louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00277043: A Phase III Randomized Trial Assessing the Utility of a Test Dose Program With Taxanes
Official title: A Phase III Randomized Trial Assessing the Utility of a Test Dose Program With Taxanes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Supportive
Ill-defined Sites
Keywords: Taxane
Test Dose
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
First posted: 2006-01-13
Enrollment: 200
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 are to determine whether a test dose program for taxanes will reduce the rate and/or severity of hypersensitivity reactions (HSR); and to determine whether a test dose program for taxanes will result in cost reduction due to decreased drug wastage.

Detailed description: Patients will be randomized on to one of two arms:

1. Test dose arm 1 mg paclitaxel or docetaxel test dose is prepared in 3 ml of normal saline and administered over two to five minutes IV push at least 30 minutes after prescribed IV and PO pre-medications. If no discernable adverse reaction ensues, the balance of the taxane dose is prepared and administered as per standard or specific chemotherapy protocol.
2. Non test dose arm The full taxane dose is prepared and administered as per standard or specific chemotherapy protocol, at least 30 minutes after prescribed IV and PO pre-medications.

Eligibility criteria: Inclusion Criteria:

* Patient must sign informed consent
* Patient must be greater than 18 years of age
* Patient must be receiving his/her first dose of either Taxol or Taxotere
* Patient must have received routine premedications for hypersensitivity reactions

Primary outcomes:
measure: Patient HSR severity will be graded with an integer from 1 to 5 using the National Cancer Institute's Common Toxicity Criteria (CTC) for allergy/immunology. All Grade 3-4 HSRs will be reported through the FDA's MedWatch program
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Ian Rabinowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06832943: The Efficacy and Safety of Robotic Bronchoscopy System-Assisted Stent Placement in Patients with Malignant Central Airway Stenosis
Official title: A Prospective Multicenter Single-Arm Trial Evaluating the Efficacy and Safety of Robotic Bronchoscopy System-Assisted Stent Placement in Patients with Malignant Central Airway Stenosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Airway Stenosis
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary aim of this research is to assess the efficacy and safety of the bronchial navigation positioning equipment in assisting stent implantation for malignant central airway stenosis while guaranteeing the safety of the participants and the scientificity of the clinical trial.


Eligibility criteria: Inclusion Criteria:

* Patients are eligible only if they fulfill all of the following criteria:

  1. Age ≥ 18 years, regardless of gender;
  2. Patients voluntarily consent to airway stent implantation and meet the requirements for airway stent implantation under general anesthesia;
  3. Confirmed as having malignant central airway stenosis through bronchoscopy and being ineligible for surgery or refusing surgery, and in need of airway stent implantation.

Patients should be able to understand the purpose of the trial, demonstrate good compliance with the examinations and follow-ups, and voluntarily participate in the clinical trial and sign the informed consent form.

Exclusion Criteria:

* Patients fulfilling any of the following criteria will be excluded from this study:

  1. Severe dysfunction of the heart, lungs, liver, or kidneys, intolerant of bronchoscopic treatment;
  2. Apparent coagulation dysfunctions;
  3. Pregnant or lactating women, or participants with a pregnancy plan during the study period;
  4. Patients with implanted cardiac pacemakers, implanted defibrillators, or other active implants;
  5. Participants allergic to photosensitizers or anesthetics, or with a history of multiple severe allergies or hereditary allergies;
  6. Participants who have participated in or are currently participating in drug clinical trials within the past 3 months, or in other medical device clinical trials within the past 30 days; Other circumstances that the investigator considers inappropriate for participation in this clinical trial.

Primary outcomes:
measure: The success rate of stent placement
timeFrame: During the bronchoscopy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00855543: Phospholipase A2 Producing Bacteria and Pre-Term Labor
Official title: Phospholipase A2 Producing Bacteria, Age at Gestation, Cervical Length Measurement and the Incidence of Pre-Term Labor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Labor
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2009-03-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obstetric patients in West Virginia

Brief summary: The purpose of this study is to better understand (1) if phospholipase A2 producing microorganisms and cytokines (IL-1, IL-4, IL-6, IL-10, and IL-13) are associated with premature labor (2) if pregnant teens are more likely to have phospholipase A2 producing bacteria than a pregnant adults and (3) if there is a difference in the cytokines between pregnant teens and adults.We hypothesize that phospholipase producing microorganisms may trigger the onset of premature labor. The following are hypothesized: (a) The microorganism cultured should show high activities of phospholipase A2 (b) The cervical length measurement predictive value should correspond to the gestation age at term (c) Vaginal flora of teen will be more susceptible to colonization with higher phospholipase A2 producing bacteria than that of an adult (d) The maternal genotype contribution to the concentration of IL-1, IL-4, IL-6, IL-10, IL-13, and TNF-alpha during the first trimester of pregnancy in teens is different in the production of inflammatory cytokines and modulators(e) The maternal genotype of teens therefore influences the production of phospholipase A2 and causes an increase in preterm delivery.


Eligibility criteria: Inclusion Criteria:

1. Gestational age \<34 weeks
2. Singleton gestation
3. Urinalysis and urine culture collected via clean catch
4. Age range 14 - 45
5. Patient receiving prenatal care at CAMC Women's Medicine Center

Exclusion Criteria:

1. In labor or with uterine contractions
2. Known fetal anomalies
3. Cerclage
4. Dark amniotic fluid suggestive of previous bleeding
5. Multiple gestation
6. Known unbalance chromosomal complement
7. Pregnant patient with prior history of excisional cervical biopsy (either cold knife, loop electrosurgical excision procedure, or laser conization)
8. Patient with mullerian anomaly
9. Patient with 2 or more D\&E secondary to spontaneous or induced abortion

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Charleston Area Medical Center/West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia Univeristy/Charleston Area Medical Center
name: Byron C Calhoun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07024043: Dexamethasone Versus Dexmedetomidine in IPACK Block to Reduce Pain Post Arthroscopic Knee Surgeries
Official title: Effect of Dexamethasone Versus Dexmedetomidine as A Local Anesthetic Adjuvant In IPACK Block for Post Operative Analgesia Following Arthroscopic Knee Surgeries
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Efficacy of Drugs in Pain Management
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators will test the effects of dexamethasone versus dexmedetomidine as adjuvant to bupivacaine in IPACK Block and it's direct effect in decreasing pain post operative following Arthroscopic knee surgeries

Detailed description: A.Preoperative settings: All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation. An informed written consent will be taken from every patient just before the surgery. B.Intraoperative and postoperative settings: On arrival to the operating room, baseline parameters such as ECG, mean arterial blood pressure, heart rate, and oxygen saturation will be recorded. Intravenous line will be inserted and IV Ringer's solution will be started, 500ml bolus will be given as a preload over 20 min before performing spinal anaesthesia and maintenance volume of 10ml\\kg. For each group, patients will be put in supine position, the procedure will be performed under complete aseptic precautions and All patients will be divided into three groups:(Group 1) for iPACK block with 0.25% bupivacaine only. (Group 2) for iPACK block with 0.25% bupivacaine and dexamthasone and (Group 3) for iPACK block with 0.25% bupivacaine and dexmedetomidine .

Eligibility criteria: Inclusion Criteria:

* Physical status: ASA I,II. Both sexes. BMI\<35

Exclusion Criteria:

* Refusal of the procedure or participation in the study by the patient. Physical status: ASA III or Above. History of allergy to the study drug. Evidence of local infection at site of injection. Major hepatic, renal, or cardiovascular dysfunction. BMI\>35.

Primary outcomes:
measure: Efficacy of Dexamethasone versus Dexmedetomidine in IPACK Block to reduce pain post Arthroscopic knee surgeries
timeFrame: 45 minutes after spinal anaesthesia
Secondary outcomes:
measure: Effect Of Dexamethasone Versus Dexmedetomidine as A Local Anesthetic Adjuvant In IPACK Block for Post Operative Analgesia following Arthroscopic Knee Surgeries
timeFrame: 45 minutes after spinal anesthesia
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Maisa Essam Abdelhaleem, MBBCH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02489643: Individualized Medical Training and Calcipotriol and Betamethasone Dipropionate Gel in Plaque Psoriasis
Official title: Role of an Individualized Medical Training in Improving Efficacy and Adherence to a 4-week Treatment With Calcipotriol and Betamethasone Dipropionate Gel for Mild-to-moderate Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2015-07-03
Enrollment: 60
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 aim of the study will be to evaluate the impact of this individualized practical training on efficacy (evaluated by Psoriasis Area and Severity Index (PASI) and Body Surface Area (BSA) score performed by a physician blinded to the study groups) and adherence (calculated as days wherein gel was applied and as BSA/weight of gel applied rate) to a 4 week long treatment with dovobet gel. On the other hand, the investigators will evaluate in both groups as demographic (as sex, age, job,..) or disease (as severity, duration, impact of quality of life,..) characteristics influence the adherence to the treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of psoriasis will be maid mainly on clinical findings. If doubts, a skin sample will be obtained and evaluated by histopathological examination.

Exclusion Criteria:

* Patients with palmoplantar, scalp, inverse, erythrodermic, guttate, pustular psoriasis will be excluded.

Primary outcomes:
measure: Efficacy as measured by PASI improvement
timeFrame: 1 month
measure: Efficacy as measured by BSA improvement
timeFrame: 1 month
Secondary outcomes:
measure: Adherence as measured by days wherein gel was applied
timeFrame: 1 month
measure: Adherence as measured by BSA/weight of gel applied rate
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02511743: Knowledge and Practice of Chinese Medical Specialists Regarding Chronic Hepatitis B Virus Infection
Official title: Knowledge and Practice of Chinese Medical Specialists Regarding Chronic Hepatitis B Virus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2015-07-30
Enrollment: 2871
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: physicians fullfill the following criterion:

1. Mainly engaged in liver disease diagnosis and treatment;
2. Diagnosis and treatment at least 10 patients with chronic Hepatitis B Virus infection per week.

Brief summary: The aim of this study was to evaluate knowledge and behavior of physicians regarding Hepatitis B Virus. The investigators designed a 30-item self-administered questionnaire assessing physicians' knowledge and behavior regarding chronic Hepatitis B Virus infection. These results provide data support for updating guidelines, continuing training, and even developing policies in medical insurance.

Detailed description: Schedule of the study:

Before March 1, 2015: study design, completing questionnaire design, and all preparatory work; Before July 1, 2015: a kick-off meeting for plot study, modifying the questionnaire, and obtaining all the questionnaires; Before September 30, 2015: finishing data entry, statistical analysis, drafting the report, and issued a final report

Eligibility criteria: Inclusion Criteria:

1. Mainly engaged in liver disease diagnosis and treatment;
2. Diagnosis and treatment at least 10 patients with chronic Hepatitis B Virus infection per week.

Exclusion Criteria:

1. young doctors working in less than one year;
2. physicians working in hospital of Traditional Chinese Medicine
3. visiting doctors.

Primary outcomes:
measure: 30-item self-administered questionnaire assessing physicians' knowledge and behavior regarding chronic Hepatitis B Virus infection.
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: guiqiang wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03407443: Pilot the Use of VA Make the Connection Campaign to Facilitate Help Seeking Among Vulnerable Veterans
Official title: Evaluation of the VA's Public Awareness Campaigns
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
Help-Seeking Behavior
Keywords: mental health promotion campaign
veterans
Lead sponsor: Canandaigua VA Medical Center
Sponsor class: FED
First posted: 2018-01-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This pilot study seeks to determine if exposure to the Make the Connection campaign messages developed by the U.S. Department of Veterans Affairs (VA) is associated with changes in mental-health related outcomes, specifically: (1) psychosocial determinants that drive help seeking behaviors (knowledge, attitudes and intentions); and (2) perceived barriers to seeking care. Participants are randomly assigned to message exposure or control (no exposure) conditions. Data from this project will inform mental health education and outreach efforts targeted towards Veterans experiencing mental health concerns.


Eligibility criteria: Inclusion Criteria:

Veterans of all gender/sex, race/ethnicities that in the past 6 months:

* utilized health services in the U.S. Department of Veterans Affairs (VA);
* screened positive on the PHQ-2, AUDIT-C or PC-PTSD and/or received a mental health diagnosis as documented in VA medical record
* Fluent in English language
* Capable of understanding goals of study
* Capable of providing verbal consent
* Willing and able to download/use study Android mobile application for duration of study

Exclusion Criteria:

* Not a U.S. Veteran who has utilized VA health care in the past 6 months
* Did not screen positive and/or was not diagnosed with mental health disorder
* Determined cognitively impaired and unable to provide verbal consent
* Determined to be in high distress during recruitment screening
* Currently institutionalized (i.e., hospitalized; incarcerated, etc.)
* Unwilling and/or unable to download and use use the study app

Primary outcomes:
measure: change in help seeking behavior
timeFrame: change from baseline behavior at 16 weeks
Secondary outcomes:
measure: Attitudes towards help seeking
timeFrame: assessed up to 16 weeks
measure: Barriers to care
timeFrame: assessed up to 16 weeks
Other outcomes:
measure: change in social support
timeFrame: change from baseline behavior at 16 weeks
Locations:
Study officials:
affiliation: Center of Excellence for Suicide Prevention, Canandaigua VA Medical Center; U.S. Department of Veterans Affairs
name: Elizabeth Karras, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06952543: Ultrasound Perfusion Estimation for Assessment of Peripheral Arterial Disease
Official title: Ultrasound Perfusion Estimation for Assessment of PAD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-05-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to develop a new noninvasive tool for early diagnosis of Peripheral Arterial Disease (PAD) and use the proposed method for monitoring the disease progression and the response to interventional treatment in PAD patients.


Eligibility criteria: Inclusion Criteria:

Patient volunteers:

* Male and Female, ages 18 years old and up
* Symptom of claudication and suspected for PAD
* Scheduled for vascular testing.

Healthy volunteers:

* Male and female, ages 18-75 years old and up
* Normal BMI
* No history of smoking, cardiovascular disease, or diabetes.

Exclusion Criteria:

Patient volunteers:

* Patients with gangrene
* Patients having surgery or stent
* Patients with ulcer on their leg
* Any health condition that does not allow proper use of ultrasound scanning
* People considered in "vulnerable" populations.

Healthy volunteers:

* Include volunteers with BMI not more than 30
* No history of smoking
* No history of (diabetes, hypertension, cardiovascular diseases)
* People considered in "vulnerable" populations.

Primary outcomes:
measure: Detection of peripheral arterial disease using ultrasound perfusion estimation
timeFrame: Up to 4 years
Secondary outcomes:
measure: Detection of peripheral arterial disease longitudinal changes using ultrasound perfusion estimation
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Azra Alizad
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00577343: Hospital Acquired and Community Acquired MRSA in GI Lab
Official title: Hospital Acquired and Community Acquired Methicillin Resistant Staph Aureus in the Outpatient Gastrointestinal Lab: A Prospective Study of Prevalence
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hospital Acquired MRSA
Community Acquired MRSA
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2007-12-20
Enrollment: 0
Sex: ALL
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: NON_PROBABILITY_SAMPLE
Study population: gastrointestinal lab of oupatient and inpatients

Brief summary: Hospital acquired and community acquired methicillin resistant staph aureus (MRSA) has become an important health issue for in recent years. Up to two thirds of patients that are hospitalized may be colonized with MRSA. The prevalence in the community is also on the rise and affects the young and healthy. It is unclear what the true prevalence of MRSA is in our own hospital and outpatient setting. This information would be relevant to how healthcare staff adhere to contact and universal precautions. : The purpose of this study is to determine the prevalence of MRSA in patients that have gastrointestinal endoscopy and endoscopic ultrasound.


Eligibility criteria: Inclusion Criteria:

* No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.

Subjects must provide signed written informed consent.

Exclusion Criteria:

* Inability to provide written informed consent.

Primary outcomes:
measure: The objective of this prospective study is to identify the prevalence of MRSA in patients that use the Indiana University GI lab.
timeFrame: less than one year
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Clarian/Indiana University Hospital
state: Indiana
Study officials:
References: