cyrilzakka/clinical-trials huggingface dataset:
Philips AirFlosser Study

In the current study, Sonicare AirFloss (AF) will be used in combination with a Manual Toothbrush (MTB) in a population of manual toothbrush users who are irregular flossers and who exhibit signs of moderate gingivitis. The alternate test arm will be allocated to a No Intervention group and will be given no test products or instruction other than to change none of their typical at home oral hygiene habits.

The aim of this study is to investigate how an AF and MTB oral hygiene intervention will affect a population of irregular flossers using the residual protein concentration method as an interproximal plaque efficacy assessment. Gingivitis reduction will be assessed using the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) indices


Eligibility Criteria:
4.1 Inclusion Criteria

Subjects accepted into the study must meet the following requirements:

* are 18-70 years;
* are in generally good health;
* have a minimum of 20 natural teeth (excluding 3rd molars);
* have 1 qualifying test site in each posterior quadrant;
* are a regular manual toothbrush user (prior periodic use of powered toothbrushes in other studies permitted);
* Irregular Flossers defined as using dental floss ≤ 2 days a week;
* be willing and able to comply with study procedures and be available at all times required for participation;
* have a Gingival Bleeding Index \> 1 on at least 20 sites;
* be a non-smoker.

4.2 Exclusion Criteria Subjects will be excluded from the study if they;

* have systemic diseases such as Down's syndrome, or known AIDS/HIV;
* have insulin dependent Diabetes;
* are pregnant or nursing by subject report;
* have a cardiac pacemaker or AICD;
* are undergoing or require extensive dental or orthodontic treatment;
* require antibiotic treatment for dental appointments;
* have used antibiotics within 4 weeks of enrollment;
* are currently using prescription-dose anti-inflammatory medications or anticoagulants (including aspirin);
* have heavy deposits of calculus, either supragingival and/or subgingival;
* have severe gingivitis or periodontitis;
* have extensive crown or bridge work and/or rampant decay;
* are currently use bleaching trays;
* have any oral or extraoral piercing on lips or in mouth with ornament or accessory;
* have a professional prophylaxis within 4 weeks of study;
* have participated in a prior study ≤ 20 days;
* are employed by an oral healthcare products company or dental research institution.
Simulated In-House Usability Study of Eclipse Continuous Positive Airway Pressure (CPAP) Device

The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device will be randomized.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years old who are impacted by obstructive sleep apnea and currently are familiar with a CPAP device.

Exclusion Criteria:

* Diagnosis of any medical or behavioral conditions that would compromise subject safety.
* Under the age of 18: target for this current version of the platform is the adult population.
The Effect of Red Blood Cells Storage Duration on Biochemical Changes in Pediatric Patients

The aim of the study is to detect if the storage duration of red blood cells has impact on some biochemical parameters after intra operative transfusion in pediatric trauma patient

* A pretransfusion draw of a few drops of patient venous blood, send for analysis by i-STAT Portable Clinical Analyser. Samples are processed immediately and provide laboratory quality results in 2 minutes using the CHEM 8+ i-STAT cartridge for measurement of:

  1. Potassium (K)
  2. Ionized Calcium (iCa)
  3. Glucose (Glu)
  4. Urea Nitrogen (BUN)/Urea
  5. Hemoglobin (Hb) and Hematocrit (Hct).
* Concurrently, a few drops of blood will be taken from the unit to be transfused will be analysed by i-STAT Portable Clinical Analyser for measurement of previous biochemical parameters.
* The details of the unit, such as draw date, volume of transfusion, and date of transfusion, will be recorded. The RBC unit will be delivered to the operative room from the blood bank in an insulated box.
* The transfusion is then given as clinically indicated at a rate of 50 to 150 mL/h based on the clinician's orders, the patient's weight, and the patient's clinical situation.
* Volumes will be transfused to children according to the following top-up transfusion equation: desired Hemoglobin (Hb) (g/dl) - actual Hemoglobin (Hb) (g/dl) x weight (kg) x 3. (usually 10-20 ml/kg).
* A second patient blood sample will be drawn one hour after the transfusion and will be analyzed by i-STAT Portable Clinical Analyser.
* Patient information will be recorded for age, weight, sex, and primary diagnosis.
* Demographic and clinical variables will be collected, to include type and quantity of all blood products and fluids received and medications administered. All surgical procedures will be documented.

Eligibility Criteria:
Inclusion Criteria:

.ASA I-II physical status patients.

* Genders Eligible for Study : both .
* Age: 2_10 years
* All non-crush trauma pediatric patients need intraoperative RBC transfusion.
* RBCs transfusion Volume within 10-20ml/kg.

Exclusion Criteria:

* Patients with renal failure (serum creatinine 1.5 mg/dL)
* Hepatic insufficiency.
* Furosemide diuresis.
* Succinylcholine for rapid sequence induction.
* Electrolytes disorders.
Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC "BIOCAD") With Methotrexate in First Line Biological Therapy of Patients With Active Rheumatoid Arthritis

The mail goal of this study is to establish superiority in efficacy of Acellbia® applied in a dose of 600 mg (Day 1 and Day 15) in combination with methotrexate in patients with active RA seropositive previously untreated with biological therapy, compared to standard therapy with methotrexate.


Eligibility Criteria:
Inclusion Criteria:

Written informed consent. Age from 18 to 80 years. Rheumatoid arthritis diagnosed at least 6 months before informed consent signing Presence of more than 8 swollen and more than 8 painful joints at screening. C-reactive protein 7 mg/l or more AND/OR erythrocyte sedimentation rate 28 mm/hour or more.

Antibodies to citrullinated cyclic peptide 20 U/ml or more AND/OR rheumatoid factor-IgM higher than upper normal limit.

Documented regular methotrexate intake for 12 weeks, stable dose from 10 to 25 mg/week during last 4 weeks before signing informed consent.

Exclusion Criteria:

Methotrexate intolerance. Felty's syndrome. Patient functional status - IV class according to ACR. Previous use of biologic drugs to treat rheumatoid arthritis, biologic drugs that deplete CD20-lymphocytes, azathioprine use in the last 28 days prior to informed consent signing, leflunomide use in the last 8 weeks prior to informed consent signing, sulphasalazine/hydroxyquinoline use in the last 28 days prior to informed consent signing, intraarticular use of corticosteroids in the last 4 weeks prior to informed consent signing, patient requires prednisolone (or analogues) in a dose more than 10 mg/day or dose is unstable during 4 weeks prior to informed consent signing, requirement in non-steroid antiinflammatory drugs if their dose was not stable during last 8 weeks prior to informed consent signing.

Patient has inflammatory joint disease otherwise than rheumatoid arthritis or systemic autoimmune diseases.

Full list of inclusion and exclusion criteria can be found in Study Protocol.
3D Printed Breast Models in the Surgical Management of Breast Cancer

To learn if providing a 3-D printed model of the breast can help breast cancer patients make decisions related to their care. During this study, some study participants will receive the 3-D printed model and some study participants will receive traditional breast imaging scans to learn if the 3-D printed model

Primary Objective:

•The objective of this prospective study is to determine the impact of 3D printed breast models, compared to 2D imaging, on breast cancer patients' decisional conflict related to treatment decision-making.

Secondary Objective:

* To observe if patients will change their initial desired surgical option (mastectomy versus lumpectomy) after viewing the 3D printed models
* To evaluate the quality of the communication between surgical providers and patients with and without the 3D printed models
* To assess the surgical outcome including the margin status
* To evaluate patient satisfaction and well-being post-surgery between the 3D printed model group and the control group as well as mastectomy versus lumpectomy subgroups
* To assess surgical providers' response to the acceptability and utility of the model

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older female
* Patient must have histologically confirmed breast malignancy
* Patient is a candidate for surgical management
* Patient has a surgeon at MDACC (main campus and/or Houston Area Locations)
* Patient has a breast MRI for extent of disease assessment at MDACC (main campus and/or Houston Area Locations).
* Patient is able to speak, read or write English
* Patient is willing to be randomized to the control or 3D printed breast model groups and is willing to sign the consent form.

Exclusion Criteria:

* Pregnant and breastfeeding patients
* Patients who had history of mastectomy, have recurrent malignancies on the mastectomy side
* Patients for whom it is not feasible to create a 3D printed breast model from breast MRI
Primary Tumor Harvest for the Purpose of Possible Use in a Future Clinical Trial in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer

The purpose of this research study is to collect tumor samples at the time of surgery and store them for possible use as part of an experimental vaccine study for the participants cancer in the future.

* Even if tumor sample is collected, the participant is under no obligation to participate in the vaccine study.
* Participants will have their regularly planned surgery as described by their surgeon. During the surgery, tumor samples will be collected. We will only collect tumor that is not needed and could otherwise be thrown away.
* The tumor samples will be frozen and placed in storage for up to two years.

Eligibility Criteria:
Inclusion Criteria:

* Clinical suspicion of advanced ovarian, fallopian tube or primary peritoneal cancer as determined by a gynecologic oncologist
* Patients are planning to undergo primary or secondary debulking surgery as part of standard of care for their disease
* Estimated life expectancy of 6 months or greater
* 18 years of age or older

Exclusion Criteria:

* More than one prior chemotherapy regimen
* Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, unstable ischemic coronary disease or congestive heart failure
* Known HIV infection
* Active second malignancy, aside from basal cell or squamous cell carcinoma of the skin
* Significant autoimmune disease, including psoriasis
* History of clinically significant venous thromboembolism
A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms and the extent to which the patient's body area is affected by the disease (compared to placebo).


Eligibility Criteria:
Inclusion Criteria:

Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization

At randomization, moderate to severe psoriasis as defined by:

* PASI score of 12 or greater and,
* IGA score of 3 or greater and,
* Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater At screening and randomization, chronic plaque-type psoriasis considered inadequately controlled by topical treatment.

Exclusion Criteria:

* Forms of psoriasis other than chronic plaque-type
* Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization
* Previous exposure to AIN457
* Ongoing use of prohibited psoriasis treatments / medications and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to
* Known immunosuppression (e.g., AIDS) at screening and / or randomization
* History or evidence of active tuberculosis at screening
* Active systemic infections (other than common cold)
* History or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years.
* Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study
* Any clinically significant abnormal laboratory tests at randomization, that in the judgment of the investigator prevents the patient from participating in the study
* Inability or unwillingness to undergo repeated venipuntures
* History or evidence of drug or alcohol abuse
* Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply
Clinical Study to Evaluate the Anti-aging Efficacy of Dermial®

Oral supplement with an HA matrix ingredient composed of HA (60-75%), sulfated GAGs (≥10%), including DS and CS, and collagen (≥ 5%) to evaluate the hydration of the stratum corneum of facial skin in healthy women showing natural signs of age-related aging versus placebo

This study includes 60 healthy volunteers in which will be evaluated if the oral supplement with Dermial \[composed of HA (60-75%), sulfated GAGs (≥10%), including DS and CS, and collagen (≥ 5%)\] is able to obtain differences versus placebo in healthy women showing natural signs of age-related aging versus placebo . It is a single-center, double-blind, randomized, placebo-controlled clinical study with proportion 1:1 between treatments.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy women between 35 and 65 years of age (inclusive), showing signs of physiological facial skin aging.
2. Women willing not to use any firming product, skin lightening, or any other topical or systemic medication known to affect skin aging or dyschromia during the study period.
3. Be informed of the nature of the study and give their IC in writing.
4. Women willing not to become pregnant during the course of the study, using contraceptive methods considered highly effective.

Exclusion Criteria:

1. Women with allergies to the ingredients in the investigational product.
2. Women who have used a dietary or nutricosmetic supplement containing HA, or who have undergone Botox or HA infiltrations, in the last 6 months prior to signing the IC.
3. Women who have undergone:

   * Superficial or medium-deep chemical peels or dermabrasion within the 6 weeks prior to signing the IC or inclusion document.
   * Deep facial chemical peel, non-ablative laser or fractional laser resurfacing in the 12 months prior to signing the IC or inclusion document.
   * Facial plastic surgery or a laser ablative procedure for photoaging in the 12 months prior to signing the IC or inclusion document.
4. Suspected uncontrolled disease, such as diabetes mellitus (DM), arterial hypertension (HT), hyperthyroidism or hypothyroidism, renal failure or liver failure.
5. Women who have received a PRP (Platelet Rich Plasma) injection as a treatment for aesthetic purposes, in the 3 months prior to inclusion by signing the IC.
6. Women who do not wish, for whatever reason, to take the supplements in the study.
7. Known pregnancy or lactation.
8. Presence of inflammatory skin disease such as psoriasis, atopic dermatitis, rosacea, acne or hidradenitis suppurativa.
9. Presence of active malignant pathologies or premalignant skin lesions such as actinic keratoses.
10. Psychiatric disorder that is not managed or any other circumstance or pathology that prevents the participant from understanding and/or complying with the study procedures.
Risk Factors of Post-ERCP Sepsis

For the treatment of numerous biliary and pancreatic problems, the procedure known as endoscopic retrograde cholangiopancreatography (ERCP) is regarded as a crucial therapeutic intervention. However, ERCP is known to be connected to a variety of issues, including post-ERCP sepsis. This study's goal is to investigate the relationship between unexplained hypotension during or just after surgery and the emergence of sepsis after ERCP.

At the Gastrointestinal Surgery Centre, Mansura University, Egypt, a cohort study will be conducted on a sample of 50 adult (18+) patients who undergoing ERCP. Hypotension that occurred during surgery or shortly after will be classified as exposure when it cannot be linked to a particular cause. In this study, post-ERCP sepsis will be the major outcome measure, while other ERCP-related sequelae will be the supplementary outcome measures.

Discussion:

The findings of this study will significantly advance our understanding of the potential link between intraoperative hypotension and the development of post-ERCP sepsis. This study's goal is to increase knowledge of the challenges presented by ERCP, which will aid in the creation of patient treatment methods that are more effective.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing ERCP for obstructive jaundice
* Adult (Older than 18 years old)
* Written Informed Consent

Exclusion Criteria:

* Already on sepsis before the ERCP
* Pregnancy
A Comparison of Duloxetine Hydrochloride, Marketed Comparator, and Placebo in the Treatment of Generalized Anxiety Disorder

This is a clinical trial assessing duloxetine and comparator to placebo in patients who have generalized anxiety disorder.


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients at least 18 years of age, presenting with generalized anxiety disorder (GAD).

Exclusion Criteria:

* Any current and primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I diagnosis other than GAD. Patients diagnosed with major depressive disorder within the past 6 months -or- patients diagnosed with panic disorder, post-traumatic stress disorder, or an eating disorder within the past year -or- obsessive-compulsive disorder, bipolar affective disorder, psychosis factitious disorder, or somatoform disorders during their lifetime
* The presence of an Axis II disorder or history of antisocial behavior, which in the judgement of the investigator would interfere with compliance with study protocol
* Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine
* History of alcohol or any psychoactive substance abuse or dependence (as defined in the DSM-IV-TR) within the past 6 months
Multi-omics Analysis of Oral-gut Microbial Profiles

Periodontitis is a chronic inflammatory disease of the tooth supporting structures induced by a dysbiosis in the oral and subgingival microenvironment of susceptible patients. The long-term swallowing of high doses of periodontal pathogenic microorganisms could induce a dysbiosis of the intestinal microbiota, favouring the establishment of an 'inflamed' microbiome in terms of composition and/or function. The present project is aimed at a better understanding of the etiopathogenetic correlation between periodontitis and intestinal dysbiosis, and aims to explore the hypothesis that periodontal treatment may influence the multi-omics profile on the oral-gut-systemic axis. 70 patients affected by stage III-IV periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. Salivary, subgingival plaque, plasma and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and after treatment. Age, gender and BMI-matched healthy individuals will be recruited as controls.


Eligibility Criteria:
Inclusion Criteria:

* periodontitis Stage III or IV
* BMI between 20 and 29 kg/m2
* free diet
* presence of at least 20 teeth

Exclusion Criteria:

* systemic diseases (including diabetes, thyroid, liver, or kidney diseases)
* dietary allergies
* use of antibiotics or probiotics during the previous 90 days
* pregnancy or breast feeding
Exploratory Study to Evaluate QR-010 in Subjects With Cystic Fibrosis ΔF508 CFTR Mutation

Exploratory proof of concept study to determine whether intranasal administration of QR-010 in subjects with cystic fibrosis, homozygous or compound heterozygous for the ΔF508 mutation, can increase the function of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR).

This is an open-label, multi-center, exploratory study to estimate the effect of intranasal administration of QR-010 on the nasal mucosa in the restoration of CFTR function, as measured by nasal potential difference (NPD), in the nasal epithelium of adult subjects with CF who are homozygous or compound heterozygous for the ΔF508 CFTR mutation.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CF as defined by iontophoretic pilocarpine sweat chloride test (sweat chloride) of \> 60 mmol/L
* Nasal potential difference (NPD) measurement at Screening consistent with CF
* Confirmation of CFTR gene mutations homozygous or compound heterozygous for the ΔF508 mutation
* Body mass index (BMI) of ≥ 18 kg/m2
* Non-smoking for a minimum of 2 years
* Stable lung function
* FEV1 ≥40% of predicted normal for age, gender, and height at Screening

Exclusion Criteria:

* Breast-feeding or pregnant
* Acute allergy or infection affecting nasal conditions not resolved within 14 days prior Screening
* Use of lumacaftor or ivacaftor
* Use of any investigational drug or device
* Hemoptysis
Single-stage Correction of Acute Angle Coxa Vara

Correction of sever degree of coxa vara in single-stage correction.

The technique described in this article illustrates how to fully correct acute angle developmental coxa vara (neck shaft angle 30 degrees) to obtain better radiological and functional outcomes.

GT transfer Subtroch. valgus osteotomy

Eligibility Criteria:
Inclusion Criteria:

* acute coxa vara

Exclusion Criteria:

* osteopenic oI
Patient Specific Guides and Surgical Planning for Periacetabular Osteotomy; Post Marketing Evaluation Study

A case series to provide post marketing evaluation of the MyPAO surgical planning and patient specific guides technology. This will be a single-centre, multi-surgeon evaluation assessing the safety of the use of these guides in periacetabular osteotomy surgery.

After enrolment, baseline data will be collected including age, sex and ethnicity of the participant. The radiographic measures of centre edge angle of Wiberg and acetabular inclination will be measured by the surgeon and patient reported outcome measures (PROMS) will be collected. The PROMS collected at usual care timepoints in patients undergoing pelvic osteotomy will be collated for use in the dataset. Peri-operative data, including clinician opinion on ease of use, intraoperative dose of radiation used and device associated adverse events, will be recorded and reported in the results.

Eligibility Criteria:
Inclusion Criteria:

* · Age greater than 18 years

  * Patient undergoing pelvic osteotomy

Exclusion Criteria:

* · Evidence of hip degeneration assessed by the surgeon on x-ray (Tonnis Grade 1 or greater)

  * Known allergy to Polyamide PA12
  * Unable to provide written informed consent