louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02719808: Study of Antiretroviral Therapy to Prevent HBV Intrauterine Infection
Official title: A Cohort Study of Tenofovir on Blocking HBV Intrauterine Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B, Chronic
Keywords: Vertical infection transmission
Tenofovir
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women with HBeAg-positive and HBV-DNA\>106copies/ml from the out-patient department of First Affiliated Hospital of Xi'an Jiaotong University

Brief summary: 500 pregnant patients with HBeAg-positive and HBV-DNA≥ 106copies /ml who will do their pregnant check in the First Affiliated Hospital of Xi'an Jiaotong University will be enrolled into the study. There will be five groups to be observed. Four groups are taking tenofovir to prevent intrauterine infection during pregnancy. One group is not taking any anti-HBV virus treatments.The clinical value and effectiveness of tenofovir on blocking HBV intrauterine infection will be evaluated; The HBV-DNA infection status of placenta tissue will be checked by quantitative Polymerase Chain Reaction (PCR) to assess the changes of HBV-DNA of placenta after treating with tenofovir and explore the mechanism of tenofovir blocking HBV intrauterine infection. The safety of Tenofovir will be assessed as well.


Eligibility criteria: Inclusion Criteria:

* pregnancy patients with HBeAg-positive and HBV-DNA≥ 106copies /ml

Exclusion Criteria:

* pregnancy patients with HBeAg-negative or HBV-DNA\<106copies /ml

Primary outcomes:
measure: deoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum
timeFrame: up to 1 year
measure: deoxyribonucleic acid of Hepatitis B Virus (HBV-DNA) in serum
timeFrame: up to 1 year
Secondary outcomes:
measure: the concentration of Interleukin 2 (IL-2)
timeFrame: up to 1 year
measure: interferon-γ (IFN-γ)
timeFrame: up to 1 year
measure: Interleukin 4 (IL-4)
timeFrame: up to 1 year
measure: Interleukin 6 (IL-6)
timeFrame: up to 1 year
measure: T cell ratio
timeFrame: up to 1 year
measure: HBV-DNA of babies
timeFrame: when the baby is 7-month-old
measure: hepatitis B e-antigen (HBeAg)
timeFrame: up to 1 year
measure: HBV-DNA in placenta tissue
timeFrame: the date of delivery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Guiqin Bai, M.D.;Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gao F, Zhang WT, Lin YY, Wang WM, Xu N, Bai GQ. Early Start Of Tenofovir Treatment Achieves Better Viral Suppression In Pregnant Women With A High HBV Viral Load: A Real-World Prospective Study. Infect Drug Resist. 2019 Nov 7;12:3475-3484. doi: 10.2147/IDR.S228982. eCollection 2019.
Clinical trial NCT05136508: The Effect of Volatile Anesthesia and Total Intravenous Anesthesia on Shedding of the Endothelial Glycocalyx in Patients Undergoing Mastectomy and Breast Reconstruction Using Deep Inferior Epigastric Artery Perforator Free Flap
Official title: The Effect of Volatile Anesthesia and Total Intravenous Anesthesia on Shedding of the Endothelial Glycocalyx in Patients Undergoing Mastectomy and Breast Reconstruction Using Deep Inferior Epigastric Artery Perforator Free Flap
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Inferior Epigastric Artery Perforator Flap Breast Reconstruction
Keywords: syndecan-1
propofol
volatile
anesthesia
deep inferior epigastric artery perforator flap breast reconstruction
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-11-29
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to investigate the effects of total intravenous and inhalation anesthesia on the damage of endothelial glucocorticoids by comparing the concentration of syndecan-1 in patients undergoing mastectomy and breast reconstruction using deep inferior epigastric artery perforator free flap

Detailed description: The aim of this study was to investigate the effects of total intravenous and inhalation anesthesia on the damage of endothelial glucocorticoids by comparing the concentration of syndecan-1 in patients undergoing mastectomy and breast reconstruction using deep inferior epigastric artery perforator free flap

Eligibility criteria: Inclusion Criteria:

1. Adult patients over 20 years old with ASA class I-III
2. Scheduled total mastectomy and deep inferior epigastric artery perforator flap breast reconstruction

Exclusion Criteria:

1. emergency surgery
2. Bilateral deep inferior epigastric artery perforator flap breast reconstruction
3. patients unable to make their own decisions, illiterate, foreigners
4. Allergy / hypersensitivity to sevoflurane or propofol 5, Current or past history or thrombosis / thromboembolism

6. patients who are taking oral contraceptives 7. Patients with renal insufficiency (eGFR 60 ml / min / 1.73 m 2 or less) 8. Patients receiving anticoagulants 9. pregnant and lactating women 10. Patients with history of psychiatric disease or neurological disease

Primary outcomes:
measure: Changes in blood concentration of syndecan-1
timeFrame: 1) 10 minutes after anesthesia induction <before surgery(base concentration)> 2) 10 minutes after sitting position 3) 1 hour after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
name: Na Young Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03377608: Modifiers of Tenofovir in the Female Genital Tract
Official title: Modifiers of Tenofovir Exposure in the Female Genital Tract of African Women on Depo-provera
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
Contraception
Keywords: tenofovir
microbiome
inflammation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: MU-JHU CARE
First posted: 2017-12-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women will be recruited from an existing cohort.

Brief summary: Two-armed, single visit, pharmacokinetic study to compare tenofovir diphosphate concentrations in cervical tissues of women on Depo-Provera contraception vs non-hormonal contraception.


Eligibility criteria: Inclusion Criteria:

* Female, or transgender female with a cervix, aged 18-35 years old
* HIV-positive
* Stable on antiretroviral regimen containing TDF for at least 2 weeks at time of enrollment.
* Virally suppressed (HIV-RNA copies \<50 copies/mL) for at least 6 months at time of enrollment.
* Willing to refrain from vaginal intercourse and use of vaginal devices such as douches and sex toys within 72 hours of the biopsy visit.
* Willing and able to give signed informed consent.

Exclusion Criteria:

* Currently pregnant or previous pregnancy within 3 months of enrollment
* Currently breast feeding
* Symptomatic vaginal infection within 2 weeks prior to enrollment
* Unexplained, undiagnosed abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior to enrollment
* History of vulvar/vaginal/ cervical dysplasia, neoplasia or cancer, atypical squamous cells of undetermined significance, condyloma, or human papilloma virus (HPV) in the past year
* Use of oral and/or vaginal preparations of antibiotic or antifungal medications within 30 days prior to the enrollment visit

Primary outcomes:
measure: Cervical Tissue Concentrations
timeFrame: Day 1
Secondary outcomes:
measure: Proinflammatory cytokines
timeFrame: Day 1
measure: Gene expression of drug metabolizing enzymes and transporters
timeFrame: Day 1
measure: Vaginal microbiome
timeFrame: Day 1
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: MU-JHU Care Ltd
Study officials:
References:
citation: Nicol MR, Eneh P, Nakalega R, Kaiser T, Kabwigu S, Isingel E, Beksinska M, Sykes C, Fowler MG, Brown TT, Staley C, Kiweewa Matovu F. Depot Medroxyprogesterone Acetate and the Vaginal Microbiome as Modifiers of Tenofovir Diphosphate and Lamivudine Triphosphate Concentrations in the Female Genital Tract of Ugandan Women: Implications for Tenofovir Disoproxil Fumarate/Lamivudine in Preexposure Prophylaxis. Clin Infect Dis. 2020 Apr 10;70(8):1717-1724. doi: 10.1093/cid/ciz443.
Clinical trial NCT05313308: A Survey of Midazolam in People With Status Epilepticus
Official title: BUCCOLAM OROMUCOSAL SOLUTION - Special Drug Use Surveillance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-04-06
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with status epilepticus who received midazolam oromucosal solution

Brief summary: This study is a survey in Japan of midazolam oromucosal solution used to treat people with status epilepticus. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects related from midazolam oromucosal solution and to check if midazolam oromucosal solution improves symptoms of status epilepticus. During the study, participants with status epilepticus will take midazolam oromucosal solution according to their clinic's standard practice. The study doctors will check for side effects from midazolam for 6 months.


Eligibility criteria: Inclusion Criteria

* Participants with non-convulsive status epilepticus
* Participants treated with study drug outside the medical institution
* Participants receiving an additional dose of study drug

Exclusion Criteria Participants have any contraindication to midazolam.

Primary outcomes:
measure: Number of Participants Who Experienced At Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: Up to 24 hours after drug administration
measure: Number of Participants With Serious Adverse Events
timeFrame: Up to 24 hours after drug administration
measure: Number of Participants With Therapeutic Success
timeFrame: Up to 30 minutes after drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda selected site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06554808: Socioeconomic Factors and Mortality in the Intensive Care Population
Official title: Impact of Comorbidity on the Association Between Socioeconomic Factors and Long-term Mortality of Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Socio-economic Status
Comorbidity
Keywords: Critical care
Intensive care
Mortality
Socio-economic status
Comorbidity
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 101745
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The first ICU admissions of patients aged 30 years and older, registered in the Swedish Intensive Care Registry (SIR) from 2009 to 2012.

Brief summary: It is important to find out how much of the socioeconomic factors´ impact on mortality on ICU patient´s can be explained by the presence of comorbidity. The aim of this study is to clarify the impact of socioeconomic factors on mortality and how much of this effect are due to comorbidity in the intensive care population.

Detailed description: The first ICU admissions of patients aged 30 years and older, registered in the Swedish Intensive Care Registry (SIR) from 2009 to 2012 were included. SIR was linked to the National Patient Register, Statistics Sweden and the Cause of Death Register using unique person identity numbers. Educational level and disposable income was reported in the year preceding the admission to intensive care to not be affected by the current illness.

Eligibility criteria: Inclusion Criteria:

* Registered in the Swedish Intensive Care Registry (SIR) from 2009 to 2012.
* The first ICU admission
* Patients aged 30 years and older

Exclusion Criteria:

* Missing registration of educational level
* Missing registration of income

Primary outcomes:
measure: Mortality
timeFrame: january 1, 2009 til december 31, 2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01317108: Prognostic and Predictive Impact of uPA/PAI-1
Official title: Adjuvant Chemotherapy in Node-negative Breast Cancer: Chemo N0
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: node-negative
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
First posted: 2011-03-17
Enrollment: 689
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Chemo-N0 (1993-1998) is the first prospective randomized multicenter trial in N0 BC designed to prospectively evaluate the clinical utility of a biomarker. It used uPA/PAI 1 as stratification criteria and randomized high-risk patients to chemotherapy versus observation; low-risk patients remained without any systemic therapy. The trial was designed to answer two principle questions:

1. Can the reported prognostic impact of uPA and PAI 1 be validated in a prospective multicenter therapy trial? Does low uPA/PAI 1 identify those low-risk N0 patients who are candidates for being spared necessity and burden of adjuvant chemotherapy?
2. Do uPA/PAI 1 high-risk patients benefit from adjuvant CMF chemotherapy?


Eligibility criteria: Inclusion Criteria:

* N0 breast cancer patients tumor size \>/= 1 and \</= 5 cm in diameter undergoing standard loco-regional treatment

Exclusion Criteria:

* M1 status

Primary outcomes:
measure: Prognostic impact of uPA/PAI-1: Number of patients disease-free in low vs. high risk groups according to uPA/PAI-1
timeFrame: DFS at 3, 5, and 10 years (depending on analysis time point)
measure: The benefit of adjuvant chemotherapy in high-risk group according to uPA/PAI-1: Number of patients disease-free vs. those relapsed at the given time points
timeFrame: DFS at 3, 5, and 10 years (depending on analysis time point)
Secondary outcomes:
measure: Overall survival
timeFrame: at 3, 5, and 10 years (depending on analysis time point).
Other outcomes:
Locations:
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Fritz Jaenicke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Janicke F, Prechtl A, Thomssen C, Harbeck N, Meisner C, Untch M, Sweep CG, Selbmann HK, Graeff H, Schmitt M; German N0 Study Group. Randomized adjuvant chemotherapy trial in high-risk, lymph node-negative breast cancer patients identified by urokinase-type plasminogen activator and plasminogen activator inhibitor type 1. J Natl Cancer Inst. 2001 Jun 20;93(12):913-20. doi: 10.1093/jnci/93.12.913.
citation: Harbeck N, Schmitt M, Meisner C, Friedel C, Untch M, Schmidt M, Sweep CG, Lisboa BW, Lux MP, Beck T, Hasmuller S, Kiechle M, Janicke F, Thomssen C; Chemo-N 0 Study Group. Ten-year analysis of the prospective multicentre Chemo-N0 trial validates American Society of Clinical Oncology (ASCO)-recommended biomarkers uPA and PAI-1 for therapy decision making in node-negative breast cancer patients. Eur J Cancer. 2013 May;49(8):1825-35. doi: 10.1016/j.ejca.2013.01.007. Epub 2013 Mar 13.
Clinical trial NCT00667108: A Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
Official title: A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter Study of Gabapentin 250 mg and 500 mg in Transient Insomnia Induced by a Sleep Phase Advance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Transient Insomnia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-25
Enrollment: 784
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep, using subjective sleep measurements, in subjects with transient insomnia induced by a sleep phase advance.


Eligibility criteria: Inclusion Criteria:

* Aged \>/= 18 years
* Females of child-bearing potential using medically-acceptable method of birth control \>/= 1 month prior to screening

Exclusion Criteria:

* Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition)
* Recreational drug use within past 30 days

Primary outcomes:
measure: Subjective sleep latency
timeFrame: Hour +8
Secondary outcomes:
measure: Subjective assessment of sleep refreshment
timeFrame: Hour +8
measure: Subjective assessment of sleep quality
timeFrame: Hour +8
measure: Karolinska Sleep Diary-Sleep (KSD) Quality Index
timeFrame: Hour +8
measure: KSD individual scores
timeFrame: Hour +8
measure: Digit Symbol Substitution Test
timeFrame: Hour +8
measure: Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score)
timeFrame: Hour +8
measure: Stanford Sleepiness Scale
timeFrame: Hour +13
measure: Vital signs
timeFrame: Hour +8
measure: Adverse events
timeFrame: Hour +13
measure: Subjective number of awakenings
timeFrame: Hour +8
measure: Subjective wake after sleep onset
timeFrame: Hour +8
measure: Subjective total sleep time
timeFrame: Hour +8
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Mount Laurel
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Spartanburg
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02316808: Cholesterol-lowering Effects of Plant Stanol Ester
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemias
Hypercholesterolemia
Hyperlipidemias
Lead sponsor: Raisio Group
Sponsor class: INDUSTRY
Collaborators: name: Indonesia University
First posted: 2014-12-15
Enrollment: 91
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient administered in a smoothie is less well known.


Eligibility criteria: Inclusion Criteria:

* total cholesterol concentration ≥ 200 mg/dL and \< 300 mg/dL, and or LDL-C concentration ≥ 130 mg/dL and \< 180 mg/dL
* were willing to consume control or plant stanol ester smoothie drinks two bottles per day immediately after a meal for four weeks,
* reachable by phone
* willing to declare written informed consent
* agreed in accordance with data protective stipulations and readiness to participate in the trial and to adhere to the study conditions.

Exclusion Criteria:

* Pregnant women
* obese
* diabetic subjects or subjects with random plasma glucose concentration \> 200 mg/dL
* hyperthyroidism, a history of metabolic, endocrine and kidney disorders
* acute or chronic severe diseases possibly interfering with the evaluation of the outcome of the clinical trial (such as AIDS, tumor diseases, malignant hypertension, cardiac insufficiency according to NYHA III-IV)
* taking lipid-lowering medication or other medications likely to affect lipid metabolism

Primary outcomes:
measure: Change (proportional) in LDL-C from baseline up to 4-weeks after plant stanol ester smoothie drink consumption.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lestiani L, Chandra DN, Laitinen K, Ambarwati FD, Kuusisto P, Lukito W. Double-Blind Randomized Placebo Controlled Trial Demonstrating Serum Cholesterol Lowering Efficacy of a Smoothie Drink with Added Plant Stanol Esters in an Indonesian Population. Cholesterol. 2018 Feb 4;2018:4857473. doi: 10.1155/2018/4857473. eCollection 2018.