cyrilzakka/clinical-trials huggingface dataset:
Normal Reference Range Study With the TEG6s Heparin Neutralization Cartridge in Healthy Volunteers

This trial holds minimal risk to the trial volunteers and consists of obtaining whole blood via venipuncture to perform coagulation parameter measurements to define a Normal Reference Range.

Written consent to participate in the study will be obtained prior to volunteer screening per site procedures.


Eligibility Criteria:
Inclusion Criteria:

• Adult volunteers (18 years of age and older) who self-identify as being in general good health.

Exclusion Criteria:

* Volunteers with any acute illness or uncontrolled chronic disease
* Volunteers with any type of cancer
* Volunteers with diabetes
* Volunteers with renal disease
* Volunteers with liver disease
* Volunteers with morbid obesity
* Volunteers with autoimmune or inflammatory diseases
* Volunteers with known coagulation and/or bleeding disorders (e.g., hemophilia, Von Willebrand's disease)
* Volunteers currently abusing alcohol (defined as more than 3 drinks for women and more than 4 drinks for men on any given day, or 7 drinks for women and 14 drinks for men throughout the week) or taking illicit drugs
* Volunteers with hereditary fibrinolytic bleeding disorders
* Volunteers with altered coagulation due to the presence of direct oral anticoagulants (e.g., apixaban, rivaroxaban, dabigatran) in the blood
* Volunteers on any fibrinolytic activators (e.g., Streptokinase, t-PA, Reteplase, Tenecteplase, Urokinase, APSAC, Staphylokinase)
* Volunteers who have had recent surgery (within the last four weeks)
* Volunteers with any injuries leading to substantial bleeding or bruising (within the last two weeks prior to blood donation)
* Volunteers with bruising, wounds, or scarring around the selected venipuncture site
* Volunteers deemed unfit for participation in the trial by the principal investigator
* Volunteers participating in another clinical trial that would not be scientifically or medically compatible with this trial
* Volunteers who have been on P2Y12 inhibitors within the last 30 days
* Volunteers receiving treatment with low molecular weight heparin (e.g., enoxaparin)
* Volunteers with altered coagulation due to the presence of drugs known to affect the coagulation status in the blood (see Table 1)
* Volunteers who have participated in this trial previously
SLNB After Nipple Sparing Mastectomy

Sentinel Lymph Node Biopsy (SLNB) after nipple sparing mastectomy (NSM) is controversial. This study aims to investigate feasibility of SLNB with radioisotope method.

Volunteer patients who has underwent to NSM at least more than 6 months prior will be included to the study. Radioisotope will be injected via intradermal route to the breast underwent to NSM patients and lymphoscintigraphy images will be obtained to detect activity in axilla. If hot nodule is detected then it will be concluded that SLNB can be performed after NSM.

Eligibility Criteria:
Inclusion Criteria: NSM with/without SLNB at least 6 months prior to this study -

Exclusion Criteria: previous axillary dissection and active breast cancer

-
Vitamin D to Reduce Colds and Asthma Attacks in Young Children

Viral infections are the main cause of asthma attacks in preschoolers, an age group with the highest rate of emergency visits due to asthma. While high doses of inhaled or oral corticosteroids provide benefits, these have been associated with adverse outcomes. Most asthmatic children have lower blood levels of vitamin D compared to non-asthmatic children. Low vitamin D level has been linked to more frequent and more severe asthma attacks as well as with higher dose requirement of inhaled corticosteroid. Recent studies show that vitamin D supplements can reduce the number of asthma attacks triggered by viral infections in children. Unfortunately, most people forget to take vitamin D every day during the fall and winter season as recommended in Canada. A solution is to give a vitamin D bolus by mouth. This has been shown to safely and effectively increase vitamin D levels in children. The investigators hypothesise that a vitamin D bolus given in clinic will sufficiently increase the blood level of vitamin D to prevent the expected winter decline in vitamin D, compared with placebo in preschool-aged children with asthma. This six-month pilot randomized controlled trial aims to: (1) show that a vitamin D bolus is superior to placebo in raising vitamin D levels; (2) record the number of asthma attacks and viral infections in enrolled participants; and (3) identify problems that may call for protocol changes.


Eligibility Criteria:
Inclusion Criteria:

* children aged 1-5 years
* physician-diagnosed asthma as per GINA guidelines
* upper respiratory tract infections as the main asthma exacerbation trigger
* ≥4 respiratory infections in the past 12 months
* ≥1 exacerbation requiring rescue oral steroids in the past 6 months or ≥2 in the previous 12 months.

Exclusion Criteria:

* extreme prematurity (\<28 weeks gestation)
* infants \<12 months of age
* breastfed infants with no vitamin D supplementation
* recent (\<1 year) immigrants from countries where rickets and malnutrition prevalent
* other chronic respiratory disease (broncho-pulmonary dysplasia; cystic fibrosis)
* endocrine disorder of calcium/ vitamin D metabolism
* disorder/ disease with associated malabsorption (inflammatory bowel disease)
* kidney/ liver disease
* sickle cell anemia
* medications known to interfere with bone metabolism/ vitamin D levels
* vitamin D supplementation \>1000 IU/ day in past 3 months
* unable to attend medical visit in 3-4 months
* plan to leave the province during the next 6 months.
Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis

The goal of this clinical trial is to compare the efficacy of hypertonic saline nebulization with adrenaline nebulization in the treatment of acute bronchiolitis in children. Main aim is to evaluate the following in both group of patients

1. Improvement in Wood-Downes clinical score (WDF score) in bronchiolitis
2. Length of Hospitalization

This is a double-blind clinical trial that will include all admitted patients with acute bronchiolitis, meeting inclusion criteria, admitted in Pediatrics department Combined Military Hospital Nowshera. Patients will be divided into two groups randomly. Group I patients will be nebulized with drug adrenaline every 6 hours and group II patients will be nebulized with hypertonic saline every 6 hours. After 24 hours and 48 hours of nebulization, researchers will record WDF score by measuring respiratory rate, heart rate, chest retractions, chest auscultation findings and SPO₂ levels. All data will be recorded on a research Performa including length of hospital stay. Data will be entered on SPSS to calculate results. Independent sample t-test was used to measure the effect of two drugs on the length of hospital stay and improvement of respiratory score with a 95% confidence interval. P value less than 0.05 will be considered as significant.

Eligibility Criteria:
Inclusion Criteria:

* All children admitted in PICU with acute bronchiolitis

Exclusion Criteria:

* children with co-exiting illnesses like

  1. Congenital Heart Disease
  2. Immunodeficiency
  3. other Infectious disease like Meningitis, encephalitis, Pneumonia, TORCH
  4. Kidneys or liver problem
  5. Seizures
Correlation Between Serum Progesterone Level And Primary Dysmenorrhea

This study will be conducted to determine the correlation between the levels of serum progesterone and Menstrual Symptoms In Young Females with primary dysmenorrhea.

One hundred adult females with primary dysmenorrhea will participate in this study. They will be recruited from the Gynaecological outpatient clinic, Kasr El Ainy University Hospital, Cairo, Egypt Many studies reported that primary dysmenorrhea was the result of increased prostaglandin, especially prostaglandin F2α (PGF2α) and prostaglandin E2 (PGE2) which produced the effect through the cyclooxygenase pathway, and further led to uterine ischemia hypoxia. Nevertheless the relationship between the serum progesterone level and menstrual symptoms was not completely clear. Hence, this study will investigate the association between the serum progesterone level and menstrual symptoms in young females with primaryf dysmenorrhea.

Eligibility Criteria:
Inclusion Criteria:

1. One hundreds adult females were suffered from primary dysmenorrhea.
2. Their age was ranged from 17 to 24 years.
3. Their body mass index was ranged from 20 to 25 kg/m2.

Exclusion Criteria:

* Any participant will be excluded from the study if they have:

  1. Irregulars or infrequent menstrual cycles.
  2. Pacemaker, Myasthenia gravis, hyperthyroidism, active tuberculosis and psychosis.
  3. Pelvic pathology.
Sentinel Node in Endometrial Cancer

Phase II, open-label, randomized pilot study.

Patients will be randomized (1:1) to receive for sentinel node screening:

1. Radiotracer (RT) via cervical administration and TUMIR
2. Combination of RT with Indocyanine Green (RT + ICG) via cervical administration and TUMIR Patients will be followed up to 1 month after the last administration of radiotracer 70 patients will be included into the study.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Histological diagnosis of endometrial cancer with criteria of high risk according to the following criteria: - unfavorable histology according to FIGO (adenocarcinoma serous, clear cell, or carcinosarcoma) - nuclear grade 3 - suspected myometrial invasion\> 50% by resonance magnetic (MR) or transvaginal ultrasound
3. Women of childbearing age should have a transvaginal ultrasound who rule out pregnancy and must commit to using methods highly effective contraceptives (vasectomized couple and sexual abstinence) until the hysterectomy is performed.
4. Patient who gives written informed consent.

Exclusion Criteria:

1. Pregnancy or lactation.
2. Suspected lymph node or distant metastatic disease in the preoperative study.
3. History of previous surgery or radiotherapy in the pelvic and paraortic lymphatic drainage areas or nodal involvement of any other etiology.
4. Body mass index (BMI) greater than 45 Kg / m2.
5. Patients who, in the researcher's opinion, are not suitable for participate, regardless of reason, including medical or clinical, or participants potentially at risk of not comply with the study procedures.
6. Known hypersensitivity to some of the active substances or excipients from RT or ICG (including previous history of hypersensitivity to products containing human albumin).
7. Hypersensitivity to sodium iodide.
8. Patients allergic to iodine.
9. Patients with clinical hyperthyroidism, thyroid adenomas autonomic and diffuse focal and autonomic disturbances of the gland thyroid.
Atopy Network - Comprehensive Allergy Centers: Medical Care of Patients With Moderate to Severe Allergic Diseases

The Atopy Registry aims to assess data about atopic disorders and their medical care in a standardized form. With this, the comparative efficacy, tolerability and safety of systemic therapies for atopic disorders should be investigated. An optional additional module "Bioanalytic" shall provide insights into further connections regarding immunology, genetics and microbiome.

The prevalence of atopic disorders increased in the western countries within the past decades. Atopic disorders are among others: food allergy, atopic dermatitis, allergic rhinitis, bronchial asthma, chronic spontaneous urticaria, eosinophilic esophagitis and chronic rhinosinusitis with nasal polyposis.

Seriously affected patients often have coexisting atopic disorders. In fact, 60-75% of the patients with a severe atopic dermatitis also suffer from an allergic rhinoconjunctivitis and 40-50% from bronchial asthma. This leads to a decreased quality of life (LG) especially in seriously affected patients.

The treatment of atopic disorders is not standardized yet. The Atopy Registry should promote the creation of a Germany-wide registry for different atopic disorders.Furthermore, the registry should characterize the medical care of patients with atopic disorders (patient satisfaction, therapy order, treatment success). This study serves as a longterm observation und is designed to compare different systemic therapies, since head-to-head studies regarding the efficacy are still missing. The analysis of biomaterial is involved to state possible correlations between endotype and phenotype.

Eligibility Criteria:
Inclusion Criteria:

* patients are at least 6 years old
* patients with a proven moderate to severe atopic disorder who are planned to receive a biologic systemic therapy
* at least one additional proven atopic disorder

Exclusion Criteria:

* \<2 atopic disorders
* poor compliance
* pregnancy or breastfeeding
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia

To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.

Patients with progressive keratoconus, pellucid marginal degeneration, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery. Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, intraocular pressure, pachymetry, and visual function questionnaire.

Eligibility Criteria:
Inclusion Criteria:

Subjects who have one or both eyes that meet criteria 1 and 1 or more of the following criteria will be considered candidates for this study:

1.10 years of age or older 2. Presence of central or inferior steepening 3. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration 4. Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as:

1. Fleischer ring
2. Vogt's striae
3. Decentered corneal apex
4. Munson's sign
5. Apical Corneal scarring consistent with Bowman's breaks
6. Scissoring of the retinoscopic reflex
7. Crab-claw appearance on topography 5. Steepest keratometry (Kmax) value ≥ 47.20 D 6. I-S keratometry difference \> 1.5 D on the Pentacam map or topography map 7. Posterior corneal elevation \>16 microns 8. Thinnest corneal point \>300 microns 9. Contact Lens Wearers Only:

a. Removal of contact lenses for the required period of time prior to the screening refraction: Contact Lens Type Minimum Discontinuation Time Soft or Scleral 3 days Rigid gas permeable 2 weeks

Exclusion Criteria:

All subjects meeting any of the following criteria will be excluded from this study:

1. Eyes classified as either normal or atypical normal on the severity grading scheme.
2. Corneal pachymetry at the screening exam that is \<300 microns at the thinnest point in the eye(s) to be treated.
3. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:

   1. History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)
   2. Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure.
4. Pregnancy (including plan to become pregnant) or lactation during the course of the study
5. A known sensitivity to study medications
6. Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
7. Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing.
Antimicrobial Photodynamic Therapy on Teeth With Molar Incisor Hypomineralization

Molar Incisor Hypomineralization (MIH) is a change in the formation of dental enamel of systemic origin that affects at least one of the first four permanent molars and usually affects incisors. During the eruption, the affected surfaces tend to fracture, exposing the dentin, which causes excessive sensitivity in addition to making the region very susceptible to the appearance of carious lesions. The objective of this research will be to evaluate the clinical effect of antimicrobial photodynamic therapy (aPDT) in permanent teeth with severe and sensitive MIH. The methodology will be based on the selection of patients from 6 to 12 years of age with permanent molar teeth, randomly divided in two groups. The selected teeth should have MIH on the occlusal surface, indicated for clinical restorative treatment. In Group 1, aPDT will be applied for the treatment of infected dentin. Afterwards, the teeth will be restored with high viscosity glass ionomer cement. In Group 2, the removal of the softened dentin around the side walls of the cavity with sharp dentine curettes and posterior restoration with high viscosity glass ionomer cement will be carried out. All patients will have clinical and radiographic follow-up with a time interval of 6 and 12 months. The data obtained will be submitted to descriptive statistical analysis to evaluate the association of categorical variables. Chi-square test and Fisher's Exact test will be used, and to analyze the correlation between the continuous variables, Pearson correlation test will be applied. For the analysis of dentin density in the scanned radiographic images and the microbiological results for colony forming units, ANOVA and Kruskal-Wallis will be applied.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children, without systemic alterations;
* Collaborative children;
* Present at least one permanent molar with active and acute caries lesion in dentin, not exceeding 2/3 and involving only the occlusal, with direct vision and access, without clinical and radiographic signs and symptoms of pulp involvement.

Exclusion Criteria:

* Child with systemic impairment;
* Non-cooperative behavior;
* Carious lesion of Class II, III, IV or V type of Black;
* Clinically: carious lesion involving enamel, deficient restorations, small carious lesions in dentin (without access to hand excavators), occult caries lesions, clinical sign and/or symptom of pulp involvement, clinical impossibility of restoration;
* Radiographically: evidence of pulpal involvement, carious lesion extending beyond 2/3 of the dentin.
Efficiency of Negative Pression Therapy With Instillation in the Debridement of Wound

the aim of the study is to evaluate the efficiency of the therapy with negative pression (TPN) and instillation in the debridement of chronic wound

it is an observation study with only the aim to evaluate the percentage of fibrin before and after the specific treatment of TPN

Eligibility Criteria:
Inclusion Criteria:

* wound with debridement

Exclusion Criteria:

-
Methodology for Developing an Occlusal Appliance With CBD Active Carrier

Evaluation of the efficacy of the occlusal appliance with active cannabidiol (CBD) molecules in TMD patients

Occlusal appliance therapies are used in TMD patients. In this research the active CBD molecules will be released from the occlusal appliance during nighttime, in population of patients suffering from TMD. The effectiveness of the myorelaxation (sEMG of mastcatory muscles activity) and analgesic effect( VAS analysis) of occlusal appliance with the CBD molecules will be compared to the traditional acrylic-resin material used so far for occlusal appliance manufacture. The aim of the research is the evaluation of the innovative material effectiveness, used for the production of the occlusal appliance.

Eligibility Criteria:
Inclusion Criteria:

* patient agreement to take part in the study
* RDC/TMD group Ia and Ib
* Bruxism Index\> 3 ( Brux-off polysomnography)

Exclusion Criteria:

* CBD allergy/hypersensitivity/ addiction
* Therapy with analgesic drugs
* Therapy with drugs affecting muscle function
* Fixed or removable dental prosthesis
* Ongoing orthodontic treatment
* Other general disorders affecting muscle tension
Evaluation of Lixisenatide Efficacy in Diabetes Mellitus Type 2 With Failure of Other GLP-1 Analog

The study aims to examine the effectiveness of the short acting GLP-1 analog, Lixisenatide to achieve glycemic control in type 2 diabetes patients, in patients with failure of long acting GLP-1 analog.

Patients who fail to achieve significant improvement in diabetes control on basal insulin and Liraglutide will be switched to basal insulin and lixisenatide treatment for 12 weeks. The primary outcomes will be changes in HBA1C and weight.


Eligibility Criteria:
Inclusion Criteria:

Type Diabetes Mellitus on combination of basal insulin therapy and GLP1 analog, with secondary failure of non-fasting glycemic control

Exclusion Criteria:

* Pregnant or lactating woman
* Renal failure (eGFR\<30)
Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation

The purpose of this study to investigate the effect of sulforaphane from macerated broccoli sprouts in humans and to evaluate less invasive methods of assessing potential anti-inflammatory drugs in CF.

The hypothesis to be tested is that sulforaphane consumed from macerated broccoli sprouts will activate Nrf2, reduce oxidative metabolites and reduce neutrophils in the oral mucosa after 5 days of therapy in healthy volunteers and CF subjects.

The study requires 6 brief outpatient visits over 8 days. Study procedures include medical history, height, weight, vital signs, blood and urine collection, nasal curettage, saline mouthwash, and ingestion of broccoli sprouts (100 gm of 3 to 5 day old raw broccoli sprouts once daily for 5 consecutive days).

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers and patients with cystic fibrosis ≥ 18 \< 50 years of age
* Healthy volunteers must be in general good health as determined by a medical history
* CF subjects must have a documented diagnosis of CF (positive sweat chloride ≥ 60 mEq/liter, by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF accompanied by one or more clinical features with the CF) phenotype
* CF subjects must have a baseline FEV1 percent predicted \> 50% (in the last year, obtained from medical record)
* CF subjects must be clinically stable: free of any acute illness for \> 14 days CF subjects must not have been prescribed any new systemic antibiotics for the 14 days prior to enrollment
* Ability to provide written informed consent
* Ability to adhere to the protocol

Exclusion Criteria:

* Use of NSAIDS (e.g., ibuprofen) or corticosteroids including inhaled steroids for the 4 weeks prior to enrollment
* Active gingival disease (active tooth or gum disease)
* History of nephrolithiasis or cholelithiasis
* Allergy to broccoli
* Any chronic condition that compromises the participant as determined by medical history
* Pregnancy
* Inability to tolerate the study procedures
* CF subjects: Infected with B. cepacia