louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01504061: Mederma to Reduce Appearance of Post Surgical Scars
Official title: The Comparison of Mederma® N&I to Mederma® Ultra Gel to Reduce the Appearance of Post Surgical Scars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scars
Keywords: surgical
scars
Mederma
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is a single-center, 20-subject, investigator-blinded study to evaluate the effect of Mederma N\&I to Mederma Ultra Gel on the appearance of post-surgical scars.

Detailed description: This is a 10-week research study designed to compare the effect of two gels on the appearance of post surgical scarring of the chest and/or back. The subject will be asked to identify two symmetrical skin growths that they would like to have removed: one on the left chest and/or back and one on the right chest and/or back. Additionally, the subject will identify a third skin growth that they would like removed which is a reasonable distance from the two symmetrical skin growths and will be located either on the back or the chest.

Inclusion Criteria:

* Healthy male and non pregnant female subjects ≥18 years of age
* have seborrheic keratoses on the right and left chest and/or back

Exclusion Criteria:

-Subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and Lidocaine.

Eligibility criteria: Inclusion Criteria:

* Subjects must be 18-70 years of age, of any race or sex.
* Subjects must be Fitzpatrick skin type I-VI.
* Subjects must have two symmetrical upper chest and/or back seborrheic keratoses and in the opinion of the investigator are good candidates for the study.

Exclusion Criteria:

* Subjects with known allergies or sensitivities to ingredients contained in the test product including onion extract and Lidocaine.
* Subjects with known history of keloids or hypertrophic scars.

Primary outcomes:
measure: Investigator assessment of post-surgical scar appearance (indices are erythema, softness, texture, and overall appearance). This assessment is accompanied by photography and dermaspectrophotometry.
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC
state: North Carolina
Study officials:
affiliation: Dermatology, Laser, and Vein Specialists of Carolinas, PLLC
name: Girish Munavalli, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03953261: Effect of Curcumin on Systemic Lupus Erythematosus
Official title: Effect of Curcumin on Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 23
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 investigator initiated study is to determine the efficacy of curcumin on disease activity of subjects with systemic lupus erythematous. Curcumin has been found to have anti-inflammatory effects and has been found to improve disease activity in lupus patients. In addition, subjects with rheumatoid arthritis as well as osteoarthritis have also found benefit for their disease activity.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 18 or older
* Diagnosed with Systemic Lupus Erythematous according to the 2012 Systemic Lupus International Collaborating Clinics Classification Criteria.
* SLEDAI score of 6 or higher
* Ability to take oral medication and be willing to adhere to the study drug regimen

Exclusion Criteria:

* Inability to provide written consent for study participation
* Use of curcumin supplements within 30 days of enrollment of study
* Liver function disorders (AST/ALT \> 2.5x upper limit of normal)
* Pregnancy or lactation
* Known allergic reactions to turmeric
* Subjects who are admitted for recent hospitalization within past 60 days
* Treatment with another investigational drug or other intervention within past 60 days
* Subjects with end stage renal disease on dialysis
* Subjects who lack the ability to provide consent

Primary outcomes:
measure: Change in SLEDAI
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
References:
Clinical trial NCT00127361: Study of Having a Female Friend as Labor Support
Official title: Evaluation of Continuous Support in Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Delivery, Obstetric
Keywords: doula
caregivers
labor support
being with woman
continuous labor support
maternal outcomes
Parturition
Lead sponsor: Saint Peters University Hospital
Sponsor class: OTHER
First posted: 2005-08-05
Enrollment: 600
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare labor outcomes in women accompanied by an additional support person (doula group) with outcomes in women who did not have this additional support person (control group).

The current study was designed with the benefits of continuous labor support in mind as well as the need for a cost-effective, affordable program to provide those services for low-income women. Its purpose was to evaluate the effects of continuous labor support provided by a female companion of the pregnant person's choosing who, with the mother, had participated in an educational program to teach her how to provide continuous labor support.

Detailed description: The purpose of this study was to evaluate the influence of a female companion in labor who had been chosen by a nulliparous, underinsured, low-income woman and who had received brief training in supportive labor techniques. The objective was to compare labor outcomes, specifically cesarean section rates, in women accompanied by this additional support person (doula group) with outcomes in women who did not have this additional support person (control group).

Eligibility criteria: Inclusion Criteria:

* Nulliparous (never given birth before)
* Singleton pregnancy
* Vertex presentation
* Low risk pregnancy
* Has a female friend willing to be a doula

Exclusion Criteria:

* Placenta previa
* Abruptio placenta
* Multiple pregnancy
* Breech presentation
* Planned operative delivery

Primary outcomes:
measure: Length of labor
measure: type of delivery
measure: type and timing of analgesia/anesthesia
Secondary outcomes:
measure: Birthweight
measure: neonatal Apgar score at 1 and 5 minutes after birth
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Saint Peters University Hospital
state: New Jersey
Study officials:
affiliation: Saint Peters University Hospital
name: Della A Campbell, PhDc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00518661: Risk Factors for Quinolone Resistance Among ESBL Producing Klebsiella Species
Official title: Risk Factors for Quinolone Resistance Among Extended-Spectrum Beta-Lactamase-Producing Klebsiella Species
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quinolone Resistance
ESBL
Klebsiella Species
Infection
Keywords: quinolone resistance
ESBL
Klebsiella species
Infection
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2007-08-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: quinolone resistant

Brief summary: This is a retrospective chart review. This proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of Klebsiella species. Additionally, the adequacy of empiric antibiotic therapy for Klebsiella bloodstream infections will be assessed.

Detailed description: This is a retrospective chart review. This proposed study aims to document the risk factors for quinolone resistance in bloodstream isolates of Klebsiella species. Additionally, the adequacy of empiric antibiotic therapy for Klebsiella bloodstream infections will be assessed. This research is (c) important because identification of risk factors may allow earlier initiation of appropriate therapy in patients infected with these bacteria. Additionally, we will identify whether horizontal spread is responsible for this increasing trend.

Eligibility criteria: Inclusion Criteria:

* must be quinolone resistant among ESBL producing klebsiella species

Exclusion Criteria:

* Those not meeting entry criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Brian Potoski, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02908061: A Study to Determine if Mesh Placement During Bladder Surgery Can Reduce the Chances of Developing a Hernia
Official title: A Prospective, Randomized Trial of Preventive Mesh Placement at the Time of Radical Cystectomy to Reduce the Chances of Developing a Parastomal Hernia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Radical Cystectomy
Keywords: Mesh Placement
Radical Cystectomy
16-1285
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 178
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 any good and bad effects of using Ultrapro mesh along with the usual bladder removal surgery, versus having the usual bladder removal surgery without the use of the mesh.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing RC and IC formation in an elective setting,for cancer.

Exclusion Criteria:

* Expected survival \< 12 months
* Salvage RC
* Distant metastatic disease

Primary outcomes:
measure: Number of patients with incidence of radiographic Parastomal Hernia
timeFrame: within 2 years of RC and IC.
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent and follow-up only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent and follow-up only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent and follow-up only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent and follow-up only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent only and Follow Up)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Bernard Bochner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05206461: Relationship Between Trunk Control and Hand Function and Quality of Life
Official title: The Trunk Control Which is Fundamental in Hemiparetic and Diparetic Cerebral Palsied Children: Its Relationship With Hand Function and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Quality of Life
Hand
Keywords: Cerebral Palsy
Trunk Control
Hand Function
Quality of Life
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 43
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with hemiparetic and diparetic Cerebral Palsy aged 5-18

Brief summary: Increasing quality of life and improving hand functions are very substantial treatment goals for physiotherapy and rehabilitation. Trunk control is important for these parameters in children with hemiparetic and diparetic Cerebral Palsy.

Detailed description: Trunk control, hanf function and quality of life measurements were carried out by a physiotherapist using the Trunk Control Measurement Scale, 9-Hole Peg Test and Pediatric Quality of Life Inventory. Participants were informed about the procedure of the tests. The evaluation period lasted 30-40 minutes for each child.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 5-18,
* Having a diagnosis of hemiparetic or diparetic CP,
* To be at the level of I-II-III according to the Gross Motor Function Classification System,
* Not having had orthopedic surgery on the upper extremity in the last 6 months,
* Not having been injected with Botulinum Toxin-A in the last 6 months,
* Accepting the study and signing the consent form.

Exclusion Criteria:

* Children who could not understand and follow simple verbal commands,
* Did not meet the inclusion criteria,
* Incomplete assessments.

Primary outcomes:
measure: Trunk Control Measurement Test
timeFrame: Baseline
measure: 9-Hole Peg Test
timeFrame: Baseline
measure: Pediatric Quality of Life Inventory
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
state: Karatay
Study officials:
affiliation: Pamukkale University
name: Feride Yarar, Asst Prof,PT
role: STUDY_CHAIR
References:
Clinical trial NCT06003361: Rise Study for Depression
Official title: Randomized Controlled Trial of a Digital Cognitive Behavioral Therapy Program for Major Depression in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Big Health Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-21
Enrollment: 61
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the efficacy of digital CBT versus waitlist in improving symptoms for adults with Major Depressive Disorder.

Detailed description: This study aims to examine the effectiveness of app-based digital CBT in individuals with a diagnosis of Major Depressive Disorder. The primary outcomes are depression symptom reduction and engagement with fulfilling activities after 5 weeks.

Eligibility criteria: Inclusion Criteria:

* Adults aged ≥22 years old
* Score ≥10 and \<20 on the 8-item Patient Health Questionnaire (PHQ-8)
* Diagnosis of Major Depression
* Current resident of the USA
* Oral and written fluency in English
* Regular access to the internet via a mobile or tablet device using Android (5 or higher) or iOS (13 or higher)
* Participant is able and willing to comply with protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form

Exclusion Criteria:

* Must not be currently receiving or be expecting to start therapy for depression, anxiety, or sleep during study participation, or have received cognitive behavioral therapy for depression, anxiety, or sleep in the past 12-months
* If on psychotropic medication, this must be stable for at least 60 days
* Past or present psychosis, schizophrenia, or bipolar disorder
* Moderate or greater suicide risk
* Treatment-resistant depression
* Hearing or vision impairment that prevents effective use of the audio-visual content of digital CBT or psychoeducation
* Intellectual disability or any Neurocognitive or Neurodevelopmental disorder that would prevent participants from following study procedures
* Any condition that the investigator believes would make participation in the study not in the best interest of the subject or would preclude successful completion of study activities
* Other exclusion criteria may apply

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-8)
timeFrame: 5 weeks post-randomization
measure: Environmental Reward Observation Scale (EROS)
timeFrame: 5 weeks post-randomization
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-8)
timeFrame: 10 weeks post-randomization
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 5 and 10 weeks post-randomization
measure: World Health Organization 5-item Wellbeing Index (WHO-5)
timeFrame: Weeks 5 and 10 post-randomization
measure: Environmental Reward Observation Scale (EROS)
timeFrame: 10 weeks post-randomization
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Big Health Inc.
state: California
Study officials:
References:
Clinical trial NCT00838461: Study Evaluating the Safety, Pharmacokinetics (PK), and Pharmacodynamices (PD) of HSD-016
Official title: Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of HSD-016 Administered Orally to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-02-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is intended to provide an initial safety assessment of HSD-016 and also to evaluate how the drug is absorbed and eliminated and its effect on the body in healthy subjects.


Eligibility criteria: Inclusion criteria:

1. Men or women of nonchildbearing potential aged 18 to 50 years.
2. Healthy as determined by investigator on the basis of medical history and physical examination, laboratory test results, and 12-lead ECG. 3. Nonsmoker or smoker of fewer than 10 cigarettes per day.

Exclusion criteria:

1. No history of thyroid abnormalities.
2. No presence or history of any disorder that may prevent the successful completion of the study.
3. No history of drug abuse.
4. No use of any systemic steroids for 3 months.
5. No history of claustrophobia.

Primary outcomes:
measure: Safety will be evaluated from reported AEs, scheduled physical, vital sign measurements, 12 lead ECGs, and clinical laboratory test results.
timeFrame: 3 months
Secondary outcomes:
measure: Levels of drug concentrations will be evaluated after receiving multiple doses of HSD-016
timeFrame: 3 months
Other outcomes:
Locations:
city: Chula Vista
country: United States
state: California
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03519061: Impact of Budesonide Irrigations on Patients With Chronic Rhinosinusitis and Impact on Sinus Surgery Rates
Official title: Impact of Budesonide Irrigations on Patients With Chronic Rhinosinusitis and Impact on Sinus Surgery Rates
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Chronic Sinus Infection
Chronic Sinusitis
Chronic Sinusitis - Ethmoidal, Posterior
Chronic Sinus Congestion
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non randomized, single arm, prospective
Primary purpose: TREATMENT

Brief summary: This study is intended to assess the impact of a 90 day course of high volume budesonide irrigations for patients who have failed other medical therapy and assessing the impact of the budesonide irrigations on the need for sinus surgery.

Detailed description: Patient who meet eligibility requirements will be given the opportunity to use a budesonide saline rinse twice daily for 90 days. At the completion of this therapy, their clinical situation will be reassessed and patients will either proceed to surgery or not. If eligible patients choose not participate, they will be offered surgery up front. The study will be assessing symptom scores using the SNOT-22 validated patient reported symptoms score, CT scans, and other measures. The study hypothesizes that a significant portion of patients that otherwise would have progressed to surgery will no longer need to have surgery based upon improvements in their overall symptoms scores after using budesonise irrigations.

Eligibility criteria: Inclusion Criteria:

* adult (\>18 yo)
* symptoms consistent with sinusitis for at least 12 weeks,
* undergone maximal medical therapy, including: extended course of antibiotics (21 days minimum), use of topical corticosteroids for a minimum of 6 weeks, use of saline rinses at least once a day for a minimum of 3 weeks
* CT showing evidence of chronic sinusitis.

Exclusion Criteria:

* pregnant women,
* age below 18,
* presence of nasal polyps or other nasal masses,
* failure to complete medical therapy,
* normal CT scan,
* intolerance to budesonide or saline irrigations via squeeze bottle (high volume, high flow).

Primary outcomes:
measure: SinoNasal Outcome Test (SNOT 22)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Kaiser Permanante Orange County
state: California
Study officials:
References: