louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06233877: Clinical Trial Evaluating Low Dose G-FLIP Plus Mitomycin C for Stage IV Pancreatic Cancer
Official title: An Open Label Phase 2 Trial to Evaluate the Safety, Tolerability, and Efficacy of Low Dose G-FLIP in Combination With Mitomycin C in Patients With Stage IV Pancreatic Cancer Who Have Failed First-Line Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: Pancreatic
low dose
Lead sponsor: Hirschfeld Oncology
Sponsor class: OTHER_GOV
First posted: 2024-01-31
Enrollment: 60
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 study focuses on advanced metastatic pancreatic cancer, testing a combination of low-dose anti-cancer drugs (G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin) with the addition of Mitomycin C. The aim is to find a safer and more effective therapy for this devastating disease.

Detailed description: Objective: Evaluate the safety, tolerability, and efficacy of G-FLIP combined with Mitomycin C for advanced pancreatic cancer.

Design: Open-label study with 60 evaluable subjects. Treatments: G-FLIP administered every 2 weeks, with Mitomycin administered every 4 weeks.

Efficacy Assessments: Based on response criteria (Complete Response, Partial Response, Stable Disease, Progressive Disease), Response Rate, Progression-Free-Survival, Overall Survival, and 12-Month Survival Rate.

Safety Assessments: Include physical exams, symptom evaluation, vital signs, ECOG performance status, clinical pathology, urinalysis, and Quality of Life assessments.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed metastatic (Stage IV) pancreatic adenocarcinoma.

  * Failed first-line chemotherapy.
  * ECOG performance status of 0-2.
  * Expected survival of more than 3 months.
  * Adequate organ function as indicated by lab values.
  * Age 18 or older.
  * Signed informed consent.

Exclusion Criteria:

* • Known brain metastases.

  * Significant cardiovascular or other uncontrolled diseases.
  * Pregnant or breastfeeding women

Primary outcomes:
measure: Overall Survival
timeFrame: Baseline, 3 months, 6 months, 1 year, and then annually up to 5 years.
measure: Response Rate
timeFrame: Baseline, 3 months, 6 months, 1 year, and then annually up to 5 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Hirscheld Oncology
state: New York
Study officials:
References:
Clinical trial NCT00203177: Rasagiline in Advanced Parkinson's Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy.
Official title: A Bi-national, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability of Rasagiline Mesylate in Advanced Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Chronic Levodopa/Carbidopa Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 254
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to look at the effectiveness, tolerability and safety of two doses of Rasagiline (0.5 mg and 1mg) in advanced Parkinson's Disease (PD) Patients who have been treated with Levodopa/Carbidopa therapy.


Eligibility criteria: Inclusion Criteria:

* Patients must have completed the Week 26 visit of TVP 1012/133 (Visit 06) in accordance with the protocol.
* Women must be postmenopausal, surgically sterile, or using adequate birth control methods. Women of childbearing potential must have a negative pregnancy test at Baseline/Month 0.
* Patients must be willing and able to give informed consent.

Exclusion Criteria:

* Serious or severe, test drug-related (probable or definite) adverse reaction in study TVP 1012/133.
* Premature discontinuation from study TVP 1012/133 for any reason.
* A clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary hepatic, renal, metabolic diseases or malignancies as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or ECG.

Primary outcomes:
measure: long-term safety and tolerability of rasagiline
timeFrame: 6 months
Secondary outcomes:
measure: long- term clinical effect of rasagiline
timeFrame: 6 months
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Margolin Brain Institute
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Rush - Presbyterian St. Luke's Medical Center
state: Illinois
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Montreal
country: Canada
facility: CHUM-Hotel-Dieu
state: Quebec
Study officials:
affiliation: Teva Neuroscience, Inc.
name: Phyllis Salzman, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01265277: Changes in Sleep Patterns and Stress in Infants Entering Child Care
Official title: Changes in Sleep Patterns and Stress in Infants Entering Child Care: Implications for SIDS Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sudden Infant Death Syndrome
Keywords: sudden infant death syndrome
SIDS
infant
licensed day care
sleep patterns
stress levels
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2010-12-23
Enrollment: 20
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infants from 0 to 3 months in the United States

Brief summary: When babies start day care, they experience many changes, some of which may affect their risk for sudden infant death syndrome (SIDS). The investigators want to find out if stress or change in the baby's sleep patterns can be a reason for this increased risk for SIDS.

Detailed description: The overall aim of this study is to describe sleep patterns in infants as they transition from home to child care, including 24-hour sleep duration, changes in the timing of daytime naps, and changes in nocturnal sleep periods; to describe potential sleep disrupters, such as temperature, light and noise, in home and child care settings that may impact sleep quality and sleep patterns; to describe markers of parent and infant stress levels during the transition to child care; to describe markers of infant circadian rhythm during the transition to child care.

Eligibility criteria: Inclusion Criteria:

* Infants who are less than 3 months of age from English-speaking families where one or both parents live in the household will be eligible to participate. If the infant will be entering child care, the infant must be entering a licensed child care center, and child care entry must be between 60 and 120 days of age.

Exclusion Criteria:

* S/he was born prematurely, with a gestational age less than 37 weeks at birth, or had a birth weight \<2500 grams (5-1/2 lbs)
* S/he has any medical problems that require ongoing care by a subspecialty physician

Primary outcomes:
measure: Sleep efficiency
timeFrame: Days -14 through +14
Secondary outcomes:
measure: Sleep duration
timeFrame: Days -14 to +14
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
Study officials:
affiliation: University of Virginia
name: Rachel Y Moon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03141047: Lifespan Integration After Sexual Trauma
Official title: Lifespan Integration After Sexual Trauma, a Randomized Treatment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptoms of Post Traumatic Stress Disorder (PTSD)
Keywords: Sexual trauma, Lifespan Integration
Lead sponsor: Insamlingsstiftelsen Wonsa, World of No Sexual Abuse
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2017-05-04
Enrollment: 63
Sex: ALL
Minimum age (years): 15
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A new psychological trauma treatment method is tested on a population (n 100) of adult women who have been sexually traumatized at one specific time 0-5 years before they enter the study.

Detailed description: One treatment session is given with the psychological treatment method Lifespan Integration (LI). The main outcome is change on Impact of Event Scale (IES) before and after the treatment. The change is analyzed and compared with the change on Impact of Event Scale (IES) among the people on the waiting list arm. Self-rating questionnaires are being used 5+/-3 days before treatment, 20 +/-3 days after treatment, and 6 months +/- 6 weeks after the first measurement.

Eligibility criteria: Inclusion Criteria:

* Sexual trauma 1-5 years before inclusion
* understanding Swedish, read and spoken

Exclusion Criteria:

* Psychotic symptoms
* drug abuse
* neuropsychiatric diagnoses ADHD and asperger

Primary outcomes:
measure: Change of Points on Impact of event scale before and after Lifespan Integration treatment after a sexual trauma
timeFrame: 3 weeks
Secondary outcomes:
measure: Change of Points of GHQ12
timeFrame: 3 weeks
measure: Change of Points of Stressful Events Survey PTSD Short Scale (NSESS)
timeFrame: 3 weeks
measure: Self Rated Health and Sickness Questionnaire
timeFrame: 3 weeks
Other outcomes:
measure: Change of Points on Impact of event scale before and after Lifespan Integration treatment
timeFrame: 6 months
measure: Change of Points of Stressful Events Survey PTSD Short Scale (NSESS)
timeFrame: 6 months
measure: Self Rated Health and Sickness Questionnaire
timeFrame: 6 months
Locations:
city: Stockholm
country: Sweden
facility: World of no sexual abuse, Wonsa
state: Stortorget 3
Study officials:
affiliation: Karolinska Institutet
name: Axel C Carlsson, Docent
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rajan G, Wachtler C, Lee S, Wandell P, Philips B, Wahlstrom L, Svedin CG, Carlsson AC. A One-Session Treatment of PTSD After Single Sexual Assault Trauma. A Pilot Study of the WONSA MLI Project: A Randomized Controlled Trial. J Interpers Violence. 2022 May;37(9-10):NP6582-NP6603. doi: 10.1177/0886260520965973. Epub 2020 Oct 21.
Clinical trial NCT02501447: Feasibility of a Stress Reduction Intervention Study in Sickle Cell Disease
Official title: Feasibility of a Stress Reduction Intervention Study in Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Stress
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 28
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: Stress is known to trigger acute pain crisis of sickle cell disease (SCD). SCD is an inherited blood disorder that afflicts about 100,000 people in the United States, and is among the most common lethal genetic diseases in the United States. Though worldwide in distribution, in the US it is most commonly found in African Americans. Its best known complication is severe, recurrent relentless pain, often known as pain crisis. Non-drug treatment for SCD pain such as cognitive coping interventions have been shown to be effective for reducing SCD pain intensity, but they are complicated, multifaceted, and time-consuming. A simple and cost-effective alternative such as guided imagery (GI) could reduce the effect of stress on SCD pain. GI is an intervention where patients listen to and view audio-visual recordings while being directed to visualize themselves being immersed in that scene or scenario. There are no published studies on the use of GI as a simple stress coping intervention or tracking stress in a systematic manner as a trigger for SCD pain.


Eligibility criteria: Inclusion Criteria:

* Adults 18 years of age or older,
* Diagnosis of SCD,
* Self-reported pain of at least 3 on a 0-10 scale related to SCD,
* Spoke and read English, and
* Self-identified as being of African or Hispanic descent.

Exclusion Criteria:

* Legally blind or physically unable to complete procedures.

Primary outcomes:
measure: Current stress
timeFrame: Immediate (baseline)
measure: Current pain
timeFrame: Immediate (baseline)
measure: Average stress intensity
timeFrame: Short-term (2 weeks)
measure: Composite pain index
timeFrame: Short-term (2 weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Illinois at Chicago
name: Miriam O Ezenwa, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ezenwa MO, Yao Y, Engeland CG, Molokie RE, Wang ZJ, Suarez ML, Wilkie DJ. A randomized controlled pilot study feasibility of a tablet-based guided audio-visual relaxation intervention for reducing stress and pain in adults with sickle cell disease. J Adv Nurs. 2016 Jun;72(6):1452-63. doi: 10.1111/jan.12895. Epub 2016 Jan 15.
Clinical trial NCT06712147: MHE3 Clinical Trial - Overcoming Obstacles
Official title: A Promotora-centric Community Collaborative to Improve Connections to Mental Health Service
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Services
Community Mental Health Services
Community Health Services
Preventive Health Services
Counseling
Community Networks
Community Participation
Hispanic or Latino
Keywords: mental health
promotores de salud
help-seeking
community resources
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-12-02
Enrollment: 192
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: OTHER

Brief summary: The goal of this clinical trial is to increase and strengthen connections between Latinx individuals and mental health services. Through this intervention, the investigators aim to improve mental health literacy, decrease stigma, increase coping skills, and increase mental health help seeking, even before they are in crisis. Participants will be asked to participate in six educational sessions hosted by Promotores de Salud.


Eligibility criteria: Inclusion criteria:

* Has heritage or self-identifies as Hispanic, Latino/a, or Latinx/e
* Must speak English or Spanish
* Primary residence is in 95116, 95122, or 95127 zip codes

Exclusion criteria:

* Persons from the same household
* First degree family member

Primary outcomes:
measure: Attitudes Toward Seeking Professional Psychological Help Scale - Short Form
timeFrame: 6 month follow up
Secondary outcomes:
measure: Mental Health Service Use
timeFrame: 3 month follow up and 6 month follow up.
measure: Attitudes Toward Seeking Professional Psychological Help Scale - Short Form
timeFrame: 1 week follow up and 3 month follow up.
measure: General Self-Efficacy Scale
timeFrame: 1 week follow up, 3 month follow up, and 6-month follow up.
measure: Treatment Expectation Questionnaire
timeFrame: 1 week follow up, 3 month follow up, and 6-month follow up.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Jennifer A Newberry, MD, JD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03697447: Endermotherapy With Burn Hypertrophic Scars
Official title: Randomized, Controlled, Within-patient, Singleblind Study to Evaluate the Efficacy of 12-weeks of Endermotherapy With Adult Burn Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burn Scar
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 19
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mechanical massage or endermotherapyTM is applied to scar tissue with the intended therapeutic value being the promotion of structural or physiological changes. These proposed changes are meant to induce more pliability, so that skin possesses the strength and elasticity required for normal mobility. The advantage of mechanical massage compared to manual massage is that it provides a standard dosage using rollers and suction valves to mobilize the tissue. However, research documenting and supporting this effect is lacking. The objective of this proposal is to document the effect of 12 weeks of endermotherapy treatment on hypertrophic scar characteristics, including erythema, pigmentation, pliability, and thickness in adult burn survivors and their subjective evaluation of itch, pain and overall scar outcome through a prospective, randomized, controlled, within-patient, single-blinded study.

Detailed description: Patients will receive 12 weeks of endermotherapy , 3 times a week.

Eligibility criteria: Inclusion Criteria:

* females and males, of any race, 14 years or older,
* a thermal injury,
* at least 3 months post-burn so that the scars will be durable enough to tolerate the proposed forces,
* at least 2 scar sites \>2.034 mm thick and within 0.5 mm of each other, and
* signed the informed patient consent form

Exclusion Criteria:

* subjects who have keloids,
* with a diagnosis of psychiatric illness clearly documented in their medical file,
* mechanism of injury is an electrical, chemical, or cold injury,
* a dermatological conditions in the region of the evaluation site, that may interfere with the study results,
* a suspected or known allergy to ultrasound gel,
* unable to understand French or English, or
* subjects who refuse to give informed consent.

Primary outcomes:
measure: Skin Thickness Changes
timeFrame: baseline, 12, 24 and 36 weeks
Secondary outcomes:
measure: Cutometer Skin Elasticity Changes
timeFrame: baseline, 12, 24 and 36 weeks
measure: Mexameter Skin Erythema Changes
timeFrame: baseline, 12, 24 and 36 weeks
measure: Itch Visual Analog Subjective Changes
timeFrame: baseline, 12, 24 and 36 weeks
measure: Pain Visual Analog Subjective Changes: VAS
timeFrame: baseline, 12, 24 and 36 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Burn Unit
state: Quebec
Study officials:
affiliation: CRCHUM
name: Bernadette Nedelec, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00300547: Preoperative Assessment for Synchronous Carcinoma or Polyps With Magnetic Resonance (MR) Colonography
Official title: Preoperative Assessment for Synchronous Carcinoma or Polyps With MR Colonography in Patients With Obstructing Cancer. A Prospective Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructing Colorectal Cancer
Keywords: colorectal cancer
polyps
Virtual colonoscopy
synchronous carcinoma
MR colonography
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Gentofte, Copenhagen
First posted: 2006-03-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to diagnose possible synchronous carcinomas and polyps with magnetic resonance (MR) colonography in patients booked for operation because of carcinoma in the descending or sigmoid colon, where a preoperative full colonoscopy is not possible. Two days before colonography, patients ingest a 200 ml Barium sulfate solution four times a day, which will render fecal masses "invisible" on the following MR colonography. The study is primarily a feasibility study with altered operative strategy as a secondary end-point. Gold standard is colonoscopy and operation.


Eligibility criteria: Inclusion Criteria:

* Obstructing colorectal cancer

Exclusion Criteria:

* Suspicion of IBD
* Pacemaker
* Metal in the body
* Claustrophobia
* Pregnancy

Primary outcomes:
measure: Feasibility of MR colonography to diagnose possible synchronous carcinomas and polyps
timeFrame: 3
Secondary outcomes:
measure: Altered operative strategy due to findings on MR colonography
timeFrame: 3
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Radiology Copenhagen University Hospital Herlev
Study officials:
affiliation: Department of Radiology Copenhagen University Hospital Herlev
name: Michael P Achiam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02271347: An Open-Label, Multicenter Study of the Safety and Anti Viral Activity of Brincidofovir (BCV, CMX001) for Ebola Virus Disease
Official title: An Open-Label, Multicenter Study of the Safety and Anti Viral Activity of Brincidofovir (BCV, CMX001) for Ebola Virus Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Ebola Virus
Lead sponsor: Chimerix
Sponsor class: INDUSTRY
First posted: 2014-10-22
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 75
Standard ages: CHILD
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 assess the safety and tolerability of Brincidofovir (BCV) when administered as an initial 200mg dose followed by 100mg twice weekly (BIW) for a total of 5 doses.


Eligibility criteria: Inclusion Criteria:

* Positive for Ebola virus RNA in plasma
* Subject must be able to ingest, absorb, and tolerate oral medication
* Subject must be willing to use adequate contraception during their participation

Exclusion Criteria:

-

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02154347: Post-marketing Clinical Trial of KAD-1229 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
HbA1c
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-06-03
Enrollment: 178
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of KAD-1229 as combination therapy with insulin for 16 weeks and up to 52 weeks administration in patients with type 2 Diabetes Mellitus who show inadequate glycemic control with diet, and insulin monotherapy, or insulin and oral hypoglycemic agent.


Eligibility criteria: Inclusion Criteria:

* Patients who has been receiving dietary therapy and a stable dose and regimen of insulin over 8 weeks before at the time of an observation term start
* Patients whose HbA1c at the time of an observation term start is 7.5% or more and less than 10.0%

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* Patients with serious diabetic complications and other serious complications

Primary outcomes:
measure: Change From Baseline in HbA1c
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
References: