louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04006535: Whole Exome Sequencing of Familial and Pediatric Forms of Vasculitis
Official title: Identification of Susceptibility Loci and Genes for Systemic Vasculitis Risk, by Analyzing Whole Exome Sequencing of Familial and Pediatric Forms of Vasculitis (FAMILYVASC Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vasculitis
Keywords: Vasculitis
Lead sponsor: French Vasculitis Study Group
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult and childhood patients (no age limit) with familial and pediatric forms of vasculitis as defined in Chapel Hill's international nomenclature in its revised 2012 version.

Brief summary: The FAMILYVASC study is a prospective observational study which will aim to identify susceptibility loci and genes for systemic vasculitis risk in patients with familial or pediatric forms of vasculitis. Genetic analysis based on whole exome sequencing will be carried out through salivary DNA.


Eligibility criteria: Inclusion criteria for subjects with vasculitis

* Children and adults
* Patients with vasculitis, as defined in the Chapel Hill International Classification in its revised version of 2012
* Patient information and signed informed consent
* Pregnant and breastfeeding women can be included in the study

Inclusion criteria for healthy subjects

* Children and adults
* Do not have vasculitis, as defined in the Chapel Hill International Classification in its revised version of 2012, or relatives on the 1st; 2nd; 3rd or 4th degree of a patient with vasculitis
* Patient information and signed informed consent
* Pregnant and breastfeeding women can be included in the study

Exclusion criteria:

* Refusal of consent or inability to obtain consent
* Dementia or unauthorized patient, for psychiatric or intellectual failure reasons, to receive information about the protocol and to give informed consent.
* Uncooperative patient, or any pathology that could make the patient potentially non-compliant to the study procedures, and patients interned for regulatory or legal reasons.

Primary outcomes:
measure: Identification of susceptibility loci and genes
timeFrame: At the moment of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin - Department of Internal Medicine
state: Ile De France
Study officials:
affiliation: French Vasculitis Study Group
name: Benjamin Terrier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01285258: Emergency Peripartum Hysterectomy: A Prospective Study in Iran
Official title: Study of Peripartum Hysterectomy for Maternal Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postpartum Hemorrhage
Keywords: Peripartum
hysterectomy
placenta accreta
mortality
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-01-27
Enrollment: 41
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of peripartum hysterectomy for maternal hemorrhage.

Detailed description: Emergency peripartum hysterectomy is a life-saving surgical procedure which performed to control massive hemorrhage. This study was conducted to determine the factors leading to and maternal mortality and morbidity rates among the women whose underwent peripartum hysterectomy with the focus on referral or non-referral patient status.

Eligibility criteria: Inclusion Criteria:

* Women who have nonresponse hemorrhage after delivery

Exclusion Criteria:

* Women who delivered before 24 weeks

Primary outcomes:
measure: death rate
timeFrame: at 2 minutes after operation
Secondary outcomes:
measure: urological complication
timeFrame: at 2 minutes after operation
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Al-zahra university hospital
Study officials:
affiliation: MD,research comittee
name: hamidreza shemshaki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06201858: A Journey Into Participation Patterns Among Patients With Hidradenitis Suppurativa
Official title: Examining Engagement Trends Among Participants in Hidradenitis Suppurativa Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Suppurativa
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with hidradenitis suppurativa who are actively considering enrolling in a clinical study for said condition, but have not yet completed enrollment and randomization.

Brief summary: This study aims to uncover the factors driving patient decisions regarding enrollment, withdrawal, or re-engagement in hidradenitis suppurativa clinical trials. Understanding these factors will significantly improve the relevance and effectiveness of future research endeavors.

Ultimately, this trial endeavors to deepen our understanding of the factors impacting hidradenitis suppurativa clinical trial participation. Enhancing participation rates could accelerate the development of innovative treatments for this debilitating condition.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years old
* Diagnosis of hidradenitis suppurativa
* Able to comprehend the investigational nature of the protocol and provide informed consent

Exclusion Criteria:

* Female patients who are currently pregnant or nursing
* Inability to perform regular electronic reporting
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Primary outcomes:
measure: Number of hidradenitis suppurativa patients who decide to enroll in a clinical research
timeFrame: 3 months
measure: Rate of hidradenitis suppurativa patients who remain in clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Saunte DML, Jemec GBE. Hidradenitis Suppurativa: Advances in Diagnosis and Treatment. JAMA. 2017 Nov 28;318(20):2019-2032. doi: 10.1001/jama.2017.16691.
citation: Garcovich S, Fania L, Caposiena D, Giovanardi G, Chiricozzi A, De Simone C, Tartaglia C, Ciccone D, Bianchi L, Abeni D, Peris K. Pediatric Hidradenitis Suppurativa: A Cross-Sectional Study on Clinical Features and Treatment Approaches. J Cutan Med Surg. 2022 Mar-Apr;26(2):127-134. doi: 10.1177/12034754211039993. Epub 2021 Oct 6.
citation: Jfri A, Nassim D, O'Brien E, Gulliver W, Nikolakis G, Zouboulis CC. Prevalence of Hidradenitis Suppurativa: A Systematic Review and Meta-regression Analysis. JAMA Dermatol. 2021 Aug 1;157(8):924-931. doi: 10.1001/jamadermatol.2021.1677.
Clinical trial NCT01109758: Effects of Fenofibrate on Gene Expression in Healthy Volunteers
Official title: Effects of Fenofibrate on Gene Expression Activity and DNA Methylation Profile in Circulating Monocytes of Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Fenofibrate
Gene Expression
DNA methylation
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-04-23
Enrollment: 26
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess how fenofibrate modify gene expression in circulating monocytes of healthy volunteers after 6 weeks.


Eligibility criteria: Inclusion Criteria:

* Male or female,
* To be aged 40-65 years,
* To be post menopausal female not receiving hormone replacement therapy,
* To have normal homocysteine, folate and vitamin B12 levels at baseline (results available for initiation of treatment),
* To be in good health as determined by medical history, physical examination, ECG, vital signs, serum/urine biochemistry and hematology.

Exclusion Criteria:

* Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, neurologic/psychiatric or emotional, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, (drug) allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking the study medication,
* Subjects who have been treated with fenofibrate in a previous study,
* Subjects who have taken a single dose of an investigational drug within 30 days or multiple doses of any investigational drug within 60 days prior to dosing

Primary outcomes:
measure: Change of gene activity of markers in circulating monocytes between Baseline and 6 weeks of fenofibrate treatment
timeFrame: Between Baseline and 6 weeks
measure: DNA methylation pattern
timeFrame: 6 weeks
Secondary outcomes:
measure: Fenofibric acid levels
timeFrame: 6 weeks
measure: urinary protein profile
timeFrame: 6 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Site 1
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT03114358: Carbapenems De-escalation as Antimicrobial Stewardship
Official title: A Cluster Randomized Controlled Trial Comparing Early and Late Carbapenems De-escalation in the Medicine Units, Maharaj Nakorn Chiang Mai Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anti-Bacterial Agents
Keywords: De-escalation
Carbapenems
Antimicrobial stewardship
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 104
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Early de-escalation of carbapenems can reduce unnecessary use of carbaepenems compared with late de-escalation without compromised clinical outcomes

Detailed description: A cluster randomized control trial was conducted among patients receiving care at the medicine units of the Maharaj Nakorn Chiang Mai Hospital.

Patients were randomly assigned into 2 groups. The standard group followed the hospital policy in which carbapenems were evaluated by ID specialist at 72 hours of admission (late de-escalation). De-escalation may occurred earlier depends upon the decision of the primary care team. The intervention group is de-escalation carbapenems early within 24 hours or no later than 72 hours of prescription by ID specialist (early de-escalation).

Clinical outcomes included rate of de-escalation within the first 24 hour, the mortality rate, and other clinical outcomes.

Eligibility criteria: Inclusion criteria

* All adult patients aged ≥ 15 years old
* received carbapenems (meropenem and imipenem/cilastatin) empirically within 24-72 hours for the first time during admission
* able to sign informed consent

Exclusion criteria

* They were in the intensive care units, or had neutropenia (absolute neutrophil count \< 1,000 cell/mm3)

Primary outcomes:
measure: The rate of de-escalation within the first 24 hour
timeFrame: 24 hours
Secondary outcomes:
measure: Mortality rate
timeFrame: 90 days
measure: Readmission within 30 days,
timeFrame: 30 days
measure: Costs of carbapenems
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03535558: Fluoroquinolone Associated Disability
Official title: Fluoroquinolone Associated Disability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchitis
Sinusitis
Urinary Tract Infections
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-05-24
Enrollment: 239306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include participants in the Truven Commercial Claims and Encounters (CCAE) database who were eligible for disability insurance and can be linked to the Truven HPM database. The study population will include individuals who had uncomplicated acute bacterial sinusitis, or bronchitis and were prescribed an oral fluoroquinolone (FQ) or oral azithromycin(AZ) and sulfamethoxazole/trimethoprim (ST) for urinary tract infection.

Brief summary: The purpose of this study is to: 1) describe drug utilization for Fluoroquinolone(FQ), Azithromycin (AZ) and Sulfamethoxazole/Trimethoprim(ST) in the entire Truven MarketScan Commercial Claims and Encounters database (CCAE) database, and specifically among individuals in the Health and Productivity Management (HPM) during the observation period; 2) describe the rate of disability associated with 2 or more System Organ Class adverse events (SOC AEs) and exposure to FQs for several acute, uncomplicated indications; and 3) compare the rates of disability for 2 or more SOC AEs and exposure to FQs and AZ/ST for the same indications.


Eligibility criteria: Inclusion Criteria:

* Participants in the Truven CCAE database who were eligible for disability insurance and can be linked to the Truven Health and Productivity Management (HPM) database
* Study participants will be included if they have 6 months of history before the first day on FQ or AZ/ST and at least 120 days afterward

Exclusion Criteria:

* If any protocol specified medical conditions or exposure to the protocol specified medications in the 6 months preceding the first qualifying dose of FQ or AZ/ST
* If participants have any disability claim in the 6 months preceding the qualifying FQ or AZ/ST dose
* If participants have the protocol specified condition-specific diagnoses within the 3 months preceding the qualifying FQ or AZ/ST exposure

Primary outcomes:
measure: Number of Participants with Disability in Temporal Proximity
timeFrame: Up to 120 days
Secondary outcomes:
Other outcomes:
Locations:
city: Titusville
country: United States
facility: Janssen Investigative Site
state: New Jersey
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development,LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT06113458: Comparing Hypertension Remote Monitoring Evaluation Redesign
Official title: Comparing Hypertension Remote Monitoring Evaluation Redesign
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hypertension
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2023-11-02
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the effectiveness of evidence-based, adapted, and tailored, patient-focused and clinic-focused strategies to improve blood pressure (BP) control in English- and Spanish-speaking patients with hypertension (HTN).


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Any sex/gender
* Any race or ethnicity
* Have hypertension or high blood pressure (BP) (BP \>=140/90 mmHg at least twice in the previous 18 months)
* Can read and write English or Spanish
* Be able to provide consent

Exclusion Criteria:

• We will exclude individuals with conditions that might have severe self-management limitations due to a disability or medical condition or might complicate remote BP monitoring, such as self-reported:

* Pregnancy
* Lactating/nursing
* Dialysis

Primary outcomes:
measure: Change in systolic BP (clinic)
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in systolic BP (home)
timeFrame: Baseline, 6 months
measure: Patient activation and satisfaction
timeFrame: Baseline, 6 months
measure: Number of participants with BP control
timeFrame: Baseline, 6 months
measure: Medication intensification when BP is uncontrolled
timeFrame: Baseline, 6 months
measure: Patient-reported medication adherence
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Urmimala Sarkar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03625258: Mutations of the Pre-core Region of Hepatite B Virus (HBV)
Official title: Influence of Mutations in the Pre-core Region of Heptatis B Virus (HBV) and Its Promoter on Serum VHB Viral Load in Chronically Infected Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B Virus
Keywords: mutations
infected patients
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the study will be carried out from the blood samples following consultations Hepatogastroenterology in the clinical follow-up of patients chronically infected with HBV. Blood samples are stored in the Virology laboratory as part of legislation on the conservation of samples during Virology analyzes.

Brief summary: Hepatitis B virus (HBV) infection constitutes a major public health threat worldwide. A total of 92 patients with HBeAg-negative chronic hepatitis B infection were recruited at Amiens University Hospital. The diagnostic workup included a physical examination.In conclusion, the study results confirmed that the HBV DNA level is associated with liver fibrosis status and that HBV viral load is strongly correlated with BCP and PC mutations, and it demonstrated that the impaired base pairing 1858-1896 mutations at the base of the bulge in the e encapsidation signal is independently associated with high serum HBV DNA levels.

Detailed description: The progression of liver disease in hepatitis B virus (HBV) infection is fostered by active virus replication. Mutations in the basal core promoter (BCP) and precore (PC) regions of the HBV genome are known to have an impact on viral replication. The aim of the present study was to assess the correlation of mutation profiles in the BCP and PC regions with the viral load in HBeAgnegative chronically infected patients. The HBV genotype, BCP/PC mutations, serum HBV DNA levels, and associated serological markers were analyzed in 92 HBeAgnegative chronically infected patients.

Eligibility criteria: Inclusion Criteria:

* Patients included will be chronic carriers (HBsAg + for more than 6 months) of HBV, with detectable serum viral load greater than or equal to 100 IU / mL, included in the queue followed by Drs. Dominique Capron and Eric N'Guyen-Khac.

These patients will not be on anti-HBV treatment.

Exclusion Criteria:

* Patients under 18 years old
* Patients with their hepatitis B
* Patients with HBV viral load undetectable or less than 100 IU / mL.
* Immunosuppressive treatments such as corticosteroids or other
* The co-infection with the hepatitis C and / or HIV virus
* Patients with cancer

Primary outcomes:
measure: Genotype of HBV for which the HBV viral load is a function of pre-core mutations
timeFrame: 2-years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU AMIENS
name: Sandrine Castelain, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02607358: Non-responders to Antiplatelet Treatment in Acute Ischaemic Stroke)
Official title: NATIS: Non-responders to Antiplatelet Treatment in Acute Ischaemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Keywords: Clopidogrel
acetacylic acid
antiplatelet therapy
HOTPR
VerifyNow
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2015-11-18
Enrollment: 496
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute Ischemic stroke patients

Brief summary: Determination of frequency of Clopidigrel- and Acetacylicacid-non-responders (HOTPR) in acute ischemic stroke patients.

Detailed description: Determination of frequency of Clopidigrel- and Acetacylicacid-non-responders (HOTPR) in acute ischemic stroke patients using the VerifyNow system.

Eligibility criteria: Inclusion Criteria:

* Suspected acute ischemic stroke and loading dose of Clopidogrel or Acetacylicacid

Exclusion Criteria:

* Previous treatment with platelet inhibitor
* NOAC or Vitamin K-antagonist treatment
* Final diagnosis other than Ischemoc stroke or Transitoric ischemic attack

Primary outcomes:
measure: Responder status
timeFrame: immediately
Secondary outcomes:
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Neurologisk afdeling
Study officials:
affiliation: Zealand University Hospital
name: Charlotte Rath, MD
role: PRINCIPAL_INVESTIGATOR
References: