cyrilzakka/clinical-trials huggingface dataset:
CenteringPregnancy Oral Health Promotion

A five-year, Phase III, multi-site, cluster randomized controlled clinical trial will evaluate the efficacy of the CenteringPregnancy (CP) Oral Health Promotion (CPOP) intervention. Intervention and control groups will be drawn from 6 CP sites. Prenatal care facilitators will conduct the intervention in group prenatal care sessions. With an average of 4 CP facilitators per site (24 facilitators), conducting 2-3 CP groups each (48-72 CP groups with 8 mother/child dyads per group), the total study population will be approximately 384 dyads. CP facilitators will be randomly assigned to either the: 1) intervention arm and deliver the CPOP intervention; or 2) control arm and deliver the usual CP curriculum. The CPOP intervention consists of two 15-minute modules: 1) maternal oral health (OH) and 2) infant OH. The data collection will continue through 12 months postpartum. For the maternal OH module, pre- and post-intervention dental exams of gingival OH and Plaque Levels, and knowledge, attitudes and behavior (KAB) questionnaires during the prenatal period will be used to assess maternal OH outcomes. For the infant OH module, pre and post-module KAB questionnaires will be completed during the prenatal period. Infant OH risk status - the presence of caries-causing bacteria (mutans streptococci and Lactobacilli) in saliva of both mother and infant will be assessed when the infant is 12 months of age to determine differences in study arms.


Eligibility Criteria:
Inclusion Criteria:

Women:

* speak, read, or write in English or Spanish
* enrolled in CP prenatal group care identified as study group
* free of any condition that requires them to take antibiotic or antibacterial medication prior to dental procedures
* provide informed consent

Babies:

* healthy with no acute or chronic medical conditions, especially those conditions that may have resulted in hospitalizations and subsequent exposure to pathologic microorganisms
* free of any condition requiring antibiotic treatment currently or within the past three months.
* mothers provide informed consent for their children at baseline

Exclusion Criteria:

- none
Selection Criteria for Safe Hepatectomy for Hepatocellular Carcinoma

Selection criteria for safe hepatectomy for HCC are not well established. The aim of this study was the validation of the selection criteria for safe hepatectomy for hepatocellular carcinoma.

All consecutive patients submitted to hepatectomy for HCC based on the same preoperative selection criteria from our prospectively-maintained liver unit database. Such criteria included the value of bilirubin (BIL), the value of cholinesterases (CHE), the presence of ascites, the presence of esophageal varices, and the rate of residual liver volume.

Eligibility Criteria:
Inclusion Criteria:

* any patient with HCC submitted to hepatic resection at our Unit in the established frame time

Exclusion Criteria:

* any patient with missing data or lost at follow-up
Post-operative Results of the Trapezometacarpal (TMC) Prosthesis for Advanced Pre-operative Deformities

Trapezometacarpal protheses are implanted for patients with trapezometacarpal arthritis. Having a pre-operative thumb adduction angle of less than 25 degrees with hyperextension, meaning a " Z-deformity " are somehow a reason to go for another surgical treatment: trapezectomy with ligament reconstruction. This study will aim at analyzing the results of another surgical treatment which is the trapezometacarpal arthroplasty in this type of deformities.


Eligibility Criteria:
Inclusion criteria:

* Patient with TMC joint arthritis
* Patient with adduction \<25 degrees
* Patients with Z deformity
* Patient operated for TMC joint arthroplasty

Exclusion criteria:

- TMC arthroplasty implanted for fractures
Frequency Analysis of Raw EEG During Sevoflurane Anesthesia in Children Younger Than 2 Years Old

The purpose of this study is to analyze raw electroencephalogram in infants younger than 2 years old undergoing general anesthesia using sevoflurane.

After obtaining an informed consent from one of the parents, patients undergo routine anesthetic induction using sodium thiopental. Bispectral index and patient state index are both monitored simultaneously. Raw electroencephalogram data are transmitted and recorded via a dedicated equipment. Anesthesia is maintained using sevoflurane with end-tidal level of less than 2 minimum alveolar concentration (MAC) adjusted to age. Fentanyl of up to 1 mcg/kg can be administered in case of increased heart rate and mean blood pressure with a degree of 30% of baseline.

During anesthesia, patients' status of sedation is defined as 'maintenance of surgical state of anesthesia (MOSSA)' when the end-tidal concentration of sevoflurane is maintained between 0.7 and 1.3 MAC and mean blood pressure and heart rate is between 80-120% of baseline.

'Emergence' is defined as a 3-minute period in the middle of continuous decrease in end-tidal concentration of sevoflurane in the range of less than 0.7 MAC and finally reaching 0.2 MAC.

Raw electroencephalogram waves are analyzed by distribution of power along frequency bands and compared according to the state of anesthesia or bispectral index / patient state index value.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged between 4 months and 2 years planned to undergo surgery under general anesthesia
* American Society of Anesthesiologists physical status 1 or 2

Exclusion Criteria:

* History of preterm birth (postconceptual age \< 32 wks) or history of mechanical ventilation immediately after birth
* Presence of genetic disease or chromosomal abnormality that can affect brain development
* Presence of disease in central nervous system
* History of head trauma or surgery involving head
* History of hypersensitivity to anesthetic drugs
* Intubated or sedated state before induction of anesthesia
* Difficulty in attaching both the bispectral index and patient state index probes to patient's forehead
* Expected operation time of less than 5 minutes
Goal-directed LCVP Based on HP in Laparoscopic Hepatectomy

The goal of this clinical trial is to learn about goal-directed LCVP based on hypovolemic phlebotomy (HP) in laparoscopic hepatectomy. The main questions it aims to answer are:

1. The safety and feasibility of HP
2. To evaluate whether HP can reduce perioperative blood transfusion ratio Participants undergoing liver resection with HP was performed by the anesthesiologist. Blood was withdrawn approximately 30 min prior to the initiation of liver parenchymal transection from central venous. The aim was to maintain the CVP between 0 to 5 cmH2O. HP volume was 5-10 mL/kg of patient body weight, generally. Participants in control group undergoing liver resection without HP.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Hepatocellular Carcinoma
* Preference for laparoscopic hepatectomy and patient agreement

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Refusal of blood product transfusion
* Active cardiac conditions (unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease, history of congestive heart failure)
* History of significant cerebrovascular disease
* Restrictive or obstructive pulmonary disease
* Uncontrolled hypertension
* Renal dysfunction (glomerular filtration rate \<60 mL/min),
* Hemoglobin \<100 g/L
* Abnormal coagulation values (international normalized ratio \>1.5 not on warfarin and/or platelet count \<100 ×109/L)
* Evidence of hepatic metabolic disorder (bilirubin \>35 mmol/L)
* Presence of active infection
* Preoperative autologous blood donation
* Patients were not allowed to receive erythropoietin at any time during the index hospitalization.
Immunogenicity Against SARS-CoV-2 in COVID-19 Close Contacts

This study will investigate the presence of SARS-CoV-2 neutralizing antibody and its association with demographic information, medical history of SARS-CoV-2 infected individuals, exposure history of close contacts, vaccination status, and compliance with the strategies for self-quarantine to prevent the transmission in the community where SARS-CoV-2 infected individuals were home-quarantined and treated.

In the 4th outbreak of the covid-19 pandemic in Ho Chi Minh City since 27 April 2021, asymptomatic or mild covid-19 patients were self-quarantined and treated at home. This home care setting could yield risk of SARS-CoV-2 transmission from the index cases to the people living surroundings. Therefore, this study will be performed to investigate the immunogenicity against SARS-CoV-2 in household members or people lived in the same municipality with home-quarantined covid-19 patients.

All people over 18 years old, living in 2 blocks (V and Y) of Ngo Gia Tu apartment, which is located in District 10, Ho Chi Minh City, will be recruited into this study. A survey will be conducted using a questionnaire to collect the data related to the basic demographic information, medical history of SARS-CoV-2 infected individuals, exposure history of close contacts, vaccination status, and compliance with the strategies for self-quarantine to prevent the transmission in the community.

At the time of recruitment, Covid-19 rapid antigen detection tests using nasopharyngeal swabs will be performed for all study subjects. In addition, a total of 5mL of intravenous blood samples will be collected for serum extraction and DNA isolation. SARS-CoV-2 neutralizing antibody levels in serum samples will be evaluated by a surrogate virus neutralization test by using NeutraLISA kit® (Euroimmun, Luebeck, Germany). DNA will be isolated and stored for further use in investigating the association of ACE2 genetic polymorphisms with the prevalence of SARS-CoV-2 neutralizing antibodies.

Eligibility Criteria:
Inclusion Criteria:

* People who lived in the two blocks (V and Y) of Ngo Gia Tu apartment, located in District 10, Ho Chi Minh City, Vietnam, from July to September 2021
* 18 years of age and older
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

* People who were diagnosed with primary or secondary immunodeficiencies induced by diseases or medical treatments (immunosuppressants, chemotherapy, radiation therapy, ect.)
Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder

The aim of this study is to investigate the efficacy, safety, and tolerability of iloperidone compared with placebo in treating acute manic or mixed episodes associated with Bipolar I Disorder.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18 to 65 years of age (inclusive)
* Diagnosed with bipolar I disorder, manic or mixed-type, per DSM-5 criteria
* Voluntary hospitalization for current manic episode

Exclusion Criteria:

* Patients with a DSM-5 diagnosis of a psychiatric disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months
* Patients who are experiencing a first manic episode or meeting criteria for rapid cycling
Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects

This is a single-center, open-label study to assess the safety and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult male and female subjects. Thirty subjects will receive a total of 6 doses of cefepime-taniborbactam (2 g cefepime/0.5g taniborbactam) administered intravenously every 8 hours. Following the sixth dose of cefepime-taniborbactam, subjects will be assigned to one of six bronchoscopy sampling times.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults 18-55 years
2. Males or non-pregnant, non-lactating females
3. Body mass index (BMI): ≥18 kg/m2 and ≤32.0 kg/m2, weight \>50.0 kg.
4. Must have negative alcohol, drug, or tobacco use/test and no use of alcohol, caffeine during the study

Exclusion Criteria:

1. History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders
2. History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
3. Recent history of known or suspected Clostridioides difficile infection
4. Abnormal ECG or history of clinically significant abnormal rhythm disorder
5. Abnormal lab tests
A Description of Bacteria in the Mouths of Patients With Severe Aplastic Anemia

Background:

- This research is being done to describe the types of bacteria found in the mouths of patients who have severe aplastic anemia (SAA) and are treated with drugs that suppress the immune system or with stem cell transplant. People with SAA who receive these treatments are more likely to get infections. Studies show that there might be a link between the bacteria in your mouth and those bacteria that can cause infections. The bacteria found in the mouths of patients with SAA will be described.

Objectives:

- To understand the changes in mouth bacteria that are related to treatment and to describe the oral bacterial environment.

Eligibility:

* Adults at least 18 years of age who are going to be treated for SAA.
* Healthy volunteers at least 18 years of age.

Design:

* Participants will answer questions about their medical history and dental care. Their mouths will be examined.
* Participants with SAA will be tested during treatment for their disease, over the course of 1 year. All participants with SAA will be tested at 3 scheduled appointments. Any participants who require a breathing tube will receive additional tests.
* Healthy volunteers will be tested during 1 visit.
* Participants will give two samples each time. A saliva sample will be taken with a disposable padded tool. Skin cells will be collected from the tongue with a small plastic brush.

The mouth is a complex biological ecosystem normally containing over 700 different species of bacteria. Some of these bacteria live in an exopolysacchride matrix biofilm and occupy specific niches in this complex oral environment. Understanding the oral environment and the microbiota that inhabit it will assist in determining their impact on health and disease. There are several studies in critically ill patients demonstrating changes in oral bacteria related to acute illness. Identification of respiratory pathogens in the mouth has led researchers to hypothesize that a relationship exists between the oral cavity and pulmonary infections. This descriptive study will characterize the oral microbiota of patients who have severe aplastic anemia (SAA). Patients will be followed for 1 year after treatment for development of respiratory symptoms that require intubation. A difference in the oral microbiome will be identified in specimens collected before and after treatment.

Eligibility Criteria:
* All adult patients who are scheduled to receive treatment for SAA will be screened for this protocol. These patients will be recruited from the numerous protocols that are actively accepting new research participants at the Clinical Center, NIH.

INCLUSION CRITERIA

Any adult patient (greater than or equal to18 years of age), diagnosed with SAA.

EXCLUSION CRITERIA

Any SAA patient found to have significant tooth loss from decay or is edentulous are excluded. This exclusion criteria will be assessed by the PI or her representative prior to signing the informed consent.
Cytidine-phosphate-guanosine (CpG) DNA in Hepatocellular Carcinoma Combination Therapy

to observe the outcome of hepatocellular carcinoma patients under the combination treatment of transcatheter arterial chemoembolization (TACE) and CpG DNA


Eligibility Criteria:
Inclusion Criteria:

* TNM (tumor node metastasis ) staging with non distant metastasis; no other tumors

Exclusion Criteria:

* having received previous treatment for liver cancer
Effects of Real vs. Soundless Acoustic Stimulation During Deep Sleep on Brain Activity, Memory, and Blood Biomarkers in Older Adults (60-85) With Mild Memory Impairment

This study aims to explore a non-invasive way to improve memory and slow cognitive decline in older adults by enhancing sleep quality. Dementia, a leading cause of death worldwide, is often associated with disturbed sleep, particularly the loss of deep, slow-wave sleep (SWS). SWS is important for memory and clearing waste from the brain. Poor SWS can worsen memory loss and allow harmful waste to build up, which may increase the risk of dementia.

The investigators are testing whether phase-locked auditory stimulation (PLAS) can improve SWS in people at a mild stage of cognitive impairment. PLAS uses short sounds played at specific moments to strengthen slow-wave brain activity during sleep. The investigators previous laboratory based research has shown that this can improve memory and help with clearing waste from the brain. Now, the investigators want to test this in a real-world setting, over a longer period, which is unfeasible in a laboratory setting.

In this study, 60 older adults will use home-use devices that deliver either real or sham (soundless) PLAS across two different 4-week periods. Memory will be tested using engaging "serious games." Before and after each experimental period, blood samples will be taken to measure dementia-related markers, and cognitive batteries will be performed. The investigators expect that PLAS will improve sleep, and that this will have a downstream effect on memory and brain clearance, potentially slowing the process of cognitive decline.

If successful, this could lead to the development of an affordable treatment that helps people maintain brain health and prevent dementia.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age between 60 and 85 years
* Cognitive impairment (subjective and/or MoCA between 23-26)
* Native German speakers or comparably fluent
* Normal or corrected-to-normal vision.
* Intact hearing
* A close cohabitant (partner/sibling) should be present to support participants in using study materials/devices.

Exclusion Criteria:

* Insomnia assessed by the Regensburg Insomnia Scale (RIS; Crönlein et al., 2013)
* Restless leg syndrome assessed by questions concerning typical symptoms.
* Sleep apnoea assessed by the Berlin Questionnaire (BQ; Netzer et al., 1999)
* Severely irregular sleep patterns assessed by the RIS and the Pittsburgh sleep quality index (PSQI; Buysse et al., 1989)
* Symptoms of depression (Geriatric Depression Scale (GDS; Yesavage et al., 1982) ≥ 5)
* History of untreated severe neurological and psychiatric diseases
* Alcohol or substance abuse
* Use of medication acting on the central nervous system
Effect of Endometrial Scratching on Assisted Reproduction Outcomes: a Randomized Controlled Trial

To examine whether endometrial scratching (or injury) using a Pipelle endometrial sampler, performed on the first seven days of the menstrual cycle, is able to improve pregnancy rates in women who will be submitted to a fresh embryo transfer.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* First four days of the menstrual cycle, just before starting controlled ovarian stimulation for planned IVF and fresh embryo transfer.
* Not have performed endometrial scratching in the last 90 days.

Exclusion Criteria:

* None
Low-dose Chemotherapy Combine With Tyrosine Kinase Inhibitor to Treat ph+ Acute Lymphoblastic Leukemia Patients

The aim of our study is to improve the major molecular remission(MMR) rate and reduce the cost to treat ph(+) Acute Lymphoblastic Leukemia (ALL) by adjusting chemotherapy regimens and the dosage of Tyrosine Kinase Inhibitor (TKI). lower the classification of chemotherapy drugs, lower the side effect brought by which this would be a grateful news for the patients once this regimens gain a successful result, which is also the final aim of our efforts.

The investigators new therapy regimens: The investigators use dexamethasone 10mg/d(d3-d7) as pre-processing therapy, dasatinib 100mg (d1-d84) plus prednisone 60mg/m2 (d1-24), reduce to d32, as inductive treatment after inductive treatment, if the patient get major molecular remission, patient will get to consolidation therapy, that is methotrexate (MTX) 3g/m2 d1, if not, this patient would be excluded from our trail. after consolidation therapy, if the patient have matched bone marrow donor, the investigators will suggest the patient receipting allogens-stem cell transplantation, otherwise, autogens stem cell transplantation can also be considered once the patient have no applicable bone marrow donor. on the other side, if the patient still not get MMR after this two cycle, maybe the patient can try Car-T, or other chemotherapy regimens.

Eligibility Criteria:
Inclusion Criteria:

1. Get signed the informed consent of patients and family members
2. Age ≥ 18 one full year of life
3. Confirm the ph + ALL at molecular biology level
4. Normal heart and lungs function
5. Normal liver and kidney function

Exclusion Criteria:

1. Leukemia in the nervous system
2. Recurrent patients
3. Allergies associated with any drug in our research
4. At the same time with other organs' malignant tumours
5. participating in other clinical researches at the same time
MEN1703 (SEL24) in Participants With Acute Myeloid Leukemia

The purpose of the clinical trial is to identify the maximum tolerated dose of MEN1703 and to further investigate its safety profile in participants with acute myeloid leukemia (AML).

Phase I/II, open-label, multi-center, dose escalation study to estimate the maximum tolerated dose of MEN1703 in participants with acute myeloid leukemia.

The clinical trial will investigate the safety profile and anti-leukemic activity of MEN1703 in participants with AML and that have no standard therapeutic options available.

The clinical trial encompasses 2 parts:

* Part 1: Ascending dose levels - the main purpose of this part of the clinical trial is to determine the highest dose of MEN1703 considered to be well tolerated.
* Part 2: Expansion cohort - the main purpose of this part of the clinical trial is to assess the safety and anti-leukemia activity of MEN1703 given at the highest tolerated dose in participant with relapsed/refractory acute myeloid leukemia, either all comers as well as harboring isocitrate dehydrogenase (IDH1/IDH2) mutations.

Participants participating to the clinical trial will take the study drug as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle.

Eligibility Criteria:
Inclusion Criteria:

* Participants with diagnosis of AML, all comers or bearing IDH1 or IDH2 mutation (completed)
* Participant has no standard therapeutic options available and has either relapsed AML unsuitable for intensive chemotherapy, with no standard therapeutic options and/or not eligible for any approved targeted therapy or primary refractory AML unsuitable for intensive chemotherapy, with no standard therapeutic options and/or not eligible for any approved targeted therapy

Exclusion Criteria:

* Anti-cancer treatments (including cytotoxic chemotherapy, radiotherapy, hormonal therapy, biologic, immunotherapy or investigational drugs) received within 14 days or 5 half-lives for targeted therapies (whichever is shorter) before first dose of study drug (to be supplemented)