cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study to Assess the Effects of a Stannous Fluoride Dentifrice on Plaque and Gingivitis

The objective of this clinical study is to assess the effects of a 0.454% stannous fluoride dentifrice on gingivitis and plaque after 3 months when compared to a negative control.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
* Have at least 16 gradable teeth;
* Agree to return for scheduled visits and follow the study procedures;
* Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
* Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study;

Exclusion Criteria:

* Having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit;
* Have any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
* Removable oral appliances;
* Fixed facial or lingual orthodontic appliances;
* Self-reported pregnancy or lactation;
* Any diseases or condition that might interfere with the safe participation in the study; and
* Inability to undergo study procedures.
Impact of Virtual Reality on the Quality of Life of Oncology Patients

Anxiety, nausea and vomiting are common side effects in paediatric patients receiving chemotherapy. chemotherapy. New evidence supports the efficacy of immersive virtual reality in improving symptoms of anxiety and distress, including nausea and vomiting, in this vulnerable group. This research will evaluate the efficacy of virtual reality in managing anxiety, nausea and vomiting in cancer patients receiving their first line of chemotherapy and will also measure the quality of life of these patients and evaluate patient and nursing staff satisfaction

For cancer patients, virtual reality proved more effective than other forms of distraction in relieving anxiety, depression and fatigue during chemotherapy. Although pain and anxiety in cancer patients are managed proactively, this study was designed to measure the quality of life of these patients, assess patient and carer satisfaction, evaluate the effectiveness of virtual reality in reducing anxiety during the first three sessions of chemotherapy, and assess the impact of virtual reality on preventive and acute chemotherapy-induced fatigue, nausea and vomiting.

This is a clinical study with a therapeutic aim using a non-medicinal, interventional, prospective, multi-centre, controlled and randomised technique, with two parallel groups. It is clinical research involving the human person category 2, involving only minimal risks and constraints. The two arms are Arm A: study questionnaires with virtual reality (VR) Arm B: study questionnaires without virtual reality, standard care (SC)

A visit will be made during the 3 cycles of chemotherapy during which arm A will be immersed in Virtual Reality with the Healthy Mind VR programme.

programme, and patients in arm B will receive standard care without hypnotic support.

There will also be a pre-inclusion visit 7 days before the first cycle. and visits at 3, 6 and 9 months after the 3 cycles of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Chemotherapy-naive patient
* Patient with first-line indication for intravenous cyclic chemotherapy
* Affiliated to a social security system
* Having received full information on the organization of the research and having given free, informed and written consent signed by the participant and the investigator
* Patient understands French or English
* Expected duration of chemotherapy session for the first 3 cycles greater than 30 minutes

exclusion criteria :

* Patient with communication disorders preventing informed consent
* Patient under legal protection (guardianship, curatorship, safeguard of justice)
* Patients suffering from epilepsy
* Severe visual or hearing impairment preventing use of headphones
* Psychiatric pathologies such as delusional disorders, hallucinations or schizophrenia.
* Patients with infections or facial wounds
* Patients with severe claustrophobia
* Patients with pacemakers
* Patients with known cognitive or learning problems,
* Patients with brain tumors or metastases,
* Patients suffering from motion sickness
* Expected duration of chemotherapy session for the first 3 cycles of 30 minutes or less.
Well-being Promotion and Sleep Hygiene Education to Improve Sleep Quality

The overall goal of this project is to evaluate the effect of enhanced psychological well-being on sleep quality. This study will demonstrate whether combining an intervention designed to promote psychological well-being with sleep hygiene education improves sleep quality in a non-clinical population of distressed adults reporting poor sleep in the absence of a diagnosed sleep disorder. The investigators expect an intervention combining elements of psychological well-being and sleep hygiene education to result in significant improvements in sleep quality measures from baseline to post-intervention, and greater improvements in sleep quality measures at post-intervention as compared with sleep hygiene education alone.

Psychological distress is often associated with poor sleep quality. The role of psychological well-being has often been neglected and most interventions for sleep improvement have focused primarily on sleep disorders. This approach is limited to those individuals who have specific conditions and little resources have been directed to the promotion of sleep quality in the general population.

This study will be a pilot parallel-arm, randomized controlled trial to assess the baseline associations between psychological well-being and different measures of sleep outcomes, determine the effect of elements of a psychological well-being promoting intervention on sleep quality, and examine effect size estimates of key sleep-related outcomes (duration, efficiency, quality) to provide essential data to inform a main efficacy trial.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Distress according to the Perceived Stress Scale
* Poor sleep quality according to the Pittsburgh Sleep Quality Index
* No diagnosis of sleep disorders
* English fluency
* Access to a computer with an Internet connection

Exclusion Criteria:

* Inability to provide informed consent for any reason
* Cognitive impairment according to the Montreal Cognitive Assessment
* Suspected presence of sleep apnea according to the Berlin Questionnaire
* Diagnosis of a chronic medical or psychiatric condition
* Severe depression or suicidal thoughts or wishes according to the Beck Depression Inventory
* Body Mass Index (BMI) ≥ 35 kg/m2
* Chronic use of medications for sleep or chronic medical and psychiatric conditions
* Any current psychological or behavioral intervention administered by a health care provider or as part of a research project
* Shift workers
* Pregnant women
* Parents or caregivers of newborns (\<1 year)
* Heavy drinkers (≥ 8 drinks/week for women and ≥ 15 drinks/week for men)
* Binge drinkers (≥ 4 drinks on a single occasion within about 2 hours for women and ≥ 5 drinks on a single occasion within about 2 hours for men
* Use of recreational or street drugs
* Heavy smokers (≥ 20 cigarettes daily)
* Heavy caffeine users (\> 400 mg a day, corresponding to about 4 or 5 cups of coffee)
A Study to Evaluate Treatment Preferences for Japanese Participants With Muscle-invasive Urothelial Carcinoma of the Bladder

The main purpose of this study is to identify important treatment attributes for post-radical cystectomy (RC) treatment for participants with MIBC (Muscle-Invasive Bladder Cancer) and assess the relative importance of treatment attributes for post-RC treatment in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Must reside in Japan and able to speak/read Japanese for the interview/survey
* Must have a clinical diagnosis of Muscle-invasive bladder cancer (MIBC):

  * ypT2-ypT4a or ypN+ MIBC, with prior neoadjuvant cisplatin chemotherapy and underwent radical cystectomy
  * pT3-pT4a or pN+ MIBC, without prior neoadjuvant cisplatin chemotherapy and underwent radical cystectomy
* Must not have received any treatment related to MIBC after radical cystectomy

Exclusion Criteria:

* Determined by the physician as being unsuitable for the study (e.g. having any clinically significant psychiatric disorder, cognitive impairment, or having difficulty with communicating in Japanese)
* Confirmed diagnosis of other primary cancers at the time of obtaining consent
* Current participation in a MIBC clinical trial
Re-evaluation of Donor-specific Anti-HLA Alloantibodies Immunoassay After Organ Transplantation, From Antigen Level to Epitope Level

Transplantation is the only treatment for end-stage organ dysfunction, with dialysis for the kidney. However, donor / recipient (D / R) tissue incompatibility accounts for the majority of long-term graft losses, through the development of serum-specific donor antibodies (DSA) to human leukocyte antigens (HLA) of donor, with a prevalence of about 10% at 2 years and 20% at 5 years.

DSA immunization is very often directed against one or a few of the donor's incompatible antigens, suggesting that epitopes (and antigens) are not all equally immunogenic. Identifying HLA epitopes that cause the most and the least immunization would help refine the graft distribution to better manage a limited resource by defining the D / R combinations to avoid or promote. Since the immunogenicity of an HLA epitope depends on the HLA of the recipient given the properties of the epitopes mentioned above, a very large cohort is needed to understand this question. To do so, it is necessary to redo these typings with a method exploring all the genes (add DQA1, DRB3 / 4/5, DPB1 and DPA1) when this has not been done after the graft as part of the standard care. This has become possible since 3 years by DNA sequencing called "new generation" (or NGS), a method that is supplanting all others for the medical care of patients in transplantation.

This study is a retrospective cohort study with 5-year follow-up. The investigators' main objective is to evaluate the predictive value of the number of mismatched HLA epitopes for the development of DSA anti-HLA de novo at 2 years. The investigators' secondary objectives are to evaluate this parameter at 5 and 8 years to determine which epitope mismatches should be favored / avoided in the future.


Eligibility Criteria:
Inclusion Criteria:

* patients (adults and children)
* patients recipients in France from 2008 to 2015 of a first kidney transplant / heart / lung / liver donor living or deceased, non-immunized anti-HLA before the transplant
* patients having preserved their graft \> 2 years
* having agreed to the use for research purposes in transplantation of the remains of the DNA and serum samples taken as part of the care of which the remains are available

Exclusion Criteria:

* no inclusion if one of the inclusion criteria is not met
Effects of Milking the Umbilical Cord on Systemic Blood Flow

Premature babies are at risk for bleeding in their brains, which can result in developmental delays or other neurological problems such as cerebral palsy. Clamping the baby's umbilical cord immediately after birth is standard, but delaying this procedure allows more of the baby's blood to move from the placenta into the baby and prevents head bleeds. However, a delay in clamping the umbilical cord is not usually done in very premature babies, because it would delay their treatment and they could get cold. Milking the umbilical cord is another way to give premature babies more of their own blood while avoiding a delay in treatment. Umbilical cord milking has been shown to improve blood pressure, decrease the need for blood transfusions, and increase the amount of urine made in the first few days of life.

The aim of this study is to determine whether umbilical cord milking improves blood flow in premature babies, and thereby reduce the occurrence of neurological problems. The investigators predict that the blood flow measured by ultrasounds of the heart will be higher in babies who receive umbilical cord milking compared to those whose cords are clamped immediately. Secondly, the investigators predict that cord milking will improve blood volume, blood pressure, and urine output, and delay the need for blood transfusions.

This will be the first study to look at the effect that umbilical cord milking has on important measures of blood flow, which can predict bleeding in the head and subsequent developmental problems in very premature babies.

Eligibility Criteria:
Inclusion Criteria:

* infants \< 32 weeks gestation

Exclusion Criteria:

* obstetrician's refusal to participate
* multiple gestations (if Di-Mo placentation) surrogate delivery
* parental desire for cord blood banking
* major congenital anomalies
* severe maternal illness
* placental abruption or previa
* ruptured uterus at delivery, or hemoperitoneum
The Impact of Bariatric Surgery on Adipocyte Metabolism

The purpose of this study is to understand how daily rhythms of behavior affect the expression of genes in fat cells, and how these daily cycles affect the way fat cells respond to insulin (a hormone that controls blood sugar levels) before and after bariatric surgery.

Bariatric surgery as a means of weight loss has become increasingly popular over the last 10-15 years. In addition to promoting weight loss, bariatric surgery has become increasingly recognized for use in the management of diabetes. Recent studies have indicated that bariatric surgery can result in a marked improvement in insulin sensitivity before long term weight loss is attained. The goal of this project is to delineate the changes in the insulin responsiveness of subcutaneous adipocytes obtained by needle biopsy 2 weeks prior to surgery vs. 12 weeks after bariatric surgery, which could account for improvements in overall insulin sensitivity seen before any long-term sustained weight loss has occurred. The investigators will also examine gene expression in adipocytes (fat cells).

Eligibility Criteria:
Obese Subjects

Inclusion Criteria:

* 18-55 years old
* Female
* BMI greater than 40 kg/m2
* Scheduled for bariatric surgery at the Center for the Surgical Treatment of Obesity at the University of Chicago
* Signed informed consent

Exclusion Criteria:

* Male
* Diagnosed with a systemic illnesses, including heart, renal, liver, or malignant disease
* Uncontrolled hypertension (blood pressure greater than 140 mmHg systolic and 90 mmHg diastolic without medication)
* use of beta blockers
* hemoglobin less than 11.5g/dL
* known allergy to lidocaine
* pregnancy
* lactation
* Subjects will not have undergone surgery, donated a unit of blood, or participated in another clinical study within the last 4 weeks prior to consent.
* Post-menopausal

Non-Obese Subjects

Inclusion Criteria:

* 18-55 years old
* Female
* BMI less than 30 kg/m2
* Signed informed consent

Exclusion Criteria:

* Male
* Diagnosed with a systemic illnesses, including heart, renal, liver, or malignant disease
* Uncontrolled hypertension (blood pressure greater than 140 mmHg systolic and 90 mmHg diastolic without medication)
* use of beta blockers
* hemoglobin less than 11.5g/dL
* known allergy to lidocaine
* pregnancy
* lactation
* Subjects will not have undergone surgery, donated a unit of blood, or participated in another clinical study within the last 4 weeks prior to consent.
* Post-menopausal
A Pilot Trial to Determine the Efficacy of Lactobacillus Rhamnosus for Reducing Colonization by Methicillin-resistant Staphylococcus Aureus (MRSA) (PROSE)

The purpose of this study is to investigate the feasibility, safety and efficacy of oral probiotic, Lactobacillus rhamnosus versus oral placebo for reducing colonization by MRSA.

Healthcare-associated infections are an important threat to patient safety. Currently, between 5 and 10 percent of patients admitted to acute care hospitals acquire one or more infections; healthcare-associated infections affect approximately 2 million patients each year in the United States, result in 90,000 deaths, and are associated with an added cost of $4.5 to $5.7 billion per year. Seventy percent of healthcare-associated infections are caused by antimicrobial resistant bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), resulting in increased antimicrobial usage, morbidity and mortality, making prevention of multiresistant bacteria essential.

Eradication of colonization has been shown to greatly reduce infection; however, there are no reliable means of providing sustained eradication of colonization. No effective means of eradicating MRSA colonization exist.

Probiotics containing strains of lactobacilli represent a novel approach to the prevention and control of antimicrobial resistance and have been studied extensively for a variety of infections. Even though various studies have shown probiotics to be effective for prevention of vaginal infections, urinary tract infections, etc no studies have examined the potential of probiotics to eradicate colonization by resistant pathogens, such as MRSA.

Eligibility Criteria:
Inclusion Criteria:

* subjects will be male or female
* 18 years of age or older
* may or may not be hospitalized
* able to take oral medications
* have been found to be colonized with MRSA or at high risk of being colonized by MRSA and are not taking antibiotics

Exclusion Criteria:

* people on antibiotics will not be eligible to participate
Trial With Eribulin or Eribulin+ Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients

Unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC).

Pre- and post-menopausal women age ≥ 18 years with unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC) with no prior line of chemotherapy in the metastatic setting, and that have shown progression while on an aromatase inhibitor-containing regimen in the metastatic setting or within six months from last aromatase inhibitor dose in the adjuvant setting. Patients must have received at least one taxane or anthracycline regimen in either the adjuvant or the neoadjuvant setting. Subjects must have adequate bone marrow and creatinine clearance functions.

Eligibility Criteria:
Inclusion Criteria:

* ER-positive and/or PR-positive breast cancer.
* HER2-negative breast cancer.
* Unresectable locally advanced or metastatic breast cancer.
* Confirmed disease progression while in the last aromatase inhibition-containing regimen in the metastatic setting.
* At least one taxane or anthracycline regimen in either the adjuvant or the neoadjuvant setting.
* Patients with no prior line of chemotherapy in the metastatic setting.
* At least 1 and up to 3 prior lines of endocrine therapy in the metastatic setting.
* ECOG score 0 or 1.
* Patients have adequate bone marrow and organ function.
* Patients must have measurable disease (RECIST v.1.1).
* Premenopausal with LHRH analogues for at least 28 days) and postmenopausal women.
* Patients must agree to not breastfeed during the study and for 3 months after the last dose of study treatment.
* Life expectancy greater or equal to 12 weeks.
* Patients agree to collection of blood samples (liquid biopsy) and optional collection of metastatic tumour sample (biopsy) at the time of inclusion and progression (if appropriate).

Exclusion Criteria:

* Have received radiation therapy or limited-field palliative radiotherapy within two weeks prior to Cycle 1, Day 1, or patients who have not recovered from radiotherapy-related toxicities.
* Have received prior chemotherapy for locally advanced or metastatic disease.
* Have peripheral neuropathy grade 2 or greater.
* QTc \> 480 msec on basal assessments, history of congenital or personal history of long QT syndrome, Brugada syndrome, or Torsade de Pointes (TdP), or uncontrolled electrolyte disorders
* Child-bearing potential women not using highly effective methods of contraception.
* Known hypersensitivity to eribulin, endocrine therapy or its excipients.
* Other malignancies within the previous two years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of cervix or breast.
* Known uncontrolled metastases to the central nervous system (CNS) or any progressing CNS disease.
* Have a serious concomitant systemic disorder incompatible with the study.
* Major surgical procedure or significant traumatic injury within 28 days prior to randomization.
* Have received any anti-cancer biology or investigational treatment within 30 days prior to randomization.
Triglyceride/High-density Lipoprotein Cholesterol Ratio in Chronic Kidney Disease

The Triglycerides (TG) to High Density Lipoprotein Cholesterol (HDL-C) ratio is a feature of insulin resistance and an independent predictor of cardiovascular risk. The investigators aimed to evaluate the relationship between TG/HDL-C ratio and the endothelial functions in patients with CKD.

Cardiovascular disease (CVD) risk is substantially increased in subjects with chronic kidney disease (CKD).The reasons for the elevated risk of CVD in patients with CKD are not fully elucidated. There is not a good prognostic tool for the prediction of increased cardiovascular risk in CKD. A simple, widely available, relatively inexpensive, and generally reproducible marker to predict the CVD risk in subjects with CKD is needed.

The Triglycerides (TG) to High Density Lipoprotein Cholesterol (HDL-C) ratio is a feature of insulin resistance and an independent predictor of cardiovascular risk. No study has been performed so far, to evaluate the role of TG/HDL ratio to predict the CVD risk in patients with CKD.

This study is designed to evaluate the relationship between TG/HDL-C ratio and the endothelial functions in patients with CKD.

Eligibility Criteria:
Inclusion Criteria:

* patients with chronic kidney disease

Exclusion Criteria:

* taking drugs that may influence endothelial function
* acute infections
Application and Monitoring of Vasoactive and Inotrope Drugs

The investigators aimed to establish current practice of application and monitoring of vasoactive and inotrope Drugs in non-cardiac surgery patients.

This survey provides a current update on a variety of cardioactive and vasoactive drugs at non-cardiac surgery patients in germany.

Eligibility Criteria:
Inclusion Criteria:

* all anesthesiologists of germany

Exclusion Criteria:

* not completely responses