and F-18 FDG PET in an intra-individual comparison.


Eligibility Criteria:
Inclusion Criteria:

1. confirmed high grade glioma (e.g., anaplastic astrocytoma, glioblastoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma)
2. being in follow-up for at least 3 months after completion of radiation therapy (with or without concurrent chemotherapy)
3. inconclusive MRI results regarding the differentiation between recurrence and radiation necrosis
4. willing and able to undergo all study procedures
5. informed consent in writing (dated and signed)

Exclusion Criteria:

1. age: less than18 years
2. if female, pregnant or breast feeding (females of child-bearing potential must use adequate contraception and must have a negative pregnancy test performed within 7 days prior to inclusion into this study)
3. contraindications for Tc-99m tetrofosmin
4. contraindications for F-18 FDG
5. close affiliation with the investigational site; e.g. first-degree relative of the investigator
6. participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
7. having been previously enrolled in this clinical trial
8. being mentally disabled
9. mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
10. Being clinically unstable or requiring emergency treatment