louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04645823: Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor
Official title: Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labor Pain
Induced; Birth
Keywords: epidural analgesia
spinal analgesia
labor pain
Lead sponsor: Women's Hospital HUS
Sponsor class: OTHER
First posted: 2020-11-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 60 parturients randomized to two different treatment arms (30 in each group)
Primary purpose: TREATMENT

Brief summary: A total of 60 parturients undergoing induction of labour will be consented to participate in the study where they will be randomized to receive either spinal fentanyl (20 µg) or epidural analgesia (fentanyl 100µg and lidocaine 80 mg).

They will be monitored for the development of analgesia for a duration of 30 minutes.


Eligibility criteria: Inclusion Criteria:

1. Signs a consent form to participate voluntarily into the trial
2. Induced labor
3. singleton pregnancy
4. primiparous
5. BMI 20-40 at the time of delivery
6. No history of allergy for lidocaine or fentanyl
7. sufficient command of Finnish language to understand the consent form and interview
8. Cervical dilatation at maximum 4 cm at the time of intervention

Exclusion Criteria:

1. Any contraindication for spinal or epidural analgesia
2. Allergy for lidocaine or fentanyl
3. The patient has received any opioid medication within 90 minutes prior to intervention

Primary outcomes:
measure: Analgesia at 20 minutes
timeFrame: 20 minutes
Secondary outcomes:
measure: Time until pain returns to 60 mm VAS
timeFrame: 30-180 minutes
measure: Ambulation during the analgesia provided by the intervention
timeFrame: 30-180 minutes
measure: Changes in the cardiotocography (fetal heart rate) within 30 minutes after the intervention
timeFrame: 0-30 minutes
measure: Pruritus
timeFrame: 0-30 minutes
measure: SAtisfaction of the parturient with the analgesia provided by the intervention
timeFrame: at 30 minutes
measure: Cervical dilatation rate cm/h during the analgesia intervention
timeFrame: 0-180 min
measure: Use of oxytocin during the analgesia study period
timeFrame: 30 min
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: HUS/Women's hospital dept of anaesthesia
Study officials:
affiliation: HUCH, Women's hospital/dept of anesthesia
name: Antti J Vaananen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salmi L, Jernman R, Vaananen A. Is epidural analgesia non-inferior to intrathecal fentanyl as initiation for neuraxial analgesia in early non-spontaneous labour? Acta Anaesthesiol Scand. 2024 May;68(5):664-674. doi: 10.1111/aas.14389. Epub 2024 Feb 16.
Clinical trial NCT03276923: Maternal Autoimmune Disease Research Alliance (MADRA) Registry
Official title: Maternal Autoimmune Disease Research Alliance (MADRA) Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autoimmune Diseases
Pregnancy Related
Systemic Lupus Erythematosus
Cutaneous Lupus
Rheumatoid Arthritis
Sjogren's Syndrome
Scleroderma
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who have been diagnosed with an autoimmune disease or a rheumatic condition.

Brief summary: This multi-site registry, centered at Duke University, will enroll pregnant women with autoimmune and rheumatologic diseases.

The main goal of MADRA is to identify ways to improve the health of women with rheumatic diseases and their babies during pregnancy.

Prior studies demonstrate the importance of increase inflammation prior to and during pregnancy on these outcomes. The future research will seek to better define these risk factors and to identify ways to may improve them.

Detailed description: At each site, the patients will be under the care of the participating rheumatologist and their local obstetrician during the pregnancy. This is a natural-history study and will not include medications, laboratory testing, or procedures outside of the standard of care.

Management of the rheumatologic disease will be directed based on patient needs by the local rheumatologist and obstetrician. Enrollment in the registry will not dictate specific therapy. The Registry will include data from each office visit during pregnancy and up to 12 months after delivery.

The registry will be ongoing, with periodic analysis of clinical data samples as specific studies are approved.

Enrollment in the registry does not significantly increase risks for a patient.

Eligibility criteria: Inclusion Criteria:

* Desire for pregnancy within 6 months or currently pregnant
* Women with systemic autoimmune disease, including:
* Lupus (systemic lupus erythematosus or cutaneous lupus)
* Antiphospholipid Syndrome or positive antiphospholipid antibodies
* Rheumatoid Arthritis
* Scleroderma (systemic sclerosis)
* Sjogren's Syndrome
* Inflammatory Arthritis (including Psoriatic Arthritis and Ankylosing Spondylitis)
* Undifferentiated Connective Tissue Disease (UCTD)
* Vasculitis
* Myositis (Polymyositis or Dermatomyositis)
* Positive Ro/SSA or La/SSB antibodies

Exclusion Criteria:

* Unable to speak English
* Unable to provide informed consent
* Unable to travel to Duke University for follow-up visits

Primary outcomes:
measure: Risk factors associated with poor pregnancy outcomes as measured by the MADRA-DAP questionnaire.
timeFrame: up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke Health
name: Megan EB Clowse, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01805323: A Retrospective Chart Review of OZURDEX® in Patients With Macular Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Edema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-03-06
Enrollment: 101
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with macular edema

Brief summary: This retrospective chart review study will describe the history of patients with retinal disease with macular edema to whom OZURDEX® (dexamethasone intravitreal implant) is administered, and assess treatment patterns and visual outcomes. OZURDEX® was previously administered according to general clinical practice.


Eligibility criteria: Inclusion Criteria:

* Retinal disease involving macular edema
* Received at least one OZURDEX® injection

Exclusion Criteria:

* None

Primary outcomes:
measure: Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)
timeFrame: Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months)
Secondary outcomes:
measure: Peak Mean Change From Baseline in Central Retinal Thickness (CRT)
timeFrame: Baseline, 2 to 26 weeks following last injection (up to 6.5 months)
Other outcomes:
Locations:
city: Quebec City
country: Canada
state: Quebec
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Lam WC, Albiani DA, Yoganathan P, Chen JC, Kherani A, Maberley DA, Oliver A, Rabinovitch T, Sheidow TG, Tourville E, Wittenberg LA, Sigouin C, Baptiste DC. Real-world assessment of intravitreal dexamethasone implant (0.7 mg) in patients with macular edema: the CHROME study. Clin Ophthalmol. 2015 Jul 10;9:1255-68. doi: 10.2147/OPTH.S80500. eCollection 2015.
Clinical trial NCT05260723: RISE - Reduce Sitting Time Among Breast Cancer Survivors
Official title: RISE - A Pilot Study to Reduce Sitting Time Among Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Sedentary Time
Breast Cancer
Keywords: Physical Function
Cognitive Function
Quality of Life
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 21
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This 3-month study will test whether a program to reduce sitting time, for breast cancer survivors experiencing some physical limitations, can improve their physical function and other important aspects of quality of life.

Detailed description: Many cancer survivors experience long-term physical problems following their cancer treatments and can often seem much older than same age peers who were never treated for cancer. This is known as accelerated aging. One way to improve accelerated aging is to increase moderate to vigorous intensity exercise; however, for many cancer survivors, especially those with physical limitations, increasing exercise levels is not possible. Another potential way to improve accelerated aging may be to decrease the amount of time spent sitting. Long periods of sitting are related to many physical and health problems. Cancer survivors spend more than 9 hours a day sitting and often increase the amount they sit after their cancer treatments. This study could help identify realistic intervention targets for many cancer survivors and be used to guide recommendations for improving physical function and quality of life after cancer.

Eligibility criteria: Inclusion Criteria:

* Breast cancer survivors (stages I-IV) at least 1 year post active treatment (e.g., chemotherapy, radiotherapy)
* Breast cancer was treated with chemotherapy, radiation, immunotherapy, and/or endocrine therapy
* self-report difficulties with physical function
* self-report low levels of moderate to vigorous physical activity
* self-report high levels of sitting time

Exclusion Criteria:

* medical condition that interferes with ability to safely stand or stay balanced
* other cancer diagnoses that occurred after their breast cancer diagnosis
* Stage IV breast cancer with brain metastases or less than 12 months life-expectancy
* unable to commit to a 3-month study

Primary outcomes:
measure: Retention rate of enrolled participants
timeFrame: 3 months
Secondary outcomes:
measure: 4 meter walk test
timeFrame: 3 months
measure: 30-second Sit-to-Stand Test
timeFrame: 3 months
measure: Timed Up and Go (TUG)
timeFrame: 3 months
measure: Patient Reported Measurement Information System - Physical Function
timeFrame: 3 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Moores UCSD Cancer Center
state: California
Study officials:
References:
Clinical trial NCT06182423: Chronic Pain Self-management for Older Adults With Cognitive Impairment: A Randomized Pilot Trial
Official title: Chronic Pain Self-management for Older Adults With Cognitive Impairment: A Randomized Pilot Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Cognitive Impairment
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-12-26
Enrollment: 57
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized pilot trial is to test a chronic pain self-management program customized for people living with both chronic pain and cognitive impairment. The main questions it aims to answer are whether this program is feasible and acceptable, and whether it shows potential for improving pain-related outcomes. Intervention group participants will receive education and support from a community health worker in 7 weekly telephone sessions, and will watch a series of educational videos discussing a variety of chronic pain self-management skills. A control group will not receive the program, but after the final data collection point will be invited to attend a one-time remote session that summarizes intervention content, and will receive all program materials. Researchers will compare intervention and control groups after the program ends to see if the intervention group has less pain interference with daily activities.


Eligibility criteria: Inclusion Criteria:

* Age \> 50 years;
* Have a cell or landline phone and internet access;
* Self-reported chronic musculoskeletal pain (pain in muscles or joints for \> 3 months); \>1 day/previous 30 when pain made it difficult to do usual activities.
* Self-reported mild cognitive impairment (MCI)/memory difficulties that at least sometimes interfere with usual daily activities

  * Willingness to meet by phone or video with a community health worker to learn potentially new ways to manage pain and commit to the duration of the program
  * Able to converse comfortably in English.

Exclusion Criteria:

* Serious acute illness or hospitalization in last month; planned major surgery in next three months that would interfere with program participation (e.g., knee replacement)
* Other issues that are judged by study team to preclude meaningful participation in study procedures (e.g. severe physical, cognitive, or psychiatric disorder).
* Current or prior participation in the parent STEPS study or the RESET (Re-Engaging in Self-Care and Enjoying Today) Study.

Primary outcomes:
measure: Change in pain interference
timeFrame: Baseline, 10 weeks from baseline
Secondary outcomes:
measure: Change in pain intensity
timeFrame: Baseline, 10 weeks from baseline
measure: Change in subjective cognitive functioning
timeFrame: Baseline, 10 weeks from baseline
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT02498223: Adjusting the Load Carried by the Soldier According to Body Composition Measurements and Aerobic Capacity
Official title: Adjusting the Load Carried by the Soldier According to Body Composition Measurements and Aerobic Capacity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Work Load
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-07-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In order to reduce the physiological and biomechanical loads that the soldiers are exposed to, the investigators want to examine new approaches for distributing the carried loads according to measurements that are specific for each soldier (body composition and aerobic capacity). A functional index (LCI=load carriage index) will provide the commander a tool for better decisions in distributing the same total load among the same number of soldiers, according to each soldier's ability.

Detailed description: 50 healthy, male and female combat soldiers will be recruited. Anthropometry and maximal aerobic capacity will be measured for each participant: Physiological evaluation: the participants will perform physical stress on a treadmill with changing slope and speed, once carrying 40% of their body weight (as the current instructions) and a second time with weight that is calculated by the examined body composition and aerobic capacity based index (LCI). The physiological response will be assessed based on heart rate, lactic acid in the blood and oxygen consumption.

Biomechanical evaluation: the biomechanical response will be measured in the biomechanical lab: pressure on the shoulder and waist from the load and straps, walk analysis and stress scatter in the foot.

By this experiment the investigators want to examine if the new index, the LCI, is physiologically and biomechanically better than the current load distribution instructions.

Eligibility criteria: Inclusion Criteria:

* Aged 18-25 years.
* Healthy soldiers volunteers.
* Without heart, cardiovascular, metabolic or respiratory illnesses.
* Without known medical illness or medication use that might endanger the participants.

Exclusion Criteria:

* existence of any of undesired conditions detailed in the inclusion criteria.
* the physician decision.

Primary outcomes:
measure: oxygen consumption
timeFrame: 3 experiment days
Secondary outcomes:
measure: Heart rate
timeFrame: 3 experiment days
measure: pressure at the shoulders and the waist
timeFrame: 3 experiment days
measure: walk analysis (composite)
timeFrame: 3 experiment days
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Sheba medical center
state: Ramat- Gan
Study officials:
affiliation: Sheba Medical Center
name: Ofir Frenkel, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05345223: A Registry Study on Primary/idiopathic Triglyceride Deposit Cardiomyovasculopathy
Official title: A Registry Study on Primary/idiopathic Triglyceride Deposit Cardiomyovasculopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Triglyceride Deposit Cardiomyovasculopathy
Keywords: triglyceride deposit cardiomyovasculopathy
TGCV
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Osaka University Graduate School of Medicine
First posted: 2022-04-25
Enrollment: 193
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (excluding under 20 years old) who have been confirmed as TGCV based on the diagnostic criteria for TGCV by a cardiologist.

Brief summary: The objective of this study is to construct a registry; in order to understand the onset status of triglyceride deposit cardiomyovasculopathy (TGCV) in Japan with patients' background and natural history of the disease, and to explore disease-specific prognostic factors.


Eligibility criteria: Inclusion Criteria:

* Adult patients who have been conﬁrmed as TGCV based on the diagnostic criteria for TGCV

Exclusion Criteria:

* The patients who refused to participate in the study by opt-out

Primary outcomes:
measure: The period between the date of TGCV diagnosis and the date of death due to any cause
timeFrame: 10 years
Secondary outcomes:
measure: Comparison of subjective symptoms, laboratory findings, and event occurrence before and after tricaprin therapy: Washout rate of BMIPP (%)
timeFrame: 10 years
measure: Comparison of subjective symptoms, laboratory findings, and event occurrence before and after tricaprin therapy: LVEF (%) (UCG or QGS)
timeFrame: 10 years
measure: Comparison of subjective symptoms, laboratory findings, and event occurrence before and after tricaprin therapy: Any cardiovascular events
timeFrame: 10 years
measure: Presence (date of occurrence or treatment) or absence of various events
timeFrame: 10 years
Other outcomes:
Locations:
city: Nagakute
country: Japan
facility: Aichi Medical University
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University
state: Aichi
city: Nishinomiya
country: Japan
facility: Hyogo Medical University
state: Hyogo
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Bunkyo
country: Japan
facility: Juntendo University
state: Tokyo
city: Chiba
country: Japan
facility: Chiba University Graduate School of Medicine
city: Fukuoka
country: Japan
facility: Kyushu University
Study officials:
affiliation: Department of Triglyceride Science, Graduate School of Medicine, Osaka University
name: Ken-ichi Hirano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01330823: L-CARnitine in the Palliative Treatment of Advanced PANcreatic Cancer (CARPAN)
Official title: L-Carnitine in the Palliative Treatment of Advanced Pancreatic Cancer (CARPAN): a Prospective, Randomised, Placebo Controlled, Double Blinded, Multicentre Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Pancreatic Carcinoma
Keywords: pancreatic carcinoma
L-Carnitine
quality of life
survival
malnutrition
cancer cachexia
fatigue
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2011-04-07
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study investigated the role of L-Carnitine supplementation on proinflammatory immune response, malnutrition, cancer cachexia and cancer related fatigue in advanced and inoperable pancreatic cancer, UICC Stage IV .

Detailed description: Pancreatic cancer has the lowest 5-year survival rate of any cancer and ranks as the fourth leading cause of cancer death world wide. Several metabolic changes are present in the whole body in case of cancer so the investigators conducted a placebo controlled, double blinded, randomized, prospective and multicentre study to investigate, whether L-Carnitine supplementation may have an impact on malnutrition, cancer cachexia and cancer related fatigue in advanced pancreatic cancer.

Study drug: L-Carnitine 4g per day (vers) Placebo Study design: A multi-centre, double blind, and placebo-controlled, randomised, parallel group study

Patient population: Patients with advanced pancreatic carcinoma Number of patients: Total of 90 patients in two equal groups number of centres: 4 (Greifswald, Magdeburg, Berlin,Heidelberg,all Germany) Duration of dosing: 12 weeks

Eligibility criteria: Inclusion Criteria:

* advanced pancreatic cancer (UICC Stage IV)
* Karnofsky Index larger than 60
* compliance
* consent to participate to the study

Exclusion Criteria:

* Child-Pugh classification of liver failure greater than Child B,
* a known second malignant tumor
* oral or parenteral supplementation with omega-3-fatty acids
* treatment with thalidomide or Infliximab
* mental or physical disorders

Primary outcomes:
measure: TNF-alpha
timeFrame: 12 weeks
Secondary outcomes:
measure: nutritional status
timeFrame: 12 weeks
measure: Quality of life
timeFrame: 12 weeks
measure: survival
timeFrame: 1 year
measure: hospital stay
timeFrame: 1 year
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald,Department of Medicine A
Study officials:
affiliation: University Medicine Greifswald
name: Markus M. Lerch, Prof.
role: PRINCIPAL_INVESTIGATOR
References: