louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05162391: Inflammation in Methamphetamine and STIs (IMSTI)
Official title: Effects of Methamphetamine Use on Risk Behavior, Systemic and Mucosal Inflammation, and Sexually Transmitted Infection (STI)/HIV Risk Among Men Who Have Sex With Men
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Methamphetamine-dependence
Rectal Gonorrhea
Rectal Chlamydia
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This clinical trial aims to investigate the effects of a decline in methamphetamine use on rectal inflammatory cytokine levels, substance use contexts, and HIV/STI risk behavior. This clinical trial also seeks to evaluate joint effects of methamphetamine use and rectal gonorrhea/chlamydia infection on rectal inflammatory cytokine levels. The proposed trial will consist of 40 MSM, half with rectal gonorrhea/chlamydia infection at enrollment (n=20), with methamphetamine use disorder that will receive contingency management for methamphetamine reduction. Following baseline measurement, participants will be observed over the course of 8 weeks, where participants will complete behavioral surveys, provide urine for drug testing, and rectal samples for measurement of rectal inflammatory cytokine levels.


Eligibility criteria: Inclusion Criteria:

* Cisgender male
* 18 years of age or older
* Understand written and spoken English
* Condomless receptive anal intercourse in past 90 days
* Meet DSM-5 criteria for methamphetamine use disorder
* Positive urine toxicology screen for MA metabolites at study entry
* Negative rectal GC/CT screen (n=20) or Positive rectal GC and/or CT screen (n=20)
* Able to provide written informed consent and willing/able to complete study visits.

Exclusion Criteria:

* Reports current treatment for another substance use disorder
* Positive test for opioids, cocaine, and/or hallucinogens
* Treatment for gonorrhea and/or chlamydia infection in past 3 months
* Presence of a condition that in the opinion of the investigator would compromise the safety of the patient or the quality of the data

Primary outcomes:
measure: Methamphetamine abstinence
timeFrame: 8 weeks
measure: Rectal inflammation
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Vine Street Clinic
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Cherie Blair
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00644891: Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications
Official title: A Comparative, Multi-Center, Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Pediatric taste test
Antibiotic taste test
cefdinir
amoxicillin
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 158
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin oral antibiotic suspension medications in pediatric subjects. It was designed to determine if Omnicef or amoxicillin is preferred to the other with regard to taste or smell.

Detailed description: The Primary Purpose for the study is "Other". Per ClinicalTrials.gov, more information regarding the primary purpose is provided here; this study is a pediatric taste test.

Eligibility criteria: Inclusion Criteria:

* Female or male child age 4 through 8 years in good general health.
* Minimum weight of 16.3 kg (36 lb).
* Willing to comply with appropriate instructions provided to complete the study.
* Written informed consent from parent/legal guardian.

Exclusion Criteria:

* Current medical condition, that in the opinion of the Investigator or designee, may interfere with the ability to discriminate taste (e.g., common cold, sinus infection, bronchial infection, etc.).
* History of allergic reaction to cefdinir, prescription (e.g. penicillins or cephalosporins) and/or OTC medications, and/or food products. History of significant medical condition (e.g., GI disorders, hematological or bleeding disorders, renal or hepatic diseases).
* Use of any oral medication, vitamins or herbal supplements within 6 hours prior to tasting.
* Temperature \> than 99.2°F.
* Participation in a clinical or marketing research study within the past 3 months.
* Sibling of another subject on the study, or living in the same household as another subject that has participated in a clinical or marketing research study within the past 3 months.
* Family member or close friend employed by an advertising agency, market research company, and/or a company that processes or manufacturers medical or health care products.

Primary outcomes:
measure: Taste/smell acceptance
timeFrame: 2 hours
Secondary outcomes:
measure: Adverse events assessment
timeFrame: 72 hours with follow-up to a satisfactory conclusion
measure: Concomitant Medications
timeFrame: 72 hours
measure: Vital signs
timeFrame: 2 hours
measure: Any clinically abnormal observations
timeFrame: 2 hours with follow-up to a satisfactory conclusion
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: St. Petersburg
country: United States
state: Florida
city: Miamiville
country: United States
state: Ohio
Study officials:
References:
Clinical trial NCT02975791: Ultrasonography Versus Palpation for Identification of the Cricothyroid Membrane
Official title: Ultrasonography Versus Palpation for Identification of the Cricothyroid Membrane
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Airway Obstruction
Keywords: Airway Obstruction
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: After a structured teaching program anaesthetists are educated in identifying the cricothyroid membrane with ultrasonography. Thereafter their ability to do so is compared with their ability to do so with palpation. In an obese volunteer

Detailed description: After a structured teaching program anaesthetists are educated in identifying the cricothyroid membrane with ultrasonography. Thereafter their ability to do so is compared with their ability to do so with palpation.

The purpose is to advise a propriety method for preanesthetic identification. In an obese volunteer

Eligibility criteria: Inclusion Criteria:

* BMI \> 40
* Female

Exclusion Criteria:

* Age below 18

Primary outcomes:
measure: Frequency of correct identification of the cricothyroid membrane
timeFrame: "2 min"
Secondary outcomes:
measure: time to correct identification of the cricothyroid membrane
timeFrame: "2 min"
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02965391: Dynamic Changes of Circulating Tumor DNA in Surgical Lung Cancer Patients
Official title: Dynamic Changes and Surveillance of Circulating Tumor DNA in Surgical Non-small Cell Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma
Non-small-cell Lung Cancer
Lung Neoplasms
Keywords: Circulating Tumor DNA
Half time
Lung cancer
Surgery
Surveillance
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2016-11-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histologically confirmed lung cancer patients who received completely tumor resection

Brief summary: Previous study showed circulating tumor DNA levels reflect the total systemic tumor burden. Circulating tumor DNA levels should decrease after complete surgery and could be increase as tumor recurrence. Few study investigated the half time of circulating tumor DNA in lung cancer patients that no criterion has been established of how to use it for surveillance.

Detailed description: For lung cancer patients who received surgery, multiple time of plasma will be collected before or after surgery. A series of mutations will be detected in plasma before surgery based on next generation sequencing. The positive mutation will be traced after surgery and in follow up.

Eligibility criteria: Inclusion Criteria:

* Suspected lung cancer before surgery
* No malignant tumor history within the past 5 years
* The pulmonary nodule is not pure ground glass opacity
* Patients must have given written informed consent

Exclusion Criteria:

* Multiple primary lung cancer
* R1,R2 resection
* Histology confirmed not non-small cell lung cancer
* Unqualified blood samples

Primary outcomes:
measure: Half-life of circulating tumor DNA after surgery
timeFrame: 3 months
Secondary outcomes:
measure: The variation of circulating tumor DNA level before and after surgery
timeFrame: 3 months
measure: Correlation of circulating tumor DNA level after surgery with tumor recurrence
timeFrame: 3 years
measure: Correlation of circulating tumor DNA level after surgery with clinical features
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Jun Wang, M.D.
role: STUDY_CHAIR
References:
citation: Chen K, Zhao H, Shi Y, Yang F, Wang LT, Kang G, Nie Y, Wang J. Perioperative Dynamic Changes in Circulating Tumor DNA in Patients with Lung Cancer (DYNAMIC). Clin Cancer Res. 2019 Dec 1;25(23):7058-7067. doi: 10.1158/1078-0432.CCR-19-1213. Epub 2019 Aug 22.
citation: Chen K, Zhao H, Yang F, Hui B, Wang T, Wang LT, Shi Y, Wang J. Dynamic changes of circulating tumour DNA in surgical lung cancer patients: protocol for a prospective observational study. BMJ Open. 2018 Feb 6;8(2):e019012. doi: 10.1136/bmjopen-2017-019012.
Clinical trial NCT03295591: Circulating Tumor Cells in mCRC for Liver Resection
Official title: Optimizing the Selection of Patients With Metastatic Colorectal Cancer for Liver Resection - An Immuno-clinical Scoring System Incorporating Circulating Tumor Cell Enumeration and Clinical Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Colorectal Cancer
Circulating Tumor Cell
Keywords: Metastatic colorectal cancer
Liver resection
Circulating tumor cells
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with colorectal cancer and liver metastasis who are planned for liver resection

Brief summary: Resection of liver metastasis is potentially curative in patients with colorectal cancer bearing liver metastasis. However, early recurrence occurs in up to 30% in 3 months after liver resection. To optimize patient selection, the investigators propose to evaluate the the value of incorporating circulating tumor cells enumeration to clinical factors in a prospective study

Detailed description: This is a single-center prospective study to evaluate the predictive value of circulating tumor cells (CTC) in patients with metastatic colorectal cancer who are planned to have curative resection of liver metastasis. Blood will be taken from patients within 7 days before liver resection. CTC enumeration is done by a highly-sensitive microfluidic platform for which CTC can be subsequently enumerated with or without sequencing performed. Patients are then followed up regularly with contrast CT scan for recurrence. The primary study endpoint is to define the cutoff value of CTC count in patients with early relapse \< 6months after liver resection. Seventy-seven patients will be recruited in 24 months.

Eligibility criteria: Inclusion Criteria:

1. Age\>=18 years
2. Signed informed consent
3. Histologically or cytologically confirmed colorectal adenocarcinoma
4. Both primary tumor and liver metastases are amenable to curative resection.

Exclusion Criteria:

1. Presence of extrahepatic metastasis
2. History of other malignancies in the last 5 years
3. Patients unable to comply with the protocol

Primary outcomes:
measure: Cutoff value of CTC counts
timeFrame: Progression free survival at 6 months
Secondary outcomes:
measure: A immuno-clinical scoring system
timeFrame: Progression free survival at 6 months
measure: Progression free survival
timeFrame: up to 5 years
measure: Overall survival
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Ka On Lam, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01385891: Clove In The Treatment Of Relapsed Or Resistant Acute Leukemia In Children
Official title: Clofarabine, Cyclophosfamide, And Etoposide For The Treatment Of Relapsed Or Resistant Acute Leukemia In Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Leukemia
Lead sponsor: Istituto Giannina Gaslini
Sponsor class: OTHER
First posted: 2011-06-30
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study Hypothesis. combination chemotherapy with Clofarabine VP16 and Cyclophosphamide is able to induce remission in resistant/refractory acute leukemias in pediatric.

Forty children with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) entered the study and received the association of clofarabine (40 mg/m2/day) in combination with etoposide (100 mg/m2/day) and Cyclophosphamide (440 mg/m2/day) in 1 or 2 induction cycles End point were complete remission (CR)or CR without platelet recovery (CRp) and toxicity


Eligibility criteria: Inclusion Criteria:

* presence of \> 25% of blast in bone marrow
* treatment with second line therapies
* patients with resistant disease i.e. with \>25% of blasts 21 days after the last cytostatic agent administration
* children with persistent high MRD level (\> 10-3) after first or further line chemotherapy, were considered eligible to the treatment
* Relapsed after \> months after SCT
* Karnofsky score \>50
* a Forced Espiratory Volume \>30%
* sufficient hepatic and renal function defined as creatinine levels \<2 × ULN, bilirubin \<1.5 × ULN
* aspartate and alanine aminotransferases \<10 × ULN.

Exclusion Criteria:

* isolated extra-medullary relapse, and active infections

Primary outcomes:
measure: response to treatment
timeFrame: after an expected average of 3 weeks after the first dose of each chemotherapy course
Secondary outcomes:
measure: Number of patients with toxicity as a measure of safety and tolerability
timeFrame: at an expected average of 4 weeks after the first dose of each chemotherapy course
Other outcomes:
Locations:
city: Genova
country: Italy
facility: G.Gaslini Children's Hospital
Study officials:
affiliation: G. Gaslini Hospital
name: Concetta Micalizzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02528591: Prospective Single-center Study Evaluating the Central Blood Pressure in Renal Transplantation
Official title: Prospective Single-center Study Evaluating the Central Blood Pressure in Renal Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant
Keywords: patient
renal transplant
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The renal transplant patient is at high cardiovascular risk compared to the general population. The cardiovascular mortality represents one of the most important causes of late graft loss. Cardiovascular risk prediction tools applied to the general population, however, are caught failing on the population of kidney transplant and tend to underestimate the actual risk.

Central blood pressure is the pressure imposed at large artery (aorta, carotid) and is directly related to the target organ (heart, kidney, brain). Central blood pressure could be a cardiovascular risk factor more robust and powerful than brachial blood pressure.

Central blood pressure may in part explain the increased risk of cardiovascular disease in the population of kidney transplant patients. A cohort of 250 kidney transplant patients will be constituted with a measure of concomitant central hemodynamic monitoring to the annual review will be conducted. The main objective of this study is to describe the central blood pressure measured by oscillometric method in renal transplanted population.


Eligibility criteria: Inclusion Criteria:

* Major Patient
* Renal transplant patient

Exclusion Criteria:

* Minor patient

Primary outcomes:
measure: central blood pressure
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Christophe MARIAT, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00587691: Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis
Official title: An Open-Label, Dose-Escalation Study of T Cell Vaccine in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Secondary Progressive
Keywords: Tovaxin
TCV
Autologous
Lead sponsor: Opexa Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is 1) to study the safety and tolerability of escalating doses of myelin peptide reactive T cells in MS patients and 2) to study the clinical effectiveness of T Cell Vaccine ion the clinical course of MS.

Detailed description: The principle of TCV is similar to that of traditional microbial vaccination where attenuated infectious agents are used to stimulate protective immune responses. Because pathogentic autoreactive T cells are viewed as pathogens in T cell-mediated autoimmune diseases, they can be used, as a vaccine to prevent and treat the diseases in which they are able to induce.

Eligibility criteria: Inclusion Criteria:

* Stable MS disease within 30 days prior to enrollment
* EDSS Score between 2 and 8 inclusively
* Failed to respond to or cannot tolerate at least 1 or more of the currently approved drugs for MS.

Exclusion Criteria:

* Women who are pregnant or breast-feeding or who plan to become pregnant during the study
* Has taken immunomodulating drugs within 60 days prior to screening
* HIV positive

Primary outcomes:
measure: Evaluation of safety and tolerability
timeFrame: Yearly Intervals
Secondary outcomes:
measure: To assess changes in EDSS Scores
timeFrame: Yearly Intervals
measure: To assess changes in the myelin-reactive profile in the blood
timeFrame: Yearly Intervals
measure: To assess changes in the frequency of MS relapses
timeFrame: Yearly Intervals
Other outcomes:
Locations:
city: Bellaire
country: United States
facility: Bellaire Neurology
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Opexa Therapeutics
name: Jaye Thompson, PhD
role: STUDY_DIRECTOR
References:
citation: Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55.
citation: Zhang J. T-cell vaccination for autoimmune diseases: immunologic lessons and clinical experience in multiple sclerosis. Expert Rev Vaccines. 2002 Oct;1(3):285-92. doi: 10.1586/14760584.1.3.285.
citation: Zhang JZ, Rivera VM, Tejada-Simon MV, Yang D, Hong J, Li S, Haykal H, Killian J, Zang YC. T cell vaccination in multiple sclerosis: results of a preliminary study. J Neurol. 2002 Feb;249(2):212-8. doi: 10.1007/pl00007867.
Clinical trial NCT05099991: Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion
Official title: Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion: a Non-Inferiority Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion, Second Trimester
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a Foley balloon is similar to osmotic dilators for preparing the cervix prior to a second trimester abortion. Procedure time will be used to compare the two different methods of cervical preparation, reflecting the ease at which the surgeon can perform through a prepared cervix. The aim is to expand effective options for cervical preparation that will can accommodate for varying patient characteristics and provider experiences.


Eligibility criteria: Inclusion Criteria:

* presenting to clinic for second trimester abortion at 18 to 23 weeks and 6 days gestation confirmed by ultrasound
* able to provide informed consent and comply with study protocol
* English or Spanish-speaking
* candidate for outpatient cervical preparation

Exclusion Criteria:

* Anyone with an allergy to misoprostol, mifepristone or any study medication
* premature rupture of membranes
* intrauterine fetal demise
* placenta previa
* suspected abnormal placentation
* evidence of infection at the time of enrollment

Primary outcomes:
measure: Procedure Time
timeFrame: Up to approximately 30 minutes
Secondary outcomes:
measure: Cervical Dilation
timeFrame: Beginning of the procedure (approximately 5 seconds to assess)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
References: