louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06751082: Real World Observational Study of Sotatercept for Pulmonary Hypertension
Official title: Sotatercept Pulmonary Hypertension Observational Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pulmonary Hypertension
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 120
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 for whom sotatercept is being or has been prescribed will be identified through the Mayo Pulmonary Hypertension Clinic.

Brief summary: The purpose of this study seeks to describe the real world initial experience with sotatercept in the treatment of pulmonary hypertension.


Eligibility criteria: Inclusion Criteria:

* Adults age 18 or greater who are being treated with sotatercept in the Mayo Pulmonary hypertension clinic.

Exclusion Criteria:

* Adults lacking capacity to consent

Primary outcomes:
measure: EmPHasis10 Questionnaire
timeFrame: Baseline, Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10
measure: Number of pulmonary hypertension vasodilator medications taken by a subject
timeFrame: Baseline, Year 10
measure: Number of patients to have a change in dose of prostanoid medications
timeFrame: Baseline, Year 10
measure: Number of patient hospitalizations
timeFrame: Baseline, Year 10
measure: Number of patients to cease therapy sessions
timeFrame: Baseline, Year 10
measure: Number of patients to discontinue prostanoid therapy
timeFrame: Baseline, Year 10
measure: Number of patients with bleeding complications
timeFrame: Baseline, Year 10
measure: Number of patients to develop Skin telangiectasias
timeFrame: Baseline, Year 10
measure: Change in 6 min walk distance
timeFrame: Baseline, Year 10
measure: Number of patients to have a change in hemodynamics
timeFrame: Baseline, Year 10
measure: Change in Right Ventricular Systolic Pressure (RVSP)
timeFrame: Baseline, Year 10
measure: Right Ventricular Strain
timeFrame: Baseline, Year 10
measure: Change in Right Ventricle (RV) function
timeFrame: Baseline, Year 10
measure: Change in capacitance
timeFrame: Baseline, Year 10
measure: Change in tricuspid regurgitation
timeFrame: Baseline, Year 10
measure: Change in Stroke Volume (SV)
timeFrame: Baseline, Year 10
measure: Change in Pulse Pressure (PP)
timeFrame: Baseline, Year 10
measure: Change in functional class
timeFrame: Baseline, Year 10
measure: Number of patients to survive without receiving a transplant
timeFrame: Baseline, Year 10
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Robert Frantz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04772482: Study on Hypoallergenic Hair Dye
Official title: Testing of Alternatives for Dark Hair Dyes in Patients With Proven Sensitization to Para-Phenylenediamine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contact Dermatitis
Allergy; Dermatitis
Dermatitis
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with sensitivity to PPD and/or PTD

Brief summary: Permanent hair dyes are commonly used in over the counter direct to consumer products and within hair salons. Allergy, also known as contact dermatitis, to hair dye is a well known phenomenon. Herein, we seek to decrease the risks of allergy to hair dyes by testing a novel version of p-phenylenediamine (PPD) with less allergy potential.

Detailed description: For patients with PPD sensitizations, it is important to find alternatives for dark hair dyes. P-toluenediamine (PTD) and potentially also 2-methoxyethyl p-phenylenediamine (ME-PPD) show cross-reactivity with PPD and therefore we want to prove that our new compounds PPD-6 and PPD-7 show no or significantly reduced cross-reactions with PPD and do not induce relevant allergic reactions in patients with proven PPD sensitizations.

Our specific aims for this study are the following:

A1) To show that PPD 6 and PPD 7 have reduced or optimally no reaction in standard patch tests in patients with proven allergy to PPD A2) To compare the sensitization pattern to other possible commercially available alternatives for hair dye, such as ME-PPD and PTD A3) To evaluate and rule out any possible non-specific irritant reaction of PPD-6 and PPD-7 in these patch tests (i.e. confirm in-vitro safety profile in-vivo)

Eligibility criteria: Inclusion Criteria:

- Proven Diagnosis of PPD and/or PTD sensitization (patch tests and clinically relevant eczematous reactions to hair dye)

Exclusion Criteria:

* Use of oral immunosuppressive, anti-inflammatory and chemotherapy medications, particularly corticosteroids for at least 1 month before testing.
* Immunocompromised patient (e.g. Cancer, Diabetes mellitus, medication, Immunodeficiency, radiation therapy)
* History of acute hepatitis, chronic liver disease or end stage liver disease.
* History of human immunodeficiency virus (HIV) or acquired immune deficiency syndrome.
* Use of illicit drugs within the past 6 months prior to study start and/or opioid use disorder.
* Pregnancy as established by questionnaire

Primary outcomes:
measure: Allergy to Study Compounds
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Paul Bigliardi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05902182: Study to Demonstrate the Efficacy and Safety of Convatec ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-adhesive Dressings to Protect Against Skin Breakdown
Official title: A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Post Market Clinical Follow up Study to Demonstrate the Efficacy and Safety of Convatec ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-adhesive Dressings to Protect Against Skin Breakdown
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Skin Breakdown
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-13
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-adhesive to protect against skin breakdown


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years and over
* Patients able and willing to provide informed consent/Personal Consultee/Nominated consultee/ Their nominated consultee
* Intact healthy skin
* Stage I pressure ulcer/injury
* Patients who are at risk of developing skin breakdown (injury), in any clinical setting, with at least one clinically vulnerable area (including but not limited to sacrum, heel, elbows, hips, ischial tuberosity and spine)
* Braden score of 12 or less

Exclusion Criteria:

* Patients with known allergies to any of the materials used in the dressing
* Subjects requiring any oxidising agents such as hydrogen peroxide or hypochlorite solutions
* Patients who are at high risk of unavoidable skin breakdown for example caused by a medical device (for example, under ventilation or faecal management systems)
* Patients with a wound of any aetiology on the area under investigation Patients who, in the opinion of the investigator, are considered unsuitable for any other reason
* Patients with a history of previous healed pressure ulcer/ injury in the area under investigation
* Patients who demonstrate a deterioration of skin from baseline skin assessment

Primary outcomes:
measure: To measure the efficacy of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ non-adhesive dressings when used to protect of skin against breakdown.
timeFrame: 2 weeks
Secondary outcomes:
measure: To assess the safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ non-adhesive dressings when used to protect skin against breakdown.
timeFrame: 2 weeks
measure: To assess the performance of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ non-adhesive dressings when used to protect skin against breakdown.
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01595282: Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage
Official title: Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: pain
suction curettage
Lead sponsor: Planned Parenthood League of Massachusetts
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2012-05-10
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effect of pre-procedural ketorolac to ibuprofen on immediate post-procedural pain scores in patients undergoing first trimester suction curettage with local anesthesia only.

Our primary hypothesis is that IM ketorolac compared to oral ibuprofen will result in an approximate 30% reduction in pain scores on a 21-point numerical rating scale immediately after the procedure.

Secondary hypotheses include:

* Pain scores on the 21-point scale will also be significantly lower in the ketorolac group immediately after cervical dilation and 15 minutes post-procedure.
* Fewer patients in the ketorolac group will rate their pain as "severe" on a subjective pain rating scale.
* Patients in the ketorolac group will be more satisfied with their pain control.
* Side effects will be similar between groups.


Eligibility criteria: Inclusion Criteria:

* Women age 18 or older seeking suction curettage at Planned Parenthood League of Massachusetts (PPLM)
* Gestational age less than or equal to 11+6, confirmed by ultrasound
* Eligible for suction curettage according to PPLM protocols
* Choice of local anesthesia

Exclusion Criteria:

* Choice of IV sedation for pain control
* Hypersensitivity to NSAIDs or lidocaine
* Contraindications to NSAIDs:

Active renal disease Active hepatic disease Gastric ulcer disease or gastritis Long-term NSAID or aspirin use Bleeding disorder

* NSAIDs taken \< 8 hours prior to procedure
* Need for cervical ripening with either misoprostol or mechanical priming agent (laminaria/Dilapan)
* Long-term narcotic use
* Unable or unwilling to complete required study procedures
* Previous participation in the study

Primary outcomes:
measure: Immediate Post-procedure Pain Score
timeFrame: Immediately (within 1 minute) after suction and speculum removal
Secondary outcomes:
measure: Pain Scores Immediately After Cervical Dilation
timeFrame: Immediately (within 1 minute) after cervical dilation prior to the introduction of the suction cannula
measure: Pain Scores 15 Minutes Post-procedure
timeFrame: Fifteen minutes after the procedure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Planned Parenthood League of Massachusetts
state: Massachusetts
Study officials:
affiliation: Planned Parenthood League of Massachusetts
name: Principal Investigator, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05023382: A Study of Teduglutide in Japanese People With Short Bowel Syndrome
Official title: Special Drug Use Investigation of Revestive Subcutaneous Injection 3.8 mg (All-case Surveillance)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Short Bowel Syndrome
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-08-26
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All participants in Japan who received teduglutide will be enrolled in this post marketing surveillance.

Brief summary: The main aims of this study are to check for side effects from treatment with teduglutide (Revestive) and how well teduglutide controls symptoms of short bowel syndrome.

The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

During the study, participants with short bowel syndrome will receive an injection of teduglutide just under the skin (subcutaneous) according to their clinic's standard practice. The study doctors will check for side effects from teduglutide for 36 months.


Eligibility criteria: Inclusion Criteria:

* All participants in Japan who received teduglutide will be enrolled in this post marketing surveillance.

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Up to 36 months
measure: Number of Participants with Serious Adverse Events
timeFrame: Up to 36 months
Secondary outcomes:
measure: Changes from Baseline in Prescription Volume of Parenteral Nutrition Intravenous (PN/IV) Support
timeFrame: Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
measure: Percent Change from Baseline in Prescription Volume of PN/IV Support
timeFrame: Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
measure: Changes from Baseline in Dose of PN/IV Support
timeFrame: Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
measure: Percent Change from Baseline of Dose in PN/IV Support
timeFrame: Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
measure: Percentage of Participants who Completely Wean off PN/IV Support
timeFrame: Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
measure: Crohn's Disease Activity Index (CDAI)
timeFrame: 36 months after teduglutide treatment initiation
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
city: Tokyo
country: Japan
facility: Takeda selected site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01216982: Effects of Omega-3 EPA/DHA for Soldiers at Risk for Mood Disorders
Official title: Effects of Omega-3 EPA/DHA for Soldiers at Risk for Mood Disorders: A Mood Resilience Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Mood Disorders
Depression
Combat Disorders
Stress Disorders
Keywords: Mood Disorders
Depression
Combat Disorders
Stress Disorders
Fatty Acids, Omega-3
Military Personnel
Docosahexaenoic Acids/*therapeutic use
Eicosapentaenoic Acid/*therapeutic use
Lead sponsor: United States Department of Defense
Sponsor class: FED
Collaborators: name: GlaxoSmithKline
First posted: 2010-10-07
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Stress-related disorders are among the most prevalent and expensive medical consequences of participation in military operations. Omega-3 fatty acids EPA/DHA derived from fish oil are known to benefit both neuronal development in the young, and cognition and mood in various populations.

It is possible that soldiers receiving Omega-3 EPA/DHA will exhibit significantly higher cognitive performance, better affect/mood state, and less combat stress symptomatology compared to the placebo after 12 weeks of supplementation. A goal would be to reduce the prevalence of combat stress injuries in military personnel.


Eligibility criteria: Inclusion Criteria:

* US Army deployed personnel
* score on a mood questionnaire

Exclusion Criteria:

* currently consume omega-3 fish oil supplements
* are currently taking antidepressant or other medications for psychiatric purposes
* pregnant
* known fish or shellfish allergy

Primary outcomes:
measure: primary psychometric assessment battery
timeFrame: 3 months
measure: omega-3 fatty acid status
timeFrame: 3 months
Secondary outcomes:
measure: secondary psychometric assessment battery
timeFrame: 3 months
Other outcomes:
Locations:
city: Camp Taji
country: Iraq
facility: US Military Base
Study officials:
affiliation: United States Department of Defense
name: Daniel T Johnston, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01376882: Cognitive and Cerebral Blood Flow Effects of 2-week Caffeine Abstinence or Maintenance
Official title: Behavioural and Cerebral Haemodynamic Effects of Caffeine Withdrawal and Caffeine Administration Following 2-week Maintenance or Abstinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Mood
Cerebral Haemodynamics
Caffeine Withdrawal
Keywords: Caffeine
Withdrawal
Cognitive function
Mood
Cerebral haemodynamics
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2011-06-20
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the effects of 2 weeks caffeine abstinence as compared to 2 weeks caffeine maintenance (300mg per day)on cognition and mood. Cerebral blood flow effects will also be assessed in a subset of participants. The role of caffeine abstinence/maintenance in the acute effects of caffeine will also be explored.

Detailed description: The current randomised, placebo-controlled, double-blind, parallel groups study aims to explore the behavioural effects of 2-weeks caffeine abstinence as well as establishing the role of abstinence in the effects of caffeine administration by administering caffeine or placebo to those in a state of chronic and acute abstinence. This research also aims to explore, in a subset of participants, the cerebral blood flow effects of caffeine abstinence and caffeine administration using Near Infrared Spectroscopy (NIRS). Cerebral blood flow will be measured both at rest and during performance of cognitive tasks.

Eligibility criteria: Inclusion Criteria:

* Male/Female
* 18 - 40 years
* Healthy
* Consume ≥ 150 mg caffeine daily
* No herbal supplements/prescription medications (excl. contraceptive pill)
* Non smoker
* Native English speaker

Exclusion Criteria:

* Diagnosis of any significant medical condition or disorder
* Any known allergy or hypersensitivity to food.
* BMI \>29.9 or \<18.5
* Blood pressure \>139/89

Primary outcomes:
measure: Cognitive performance
timeFrame: 2 weeks
Secondary outcomes:
measure: Mood
timeFrame: 2 weeks
measure: Cerebral haemodynamic
timeFrame: 2 weeks
measure: Sleep
timeFrame: 2 weeks
measure: Caffeine withdrawal
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Brain, Performance and Nutrition Research Centre, Northumbria University
state: Tyne and Wear
Study officials:
affiliation: Northumbria University
name: Crystal Haskell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00898482: Collecting and Storing Samples of Blood From Patients With Pancreatic Cancer and Healthy Participants
Official title: Pancreatic Cancer Serum and Peripheral Blood Lymphocyte Repository
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Keywords: adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: PROBABILITY_SAMPLE
Study population: The three cohorts are: 1) Healthy individuals, 2) At risk individuals and 3) Cancer patients.

Brief summary: RATIONALE: Collecting and storing samples of blood from patients with cancer and healthy participants to test in the laboratory may help the study of cancer in the future.

PURPOSE: This study is collecting and storing samples of blood from patients with pancreatic cancer and healthy participants.

Detailed description: OBJECTIVES:

* Establish a central pancreatic cancer specimen (including serum and peripheral blood lymphocytes) repository to serve as a resource for current or future scientific studies.
* Utilize the clinical database to perform clinicopathologic correlation with the results of those studies.
* Test new hypotheses as they emerge.

OUTLINE: This is a prospective study.

Blood is collected from patients with pancreatic cancer at baseline and then every 3-6 months for up to 2 years. All other participants have blood collected at baseline and complete questionnaires at baseline and then every 3-6 months for up to 2 years. Serum and peripheral blood lymphocytes obtained from the blood samples are frozen and stored.

PROJECTED ACCRUAL: A total of 200 patients and 200 other participants will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Histologically confirmed pancreatic malignant neoplasm
  * Serologically or image-confirmed diagnosis of pancreatitis or nonmalignant pancreatic disease
  * Healthy, at-risk participant meeting the following criteria:

    * Smoker, diabetic, and/or has a family history of pancreatic cancer
  * Healthy participant (no history of cancer)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Establishment of a central pancreatic cancer specimen repository
timeFrame: No time frame
measure: Utilization of the clinical database to perform clinicopathologic correlation with the results of current or future scientific studies
timeFrame: No time frame
measure: Test new hypotheses as they emerge
timeFrame: No time frame
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Daniel A. Laheru, MD
role: STUDY_CHAIR
References: