cyrilzakka/clinical-trials huggingface dataset:
Diode Laser Study for Periodontal Maintenance Patients

This study tries to determine whether the additional use of laser with "cleaning" (known as scaling and root planning) will result in the reduction of inflammation, reduction of bleeding upon examination and reduction of pocket depth in patients who are being maintained on a regular basis but have pocket depths that are ≥5mm with bleeding. When a pocket is bleeding, it is inflamed. It is usually "cleaned" with periodontal instruments (root-planed) to establish health. Some research also advocates using laser therapy to treat a bleeding pocket. Laser therapy is presently being performed in some dental offices and dental colleges. This research is trying to see if the additional laser therapy is beneficial.

The purpose of this study is to determine whether the adjunctive use of diode laser with scaling and root planing is more effective than scaling and root planing alone in clinically reducing periodontal pocket depth (PD), reducing bleeding on probing (BOP) and gaining of clinical attachment level (CAL). It also assesses whether diode laser with scaling and root planing will have an effect on cytokines and inflammatory biomarkers compared to root planing alone.

Any adult who is currently a routine periodontal maintenance patient and has one or more ≥ 5mm pockets with BOP will be invited to participate in the study. If they choose to participate, they will sign an informed consent. Crevicular fluid samples from each test site and another non-involved site in the mouth will be collected utilizing the standard protocol and frozen for later analyses of the presence of certain inflammatory biomarkers (IL-1β). Baseline data (i.e., PD, CAL, BOP, suppuration, supragingival plaque, subgingival restorative margins, smoking status) will be collected. The involved teeth will then be randomly treated with scaling and root-planing with hand instruments and diode laser (test) or scaling and root-planing with hand instruments alone. The patient will return 3 months later for follow-up data collection. He/she will then receive his/her regular 3 month maintenance therapy.

The changes between baseline and 3 months for the clinical parameters and gingival crevicular fluids' inflammatory biomarkers will be compared between test and control experimental sites.

Eligibility Criteria:
Inclusion Criteria:

* Any adult periodontal maintenance patient having had chronic periodontitis with last active therapy at least 3 months prior and with 1 or more sites/subject with ≥5mm probing depth that have bleeding on probing and/or suppuration. They have signed an informed consent form to participate in the study.

Exclusion Criteria:

* Subjects who are un-controlled diabetics, use NSAIDS regularly for chronic disease/pain, used antibiotics for the last 3 months, require antibiotic coverage for therapy, are pregnant and below age 30.
Effects of EMONO in Children During Dental Care

The main objective of this project is to evaluate the effects sought and the effects felt by children when EMONO is used in pediatric dental care. The Investigators will try to characterize the children who have submitted a request to extend contact with EMONO. The maintenance of a framework for the safe use of this drug whose place in dental care is fundamental and the benefit ratio is very favorable is essential.

Some narcotic drugs and psychotropic drugs associated with a risk of misuse or identified dependence and are, moreover, the object of a reinforced surveillance. This is the case of EMONO (Equimolar Oxygen and Nitrogen Protoxide Mix), which is part of the ANSM (French National Agency for Medicines and Health Products Safety) list of drugs with enhanced surveillance. EMONO is a gas composed equally of oxygen and nitrous oxide (also called laughing gas). He has had a marketing authorization in France since 2001. Until 2009, it was reserved for hospital use. Since 2009, a modification of its MA has enabled the release of the hospital reserve, EMONO can now be used in city medicine and dental surgery. The ANSM has made its provision outside health facilities conditional on the implementation of a common national RMP, accompanied by a national monitoring of pharmacovigilance and addictovigilance. The latter is under the responsibility of CEIP-A of Nantes.

The use of EMONO in pediatric dental care is a particular mode of use in a pediatric population in which the administration of EMONO is often the first administration of a psychoactive substance known for its positive effects (euphoria). Health professionals daily observe children, who after care under EMONO, have a strong appetite for EMONO and claim for any intervention. It would be necessary to understand why, and to estimate the number of children involved. Do children feel positive effects during these actions, which could lead to a wish to prolong the contact with the gas, in search of an effect other than therapeutic? The main objective of this project is to evaluate the effects sought and the effects felt by children when EMONO is used in pediatric dental care. The investigators will try to characterize the children who have submitted a request to extend contact with EMONO. The maintenance of a framework for the safe use of this drug whose place in dental care is fundamental and the benefit ratio is very favorable is essential.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 3 to 15, requiring care under MEOPA

Exclusion Criteria:

* Do not fit into the inclusion criteria
Study of Fludarabine Drug Exposure in Pediatric Bone Marrow Transplantation

Fludarabine is a chemotherapy drug used extensively in bone marrow transplantation. The goal of this study is to determine what causes some children to have different drug concentrations of fludarabine in their bodies and if drug levels are related to whether or not a child experiences severe side-effects during their bone marrow transplant. The hypothesis is that clinical and genetic factors cause changes in fludarabine drug levels in pediatric bone marrow transplant patients and that high levels may cause severe side-effects.

Fludarabine is a nucleoside analog with potent antitumor and immunosuppressive properties used in conditioning regimens of pediatric allogeneic hematopoietic cell transplantation (alloHCT) to promote stem cell engraftment.

This is a single-center, pharmacokinetic-pharmacodynamic (PK-PD) study investigating the clinical pharmacology of fludarabine in 45 children undergoing alloHCT at University of California, San Francisco Benioff Children's Hospital.

Patients would receive fludarabine regardless of whether or not they decide to consent to PK sampling.

Fludarabine doses will not be adjusted based on PK data.

We will apply the combination of a D-optimality-based limited sampling strategy and population PK methodologies to determine specific factors influencing fludarabine exposure in pediatric alloHCT recipients and identify exposure-response relationships.

Subjects will undergo PK sampling of plasma (f-ara-a) and intracellular (f-ara-ATP) drug concentrations over the duration of fludarabine therapy (3 to 5 days).

To evaluate sources of variability impacting fludarabine exposure clinical data will be obtained from the patient's medical chart on each day of PK sampling.

A single blood draw for the collection of DNA and genotyping of single nucleotide polymorphisms of genes involved in fludarabine activation, transport or elimination will occur in all patients.

To assess exposure-response relationships neutrophil engraftment, treatment-related toxicity, and survival data will be collected through day 100 post-transplant.

Eligibility Criteria:
Inclusion Criteria:

* Children 0-17 years of age
* Undergoing alloHCT for the treatment of malignant or nonmalignant disorder
* Receiving fludarabine-based preparative regimen

Exclusion Criteria:

* Any child 7-17 years of age unwilling to provide assent
* Parent or guardian unwilling to provide written consent
Single Session Pain Education

To pilot single session pain education classes aimed at improving outcomes and behaviors in patients with chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* chronic pain patients, pain longer than 3 months
* ability to adhere to and complete study protocols

Exclusion Criteria:

* not fluent in English
* recent injury at the discretion of the researcher
* previous completion of pain education class at the discretion of the researcher
* current cancer diagnosis or other medical condition at the discretion of the researcher
Application of Cognitive Training Based on the Remind Strategy in Glioma Patients With Cognitive Impairment

The purpose of this study is to form an interdisciplinary team to dynamically evaluate patient cognitive outcomes and develop an individualized cognitive training program for Chinese brain tumor patients

Adult patients diagnosed with glioma who meet the inclusion criteria will be enrolled in this study. Patients admitted to Neurosurgery Ward 1 and Ward 2 will be assigned to the intervention group, while those admitted to Neurosurgery Ward 3 and Ward 4 will serve as the control group. The intervention group will receive cognitive rehabilitation training based on the Remind strategy in addition to standard rehabilitation care, whereas the control group will receive only standard rehabilitation care. Assessment of patients' cognitive function, quality of life, psychological status, and the effectiveness of cognitive training intervention will be conducted on the first day of admission, one day before discharge, and at the end of the intervention period.

Eligibility Criteria:
Inclusion Criteria:

1. Conforming to the diagnostic criteria outlined in the "Chinese Clinical Guidelines for Diagnosis and Treatment of Central Nervous System Gliomas (2015)" ;
2. Patients diagnosed with brain gliomas through histopathological and/or cytological examination;
3. MoCA (Montreal Cognitive Assessment) score ≤ 26;
4. Karnofsky Performance Status (KPS) score ≥ 60, with no history of past illnesses;
5. Age ≥ 18 years;
6. Clear consciousness;
7. Willingness to participate and signed informed consent form.

Exclusion Criteria:

1. Diagnosed with neurological or psychiatric disorders within the past two years;
2. Impaired consciousness;
3. Accompanied by severe complications such as infections;
4. Nursing Delirium Screening Checklist (Nu-DESC) score ≥ 2;
5. Patients with changes in condition or requiring repeat surgery;
6. Patients with multiple intracranial tumors;
7. Inability to effectively complete the questionnaire or withdrawal during the study.
Bupivacaine Pharmacokinetics Following TAP Block

The aims of this study are to determine population PK parameters of bupivacaine in children following TAP block using a population-based PK approach, and to evaluate the influence of patient covariates on drug disposition.

The number of published pediatric studies on the use of transversus abdominis plane (TAP) block has increased in recent years. The transversus abdominis plane (TAP) block has been used for postoperative analgesia for surgery to the abdominal wall and involves the injection of local anesthetic solution into a plane between internal oblique (IO) and transversus abdominis (TA) muscles. The TAP block has the advantage of providing unilateral analgesia in instances of non-midline abdominal incision and is particularly useful in cases where epidural blockade is either contraindicated or technically or logistically not feasible. Bupivacaine and ropivacaine have been used as local anesthetics for TAP blocks in published studies to date. However, no data exist regarding the pharmacokinetics of bupivacaine after TAP block in children. The aims of this study are to determine population pharmacokinetic (PK) parameters of bupivacaine in children following a TAP block, using a population-based PK approach.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving a TAP block as part of routine anesthetic management
* Patients older than 3 months and less than 18 years of age
* Patients weighing ≥ 6 kg
* Patients with American Society of Anesthesiologists (ASA) score 1-3

Exclusion Criteria:

* Patients with known severe preexisting liver disease
* Patients with known severe (i.e. requiring dialysis) preexisting renal disease
* Patients who will be discharged the day of surgery
* Refusal to consent
A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study

Treatment of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss.

This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of four (4) concentrations of DE-126, when compared with latanoprost (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension.

The IOP will be measured at 3 different times throughout the day, over 6 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, vital signs, and clinical laboratory tests. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Provide signed written informed consent
* Diagnosis of POAG or OHT in both eyes
* Qualifying corrected visual acuity in each eye
* Qualifying central corneal thickness in each eye
* Qualifying Day 1 IOP measurement at 3 time-points in both eyes
* Qualifying Anterior chamber angle

Exclusion Criteria:

* History of ocular surgery specifically intended to lower IOP
* Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period
* Advanced glaucoma in either eye
* Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry
* Any ocular surgery or ocular laser treatment within 90 days prior to Visit 1 (Screening) and throughout the study in either eye
* Females who are pregnant, nursing, or planning a pregnancy
Bioequivalency Study of Levetiracetam 750 mg Tablets Under Fasting Conditions

The objective of this study was to prove the bioequivalence of Levetiracetam 750 mg Tablets under fasted conditions


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Levetiracetam or any comparable or similar product.
Asthma, Missed Immunizations, and Vitamin D Deficiency in Atopic Dermatitis

Atopic dermatitis is a chronic skin disease with pruritus as one of its main features. Because of the symptomatic nature of their condition, pediatric patients with atopic dermatitis may preferentially seek care in the subspecialty dermatology clinic while falling behind in visits to their primary care provider. This cross-sectional study in patients attending the Dermatology Clinic at Children's Hospital of Wisconsin will screen for common conditions associated with atopic dermatitis and subsequently treat or refer patients for appropriate care. The investigators hypothesize that Milwaukee County pediatric patients with atopic dermatitis will have a high prevalence of asthma needing treatment, missed immunizations requiring catch-up, and vitamin D deficiency necessitating replacement therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with atopic dermatitis by a Children's Hospital of Wisconsin (CHW) pediatric dermatologist
* Age 1- 18 years old
* Primary residence in Milwaukee County

Exclusion Criteria:

* Other chronic, systemic diseases other than asthma or environmental allergies
* Hyperimmunoglobulin E or Job syndrome
* Ichthyosis disorder other than ichthyosis vulgaris
* Prior systemic therapy or phototherapy for atopic dermatitis
* Ongoing or prior treatment for known Vitamin D deficiency
* On chronic systemic corticosteroids for asthma
Complications in Parotid Surgery

The investigators conducted a prospective study of 132 patients undergoing benign parotid surgery at our department. Their primary objective was to analyze the incidence of and contributing factors associated with temporary and permanent postoperative facial palsy with strictly standardized methods in facial nerve function evaluation. Also other complications occurring within 12 months of operation were recorded.

Patients who underwent parotid surgery at the Department of Otorhinolaryngology - Head and Neck Surgery, Helsinki University Hospital, Helsinki, Finland, between September 2011 and November 2012 were prospectively enrolled. Exclusion criteria were age under 18, suspicion of malignancy or facial schwannoma, a tumor extending into the parapharyngeal space, and previous parotid surgery exposing facial nerve.

Eligibility Criteria:
Inclusion Criteria:

* parotid gland tumour surgery

Exclusion Criteria:

* age under 18
* suspicion of malignancy or facial schwannoma
* a tumor extending into the parapharyngeal space
* previous parotid surgery exposing facial nerve
Impact of Daylight on Patients With Acute Myocardial Infarction

The study tests if intense light could be a potential therapy in humans after myocardial infarction by inducing Per2.

Damage to the heart caused by a myocardial infarction (heart attack) occurs most often during the early morning hours (6AM). Thus, the involvement of the circadian system (circa= approximately day) has been suggested. The circadian system in humans or animals is based on the rotation of the earth with day and night phases. When humans (or animals) wake up light shines in their eyes and the body receives a signal that the day starts. For the human body it means that certain proteins (named clock, period etc) are produced. The protein that determines the length of a day (awake and sleep period) is called Period 2 (Per2). Recent data indicated that the Per2 protein in hearts from mice is induced after daylight exposure (daylight with an intensity comparable to a bright day at the beach was used, approx. 10 000 LUX). This more Per2 was able to protect the heart from being damaged by no blood going to the heart (protection from a heart attack). This protection was based on a more efficient use of sugars (carbohydrates). Thereby the heart needs less oxygen. Current data indicate that human Per2 is also induced by light exposure and can be detected in human plasma samples.

In this study Per2 transcript and protein levels will be analyzed in patients that just experienced a heart attack with and without intense light (daylight) therapy utilizing blood samples (erythrocytes and leukocytes).

Eligibility Criteria:
Inclusion Criteria:

* Patients with an acute myocardial infarction
* Healthy volunteers
* Must speak and understand English

Exclusion Criteria:

* Patients with an acute myocardial infarction but are too sick, e.g. severe symptoms, chest pain, generally unstable, etc.
Effect of Annona Muricata Leaves on Colorectal Cancer Patients and Colorectal Cancer Cells

Annona muricata L., include the leaves, is found to contain biologically active Annonaceous acetogenins and plant polyphenols that are important components of human diet and a number of them are considered to have chemopreventive and therapeutic properties against cancer.

To confirm previous findings in in vitro, animal study and traditionally use, a human, ex vivo and in vitro studies were conducted to evaluate the effects of consecutive ingestion of A. muricata leaves extract for eight weeks.

Colorectal cancer patients were randomly assigned to receive either A. muricata leaves extract or placebo. Dietary intakes and anthropometry were assessed with food record every two weeks. Blood parameters, nutritional status, quality of life, fecal butyrate level, and systemic inflammation of patient were assessed at the beginning and the end of study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Colorectal Carcinoma
* Have undergone standard therapy
* Satisfactory haematological or biochemical functions
* Karnofsky performance status of ≥ 60%
* Willing not to take probiotic supplement during study period

Exclusion Criteria:

* Uncontrolled hypertension
* Serious heart, kidney, liver endocrine or neurologic/psychiatric diseases
* Physical and mental disability that renders them unable to verbally communicate
* History of recent cancers
* Pregnant, lactating, or not using adequate contraception
* Patient on other investigational drug
Nosocomial Outbreak of BHRe in an Intensive Care Unit During SARS-CoV-2 Pandemic

Multidrug Resistant (MDR) bacteria have become a major worldwide public health challenge and hospitals are now increasingly faced with management of local outbreaks involving such pathogens. Especially, intensive care units (ICU) provide an ideal background for outbreaks caused by MDR bacteria among which carbapenemase-producing Enterobacteriaceae (CPE) can be found. Among CPE involved in ICU outbreaks, VIM producers have been reported worldwide, and described as especially difficult to control. The COVID-19 pandemic and all of the measures health workers have to implement to fight the spread of SARS-Cov-2 have also impacted the management of such outbreaks. In this retrospective study, the investigators aim to describe the management of an outbreak caused by a VIM-producing Enterobacter cloacae strain during the 2020 COVID-19 pandemic in an ICU, and show the importance of concerted measures and actions implemented at multiple levels to prevent the spread of this MDR strain.

Multidrug Resistant (MDR) bacteria have become a major worldwide public health challenge and hospitals are now increasingly faced with management of local outbreaks involving such pathogens. Especially, intensive care units (ICU) provide an ideal background for outbreaks caused by MDR bacteria among which carbapenemase-producing Enterobacteriaceae (CPE) can be found. Among CPE involved in ICU outbreaks, VIM producers have been reported worldwide, and described as especially difficult to control. The COVID-19 pandemic and all of the measures health workers have to implement to fight the spread of SARS-Cov-2 have also impacted the management of such outbreaks. The likely source of an outbreak is not always easy to pinpoint, but some common sources can be cited: an index patient with a history of hospitalization abroad, a contaminated instrument, and/or an environmental reservoir. CPE outbreaks in ICU usually have multifactorial origins, thus needing to combine several actions to be controlled. Infection and prevention control (IPC) measures habitually rely on patients screening, use of contact precautions, staff education, enhanced environmental cleaning, cohorting of patients and staff as well as a proper antimicrobial stewardship. Investigation of these outbreaks and implementation of IPC measures are ensured by various professional categories in the hospital. This implies a tight cooperation and communication between all involved healthcare workers.

In this retrospective study, the investigators aim to describe the management of an outbreak caused by a VIM-producing Enterobacter cloacae strain during the 2020 COVID-19 pandemic in an ICU, and show the importance of concerted measures and actions implemented at multiple levels to prevent the spread of this MDR strain.

Eligibility Criteria:
Inclusion Criteria:

* patients who have stayed in ICU
* patients with positive sample to E. cloacae VIM between March and October 2020

Exclusion Criteria:

* patients who didn't agreed to be included