louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00589654: Menstrual Cycle Maintenance and Quality of Life: A Prospective Study
Official title: Menstrual Cycle Maintenance and Quality of Life: A Prospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Amenorrhea
Menstrual Cycle
Breast Cancer
Keywords: amenorrhea
menstrual cycle
Breast cancer
questionnaire
97-127
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-01-10
Enrollment: 810
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stage 1-3 breast cancer patients 18-45 years of age will be identified. Those with normal menstrual cycles will be eligible.

Brief summary: Very little is known about the incidence, onset, time course, and symptomatology of premature menopause induced by breast cancer therapy. No prospective study exists. The purpose of the present study is to identify determinants of treatment-related amenorrhea nad its effect on quality of life in a cohort of youg breast cancer patients.


Eligibility criteria: Inclusion Criteria:

* Non-institutional (community dwelling) woman of any race
* Between 18-45 years at the first screening visit
* Have regular menstrual cycles
* Diagnosed with invasive breast cancer stage I, II, III within the previous eight months
* Have physician agreement for patient participation

Exclusion Criteria:

* No menstrual bleeding cycles
* Psychiatric or psychologic abnormality precluding the informed consent process or which would decrease compliance
* Previous malignancy (excepting basal and squamous skin cancer and stage 0 cervical cancer)
* Stage IV breast malignancy
* Residency outside United States
* No telephone

Primary outcomes:
measure: The overall goal of the proposed research is to recruit and follow young breast cancer patients aged 45 and younger, in order to examine menstrual cycle maintenance.
timeFrame: Conclusion of the study
Secondary outcomes:
measure: Examine possible predictors of treatment-related amenorrhea including age, smoking history, race, and treatment variables
timeFrame: Conclusion of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Tracy-Ann Moo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00195754: A Phase III Open-Label, Multi-Center, Long-Term Extension Study of Depakote ER in Subjects Who Either Completed or Prematurely Discontinued Due to Ineffectiveness From Study M02-488.
Official title: The Safety of Divalproex Sodium Extended Release Tablets in Migraine Prophylaxis: An Open-Label Extension Study in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraines
Keywords: Migraines
Depakote ER
divalproex sodium
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 114
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if long-term treatment, up to 1 year, with Depakote ER is safe in the reduction of occurrence of migraine headaches in adolescents.


Eligibility criteria: Inclusion Criteria:

* Subject and subject's legal representative have voluntarily signed and dated an IRB-approved informed assent form and an IRB-approved informed consent form, respectively, before any study-specific procedures or tests are performed;
* The subject was randomized into Study M02-488 and either completed the study or prematurely discontinued due to ineffectiveness; and
* The subject is male or non-pregnant, non-lactating female

Exclusion Criteria

* Female, of childbearing potential, and not using an effective method of birth control (e.g., total sexual abstinence or contraceptives).
* Experienced a serious adverse event in Study M02-488 which the investigator considered "possibly" or "probably related" to study drug; or
* In the investigator's opinion, long-term treatment with Depakote ER for migraine prophylaxis is contraindicated.
* For any reason, subject is considered by the investigator to be an unsuitable candidate to receive divalproex sodium or to participate in this study.

Primary outcomes:
measure: Safety outcome measure
timeFrame: 12 months
Secondary outcomes:
measure: Migraine headache rate
timeFrame: 12 months
Other outcomes:
Locations:
city: North Chicago
country: United States
facility: Global Medical Information - Abbott
state: Illinois
Study officials:
affiliation: Abbott
name: Global Medical Information 800-633-9110
role: STUDY_DIRECTOR
References:
Clinical trial NCT04905654: Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura
Official title: Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache, Migraine
Aura
Keywords: Levcromakalim
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To investigate the migraine inducing effect of levcromakalim in patients with migraine with aura.


Eligibility criteria: Inclusion Criteria:

* Migraine with aura patients of both sexes.
* 18-70 years.
* 50-100 kg.

Exclusion Criteria:

* Headache less than 48 hours before the tests start
* Daily consumption of drugs of any kind that investigator deems might affect study results or safety.
* Pregnant or nursing women.
* Cardiovascular disease of any kind, including cerebrovascular diseases.
* Tension type headache (TTH) according to International Classification of Headache Disorders version 3 more than 5 times a month on average during the past year
* Known cluster headache according to International Classification of Headache Disorders version 3.
* Psychiatric disorder
* Smoking or abuse of drugs or alcohol
* Hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg) on day of inclusion.
* Hypotension (systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<50 mmHg) on day of inclusion.

Primary outcomes:
measure: Headache incidence
timeFrame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
measure: Migraine incidence
timeFrame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
measure: Aura incidence
timeFrame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
Secondary outcomes:
measure: Headache intensity
timeFrame: 10 minutes before until 24 hours after infusion of levcromakalim or placebo
measure: Heart rate
timeFrame: 10 minutes before until 120 minutes after infusion of levcromakalim or placebo
measure: Blood pressure
timeFrame: 10 minutes before until 120 minutes after infusion of levcromakalim or placebo
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
state: Copenhagen
Study officials:
affiliation: Danish Headache Center
name: Messoud Ashina
role: STUDY_DIRECTOR
References:
Clinical trial NCT06318754: Large-Bore Mechanic Thrombectomy for the Treatment of Symptomatic Portomesenteric Vein Thrombosis
Official title: Large-bore Mechanical Thrombectomy for the Treatment of Symptomatic Portomesenteric Vein Thrombosis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Thrombosis
Thrombectomy
Portal Vein
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Inari Medical
First posted: 2024-03-19
Enrollment: 0
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: Adults undergoing a large-bore thrombectomy procedure for PMVT in the Division of Vascular and Interventional Radiology (VIR) at University of Maryland Medical Center.

Brief summary: A single site study evaluating the safety, feasibility, and effectiveness of percutaneous large-bore mechanical thrombectomy using the Inari Triever Aspiration Catheter for the treatment of portomesenteric vein thrombosis (PMVT).

Detailed description: This is a single center, prospective, investigator-initiated observational study of adults undergoing mechanical thrombectomy as part of clinical care for portomesenteric vein thrombosis (PMVT).

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years,
* PMVT diagnosed on cross-sectional imaging such as contrast-enhanced CT or MRI abdomen
* Symptomatic PMVT (persistent symptom, worsening abdominal pain after initiation of anticoagulation, development of peritonitis, complication of portal hypertension in cirrhosis (variceal bleeding or worsening ascites), and poor surgical candidates
* Speaks and understands English language

Exclusion Criteria:

* Age \< 18 years
* no PMVT diagnosed on cross-sectional imaging such as contrast-enhanced CT or MRI abdomen
* Malignant PMVT
* chronic PMVT including presence of cavernoma and network of prominent collateral vessels in porta hepatis on cross-sectional imaging.
* asymptomatic PMVT
* life expectancy \< 6 months
* Does not speak or understand English language

Primary outcomes:
measure: Technical Success
timeFrame: Time of intervention
measure: Clinical Success
timeFrame: 1 week, 1 month and 3 months post intervention
measure: Primary Patency
timeFrame: 3 months post intervention
measure: Intermediate functional success
timeFrame: Time of intervention
Secondary outcomes:
measure: Secondary Patency
timeFrame: 3 months post intervention
measure: Duration of hospitalization
timeFrame: 3 months post intervention
measure: Duration of ICU days
timeFrame: 3 months post intervention
measure: Blood loss during intervention
timeFrame: At time of intervention
measure: Transfusion
timeFrame: 3 months post intervention
measure: Major and minor complications
timeFrame: 1 week, 1 month, and 3 months post intervention
measure: 30-day mortality
timeFrame: 30 days post intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01177254: Exposure to Potential Cytochrome P450 Pharmacokinetic Drug-Drug Interactions Among Osteoarthritis Patients: Incremental Risk of Multiple Prescriptions
Official title: Exposure to Potential Cytochrome P450 Pharmacokinetic Drug-Drug Interactions Among Osteoarthritis Patients: Incremental Risk of Multiple Prescriptions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low Back Pain
Keywords: retrospective chronic low back pain
Lead sponsor: NEMA Research, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-06
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: retrospective chronic low back pain patients taking opioids

Brief summary: Using a retrospective analysis of a large commercial claims database and a Medicare database, the investigators evaluated DDEs that have the potential to cause DDIs among chronic low back pain (cLBP) patients on long-term opioid analgesia, which metabolizes through the CYP450 enzyme system, concomitant with other CYP450-metabolized drug(s).


Eligibility criteria: Inclusion Criteria:

* chronic low back pain

Exclusion Criteria:

* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05963854: Food Survey, Curbside, Remote APPs SC
Official title: An Innovative, Accessible, and Flexible Approach for Household Food Waste Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Waste Management
Recycling
Climate
Nutrition Sciences
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Martin, Corby, K., M.D.
First posted: 2023-07-27
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from the greater Columbus, OH and Baton Rouge, LA regions.

Brief summary: The proposed research will create accurate and standardized household FW measurement methodologies that foster serial and longitudinal assessments as well as confident and convenient one-time measurement by stakeholders. The investigators will have participants simutaneously deploy (1) retrospective surveys (2) curbside audits.


Eligibility criteria: Inclusion Criteria:

* Male or Female, age 18 years and older
* Willing and able to store household food waste for curbside pickup by a third-party waste pickup company
* Internet or Wi-Fi availability to complete online surveys

Exclusion Criteria:

* Not willing to adhere to study procedures and study visit timelines
* Any condition or circumstance that in the judgement of the PI could interfere with study participation

Primary outcomes:
measure: Total Household Food Waste
timeFrame: 1 week
Secondary outcomes:
measure: Household Food Waste Energy
timeFrame: 1 week
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Pennington Biomedical Research Center
name: John W Apolzan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04293354: Analgesic Efficacy of Serratus Anterior Plane Block in The Rib Fractures Pain
Official title: Analgesic Efficacy of Serratus Anterior Plane Block in The Rib Fractures Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Serratus Plane Block
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Serratus Anterior Plane Block (SAPB) is a facial plane block that was first described by Blanco in 2013 and that blocks the lateral cutaneous branches of the T2-T9 intercostal nerves, the intercostobrachial nerve, n. thoracic longus, n. thoracodorsalis nerves. Case and case series have been reported in the literature on the use of SAPB in rib fractures, and it has been reported as an effective analgesia method. We apply SAPB to patients with rib fractures with pain in our clinic.

Our aim is to evaluate SAPB for patients with rib fractures pain and to compare them with the control group in terms of total analgesic consumption and pain scores.

Detailed description: After Ethics Committee approval patients with rib fracture pain and have a Numerical Rating Scale (NRS) score of ≥ 4, included the study. The patients were randomized by the closed envelope method. The patients were divided into two groups as the SAPB-performed group (Group S) and the Control group (Group K). Intravenous patient-controlled analgesia (PCA) device prepared with tramadol was applied to all patients.

Eligibility criteria: Inclusion Criteria:

Rib fracture pain and had a Numerical Rating Scale (NRS) score of ≥ 4 ASA I-II-III

Exclusion Criteria:

Patients with infection at the injection site Coagulopathy Allergy to amide-type local anesthetics History of peripheral neuropathy Hepatic and/or renal failure Refusing the procedure

Primary outcomes:
measure: Analgesic consumption
timeFrame: up to 24 hour
Secondary outcomes:
measure: Numerical Rating Scale (NRS)
timeFrame: at 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours
Other outcomes:
Locations:
city: Kahramanmaras
country: Turkey
facility: Kahramanmaras Sutcu Imam University Hospital
Study officials:
References:
citation: Okmen K, Okmen BM. The efficacy of serratus anterior plane block in analgesia for thoracotomy: a retrospective study. J Anesth. 2017 Aug;31(4):579-585. doi: 10.1007/s00540-017-2364-9. Epub 2017 Apr 26.
citation: Teksen S, Oksuz G, Oksuz H, Sayan M, Arslan M, Urfalioglu A, Gisi G, Bilal B. Analgesic efficacy of the serratus anterior plane block in rib fractures pain: A randomized controlled trial. Am J Emerg Med. 2021 Mar;41:16-20. doi: 10.1016/j.ajem.2020.12.041. Epub 2020 Dec 23.
Clinical trial NCT01643954: Retrospective/Prospective Analysis of Surgical Outcomes of Robotic Prostatectomy at The James
Official title: Retrospective/Prospective Analysis of Surgical Outcomes of Robotic Prostatectomy at Ohio State University/The James.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: prostatectomy
surgery
prostate cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 1531
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a retrospective/prospective Analysis of surgical outcomes of robotic prostatectomy.

Detailed description: This retrospective / prospective study will allow us to collect and analyze the presurgical, peri-operative, and outcome data of patients who undergo robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center, beginning February 2008 onwards.

Eligibility criteria: ARM A:

Inclusion Criteria:

* Patients with prostate cancer who have undergone robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center.
* Ability to understand and willingness to sign the written informed consent document.
* 18 years and older

ARM B:

Inclusion Criteria:

* Patients with prostate cancer that will undergo robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center.
* Ability to understand and willingness to sign the written informed consent document.
* 18 years and older

Primary outcomes:
measure: Collect and analyze descriptive characteristics of patient population and summarize patient outcome data.
timeFrame: up to 20 years
Secondary outcomes:
measure: Correlate the patient characteristics to the surgical outcomes.
timeFrame: up to 20 years
measure: Determine the overall survival
timeFrame: up to 20 years
measure: Determine the rate of local recurrence in patients undergoing robotic prostatectomy and compare these metrics to historical controls.
timeFrame: up to 20 years
measure: disease- free survival
timeFrame: up to 20 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Steven Clinton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05730933: An Intervention Study to Improve Therapeutic Compliance in Adult Patients With Eosinophilic Esophagitis.
Official title: An Intervention Study to Improve Therapeutic Compliance in Adult Patients With Eosinophilic Esophagitis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eosinophilic Esophagitis
Keywords: eosinophilic esophagitis
maintenance treatment
compliance
intervention
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 72
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: In many chronic conditions adherence to long-term treatment is a challenge, also for patients with eosinophilic esophagitis. Interventions, such as behavioral, educational and reminder interventions might improve treatment adherence. With this trial the investigators want to assess the effects of additional education in combination with more frequent follow up and patient reminders on adherence to treatment in adult patients with eosinophilic esophagitis.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Male or female patient
* Age \>18 years
* Previous diagnosis of EoE, confirmed by histopathology, with the presence of \>15 eosinophilic granulocytes per high power field (hpf) in esophageal biopsies
* Current maintenance treatment for EoE with a PPI or swallowed topical corticosteroids or about to start with these maintenance medications as decided during regular clinical practice

Exclusion Criteria:

* Severe and clinically unstable concomitant disease that may interfere with the subject's ability to participate in the study
* Receive investigational treatment during the study
* Dilation of esophagus required
* Insufficient Dutch or English language skills to understand patient information leaflets

Primary outcomes:
measure: Treatment adherence at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Treatment adherence at 6 months
timeFrame: 6 months
measure: Treatment adherence at 12 months
timeFrame: 12 months
measure: Differences in self-reported treatment adherence measured by brief-IPQ
timeFrame: 12 weeks, 6 months and 12 months.
measure: Differences in self-reported treatment adherence measured by BMQ
timeFrame: 12 weeks, 6 months and 12 months.
measure: Differences in self-reported treatment adherence measured by 8-point MMAS
timeFrame: 12 weeks, 6 months and 12 months.
measure: Differences in self-reported treatment adherence measured by MARS questionnaire
timeFrame: 12 weeks, 6 months and 12 months.
measure: Change in clinical symptoms measured by DSQ questionnaire
timeFrame: 12 weeks, 6 months and 12 months
measure: Change in clinical symptoms measured by SDI questionnaire
timeFrame: 12 weeks, 6 months and 12 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
Study officials:
References: