louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06978595: Primary Colorectal Signet Ring Cell Carcinoma and the Risk of Multiple Primary Gastrointestinal Malignancies
Official title: Primary Colorectal Signet Ring Cell Carcinoma and the Risk of Multiple Primary Gastrointestinal Malignancies: a Retrospective Cohort Based on SEER Database From 2000-2021
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Carcinoma
Cancer
Signet Ring Adenocarcinoma of the Colon
Keywords: signet ring carcinoma
SEER
Cancer
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 8171
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with primary colorectal SRCC between 2000 and 2021 were included. Demographic characteristics extracted included race (White, Black, and other races: American Indian/Alaska Native and Asian/Pacific Islander), age (pediatrics: \<18 years, young adults: 18-39 years, middle-aged: 40-64 years, elderly: ≥65 years, according to the WHO classification), marital status (married, unmarried, or unknown), and year of diagnosis. Tumor-related variables included stage (in situ, localized, regional, distant, per SEER staging definitions \[19\]), tumor grade (well-differentiated/grade I, moderately differentiated/grade II, poorly differentiated/grade III, undifferentiated anaplastic/grade IV, and unknown grade), and treatment-related variables (chemotherapy, radiation, and surgery).

Brief summary: This original research investigates the critical issue of gastrointestinal (GI) second primary malignancies (SPMs) in patients with signet ring cell carcinoma (SRCC), a rare and aggressive subtype of colorectal cancer. Utilizing the Surveillance, Epidemiology, and End Results (SEER) database, the investigators assessed the risk of GI SPMs, particularly within 2-11 months post-SRCC diagnosis.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with primary colorectal SRCC between 2000 and 2021
* Latency exclusion period of two months

Exclusion Criteria:

* patients with unknown age data

Primary outcomes:
measure: The standardized incidence ratio of developing gastrointestinal second primary malignancies following primary colorectal signet ring cell carcinoma
timeFrame: from Jan, 2000 till Dec, 2021
Secondary outcomes:
measure: The excess risk of developing gastrointestinal second primary malignancies following primary colorectal signet ring cell carcinoma
timeFrame: from Jan, 2000 till Dec, 2021
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University
Study officials:
References:
Clinical trial NCT06011395: Smart Wearable Insights to Prevent Exacerbations and Recurrence - Rehabilitation Study: SWIPER-REHAB
Official title: Smart Watch Insights to Prevent Exacerbations and Recurrence - Rehabilitation Study: SWIPER-REHAB
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiovascular Diseases
Keywords: Cardiac rehabilitation
Prevention
Digital health
Smart wearables
Remote patient monitoring
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at Imperial College Healthcare NHS Trust eligible for cardiac rehabilition

Brief summary: Aims of the study:

* To measure the rate of completion of a digital cardiac rehabilitation programme at Imperial College Healthcare NHS Trust (ICHNT)
* To measure the health economic impact of a digital cardiac rehabilitation programme at ICHNT

Any adult patient eligible for ICHNT cardiac rehabilitation (CR) programmes is eligible to participate. Participants will receive a commercially available smart watch and be asked to wear the device as much as possible. In addition, they will be asked to download a smartphone application called 'Imperial Healthy Hearts', which displays movement and information on heart rate, breathing and oxygen levels to both the participant and the research team (digital data). The Healthy Hearts app also allows the direct care team to provide educational materials to patients as part of their routine care.

The clinical content and structure of the CR programme is determined by the clinical CR team, and does not deviate from established local and national standards and practices.

Researchers will capture physiological data such as heart rate, respiratory rate, blood pressure (where available) and oxygen saturation (where available) via the Healthy Hearts platform. Researchers will also capture clinical information from the electronic health record, and will compare CR programme uptake and completion rates with historical data and national targets.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or above
* Able to give informed consent
* Eligible for Cardiac Rehabilitation programme

Exclusion Criteria:

* Any wrist wound, skin pathology or other feature that would prohibit the wearing of a smartwatch
* Any visual impairment preventing the use of the Fitbit or smartphone application.

Primary outcomes:
measure: Uptake of cardiac rehabilitation
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life assessment (EQ-5D-5L)
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Nicholas S Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02905695: Post-partum Perineal Pain - Chirocaine®
Official title: Contribution of the Local Infiltration of Chirocaine® in the Management of the Post-partum Perineal Pain After Episiotomy or First-degree Tear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-partum Perineal Pain
Episiotomy
Vaginal Tear
Keywords: Post-partum Perineal pain
Episiotomy
First-degree tear
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this placebo-controlled clinical trial is to assess the effectiveness of the local infiltration of the analgesic Chirocaïne® on perineal pain after episiotomy or first-degree tear. The pain intensity is measured in immediate postpartum period by using a numerical rating scale (NRS) at the following times: H2, H4, H8, H12, H24, H36, H48 during rest, defecation and during activities. The safety of Chirocaïne® and the patient satisfaction are also evaluated at each time.


Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:
* Patients aged 18-45 years
* Single pregnancy.
* Vaginal normal birth in cephalic presentation or assisted vaginal delivery by vacuum extractor.
* Patients having a mediolateral episiotomy or a first-degree perineal tear, epidural analgesia.
* Patients affiliated to a national insurance scheme
* Patients who have given their written consent

Exclusion Criteria:

* Patient not speaking, reading, writing French.
* Multiple pregnancy.
* Breech delivery or instrumental delivery by forceps or spatula.
* Intact perineum.
* No epidural analgesia.
* Patient who represent contraindication to local anesthetics, severe arterial hypotension.
* Previous tear requiring sutures.

Primary outcomes:
measure: Post-partum perineal pain measured by a numerical rating scale
timeFrame: 8 hours post partum
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Jean-Marc Ayoubi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05909514: Investigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Provoked Vestibulodynia
Official title: Investigating the Effectiveness of PelvicSense(R) on Pain and Sexual Outcomes in Provoked Vestibulodynia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Provoked Vestibulodynia
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will examine the effectiveness of the PelvicSense 3-month online program on pain and other outcomes in those with provoked vestibulodynia. This study is prospective in nature and will involve several assessment points: baseline, immediately post-treatment (at the end of the 3 month program), and 3-month follow up. All aspects of the study will be conducted remotely (e.g., online, email, video calls), and participants will be at least 18 years of age, fluent in English, and experience pain due to provoked vestibulodynia for at least 3 months with a physician diagnosis. Participants are expected to continue their treatment as usual and this information will be documented throughout the study.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* fluent in English
* have a formal diagnosis of PVD for at least 3 months

Exclusion Criteria:

* younger than 18 years of age
* nonfluent in English
* self-identified diagnosis
* PVD duration of less than 3 months

Primary outcomes:
measure: Pain intensity
timeFrame: Baseline
measure: Pain intensity
timeFrame: At the end of the 3 month program
measure: Pain intensity
timeFrame: 3 months after the end of the program
Secondary outcomes:
measure: Pain catastrophizing
timeFrame: Baseline
measure: Pain catastrophizing
timeFrame: At the end of the 3 month program
measure: Pain catastrophizing
timeFrame: 3 months after the end of the program
Other outcomes:
measure: Sexual distress
timeFrame: Baseline
measure: Sexual distress
timeFrame: At the end of the 3 month program
measure: Sexual distress
timeFrame: 3 months after the end of the program
measure: Pain self-efficacy
timeFrame: Baseline
measure: Pain self-efficacy
timeFrame: At the end of the 3 month program
measure: Pain self-efficacy
timeFrame: 3 months after the end of the program
Locations:
city: Kingston
country: Canada
facility: Sexual Health Research Laboratory, Department of Psychology, Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Caroline Pukall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05884814: Timing of Resistance Exercise in Type 1 Diabetes
Official title: Timing of Resistance Exercise, Glucose Control and Exercise Adaptations in People With Type 1 Diabetes: a Randomised-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: exercise
circadian rhythm
glucose control
muscle
strength
Lead sponsor: Dasman Diabetes Institute
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1:1 parallel group design
Primary purpose: TREATMENT

Brief summary: The aims of the current study are

1. to compare the effects of acute morning and afternoon resistance exercise on blood glucose levels in people with type 1 diabetes.
2. to compare the effects of morning and afternoon resistance exercise training on cardiometabolic health outcomes in people with type 1 diabetes


Eligibility criteria: Inclusion Criteria:

* Physician confirmed type 1 diabetes for at least 1 year
* Stable insulin therapy for 3 months prior to the study

Exclusion Criteria:

* BMI of 45 or higher
* BP of 160/100mmHg or higher
* autonomic neuropathy
* severe proliferative retinopathy
* joint or limb injuries preventing weight-bearing activity
* autonomic neuropathy
* severe proliferative retinopathy
* any other medical condition that prevents participants from exercising safely.

Primary outcomes:
measure: Change in muscle strength
timeFrame: Change from baseline to 12 weeks
measure: Change in interstitial glucose time in range
timeFrame: Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session
Secondary outcomes:
measure: Change in appendicular skeletal muscle mass
timeFrame: Change from baseline to 12 weeks
measure: Change in whole body fat mass
timeFrame: Change from baseline to 12 weeks
measure: Change in physical function
timeFrame: Change from baseline to 12 weeks
measure: Change in HbA1c
timeFrame: Change from baseline to 12 weeks
measure: Change in interstitial glucose average
timeFrame: Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session
measure: Change in interstitial glucose variability
timeFrame: Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session
measure: Change in interstitial glucose time in hypoglycaemia
timeFrame: Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session
measure: Change in interstitial glucose time in hyperglycaemia
timeFrame: Change from 6 hours before (baseline) to 6 hours after (post-exercise) an exercise training session
Other outcomes:
Locations:
city: Kuwait City
country: Kuwait
facility: Dasman Diabetes Institute
Study officials:
References:
Clinical trial NCT02776514: Steroids, Hyaluronic Acid or Platelet Rich Plasma Versus Placebo for the Knee Osteoarthritis
Official title: Intraarticular Injections of Steroids, Hyaluronic Acid or Platelet Rich Plasma Versus Placebo for the Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
Collaborators: name: Stiftung für Rheumaforschung Zurich
name: Stiftung Marie-Lou Ringgenberg Bern
First posted: 2016-05-18
Enrollment: 120
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: This study investigates clinical outcome and imaging outcome parameters after intraarticular injection of steroids, platelet-rich-plasma (prp), hyaluronic acid or placebo in patients with early osteoarthritis of the knee joint.

Detailed description: Osteoarthritis of the knee joint is a very common disease in middle aged and elderly patients. This study evaluates the efficiency of different commonly used substances for intraarticular, non-operative treatment in early stages of this disease.

120 patients receive an fluoroscopic guided injection in the knee joint: 30 patients get injection with steroids 30 patients get injection with prp 30 patients get injection with hyaluronic acid 30 patients get injection with placebo (iopamiro contrast media)

Primary outcome: - clinical outcome (pain using numeric rating scale)

* Magnetic Resonance imaging (cartilage defects etc.)

Eligibility criteria: Inclusion criteria:

* gonarthritis Kellgren 1,2,3 with symptoms
* german speaking
* informed consent

Exclusion criteria:

-age under 18, gonarthritis, Kellgren 4, anticoagulation therapy, known inflammatory disease or infection, cardiovascular disease NYHA IV, immunosuppression, contraindication for MRI, pregnancy, no informed consent, NSAR 3 days before injection, etc.

Primary outcomes:
measure: Pain assessment
timeFrame: up to 24 months after injection
measure: Magnetic Resonance imaging
timeFrame: up to 12 months after injection
measure: Magnetic Resonance imaging
timeFrame: up to 12 months after injection
Secondary outcomes:
measure: WOMAC score (stiffness, difficulty)
timeFrame: up to 24 months after injection
measure: Tegner Activity Scale
timeFrame: up to 24 months after injection
measure: Knee mobility and thigh circumference
timeFrame: 3 month after injection
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Balgrist
Study officials:
affiliation: Radiology University Hospital Balgrist
name: Andrea B Rosskopf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06389214: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease
Official title: A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Keywords: dry eye
reproxalap
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-29
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Detailed description: Dry eye chamber challenge trial.

Eligibility criteria: Inclusion Criteria:

* Eighteen to 70 years of age at the time of screening (either gender and any race)
* Ability to provide written informed consent
* Reported history of ocular discomfort associated with dry eye disease for at least 6 months prior to Visit 1
* Reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to Visit 1

Exclusion Criteria:

* Clinically significant slit lamp findings, intraocular pressure, and visual acuity findings at Visit 2 that may include active blepharitis, severe meibomian gland dysfunction, lid margin inflammation, glaucoma, ocular allergy, infection or any other disorder that, in the opinion of the Investigator, may interfere with trial conduct or assessments
* Diagnosis at Visit 1 of an ongoing ocular infection (bacterial, viral, or fungal), active ocular inflammation, or history of inflammatory disease that, in the opinion of the Investigator, could interfere with trial conduct or assessments
* Contact lens use within 7 days of Visit 1 or anticipated use of contact lenses during the trial
* Laser-assisted in situ keratomileusis (LASIK) surgery within 12 months of Visit 1 and/or planned ocular and/or lid surgeries during the trial or any other ocular surgery within 6 months of Visit 1
* Systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of Visit 1, or any planned immunomodulatory therapy during the trial
* Eye drop use within 2 weeks of Visit 1 and/or an unwillingness to discontinue any topical ophthalmic prescription or over-the-counter solutions, artificial tears, gels, or scrubs for the duration of the trial (excluding medications allowed for the conduct of the trial)

Primary outcomes:
measure: Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 2 and Visit 4
timeFrame: From Day -14 to Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Cliantha Research
state: Ontario
Study officials:
affiliation: Cliantha Research
name: Patricia Couroux, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00159614: Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment
Official title: Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With Congestive Heart Failure (CHF) and Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure, Congestive
Renal Insufficiency
Keywords: renal insufficiency
diuretic
heart failure, congestive
Lead sponsor: NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2005-09-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the safety and tolerability of KW-3902IV and measure its effect on renal function.


Eligibility criteria: Inclusion Criteria:

* Stable congestive heart failure
* Impaired renal function
* Taking oral loop diuretic

Exclusion Criteria:

* Acutely decompensated (unstable) and end stage heart failure
* Diuretics other than loop diuretics
* Pregnant or nursing
* Inability to follow instructions
* Participation in another clinical trial within past 30 days

Primary outcomes:
measure: Comparison of KW-3902IV alone or with loop diuretic on renal function.
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
city: Baltimore
country: United States
state: Maryland
city: Ayer
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Kalamazoo
country: United States
state: Michigan
city: Tullahoma
country: United States
state: Tennessee
Study officials:
References:
citation: Dittrich HC, Gupta DK, Hack TC, Dowling T, Callahan J, Thomson S. The effect of KW-3902, an adenosine A1 receptor antagonist, on renal function and renal plasma flow in ambulatory patients with heart failure and renal impairment. J Card Fail. 2007 Oct;13(8):609-17. doi: 10.1016/j.cardfail.2007.08.006.