louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03644498: Study to Determine if the Flu Vaccine Increases the Risk of Muscle Damage in Participants Taking Drugs That Block Certain Proteins Made by Some Types of Immune System Cells
Official title: Risk of Muscle Damage in Cancer Patients Exposed to the Influenza Vaccine While Receiving Checkpoint Inhibitor Therapies: A Nested Case Control Study Using Claims Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: influenza
myositis
myocarditis
rhabdomyolysis
checkpoint inhibitors
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-08-23
Enrollment: 1056
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All participants in this study will be enrolled in the PharMetrics or MarketScan database and will have exposure to at least one checkpoint inhibitor

Brief summary: A retrospective, observational study conducted on cancer patients receiving a drug that blocks certain proteins made by some types of immune system cells


Eligibility criteria: Inclusion Criteria:

* Treatment with a checkpoint inhibitor (CPI)
* Age greater than or equal to 18 years on date of first claim for a CPI
* ICD-9 or ICD-10 code for a malignancy within 180 days prior to the first claim for any CPI, and
* Greater than or equal to 180 days of continuous pharmaceutical and medical benefit enrollment in the database prior to the first claim for any CPI

Exclusion Criteria:

* Less than 18 years of age

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Incidence of myocarditis
timeFrame: Approximately 7 years
measure: Incidence of myositis
timeFrame: Approximately 7 years
measure: Incidence of rhabdomyolysis
timeFrame: Approximately 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04477798: Protein Classifier for Thyroid Indeterminate Nodules
Official title: Protein Classifier for Thyroid Indeterminate Nodules： a Multi-center Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Nodule
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In multi-center, prospective, double-blind cohorts, PCT-DIA/MS protein classifier supported by artificial neural networks will be validated to classify thyroid indeterminate nodules.


Eligibility criteria: Inclusion Criteria:

1. Patients with aged 18 to 70 years old;
2. Patients with thyroid nodules who have not been treated with drugs;
3. Patients who were diagnosed as Bethesda III and IV by cytology and pathology before operation;
4. Patients who underwent total / partial thyroidectomy and had histopathological reports of corresponding cellular pathological punctured nodules;
5. Patients voluntarily participate in the study after informed consent.

Exclusion Criteria:

1. Patients without operation;
2. Patients with insufficient FNA sample size (judged by the laboratory).

Primary outcomes:
measure: protein classifier
timeFrame: immediately after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital Affiliated to Zhejiang University Medical College
state: Zhejiang
Study officials:
affiliation: First People's Hospital of Hangzhou
name: Dingcun Luo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01762098: Chronic Endometritis in Patients With Recurrent Miscarriages or Repeated Implantation Failures in In-vitro Fertilization
Official title: Prevalence of Chronic Endometritis in Patients With Recurrent Miscarriages or Repeated Implantation Failures in In-vitro Fertilization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Endometritis
Abortion, Spontaneous
Keywords: In vitro fertilization
Hysteroscopy
Endometrial biopsy
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2013-01-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population with recurrent miscarriage or repeated embryo implantation failures.

Brief summary: Chronic endometritis is a persistent inflammation of the endometrium. Chronic endometritis is asymptomatic or little symptomatic. Sometimes, patient with chronic endometritis can have genital bleeding, pelvic chronic pain, pain during sexual relations, persistent vaginal white loosing. The hysteroscopy can detect the presence or absence of chronic endometritis.

Some studies showed that the endometritis could have an impact on the embryo implantation and could explain recurrent miscarriages or repeated embryo implantation failures.

The goal of this study is to evaluate the frequency of the chronic endometritis in patients with recurrent miscarriages or repeated embryo implantation failures


Eligibility criteria: Inclusion Criteria:

Group repeated miscarriages

* Women aged 18 to 43 years
* ≥ 2 miscarriages before 14 weeks of gestation
* Genetic (karyotype x2), thrombophilic and endocrine assessment should be completed

Group of implantation failure in In-vitro fertilization

* Women aged 18 to 45 years
* Absence of pregnancy after 3 good quality embryos transferred in women under 35 years and 4 embryos in the 35 years and over.

Exclusion Criteria:

* Positive pregnancy test
* Unexplained bleeding
* Incomplete miscarriage assessment
* Uterine malformation
* Antibiotic treatment during or within one month prior to the biopsy

Primary outcomes:
measure: Rate of chronic endometritis
timeFrame: 1 day
Secondary outcomes:
measure: Pregnancy rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Pierre-Emmanuel Bouet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bouet PE, El Hachem H, Monceau E, Gariepy G, Kadoch IJ, Sylvestre C. Chronic endometritis in women with recurrent pregnancy loss and recurrent implantation failure: prevalence and role of office hysteroscopy and immunohistochemistry in diagnosis. Fertil Steril. 2016 Jan;105(1):106-10. doi: 10.1016/j.fertnstert.2015.09.025. Epub 2015 Oct 9.
Clinical trial NCT01637298: Biomarkers to Detect Anal Intraepithelial Neoplasia in Thai Men Who Have Sex With Men
Official title: The Thai Red Cross AIDS Research Centre
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anal Intraepithelial Neoplasia
Keywords: Histological HGAIN
detected biomarkers
MSM population
HPV subtypes
AIN study
HIV-positive and HIV-negative MSM
anal cytology and biomarkers
likelihood of AIN development at month 12 and yearly thereafter
Lead sponsor: Thai Red Cross AIDS Research Centre
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: SEARCH Research Foundation
name: Chulalongkorn University
First posted: 2012-07-11
Enrollment: 450
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: MSM with HIV negative and positive in Thailand

Brief summary: The goals of this application are to assess the usefulness of biomarkers, including p16 proteins, minichromosome maintenance (MCM) proteins, high-risk human papillomavirus (HPV) types, and E6 and E7 mRNA/oncoproteins, as adjunct tools to anal Pap smear in identifying HGAIN and to study the impact of HIV infection on the characteristics of anal cytology (by anal Pap smear) and biomarkers. To fulfill these goals, in addition to routine practice, it will be necessary to follow 450 MSM (315 HIV-positives and 135 HIV-negatives) over 60 months, and perform HRA and biomarkers on all clients at baseline and every 12 months. Information from this study would inform AIN screening and follow up approaches in HIV-positive and HIV-negative MSM in both resource-limited and resource-rich settings.

Detailed description: The goals of this application are to assess the usefulness of biomarkers, including p16 proteins, MCM proteins, high-risk HPV types, and E6 and E7 mRNA/oncoproteins, as adjunct tools to anal Pap smear in identifying HGAIN and to study the impact of HIV infection on the characteristics of anal cytology (by anal Pap smear) and biomarkers. To fulfill these goals, in addition to routine practice, it will be necessary to follow 450 MSM (315 HIV-positives and 135 HIV-negatives) over 60 months, and perform HRA and biomarkers on all clients at baseline and every 12 months. Information from this study would inform AIN screening and follow up approaches in HIV-positive and HIV-negative MSM in both resource-limited and resource-rich settings.

Eligibility criteria: Inclusion Criteria:

* MSM with HIV negative
* MSM with HIV positive

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01264198: The Role of Resistance Training in Non Alcoholic Fatty Liver Disease
Official title: The Role of Resistance Training in Non Alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NAFLD (Non-Alcoholic Fatty Liver Disease)
Resistance Training
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-12-21
Enrollment: 82
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effect of RT on clinical and metabolic parameters in patients with NAFLD.

Detailed description: Background: Non Alcoholic Fatty Liver Disease (NAFLD) is the most prevalent liver disease in developed countries with a prevalence rate of 20-30 % of adults. About 10-25% of these individuals are estimated to meet the current diagnostic criteria for Non Alcoholic Steatohepatitis (NASH) and some may progress to Cirrhosis and liver failure. NAFLD is now recognized as the hepatic manifestation of the metabolic syndrome. Recent data shows that NAFLD might also predict the tendency to develop diabetes mellitus and coronary artery disease. The drug of choice for NAFLD is yet to be found. The recommended treatment of NAFLD includes weight reduction and Physical Activity (PA), but the data of the effect of Resistance Training (RT) PA on NAFLD is scant.

Aim of the study: To evaluate the effect of RT on clinical and metabolic parameters in patients with NAFLD. Study design: Randomized Clinical Trial. Patients will be randomly allocated to 2 arms (intervention and control). The intervention arm will perform RT, whereas control arm will be advised to perform home stretching. Medical examination will be performed at week 0 (baseline) and at week 13 using uniform protocols.

Eligibility criteria: Inclusion Criteria:

* Ultrasound diagnosed fatty liver.

Exclusion Criteria:

* Presence of HBsAg or anti-HCV antibodies (will be obtained from blood tests at the liver clinic).
* Patients with known diabetes treated with antidiabetic medications.
* Patients with known kidney disease, CHD, lung disease, inflammatory bowel disease.
* Excessive alcohol consumption ≥ 30 g/day in men or 20 g/ day in women.

Primary outcomes:
measure: The HRI value will be reduced in the intervention arm as compared to the The The change in Hepato-Renal Index (HRI) evaluated by ultrasound (US).
timeFrame: week 0 and week 13
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Ran Oren, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zelber-Sagi S, Azar S, Nemirovski A, Webb M, Halpern Z, Shibolet O, Tam J. Serum levels of endocannabinoids are independently associated with nonalcoholic fatty liver disease. Obesity (Silver Spring). 2017 Jan;25(1):94-101. doi: 10.1002/oby.21687. Epub 2016 Nov 15.
Clinical trial NCT03101098: Retroperitoneal Ligation of Uterine Artery in Total Laparoscopic Hysterectomy for Enlarged Uterus
Official title: Retroperitoneal Ligation of Uterine Artery in Total Laparoscopic Hysterectomy for Enlarged Uterus: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Hysterectomy
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 54
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized trial is aimed to investigate the role of retroperitoneal TLH in enlarge uterus.

Detailed description: Laparoscopic hysterectomy is one of the most common gynecologic surgeries worldwide. Generally, in total laparoscopic hysterectomy (TLH), uterine arteries are coagulated or transected close to the uterus, alongside the cervix, like surgical technique of a conventional total abdominal hysterectomy. Recently, several studies showed that ligation of uterine artery where it originates from the internal iliac artery during TLH (so-called "retroperitoneal TLH") is effective for reducing blood loss. However, the application of this technique to clinical practice have not been well investigated in terms of its efficacy and safety. Moreover, most of the previous studies on retroperitoneal TLH were small case series or retrospective comparative studies with conventional TLH. Therefore, the investigators conducted this randomized trial to investigate the role of retroperitoneal TLH in enlarge uterus.

Eligibility criteria: Inclusion Criteria:

* absence of pregnancy at the time of presentation
* uterine volume between 12 and 18 weeks of gestation by pelvic examination
* appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)

Exclusion Criteria:

* any suggestion of malignant uterine or adnexal diseases
* any major medical comorbidities or psychiatric illnesses, which could affect follow-up and/or compliance
* an inability to understand and provide written informed consent.

Primary outcomes:
measure: Operative blood loss
timeFrame: Operation day
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Taejong Song, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01602198: Study of Exelon Transdermal Patch in Amnestic Mild Cognitive Impairment Patients
Official title: 24-week, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Exelon® [Rivastigmine] Transdermal Patch in 120 APOE e4 Positive Amnestic MCI Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mild Cognitive Disorder
Mild Cognitive Impairment
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2012-05-18
Enrollment: 1
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The goal of this project is to determine if task-activated fMRI is sensitive to the central cholinergic deficit associated with Mild Cognitive Impairment.

Detailed description: Clinical studies suggest that cholinesterase inhibitors (ChEIs) exert a cognitive benefit with chronic use among MCI and AD patients. Some studies also demonstrate a slight treatment benefit for persons who are APOE 4 positive. We propose to conduct a 24-week, randomized, double-blind, placebo-controlled, parallel group study of the Exelon® \[rivastigmine\] transdermal patch in 120 aMCI patients who have one or both APOE 4 alleles. Our preliminary analyses indicate that aMCI patients, even those who convert to AD, exhibit increased fMRI activation on our semantic memory activation task relative to not at-risk healthy participants and that increasing activation over time correlates with declines on neuropsychological testing. In addition, our preliminary data indicate that ChEI treated aMCI patients demonstrate normalization (i.e. reduction) in the magnitude of task-related neural activation over time relative to an untreated group. Furthermore, changes in fMRI magnitude demonstrated greater sensitivity to cholinergic modulation than changes on neuropsychological testing.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of amnestic MCI
* In good general health with no diseases expected to interfere with the study
* Ability to undergo MRI
* Fluent in English
* Stable prescription dosages 1 month prior to testing
* Carrier of the APOE e4 allele (determined by blood draw at screening visit)

Exclusion Criteria:

* Neurological illness/conditions
* Medical illnesses/conditions that may affect brain function
* Prior history of use of any cholinesterase inhibitor
* Instable or severe cardiovascular disease or asthmatic condition

Primary outcomes:
measure: Change in BOLD Response on Functional Magnetic Resonance Imaging (fMRI)
timeFrame: baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Stephen M Rao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05598398: NPWTi on Closure of Chronic Pressure Sores
Official title: Evaluation of Vacuum-Assisted Closure Veraflo Therapy With Cleanse Choice Dressing on Wound Healing in Patients With Pressure Sores: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pressure Sore
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: 3M
First posted: 2022-10-28
Enrollment: 62
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 primary objective of this study is to assess the effectiveness of the Negative Pressure Wound Therapy system with instillation therapy (NPWTi) on closure of chronic pressure sores. This intervention will be compared to wet-to-dry dressings, which is standard of care. In this post-market, on-label study, we hope to show that the NPWTi system more effectively closes pressure sores following debridement than traditional care.


Eligibility criteria: Inclusion Criteria:

1. Ischial and sacral wounds at stage 3 and 4.
2. Any pressure sore that has the potential for a good seal.

Exclusion Criteria:

1. Any pressure sore that does not have potential for a good seal.
2. Patients with fecal incontinence (due to potential for pressure sore to be near the anus).
3. Patients who by the opinion of the Principal Investigator are not candidates for surgical closure (age, BMI, comorbidities, etc.).
4. Patients who are pregnant. This is standard of care for surgery anyway, and there is uncertainty of how both the surgery and intervention would affect the fetus. We therefore stress any form of birth control, abstinence, and method to prevent pregnancy for those enrolled in the study.

Primary outcomes:
measure: Total Length of Stay
timeFrame: up to 3 months
Secondary outcomes:
measure: Cost Analysis
timeFrame: Through study completion, approximately 5 months
measure: Number of debridements
timeFrame: Through study completion, approximately 5 months
measure: Successful closure of pressure sores
timeFrame: 2 weeks and 6 weeks post-closure surgery
Other outcomes:
measure: Proteomic analysis
timeFrame: 1 year post-closure surgery
measure: Bioburden assessment
timeFrame: Through study completion, approximately 5 months
measure: Wound characteristic assessments
timeFrame: 1 year post-closure surgery
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Robert Galiano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01555398: Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of HIP0901 Capsule
Official title: Open-label, Randomized Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of Fenofibric Acid for HIP0901 Capsule in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Fenofibric acid
HIP0901
food effect
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2012-03-15
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of food on the pharmacokinetic characteristics of fenofibric acid for HIP0901 capsule.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers, age between 20 and 45
* Informed of the investigational nature of this study and voluntarily agree to participate in this study
* Weight\>50kg, BMI of \>18kg/m2 and \<27kg/m2 subject

Exclusion Criteria:

* Acute disease within 28 days prior to start of study drug administration
* Use of any prescription medication within 14 days prior to Day 1
* Use of any medication within 7 days prior to Day 1
* Has a severe medical history of hypersensitivity to fibric acid derivative
* Participation in another clinical study within 30 days prior to start of study drug administration

Primary outcomes:
measure: AUC of Fenofibric acid
timeFrame: 0-96 hrs
measure: Cmax of Fenofibric acid
timeFrame: 0-96 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Ji-Young Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: