louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05327361: LiftActiv B3 in Post Inflammatory Hyperpigmentation (PIHP)
Official title: Evaluation of the Depigmenting Effect of Liftactiv B3 Serum (Split Face) in Patients With Mild to Moderate Facial Post-acne PIHP for 3 Months
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acne
Post Inflammatory Hyperpigmentation
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Vichy Laboratoires
First posted: 2022-04-14
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to measure the depigmenting effect of a serum product called Liftactiv B3 in patients with mild to moderate facial PIHP (Post Inflammatory Hyper Pigmentation)


Eligibility criteria: Inclusion Criteria:

* Multiethnic subjects
* 18 to 50 YO
* Phototype III-VI
* All skin types
* 50% with sensitive skin (declarative)
* Symmetrical mild to moderate facial post-acne PIHP lesions with IGA scale
* Mild active acne (less than 10 retention and 5 inflammatory lesions)
* Agreeing not to change their lifestyle during the study period.
* Capable of reading the documents presented to them, of adhering to the study regulations and accepting the limitations.
* Available to follow the study
* Agreeing to participate and having signed the informed consent

Exclusion Criteria:

* Moderate to severe active acne
* Patients under topical or systemic retinoids
* Patients under systemic immunosuppressants
* Patients under active treatment of PIHP (including topicals or procedures) within the last 3 months
* Patients treated with facial procedures within the last 3 months
* Pregnancy
* Patient with a recent change in contraception (since less than 6 months)
* Known allergy to any component of tested product
* Not presenting with the conditions needed to comply with the protocol.
* Unable to give their informed consent
* Not available to follow the study in its entirety

Primary outcomes:
measure: Post Inflammatory Hyperpigmentation (PIHP) Change
timeFrame: Baseline, 1 month, 2 months and 3 months
Secondary outcomes:
measure: Change in the Investigators Global Assessment (IGA) Scale
timeFrame: Baseline, 1 month, 2 months and 3 months
measure: Change in Skin Condition Evaluation Scores
timeFrame: Baseline, 1 month, 2 months and 3 months
measure: Change in Global Efficacy Assessment
timeFrame: 1 month, 2 months, and 3 months
measure: Change in Global Tolerance Score
timeFrame: 1 month, 2 months, and 3 months
measure: Change in Cosmeticity Questionnaire and Acceptability
timeFrame: 1 month, 2 months, and 3 months
measure: Exposome Questionnaire
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
Study officials:
References:
Clinical trial NCT00579761: Retrospective Review of Management of Infective Endocarditis
Official title: A Retrospective Review of the Management of Infective Endocarditis in Patients at Virginia Commonwealth University Medical Center From 1996-2006
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Endocarditis
Keywords: Endocarditis
neurological deficit
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects that have undergone surgical treatment for infective endocarditis at VCU medical Center from 1996 to present

Brief summary: This is an analysis of the outcomes of patients having undergone surgical intervention for infective endocarditis.

Detailed description: This study will look at the presentations, epidemiology, risk factors, modalities of diagnosis; and the role of specific investigatory tools with surgical intervention and timimg of intervention in patients who underwent surgical treatment for infective endocarditis. Morbidity and Mortality post surgery and prognosis including long term outcome of our patients will be analyzed. Special attention will be made to those patients with pre-operative neurological deficit.

Eligibility criteria: Inclusion Criteria:

* Have undergone surgical treatment for infective endocarditis

Exclusion Criteria:

* Less than 18 years old

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonweath University MCV Hospital
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University Department of Cardiothoracic Surgery
name: Vigneshwar Kasirajan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02822261: Sun Protection Factor Assay
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-07-04
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05352061: Addressing Psychosocial Comorbidities in HIV Treatment and Prevention 2b
Official title: Addressing Psychosocial Comorbidities in HIV Treatment and Prevention: Phase 2b
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Medication Adherence
Mental Health Issue
Keywords: HIV Medication Adherence
Mental Health
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-04-28
Enrollment: 75
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 purpose of this study is to learn about ways to better support people living with HIV with their HIV treatment and cope with mental health challenges and/or substance use concerns.


Eligibility criteria: Inclusion Criteria:

1. Age: 18 years or older
2. HIV positive
3. Evidence of uncontrolled virus (e.g., \> 20 copies/ml) within the past 12 months as verified by medical record
4. Group 1: (Men who have sex with men (MSM) who have used stimulants within the past 4 months (approximately 10 participants))OR Group 2: transgender women (approximately 10 participants) OR Group 3: Emerging adults between the ages of 18 and 26 (inclusive; approximately 10 participants)

Exclusion Criteria:

1. Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview
2. Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania) that would interfere with study participation
3. Opinion of the PI that the participant would be at risk for harm to self or others
4. Currently receiving CBT for a psychiatric disorder, or received a course of CBT in the past year.

Primary outcomes:
measure: Percentage of participants who completes the follow up assessment
timeFrame: 8 months
Secondary outcomes:
measure: ART Medication Adherence
timeFrame: Up to 8 months
measure: Percentage of participants with undetectable viral load
timeFrame: Up to 8 months
measure: Percentage of participants with improvement in syndemic, behavioral health outcomes
timeFrame: Up to 8 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Steven A Safren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02627261: Multiple Myeloma Minimal Residual Disease
Official title: Comparison of Three Methods to Evaluate Residual Disease in Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: residual disease
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: Janssen, LP
First posted: 2015-12-10
Enrollment: 48
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: This study will focus on adult patients with multiple myeloma and who will receive a treatment with high-dose melphalan and autologous bone marrow transplantation

Brief summary: Three methods including flow cytometry, next generation sequencing and determination of circulating tumor cells will be performed at different time points in patients with previously undiagnosed multiple myeloma in order to determine the most sensitive method to detect residual disease


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years
* previously undiagnosed myeloma
* eligible for high dose therapy and bone marrow transplantation
* signed consent

Exclusion Criteria:

* ongoing therapy for another neoplasia
* Patients with other hematologic malignancies,
* patients deprived of liberty for administrative or judicial reasons
* previously treated for myeloma

Primary outcomes:
measure: Quantification of residual disease
timeFrame: Residual disease is assessed up to 18 months after inclusion
Secondary outcomes:
measure: kinetic of variation of the residual tumor cells detected by flow cytometry method
timeFrame: 18 months
measure: kinetic of variation of the residual tumor cells detected by new generation sequencing method
timeFrame: 18 months
measure: kinetic of variation of the circulating tumor cells
timeFrame: 18 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Huriez
city: Nantes
country: France
facility: Centre Hospitalier Universitaire Hôtel-Dieu de Nantes
city: Pierre Bénité
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
References:
Clinical trial NCT02099461: Effect of Denosumab on Cellular Biomarkers in the Human Breast
Official title: A Randomized, Stratified, Open-label, No-treatment-controlled, Parallel Group, Multicenter Phase 1 Trial to Evaluate the Effect of Denosumab on Cellular Proliferation in the Human Breast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer, Female, Breast
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-03-31
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate whether administration of denosumab results in a decrease compared to the control group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation index.


Eligibility criteria: INCLUSION CRITERIA:

* Willing to use, in combination with her partner, 2 non-hormonal methods of effective contraception or practice sexual abstinence. Subjects who are surgically sterile (eg, history of hysterectomy) or whose sexual partner is sterile (eg, history of vasectomy) are not required to use contraceptive measures
* Laboratory tests are within clinically acceptable range
* Clinically acceptable physical exam and no history or evidence of any clinically significant medical disorder that would pose a risk to subject safety or interfere with study evaluations or procedures.

EXCLUSION CRITERIA:

* Female subject with a prior history of breast cancer; breast implant in the breast to be biopsied; Known history of fibrocystic breast disease
* Subject is unable or unwilling to provide breast biopsy tissue from the upper outer quadrant of her breast
* Pregnant or plans to become pregnant while exposed to investigational product
* Lactating/breastfeeding or plans to breastfeed while exposed to investigational product
* Recent use of any non-approved medications or devices
* Uncontrolled thyroid disorder
* Significant dental/oral disease
* Planned invasive dental procedures
* Positive urine screen for alcohol and/or drugs

Primary outcomes:
measure: Log Ratio of Post-baseline to Baseline Ki-67 Index in Mammary Epithelial Cells
timeFrame: Baseline and Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Research Site
state: California
city: Hollywood
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01268761: GnRH Antagonist for Treatment of Early Ovarian Hyperstimulation Syndrome
Official title: Usefulness of GnRH Antagonist Administration in the Treatment of Early Ovarian Hyperstimulation Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Hyperstimulation Syndrome
Effects of Gonadotropin
Oocyte Maturation
Keywords: Ovarian hyperstimulation syndrome (OHSS)
GnRH antagonist
Ascitis.
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2010-12-31
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to analyze the effectiveness of GnRh antagonist in the treatment of early ovarian hyperstimulation syndrome.

Detailed description: Ovarian hyperstimulation syndrome (OHSS) is a serious complication of ovarian stimulation protocols. Gonadotrophin-releasing hormone (GnRH) antagonist administration in the luteal phase was recently proposed as a new approach for the management of patients with established severe OHSS We analyze the response of egg donors with moderate- severe early ovarian hyperstimulation syndrome after a GnRH antagonist stimulation protocol to the administration of a daily doses of GnRH antagonist (Cetrorelix 0.25) during 7 days after the second day of oocyte retrieval compared with placebo (saline solution).

Eligibility criteria: Inclusion Criteria:

* Egg donors
* Volunteers.
* 18-35 years old
* Healthy
* BMI \< 30
* OHHS after oocyte retrieval defined as ascitis \> 9 cm2 associate to abdominal pain, sickness, abdominal distention,or haematocrit (Ht) \>45% an white blood cell count \>15,000/mm3 or creatine \> 1.2 mg/dl or transaminases \> 40 IU/liter

Exclusion Criteria:

* BMI \> 30
* Allergy to GnRH antagonist

Primary outcomes:
measure: Ultrasound
timeFrame: one week
measure: Blood measurements
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
affiliation: IVI Valencia
name: Juan Giles, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00408161: Contingency Management for Chronic Recidivist Alcohol-Dependent Patients
Official title: Contingency Management for Chronic Recidivist Alcohol-Dependent Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependence
Keywords: Contingency Management
Alcohol Dependence
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2006-12-06
Enrollment: 104
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 evaluate the efficacy of prize contingency management (CM) in reducing in-patient detoxification services for chronic recidivist alcohol-dependent patients.

Detailed description: This study evaluates the efficacy of prize contingency management (CM) in reducing in-patient detoxification services for chronic recidivist alcohol-dependent patients. 116 alcohol-dependent patients who have received 4 or more alcohol detoxifications in a calendar year will be randomly assigned to one of two 6-month treatment conditions: standard case management treatment, or standard case management treatment plus CM. In the CM condition, patients earn the chance to win prizes by submitting negative breath samples and by complying with steps toward treatment goals, such as attending outpatient substance abuse treatment services, attending appointments with low income housing programs, or complying with outpatient psychiatric treatment. Treatment services received, alcohol and drug use, psychosocial functioning, and HIV risk behaviors will be measured pre-treatment and at months 1, 3, and 6 (post-treatment), and at follow-ups scheduled for 9, 12, and 18 months after intake.

Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* Four or more inpatient alcohol detoxifications in the previous 12 months
* current diagnosis of DSM-IV alcohol dependence

Exclusion Criteria:

-

Primary outcomes:
measure: number of detoxifications
timeFrame: 9, 12, and 18 months after intake
measure: objective alcohol use
timeFrame: 9, 12, and 18 months after intake
measure: self-reported alcohol use
timeFrame: 9, 12, and 18 months after intake
Secondary outcomes:
measure: ASI composite scores
timeFrame: 9, 12, and 18 months after intake
measure: BSI scores
timeFrame: 9, 12, and 18 months after intake
measure: HRBS scores
timeFrame: 9, 12, and 18 months after intake
measure: objective drug use
timeFrame: 9, 12, and 18 months after intake
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Nancy M Petry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05852561: Comparison of Superficial+Deep Vs. Deep Serratus Anterior Plan Block in Video-Assisted Thoracic Surgery
Official title: Comparison of Combined Superficial and Deep Serratus Anterior Plan Block Versus Deep Serratus Anterior Plan Block for Postoperative Pain Control in Video-Assisted Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Thoracotomy is one of the most painful surgeries; Video-assisted thoracoscopic surgery (VATS) has been developed to reduce the surgical stress of thoracotomy. However, patients may experience moderate to severe pain within the first 24 hours after VATS. Intravenous opioids are frequently used to provide postoperative analgesia, and accordingly, side effects such as postoperative nausea/vomiting and respiratory depression can be seen.

The aim of this study is to compare Superficial+Deep Vs. Deep Serratus Anterior Plan Block for postoperative pain control in VATS cases.


Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologist's physiologic state I-III patients
2. To undergo Video Assisted Thoracic Surgery
3. Being between the ages of 18-65 years

Exclusion Criteria:

* having a known heart, kidney, liver or hematological disease
* having a history of peptic ulcer, gastrointestinal bleeding, allergy, chronic pain
* Routine analgesic use and history of analgesic use in the last 24 hours
* Not willingto participate in the study
* Uncooperative patients who have coagulopathy or use anticoagulant drugs
* To be allergic to one of the drugs to be used
* Contraindication for Video Assisted Thoracic Surgery

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: first 24 hours
Secondary outcomes:
measure: Visual analog pain score
timeFrame: first 48 hours
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ali Ahiskalioglu
Study officials:
affiliation: Ataturk University
name: Elif Oral Ahiskalioglu
role: STUDY_DIRECTOR
References:
citation: Lee J, Kim S. The effects of ultrasound-guided serratus plane block, in combination with general anesthesia, on intraoperative opioid consumption, emergence time, and hemodynamic stability during video-assisted thoracoscopic lobectomy: A randomized prospective study. Medicine (Baltimore). 2019 May;98(18):e15385. doi: 10.1097/MD.0000000000015385.
citation: Qiu L, Bu X, Shen J, Li M, Yang L, Xu Q, Chen Y, Yang J. Observation of the analgesic effect of superficial or deep anterior serratus plane block on patients undergoing thoracoscopic lobectomy. Medicine (Baltimore). 2021 Jan 22;100(3):e24352. doi: 10.1097/MD.0000000000024352.