cyrilzakka/clinical-trials huggingface dataset:
8% L-Arginine/Calcium Carbonate Toothpaste in Comparison to Strontium Acetate Toothpaste for Hypersensitive Dentin

Dentinal hypersensitivity \[DH\] is a common condition in daily practice, especially in patients who have abrasion, attrition, gingival recession and erosion of teeth. It can affect individuals in the age range of 20-50 years.In a recent systematic review, it was reported that no gold standard treatment modality for dentin hypersensitivity has been established Thus there is a need to evaluate new formulations in different settings and in different populations and to compare those to commonly used agents seeking better results in pain relief for our patients. Studies showed that dentifrice formulations containing 8% arginine in combination with calcium carbonate and fluoride have the ability to plug dentinal tubules, by clumping of both arginine and calcium carbonate that bind with the negatively charged dentin . Aim of the study is to clinically evaluate toothpaste containing 8% arginine, calcium carbonate, and sodium mono-fluorophosphate, in comparison to toothpaste, containing 8% strontium acetate and NaF on the relief of DH in chronic periodontitis patients.

1. Each eligible patient will be given a number.
2. All eligible patients will receive mechanical debridement in 1 or 2 sessions within 1 week before final evaluation.
3. The hypersensitive teeth will be isolated with cotton rolls, and stimuli will be applied to each tooth for final evaluation after scaling and debridement.
4. Air Sensitivity scale is used to assess sensitivity to air blast, while cold water test and tactile test will be held and assessed by Visual Analog Scale (VAS) , which score from 0 (no pain) to 10 (intense pain).
5. Patients will be handed a 30ml. white package written on it the previously assigned number to them and instructed to brush twice daily with the assigned toothpaste by a soft-bristled toothbrush for 8 weeks, with several returns to the clinic for re-evaluation and to take the refill of the assigned number of toothpaste.
6. Air blast sensitivity score and VAS will be evaluated again weekly and till the end of the evaluation period.

Eligibility Criteria:
Inclusion Criteria:

1. Slight to moderate chronic periodontitis patients diagnosed according to criteria of (Parameter on chronic periodontitis with slight to moderate loss of periodontal support.

   American Academy of Periodontology., 2000) as follows : Probing pocket depths up to 6mm Clinical attachment loss (CAL) up to 4mm Class I (incipient) furcation involvement Radiographic evidence of bone loss.
2. At least 2 teeth presenting hypersensitive areas on facial surfaces of teeth with score 2 or 3 on the air sensitivity scale (Pepelassi et al., 2015)
3. Provision of written informed consent

Exclusion Criteria:

1. Chipped teeth.
2. Defective restorations.
3. Deep dental caries or large restorations showing pulpal response.
4. Ongoing treatment with anti-inflammatory drugs.
5. Ongoing treatment for tooth hypersensitivity.
6. Pregnancy.
7. Uncontrolled metabolic diseases.
8. Psychiatric disorder.
9. Smoking
Lymphedema Screening

Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, there is no established screening program for lymphedema. This cross-sectional study will investigate diagnostic modalities in screening for lymphedema in patients with and without known lymphedema after breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Previous breast cancer treated with axillary lymph node dissection
* No recurrence
* Understand the study
* Can talk, read and understand Danish

Exclusion Criteria:

* Pregnant or breast feeding
* Lymph node dissection from other basins
* Psychiatric disorder
* Not possible to perform indocyanine green lymphangiography
Medication Review Focusing on Anticoagulation Therapy in Swiss Community Pharmacies

Oral anticoagulation therapy (OAC) entails a high potential for adverse events and strict adherence is needed.Thus, medication review and identification of safety issues and knowledge gaps about OAC is critically important. The polymedication check (PMC) is a reimbursed intermediate medication review focusing on adherence and medication management for Swiss primary care. Investigators aime to assess the impact of the PMC extended with a semi-structured interview focusing on OAC.


Eligibility Criteria:
Inclusion Criteria:

* intake of an oral anticoagulant
* more than 3 drugs over at least 3 months prior to recruitment
* german language (written and spoken)
* medicines use in self management

Exclusion Criteria:

* living in a nursing home
* provision of polymedication check in the past
Psychosocial Mobile App for Chronic Graft-Versus-Host Disease

The purpose of this research study is to see whether a psychosocial mobile app called Horizons is effective at improving quality of life, symptom burden, psychological distress, and coping in patients living with chronic graft-versus host disease (GVHD)

Frequently patients living with chronic GVHD experience physical and emotional symptoms during the course of illness that impacts their quality of life. Patients also often report difficulty managing many of the tasks they need to do to manage their chronic GVHD. They also frequently have a lot of questions about chronic GVHD and the expected trajectory of this illness.

The purpose of this research study is to see whether a psychosocial mobile app called Horizons is effective at improving quality of life, symptom burden, and psychological distress in patients with chronic GVHD

* This study will randomly assign participants to either receiving Horizons plus usual care or usual care alone.
* Enrolled participants will be on the research study for up to sixteen weeks and it is expected that about 120 people will take part in this research study.

The Leukemia and Lymphoma Society is supporting this research by providing funding.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years) who underwent allogeneic hematopoietic stem cell transplant (HCT).
* Have moderate to severe chronic GVHD based on their oncology clinician assessment as documented in the Electronic Health Record.
* Ability to comprehend and speak English as the HORIZONs app is only available in English.

Exclusion Criteria:

-Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures.
BNT162b2 Messenger Ribonucleic Acid (mRNA) Covid-19 Vaccine in Cancer Patients on Active Treatment

In this Italian observational study the antibody titer reactogenicity to Pfizer Severe Acute Respiratory Syndrome (SARS) - Coronavirus (CoV-2) RNA vaccine in cancer patients under active antitumor treatment will be evaluated at 21 and 42 days and after 6 months. Furthermore patients safety will be monitored. Factors affecting immunogenicity (or lack of), including cancer treatment, will be the primary aim of the study.

This is an observational non-interventional study in cancer patients. The study will evaluate the safety, tolerability and immunogenicity of Pfizer SARS-CoV-2 RNA vaccine against COronaVIrus Disease-19 (COVID-19) which will be delivered in the deltoid muscle in 2-dose (separated by 21 days). Blood will be collected in two 5 milliliters (mL) vacuettes for serum Immunoglobulin G (IgG) and Cytokine assessment, at baseline and after 21 days, immediately before the first and the second dose, respectively, then after 42 days from the first dose and finally after 6 months from the baseline. A panel of 22 cytokines (Biorad) will be measured at baseline and after 21 and 42 days in four groups consisting of: no responders (S1/S2 IgG\<15 Arbitrary Unit AU/ml at 42 days), slow responders (S1/S2 IgG\<15 AU/mL after 21 days and \>15 AU/mL after the second dose), fast responders (S1/S2 IgG\>15 AU/mL after the first 21 days) and immunized patients (S1/S2 IgG\>15 AU/mL at baseline). At baseline, at 42 days and 6 months questionnaires for psychological testing will be dispensed for completion to patients.

After 42 days from the first dose, 15 mL of heparinized peripheral blood from both non-responders (S1/S2 IgG\<25 AU/mL) and responders will be used for isolation of different Cluster of Differentiation 4 (CD4+) and CD8+ T cell subpopulations and analysis of their capability to undergo activation/proliferation in response to specific SARS- CoV-2 derived peptides.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* On treatment for cancer during the last 6 months or being treated \>6 months ago but being ultravulnerable
* About to receive "Pfizer-BioNTech COVID-19" vaccine
* Lymphocyte count≥0.5x10\^9/L

Exclusion Criteria:

* Subjects who are not eligible for "Pfizer-BioNTech COVID-19" vaccine administration
* Inability and/or unwillingness to sign written informed consent
The Biofeedback Therapy in Solitery Rectal Ulser Patients BIOFEEDBACK THERAPY

Dissynergic defecation causes solitery rectal ulcer. The biofeedback therapy improves dissynegy and heals soliter rectal ulcer.

dyssynergia treating ulcers caused by treatment with biofeedback

Eligibility Criteria:
Inclusion Criteria:

* solitary rectal ulcer in rectosigmoidoscopy
* type 1 or 3 dissynergic defecation
* to accept to participate to study and sign informed consent

Exclusion Criteria:

* previously applied biofeedback
* serious psychiatric disorder
* previous anorectal surgery
* the presence of active malignancy
Evaluate the Efficacy of Disopyramide Therapy in Hypertrophic Obstructive Cardiomyopathy Patients

Population study- patients with obstructive hypertrophic cardiomyopathy that are treated with disopyramide.

Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide.

Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide.

Eligibility Criteria:
Inclusion Criteria:

* hypertrophic cardiomyopathy that treated with disopyramid

Exclusion Criteria:

* pregnancy
* pacemaker
Validation of the Quark RMR Calorimeter (Cosmed) Versus Deltatrac II (GE Health Care Clinical Systems)

Measurement of energy expenditure at rest (12 hours fasting) and in dynamic phase after a meal (600kcal) to compare the results of the two calorimeters in standardized conditions for the validation of quark RMR versus Deltatrac II

Clinically, energy expenditure is usually estimated using predictive equations, such as the Harris-Benedict equation, which consider the patient's weight, height, age and sex to determine energy needs. However these have been shown to be unsystematically incorrect and may vary by 70-140% when compared with indirect and direct calorimetry measurements.

That is why the most popular method of measurement of energy expenditure in research is via indirect calorimetry using a metabolic cart. Indirect calorimetry is the measurement of the volume of oxygen consumption and carbon dioxide production.

Actually, there are few numbers of indirect calorimeters available commercialy. The Deltatrac II metabolic cart was the gold standard. It has been extensively used in clinical research both for resting metabolic rate and substrate oxidation measurement during postprandial or an insulin clamp. The Quark RMR is also a metabolic cart too which was launched on the market to compete with the others calorimeters measuring resting metabolic rate.

As the Quark RMR and Deltatrac II use the same measure device (paramagnetic analyser for oxygen detection, infrared absorption for carbon dioxide detection) with the same sensitivity and time response according to constructor's data, we want to compare these two calorimeters for the measurement of energy expenditure and substrate oxidation at rest and during a meal in standardized conditions.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 60 years old
* BMI between 20 and 35 kg/m²
* Weight stable for at least 2 months
* Safety subject during medical consultation
* Normal TSH -CRP -glycemia - creatinin

Exclusion Criteria:

* Medical or surgical history which may affect energy expenditure (renal -cardiovascular -hepatic- endocrine-inflamatory diseases)
* Drug use that could affect energy expenditure (steroids, nicotine substitutes, thyroid hormones)
* Eating disorder
* Intensive sportive activity (Baecke's score \>5)
* Subjects who Smoke
* Claustrophobic subjects
* Pregnant women
Impact of Pharmaceutical Interviews Regarding the Management of Adverse Effects Related to the Antibiotic Therapy Used to Treat Osteoarticular Infections During Return Home

The primary objective is to evaluate the impact of Pharmaceutical Interviews in the patient self-management of non-severe side effects caused by antibiotics prescribed for the treatment of osteoarticular infections when the patient returns home.


Eligibility Criteria:
Inclusion Criteria:

* Patient \> or =18 years;
* Informed consent signed;
* French-speaking and reading;
* Affiliated to a social insurance;
* Benefiting from medical and surgical care for an osteoarticular infection;
* Treated with an oral antibiotic therapy on discharge from hospital.
* Indication of the antibiotic therapy osteoarticular infection;
* Return home immediately after discharge.

Exclusion Criteria:

* Refusal to participate
* Protected adult patient, under guardianship or curatorship.
* Minor patient
* Patient benefiting from an AME.
* Pregnant or breastfeeding woman.
* Non-French speaking patient.
* Patient unable to understand the course of the study.
* Patient with a documented history of cognitive or psychiatric disorders.
* Patient treated with oral antibiotic therapy for an indication other than osteoarticular infection.
* Patient treated with parenteral antibiotic therapy.
* Discharge: Institution (EHPAD), rehabilitation or other health establishment.
* Patient systematically using one of the symptomatic treatments proposed in the discharge prescription before hospitalization.
Skin-to Skin Contact on Newborn Temperature

This study will compare standard methods of stabilizing a newborn's temperature after birth with mother-infant skin-to-skin contact for stabilizing newborn temperature. The study will look at the effects of each warming method on the timing of newborns' initial bath and the effects on newborn initiation and percent weight loss by discharge.

The study will use a randomized controlled trial (RCT) design to test a clinical intervention at TriHealth Good Samaritan Hospital. Study participants will be randomized to the intervention group (IG), which will implement mother-baby Skin-to-Skin (STS) immediately after vaginal birth, or to the control group (CG), which will receive standard care for newborn and mother immediately after vaginal birth.

This study will test the hypothesis that mother-baby STS contact implemented immediately after delivery for a minimum of the newborn's first 60 minutes and with a resumption of STS (if a 15-minute break in STS occurs at some point after the first hour) until the newborn's temperature stabilizes after the initial bath will result in:

1. Improved newborn temperature stability and thermoregulation for newborns whether breast or formula-fed.
2. Initiation of effective breastfeeding behavior within 90 minutes of birth and the addition of at least one more breastfeeding within four hours of birth for breastfed newborns.
3. Avoidance of newborn weight loss of 10% or greater.


Eligibility Criteria:
Inclusion Criteria:

* Woman in labor presenting with
* An uncomplicated pregnancy
* Full-term gestation: 38 0/7 weeks
* Single gestation
* Vertex presentation
* Plans to deliver without general anesthesia
* Likelihood of a vaginal delivery

Exclusion Criteria:

* A complication of pregnancy at the time of admission
* An inability to speak or understand English language
* Preterm gestation: 37 6/7 weeks
* A multiple gestation
* Non-vertex presentation
* Plan for delivery with general anesthesia
* Planned Cesarean delivery
Iron Prehabilitation in Endometrial Cancer

Endometrial cancer patients often have iron deficiency anemia before surgery, which can be effectively treated with oral iron supplementation. Anemia and blood transfusions have been previously associated with perioperative infectious diseases. In the present study the investigators will evaluate the impact of perioperative iron supplementation on the incidence of perioperative infections.

Prehabilitation has a multimodal conception based on three fundamental pillars: improvement of the patient's physical condition, nutritional optimization and other measures such as smoking cessation and correction of anemia.

As in the case of multimodal rehabilitation protocols, the actions of prehabilitation programs have synergistic effects, that is, small changes that, by themselves, do not have clinical significance but when added up, they produce a significant improvement in the postoperative evolution of patients.

Surgical site infections (SSIs) are considered to be the most common nosocomial infections among surgical patients and constitute a heavy and potentially preventable economic burden on health care providers. Although the impact of blood transfusion on the risk of SSI remains controversial, several studies have shown that anemia and transfusion predispose to postoperative bacterial infections.

In the present study the investigators seek to evaluate the impact of per os iron prehabilitation on perioperative outcomes of endometrial cancer patients, including need for transfusion and infectious morbidity.

Eligibility Criteria:
Inclusion Criteria:

Women with endometrial cancer enrolled in the surgical list

Exclusion Criteria:

Women with endometrial cancer requiring immediate surgery due to life-threatening hemorrhage
Relevance of Reactive Hypoglycemia During an OGTT in Everyday Life Using Continuous Glucose Measurement

This research project aims to investigate the everyday relevance of reactive hypoglycemia (hypoglycemia after a glucose load) in the oral glucose tolerance test (OGTT). Therefore, blood glucose profiles in everyday life will be examined using continuous glucose measurement (Free Style Libre PRO IQ system) over a period of 14 days in affected persons.

The aim of this analysis is to examine people who underwent an OGTT due to various endocrinological and metabolic issues and developed reactive hypoglycemia, defined as a drop in blood glucose \<70mg/dl during the course of the test. During OGTT routine laboratory testing will be performed as part of routine clinical practice. In order to investigate the occurrence and perception of hypoglycaemia in the everyday lives of those affected, their blood glucose profiles will be recorded and evaluated over a period of 14 days.

In addition, the perception of (suspected) hypoglycemia and counteraction will be documented. Anthropometric data will be recorded and a bioelectrical impedance analysis performed to check a correlation with the body composition. Subjects will be recruited via the endocrinology outpatient clinic as part of medical care. To date, very little CGM data are available on the frequency and extent of reactive hypoglycemia in the everyday lives of people without diabetes mellitus. Therefore, 20 subjects with hypoglycemia in the OGTT will be included in this exploratory pilot study for hypothesis generation in order to investigate the occurrence and perception of hypoglycemia in everyday life.

Eligibility Criteria:
Inclusion Criteria:

* hypoglycemia during a 75 g oral glucose tolerance test defined as glucose level below 70 mg/dl at timepoint 180 min.
* written consent

Exclusion Criteria:

* diabetes mellitus
* use of medication interfering with glucose metabolism (steroid, antidiabetic medications)
* surgery of upper GI-tract
* known plaster allergies
* any other clinical condition that would endanger participants safety or question scientific success according to the physicians opinion
Allergy and Ashthma in Children Who Were Fed Supplemented Infant Formula

Allergy and Asthma study of children (3 - 7 Years of age) who participated in randomized trials of supplemented infant formula during infancy conducted by The Retina Foundation of the Southwest .


Eligibility Criteria:
Inclusion Criteria:

* Children who participated in randomized trials of supplemented infant formula conducted by The Retina Foundation of the Southwest during infancy

Exclusion Criteria:

-
Haemophilus Influenzae Pneumonia in Adults

Haemophilus influenzae is a Gram-negative coccobacillus capable of colonizing and infecting the human respiratory tract.

In the adult population, patients with an abnormality of their mucociliary epithelium and a deficiency in innate or adaptive immunity are particularly exposed.

The Infectious and Tropical Diseases department of Necker-Enfants Malades hospital has noted a recent increase in the number of cases of respiratory infections due to H. influenzae, with a high frequency of early relapses and recurrences despite appropriate treatment.

The research focuses on lower respiratory infections (pneumonia) caused by Haemophilus influenzae in adults, excluding pneumonia acquired under mechanical ventilation linked to Haemophilus influenzae in patients in 13 AP-HP hospitals during 12 months, from 09/01/2022 to 08/31/2023.

Haemophilus influenzae is a Gram-negative coccobacillus capable of colonizing and infecting the human respiratory tract.

In the adult population, patients with an abnormality of their mucociliary epithelium and a deficiency in innate or adaptive immunity are particularly exposed.

The Infectious and Tropical Diseases department of Necker-Enfants Malades hospital has noted a recent increase in the number of cases of respiratory infections due to H. influenzae, with a high frequency of early relapses and recurrences despite appropriate treatment.

The research focuses on lower respiratory infections (pneumonia) caused by Haemophilus influenzae in adults, excluding pneumonia acquired under mechanical ventilation linked to Haemophilus influenzae in patients in 13 AP-HP hospitals during 12 months, from 09/01/2022 to 08/31/2023.

The main objective of the study is to identify factors associated with relapse in hospitalized adult Haemophilus influenzae pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* Acute respiratory symptoms: cough and/or dyspnea and/or purulent sputum or worsening of the color of the sputum for patients with chronic respiratory pathology, chest pain, desaturation defined by saturation \< 95% in ambient air
* Inflammatory syndrome: fever ≥ 38.5°C or CRP ≥ 30 mg/L
* Pulmonary imaging (x-ray or CT scan) compatible with pneumonia
* Good quality respiratory sample (for cytobacteriological examination of sputum (CBES) : leukocytes \> 25/mm3 and cells \< 10/mm3) positive in culture for H. influenzae at a significant threshold (for CBES ≥ 107 CFU/mL, for "standard" bronchial aspirate ≥ 105 CFU/mL, for protected bronchial aspiration ≥ 103 CFU/mL, for bronchoalveolar lavage ≥ 104 CFU/mL)
* Respiratory antibiotic therapy started by the clinician

Exclusion Criteria:

* Age \< 18 years
* Opposition formulated (following receipt of the study information note)
* Legal protection measure (impossibility of collecting non-opposition)
* Ventilator-associated pneumonia (VAP)