louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00591331: Phototoxicity Potential of NatrOVA Creme Rinse - 1%
Official title: Phase 1 Evaluation of the Phototoxic Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Head Lice
Keywords: Head Lice
Lead sponsor: ParaPRO LLC
Sponsor class: INDUSTRY
First posted: 2008-01-11
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the primary irritation potential of NatrOVA Creme Rinse - 1% in humans, after exposure to UV radiation.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects 18-65 years of age and in good health.
2. Fitzpatrick skin type I, II or III

Exclusion Criteria:

1. History of severe reactions from exposure to sunlight
2. Known allergies or sensitivities to adhesives in patches
3. Inability to evaluate the skin in and around the test sites
4. Diabetes requiring medication
5. Clinical significant skin disease
6. Asthma or other severe respiratory disease
7. Known immunological disorders such as HIV, AIDS, lupus,rheumatoid arthritis
8. History or current skin cancer
9. Mastectomy for cancer involving removal of lymph nodes draining the test sites
10. Epilepsy
11. Pregnancy, lactation, or planned pregnancy during study period
12. Chronic use of systemic antihistamine medication within 14 days of screening
13. Use of anti-inflammatory drugs within 2 days of Screening Visit 1
14. Currently receiving allergy injections
15. Use of immunosuppressive drugs
16. Topical drugs used at the test site within 7 days of Screening Visit 1
17. Current participation in any clinical trial
18. Participation in any patch test for irritation or sensitization or UV exposures within 4 weeks of study start
19. Use of any investigational drug therapy within 4 weeks of study start.

Primary outcomes:
measure: Safety endpoint will be visual grading of UV irradiated test sites and assessments of adverse experiences
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: St. Petersburg
country: United States
facility: Hill Top Research
state: Florida
Study officials:
affiliation: Hill Top Research
name: John V Murray, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05988931: Technology Interventions for Youth Alcohol Use
Official title: Comparing Scalable Technology-Driven Brief Intervention Packages for Youth Alcohol Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2023-08-14
Enrollment: 1400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effects of two programs to prevent/reduce alcohol misuse among youth primary care patients. Depending on their study condition, youth will receive a brief web-based computer program or the web program + 8 weeks of supportive text messages. Parents/caregivers of youth are encouraged to use a freely available app to guide conversations with their child about drinking. This study will have significant impact by evaluating response to these scalable interventions which can be deployed widely in clinical care settings.


Eligibility criteria: Inclusion Criteria:

* patients age 12-17 within the Michigan medicine pediatric care system who had an appointment date within the past 2 years; and
* past 12-month alcohol use; and
* patient has a phone that can receive text messages

Exclusion Criteria:

* patients who do not understand English; or
* patients deemed unable to provide informed consent due to conditions that preclude understanding of assessment or intervention content; or
* parent/guardian consent is not obtained; or
* another child in household already enrolled in the study; or
* ongoing participation in another behavioral health research study

Primary outcomes:
measure: Change in Alcohol Consumption
timeFrame: 3-, 6-, 9- and 12- months post baseline
Secondary outcomes:
measure: Change in Alcohol Related Consequences
timeFrame: 3-, 6-, 9- and 12- months post baseline
measure: Change in Other Drug Use
timeFrame: 3-, 6-, 9- and 12- months post baseline
measure: Change in Other Drug Use Consequences
timeFrame: 3-, 6-, 9- and 12- months post baseline
measure: Change in Depression Symptoms
timeFrame: 3-, 6-, 9- and 12-month post baseline
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Maureen Walton, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Erin Bonar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06516731: A Single Group Study to Evaluate the Effects of a pH Balanced Cleanser on Women's Intimate Health.
Official title: A Single Group Study to Evaluate the Effects of a pH Balanced Cleanser on Women's Intimate Health.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Health
Vaginal pH
Keywords: pH Balanced Cleanser
Vaginal Health
Women's Health
Intimate Hygiene
Intimate Skin Care
Lead sponsor: Love Wellness
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-07-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This virtual single-group study will last 8 weeks, involving the daily use of a pH Balanced Cleanser by 40 female participants. The study aims to evaluate the effect of the cleanser on signs of vulvar and vaginal health and its tolerability.

Detailed description: Participants will use the Love Wellness pH Balanced Cleanser daily during showers. Questionnaires will be completed at Baseline, first use, Week 2, Week 4, Week 6, and Week 8. Vaginal pH testing will be conducted weekly using Vaginox vaginal pH testing strips. The primary objective is to assess parameters of vulvar and vaginal health, while the secondary objective is to evaluate product tolerability.

Eligibility criteria: Inclusion Criteria:

* Female participants aged 18+
* Self-reported issues with vaginal odor, itching, or intimate skin discomfort
* Previous use of vaginal cleansers without severe adverse reactions
* Generally healthy without uncontrolled chronic diseases
* Willing to avoid intra-vaginal products during the study
* Consistent use of any vaginal health-targeted supplements for at least 3 months prior

Exclusion Criteria:

* Pre-existing chronic conditions preventing protocol adherence
* Planned reproductive health procedures
* Recent changes in medications or supplements targeting vaginal health
* Known severe allergic reactions
* Pregnancy, breastfeeding, or attempting to conceive
* Unwillingness to follow study protocol
* History of vaginal, cervical, vulvar, uterine, or ovarian cancer
* Recent changes or discontinuation of hormonal birth control
* Recent surgeries or invasive treatments

Primary outcomes:
measure: Effect of pH Balanced Cleanser on Vulvar and Vaginal Health
timeFrame: Baseline, first use, Week 2, Week 4, Week 6, Week 8
measure: Effect of pH Balanced Cleanser on Vulvar and Vaginal Health
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Tolerability of pH Balanced Cleanser
timeFrame: Baseline, first use, Week 2, Week 4, Week 6, Week 8
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT05981131: Follow up of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC)
Official title: QUILT-205: Long-Term Follow-Up of Subjects in QUILT-2.005 Phase 1b Trial of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non Muscle Invasive Bladder Cancer
Lead sponsor: ImmunityBio, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-08
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who were enrolled and completed treatment with intravesical N-803 plus BCG in QUILT-2.005 phase 1b.

Brief summary: The purpose of this clinical trial is to obtain long-term follow-up information and status of bladder cancer for patients who received study treatment in the QUILT-2.005 study.

Detailed description: All 9 subjects that completed QUILT-2.005 phase 1b are planned to be enrolled in this study.

Thus, the maximum enrollment for this study is 9 subjects. All enrolled subjects will be followed every 12 months for life, or until withdrawal of consent, or if the Sponsor closes the study.

Eligibility criteria: Inclusion Criteria:

* Enrolled and treated with intravesical N-803 plus BCG in the phase 1b portion of QUILT-2.005.

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Obtain Long Term Follow-Up data to be summarized using descriptive statistics
timeFrame: assessed up to 60 months
measure: Assess the Complete response yearly
timeFrame: assessed up to 60 months
measure: Asses Disease-free Survival
timeFrame: assessed up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Island Urology
state: Hawaii
Study officials:
affiliation: ImmunityBio, Inc.
name: Bobby Reddy, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04137731: Use of Interferential Current (IFC) Therapy After Total Knee Arthroplasty
Official title: The Effect of Short Term Patient Outcomes With the Use of Interferential Current Therapy After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Ortho IFC LLC
First posted: 2019-10-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Interferential Current Therapy (IFC) is a form of electrical therapy that utilizes two simultaneous low frequency electrical stimulation which when they cross interfere with one another resulting in an interference or beat frequency. This beat frequency provides a therapeutic area of relief by blocking painful stimuli at the area of interest. IFC is different from the other electrical treatment modalities used because the cancellation effect allows for establishment of the treatment area to be in the deeper tissues of the body, whereas other electrical modalities can only be used to treat superficial body parts that lie just under the skin.

The main objective of this proposed study is to assess the post-operative short term outcomes of the patients who receive IFC treatment during their post-total knee arthroplasty (TKA) surgery hospital stay. The implications of the study would be improved patient outcome which could result in shorter hospital stay, reduced use of opioid medication, decreased need for manipulation under anesthesia and reduced re-admission rate.


Eligibility criteria: Inclusion Criteria:Adult patients with knee osteoarthritis who have failed conservative therapy and undergoing elected TKA.

-

Exclusion Criteria:

i. \<18 years old ii. Any patient with pacemaker or any electrical stimulator device iii. Patients without capacity to consent for the study iv. Patients not able to have local nerve block or spinal anesthesia v. Patients with prior chronic opioid use vi. Patients who are categorized to have 'Severe' fear and anxiety responses to pain, according to the Pain catastrophizing scale (PCS) survey.

Primary outcomes:
measure: Post-operative Opioid Pain Medication Usage
timeFrame: 24 hours after surgery
measure: Post-operative Opioid Pain Medication Usage
timeFrame: 48 hours after surgery
measure: Visual Pain Score (VAS)
timeFrame: 24 Hours after surgery
measure: Visual Pain Score
timeFrame: 48 Hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Zeynep Seref-Ferlengez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montefiore Medical Center
name: Sun Jin Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04782531: Variations of Portal Flow During the Respiratory Cycle in Healthy Volunteers
Official title: Variations of Portal Flow During the Respiratory Cycle in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Amplitude
Portal Blood Flow
MRI
Echo Planar Imaging
Keywords: Respiratory amplitude
Portal Blood Flow
MRI
Echo Planar Imaging
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The analysis of portal vein blood flow is important when assessing the severity and progression of liver disease. It is important to understand normal liver regulation in order to appreciate the evaluation of the effect of treatment during the disease progression. The influence of respiration on hepatic hemodynamics is still poorly understood, although some studies have shown a significant impact. The purpose of this project is to quantify the blood flow variations in the portal vein at different positions during the respiratory cycle by using a fast MRI sequence and an Echo Planar (EPI) acquisition.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 ans
* Healthy subject without history of hepatic disease

Exclusion Criteria:

* history of hepatic pathology
* pregnant woman
* claustrophobia
* major obesity
* any contraindication to MRI exam

Primary outcomes:
measure: flow rates variation between the fast sequence averaged values and the standard sequence
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT02946931: All-Case Surveillance of Prizbind®
Official title: The Drug Use-results Survey (All-Case Surveillance) on Prizbind® for Intravenous Solution 2.5 g in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-10-27
Enrollment: 1402
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: Patients who are prescribed with Prizbind

Brief summary: To evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under Japanese clinical condition.


Eligibility criteria: Inclusion criteria:

Patients who are prescribed with Prizbind® for Intravenous Solution 2.5 g by the discretion of investigators

Exclusion criteria:

None

Primary outcomes:
measure: Number of Patients With Adverse Drug Reactions (ADRs)
timeFrame: From the first intake of Prizbind® for Intravenous Solution 2.5 g to the end of the observation period for each patient, up to 74 days.
Secondary outcomes:
measure: Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)
timeFrame: From the end of the first infusion up to 4 hours after the last infusion on Day 1.
measure: Number of Patients in Each Category of Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)
timeFrame: From the end of the first infusion up to 4 hours after the last infusion on Day 1.
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Yasaka M, Yokota H, Suzuki M, Asakura H, Yamane T, Ogi Y, Ochiai K, Nakayama D. Idarucizumab for Emergency Reversal of Anticoagulant Effects of Dabigatran: Interim Results of a Japanese Post-Marketing Surveillance Study. Cardiol Ther. 2020 Jun;9(1):167-188. doi: 10.1007/s40119-020-00165-8. Epub 2020 Mar 9.
Clinical trial NCT05426031: Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass
Official title: Optimal Protamine Dosing for Heparin Reversal Following Cardiopulmonary Bypass: A Blinded Randomized Control Trial Comparing Two Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coagulation; Intravascular
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 130
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 compare two different dosing strategies of a drug named protamine.


Eligibility criteria: Inclusion Criteria:

* Patients greater than or equal to 18 years of age undergoing elective cardiac surgery with cardiopulmonary bypass.
* Patients must that have a calculated protamine dose greater than 250 mg based on standard 1:1 initial heparin to protamine dosing calculation.

Exclusion Criteria:

* Patients who are under 18 years of age or pregnant.
* Patients undergoing emergency surgery (ASA class E).
* Patients with known coagulation disorders.
* Patients requiring circulatory arrest or deep hypothermia.
* Patients who have not had the appropriate interruption in coumadin, direct oral anticoagulants or non-aspirin antiplatelet agents.
* Patients on pre-operative intravenous unfractionated heparin infusions.
* Patients ineligible for heparin administration due to known adverse reactions including allergy or heparin induced thrombocytopenia or known heparin resistance.
* Patients who are unable to provide informed consent in the form of a signature.
* History of adverse reaction to protamine.
* Have any condition that, in the opinion of the investigator, will compromise the well-being of the patient or the study, or prevent the patient from meeting or performing study requirements.

Primary outcomes:
measure: Activated Clotting Time
timeFrame: Baseline (before start of surgery)
measure: Activated Clotting Time
timeFrame: up to 4 hours (after cardiopulmonary bypass surgery)
Secondary outcomes:
measure: Additional Protamine Dosing
timeFrame: Up to 4 hours
measure: Chest Tube Output
timeFrame: Up to 24 hours
measure: Count of Participants Receiving Red Blood Cell Transfusion
timeFrame: Up to 4 hours
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Michael Fabbro, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00393731: A Randomized, Control Trial for Preinduction Cervical Ripening
Official title: A Randomized, Control Trial for Preinduction Cervical Ripening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Labor, Induced
Keywords: labor
induction
misoprostol
oxytocin
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2006-10-29
Enrollment: 540
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to compare the vaginal delivery rates in women undergoing induction of labor with an unripe cervix between oxytocin induction alone and preinduction cervical ripening with prostaglandin El (misoprostol). Secondary goals are to measure and compare the time intervals to delivery between the two methods.


Eligibility criteria: Inclusion Criteria:

* Women that are hospitalized for induction of labor that have a Bishop's score \<5
* singleton gestation
* cephalic presentation
* 24 weeks gestational age

Exclusion Criteria:

* Prior uterine surgery
* malpresentation
* placenta previa or abruption
* clinically suspected or diagnosed intra amniotic infection
* genital HSV infection
* multiple gestation
* premature rupture of the membranes
* active labor
* maternal/fetal conditions that may preclude labor induction in the opinion of the investigators

Primary outcomes:
measure: Vaginal Delivery rates
Secondary outcomes:
measure: Time interval to delivery
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon B. Johnson Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Michael Lucas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00980031: Aldosterone Blockade to Prevent Myocardial Remodeling In Patients With Controlled Essential Hypertension
Official title: Aldosterone Blockade to Prevent Myocardial Remodeling In Patients With Controlled Essential Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Myocardial Remodeling
Keywords: Aldosterone Blockade
Aldosterone Receptor Blockers
cardiac chamber size
wall thickness
left ventricular ejection fraction
left atrial volumes
diastolic function
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2009-09-18
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this project is to investigate the effects that the addition of aldosterone blockade with eplerenone will have on the progression of diastolic dysfunction in patients with controlled essential hypertension.

Detailed description: The purpose of this project is to determine if eplerenone, an aldosterone blocker, prevents remodelling of the heart in patients with controlled essential hypertension, defined as having a blood pressure of equal to or less than 130/80 in diabetics and equal to or less than 140/90 in non-diabetics. This study will investigate if the addition of 25 milligrams of eplerenone daily to a subject's hypertension medication regimen will prevent the progression or development of diastolic dysfunction. Echocardiography will be used to measure the changes in heart structure of subjects receiving eplerenone versus subjects receiving placebo (a drug that may resemble the study drug but contains no active ingredient). Approximately 30 subjects will take part in this study.

Eligibility criteria: Inclusion Criteria:

* Treated and controlled hypertension
* Less than 140/90 in non-diabetics
* Less than 130/80 in diabetics

Exclusion Criteria:

* currently receiving an aldosterone blocker
* clinical evidence of congestive heart failure
* prior myocardial infarction
* renal dysfunction with a creatinine clearance of less than 40ml/min
* serum potassium \> 5.5meq/L at initiation
* concomitant use of a medication that inhibits the CYP3A4 enzyme (ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir)

Primary outcomes:
measure: Myocardial Remodeling (cardiac chamber sizes, wall thickness, left ventricular ejection fraction, left atrial volumes, and diastolic function) assessed by transthoracic echocardiogram
timeFrame: 6 months
Secondary outcomes:
measure: Blood Pressure
timeFrame: 6 months
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University Medical Center (including ambulatory centers)
state: Nebraska
Study officials:
affiliation: Creighton Cardiology
name: M Jeff Holmberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: