louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02150005: Non-surgical Periodontal Treatment on Hemogram, Lipid and Glycemic Profiles in Patients With Coronariopathies
Official title: Effects of Non-surgical Periodontal Treatment on Hemogram, Lipid and Glycemic Profiles of Patients With an Indication for Surgical Coronary Revascularization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Coronariopathy
Keywords: periodontal diseases
cardiovascular diseases
periodontitis treatment
Lead sponsor: Universidade Veiga de Almeida
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2014-05-29
Enrollment: 22
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: The aim of this study was to examine the effects of non-surgical periodontal treatment on the hemogram, glycemic and lipid profiles in cardiopathic patients with an indication for surgical revascularization.

Materials and Methods: Twenty-two patients with chronic periodontitis, over 35 years of age (mean age 59.45 years) randomly assigned into 2 groups were evaluated. Test group (n=11), received periodontal treatment before the surgical procedure, and control group (n=11), did not received periodontal treatment prior to surgery.


Eligibility criteria: Inclusion Criteria:

* Undergoing cardiovascular treatment;
* Eight viable teeth in the oral cavity;
* Four periodontal sites with periodontal probing depths ≥5mm in different teeth.

Exclusion Criteria:

-

Primary outcomes:
measure: Reduction in probing depth in sites with PPD>3mm
timeFrame: Baseline and 90 days after the initial exam
measure: Reduction in probing depth in sites with PPD>5mm
timeFrame: Baseline and 90 days after the initial exam
measure: Reduction in probing depth in sites with CAL>3mm
timeFrame: Baseline and 90 days after the initial exam
measure: Reduction in probing depth in sites with CAL >5mm
timeFrame: Baseline and 90 days after the initial exam
measure: Leukocyte count
timeFrame: Baseline and 90 days after the initial exam
measure: Glucose
timeFrame: Baseline and 90 days after the initial exam
measure: Hemocyte
timeFrame: Baseline and 90 days after initial exam
measure: Hemoglobin
timeFrame: Baseline and 90 days after initial exam
measure: Total Cholesterol
timeFrame: Baseline and 90 days after initial exam
measure: High density lipid
timeFrame: Baseline and 90 days after initial exam
measure: Low density lipid
timeFrame: Baseline and 90 days after initial exam
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05120505: Metformin in Children With Fragile X Syndrome
Official title: Efficacy and Safety of Metformin in the Treatment of Fragile X Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Fragile X Syndrome
Metformin
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a controlled trial of metformin in children with fragile X syndrome(FXS). The age of FXS children range from 2 to 16 years old. Participants will be randomized in a double-blind design to either drug or placebo for 6-month period. The primary objectives are to assess metformin in treatment of behavior problems, cognitive and language with fragile X syndrome.

Detailed description: This is a single-center study at the Children's Hospital of Fudan University for FXS patients aged 2 to 16 years inclusive. It is a randomized, double-blind, placebo-controlled trial of metformin.

Studies showed that there were pathogenically over activates of mTOR and MAPK/ERK pathways in FXS. Metformin, a guanidine derivative ,has been shown to reduce mTORC1 pathway activity in an AMPK-dependent manner and has also been shown to reduce MAPK pathway activity. Metformin treatments for FXS have been reported in animal experiments, some open label trials of metformin in FXS patients had been reported. Therefore, metformin has potential to rescue symptoms in children with FXS.

In this study, researchers hope to investigate the improvement effect of metformin on FXS symptoms such as behavior problems, cognition, language.

The intervention period is 6 months, follow-up visit at 1 year. The researchers will also assess the side effects of the study medication throughout the trial.

Eligibility criteria: Inclusion Criteria:

* Genetic testing confirms the diagnosis of FXS
* Participate in the study with the informed consent of the guardian
* BMI\>the 3rd percentile
* Not taking more than 2 therapeutic drugs
* Able to receive regular follow-up visits

Exclusion Criteria:

* Malnutrition
* Primary heart disease
* Severe infection or acute clinical illness
* Gastrointestinal, renal, or hepatic disease
* Previous history of lactic acidosis
* previous use of metformin intolerant
* Use of angiotensin converting enzyme inhibitors, use of anticoagulants, vitamin B12 deficiency, alcohol consumption
* Unstable systemic diseases other than FXS
* Changes in clinical medication

Primary outcomes:
measure: Change of scores of Aberrant Behavior Checklist (ABC)
timeFrame: From baseline to the 6th month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT02884505: Improving the Assessment of Hypersomnolence
Official title: Improving the Assessment of Hypersomnolence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorders of Excessive Somnolence
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for polysomnography and multiple sleep latency test at the University of Wisconsin-Madison

Brief summary: The overall purpose of this study is to employ a pragmatic, multidimensional assessment of hypersomnolence that "piggybacks" on routine clinical care in patients with suspected disorders of central nervous system (CNS) hypersomnia, to determine whether these additional objective and subjective assessments are useful in the diagnosis and management of these patients.


Eligibility criteria: Inclusion Criteria:

* Age 18-89
* Referred for polysomnography/multiple sleep latency test at Wisconsin Sleep, the sleep medicine clinic and laboratory of the University of Wisconsin-Madison

Exclusion Criteria:

* unstable medical condition that, in the opinion of the investigators, would make it unsafe for the subject to participate

Primary outcomes:
measure: Proportion of Patients Categorized with Hypersomnolence
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison, Department of Psychiatry
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: David T Plante, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02374905: Testing Interventions to Reduce Alcohol Consumption Among Outpatients in a Dental Setting
Official title: Assess and Improve Patient's Self-reported Alcohol Consumption While Attending the Oral Medicine Clinic
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alcohol Addiction
Mouth Diseases
Keywords: drinksmeter
alcohol counselling
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
First posted: 2015-03-02
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators wish to investigate the feasibility of using a web based drinking app (www.drinksmeter.com) to reduce alcohol consumption among patients attending an outpatient clinic in a dental setting.

Detailed description: Any intervention on alcohol use is relevant to patients attending an oral medicine clinic, as alcohol can contribute to/or worsen mouth disorders. For example, research confirms that white and red patches of the lining of the mouth in regular tobacco and alcohol users can change to mouth cancer. Many people do not know that drinking alcohol would increase their mouth cancer risk.

Any new or follow-up patients attending our clinic and reporting drinking over the recommended guidelines (as given by European Code Against Cancer) will be eligible to participate. The study will start on the first visit to the clinic and/or at their follow-up visit. For each volunteer the study will last 3 months. Participants will be allocated to two groups, those receiving routine brief counselling on the day of their visit and those to whom a web-based electronic tool to self-assess is introduced. They will be motivated to use it in the following weeks to reduce consumption . The study will evaluate alcohol consumption levels using tested questionnaires at base-line and exit.

The investigators will assess the feasibility of the use of an electronic tool in our study population, whether it provided better outcomes compared to standard care.

Eligibility criteria: Inclusion Criteria:

* Patient attending the Department of Oral Medicine at King's College Hospital and consuming alcohol over recommended guidance (European Code Against Cancer)

Exclusion Criteria:

* Patient which cannot understand English
* Complete lack of IT literacy
* Patient in contact with a specialized alcohol service

Primary outcomes:
measure: Reduction in mean number of alcohol units consumed per week
timeFrame: 6-12 months
Secondary outcomes:
measure: Improvement of AUDIT-10 (Alcohol Use Disorders Identification Test) Questionnaire Score
timeFrame: 6-12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital
state: Lambeth
Study officials:
affiliation: King's College London
name: Saman Warnakulasuriya, BDS,PhD,DSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT05548205: Effect of 2-Week Continuous Glucose Monitoring on Glycemic Management in Patients New-to-Insulin on Hospital Discharge
Official title: Effect of 2-Week Continuous Glucose Monitoring on Glycemic Management in Patients New-to-Insulin on Hospital Discharge
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Keywords: Continuous Glucose Monitoring (CGM)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study will be a randomized, prospective, non-blinded study of 120 participants with type 1 or type 2 diabetes that are new-to-insulin on hospital discharge. On hospital discharge, participants will be assigned to either the intervention of wearing a continuous glucose monitor (CGM) for 2 weeks or blood glucose monitoring (BGM) for 2 weeks. They will have a 2-week follow up visit, during which insulin doses will be adjusted as needed, and a 3-month follow-up visit, at which point HbA1c will be measured.


Eligibility criteria: Inclusion Criteria:

1. Male or female aged 18-100 years
2. Known history of type 1 or type 2 diabetes
3. Admitted to NYU Langone Hospital - Long Island between September 1st, 2022 and August 31st, 2023
4. New initiation of insulin therapy, including basal insulin regimen, basal-bolus insulin regimen, or mixed insulin regimen at the time of hospital discharge

Exclusion Criteria:

1. Prior to admission use of home insulin therapy
2. Current use of systemic corticosteroids
3. Active pregnancy; as pregnancy requires different blood glucose targets, subjects known to be pregnant will be excluded from this study. Subjects will not be tested for pregnancy outside of testing performed in routine medical care; pregnancy will be determined by patient self-reporting. Females of childbearing potential will not be instructed to avoid pregnancy, however if they became pregnant during the study (detected by self-reporting), they will be withdrawn from the study.

Primary outcomes:
measure: Percentage Change in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Month 3 Post-Discharge
Secondary outcomes:
measure: Number of Hospital Admissions
timeFrame: Up to Month 3 Post-Discharge
measure: Number of Emergency Department (ER) Visits
timeFrame: Up to Month 3 Post-Discharge
measure: Number of Hypoglycemic Events
timeFrame: Up to Month 3 Post-Discharge
Other outcomes:
Locations:
city: Mineola
country: United States
facility: NYU Langone Hospital - Long Island
state: New York
Study officials:
affiliation: NYU Langone Hospital - Long Island
name: Stanislaw Klek
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04088305: Vancomycin Dosage Strategy Based on a Trough Concentration Model
Official title: Clinical Evaluation of a Vancomycin Dosage Strategy Based on a Serum Trough Concentration Model in Elderly Patients With Severe Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumonia, Staphylococcal
Keywords: pneumonia
vancomycin
trough concentration
elderly patients
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 66
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study design:

Allocation: Randomized Endpoint classification: Efficacy study Masking: Open label Primary purpose: Treatment Primary endpoint: Incidence of reaching the target serum trough concentration Secondary endpoint: Clinical efficiency, Antibiotic use, acute kidney injury.

Detailed description: This is a prospective randomized control trial. There are two groups, study group and control group. Patients of study group accepted vancomycin strategies decided by a serum trough concentration model, and patients of control group accepted vancomycin dosage decided by attending physician. The primary endpoint is the incidence of reaching the target serum trough concentration, the secondary endpoint are clinical efficiency, antibiotic use and side effects such as acute kidney injury, etc.

Eligibility criteria: Inclusion Criteria:

* Patients with doubted or diagnosed Methicillin-resistant Staphylococcus aureus severe pneumonia, and need vancomycin treatment.
* Sixty years and older.

Exclusion Criteria:

* younger than 60 years old
* Accepted blood purification therapy
* Pregnancy
* Positive HIV antibody titre
* Had known or suspected tuberculosis or other infections caused by fungi at baseline.

Primary outcomes:
measure: The incidence of vancomycin therapeutic serum trough concentrations
timeFrame: before the fifth vancomycin dosage
Secondary outcomes:
measure: Clinical success rate
timeFrame: Seven days after vancomycin withdrawal.
measure: Vancomycin doses
timeFrame: At the end of vancomycin therapy, an average of 10 days.
measure: Incidence of acute kidney injury
timeFrame: At the end of vancomycin treatment, an average of 10 days.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospita
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Qingtao Zhou, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01749605: A Pilot Comparison of Short-course Nitrofurantoin in Females With Uncomplicated Bacterial Cystitis in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Uncomplicated Bacterial Cystitis
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2012-12-13
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pilot study to compare the efficacy and safety of 3-day, twice-daily regimens of nitrofurantoin and ciprofloxacin in emergency department (ED) patients presenting with UBC.


Eligibility criteria: Inclusion Criteria:

* pre-menopausal females
* ages 18-45 years old
* symptoms of a UTI (dysuria, frequency, urgency)

Exclusion Criteria:

* Onset of symptoms \>7 days prior to the ED visit
* Non-English speaking
* Symptoms of pyelonephritis
* Diabetic
* Indications of sepsis
* Immunocompromised
* Currently using prophylactic antimicrobials
* Medications that could interfere with study drug
* Pregnant
* Lactating
* History of kidney or liver disease
* Vaginal symptoms
* Presence of a urinary catheter
* Treatment for UBC \<2 weeks prior to ED visit
* Known allergy to study drug
* Unavailable for follow-up

Primary outcomes:
measure: Number of Participants With Clinical Cure at Day 7
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
References:
Clinical trial NCT04361305: Observational Study of Pharmacological Treatment for Premature Ejaculation Concurrent With Erectile Dysfunction
Official title: Multicenter Study of the Efficacy and Safety of Dapoxetine Combined With Tadalafil in Men With Premature Ejaculation and Concomitant Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Premature Ejaculation
Erectile Dysfunction
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Premature ejaculation (PE) is a common disease in the andrology clinic. Currently, the effectiveness and outcome differences of drug treatment still need to be studied and demonstrated. Premature ejaculation concurrent with erectile dysfunction (ED) is common in outpatient clinics. The preferred treatment plan for these patients still needs to be further studied and explored, and the difference in the efficacy of different treatment regiments remain to be evaluated.


Eligibility criteria: Inclusion Criteria:

1. PE concurrent with ED: the IELT is less than 3 minutes, the PEDT score is ≥11 points, and 5≤IIEF-5≤21 points.
2. 18-60 years old, outpatient or physical examination population, with regular sex partners and regular sex life;
3. Having the data below,and willing to participate in the trial（1）Demographic information: age, gender, nationality, birthplace, etc;(2) Physical examination data: height, weight, abdominal circumference, blood pressure, heart rate, etc ;(3) Medical history data: history of present illness, past medical history, family history, etc;(4) Scale evaluation: Premature Ejaculation Diagnostic Tool (PEDT), Premature Ejaculation Profile (PEP), International Erectile Function Score-5(IIEF-5), Erectile Hardness Grading Score (EHGS), Clinical Global Impression of Change (GICC);

Exclusion Criteria:

1. Age \<18 years or\> 60 years;
2. There is a history of acute and chronic diseases, major trauma and surgery, etc;
3. A long history of medication;
4. There is a history of unstable myocardial infarction and cerebral infarction;
5. A history of cardiogenic shock, severe heart failure, severe ventricular arrhythmia, etc;
6. There are serious diseases such as malignant tumors, chronic liver and kidney diseases, etc.

Primary outcomes:
measure: The change of Premature Ejaculation Profile (PEP) at week 8
timeFrame: Baseline, Week 8
measure: The change of International Index of Erectile Function -5(IIEF-5) at week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Incidence of adverse reactions
timeFrame: Baseline, Week 8
measure: The change of Erection Hardness Score (EHS)
timeFrame: Baseline, Week 8
measure: Clinical Global Impression of Change (GICC)
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02183805: Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Metastatic Triple-negative Breast Cancer
Official title: Phase II Study of Chemotherapy Followed by Peripheral Stem Cell Transplantation as First Line Therapy for Metastatic Triple-negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma Breast Stage IV
Keywords: triple negative breast cancer
autologous hematopoietic stem-cell transplantation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-07-08
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

Detailed description: To explore the progression-free survival of patients with metastatic triple-negative breast cancer treated with peripheral blood stem cell transplant (PBSCT) followed by high dose chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) 0 or 1.
* Histologically or cytologically proven diagnosis of breast cancer with evidence of locally recurrent or metastatic disease.
* Documentation of estrogen and progestin receptor (ER/PR) negative status and HER2/neu receptor negative status (ie, FISH negative or immunohistochemistry 0 or +1).
* Obtained complete response or Good partial response after first line chemotherapy.
* Normal organ function required prior to study entry.
* Willingness to comply with treatment plans and other study procedures.

Exclusion Criteria:

* Uncontrolled central nervous system (CNS) involvement with disease
* Fertile women unwilling to use contraceptive techniques during treatment
* Females who are pregnant
* Organ dysfunction.
* Patients may not be receiving any other investigational agents.

Primary outcomes:
measure: Progression free Survival
timeFrame: 24 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Zhong-Yu Yuan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: