louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01645774: Comparing Pain and Bruising of Subcutaneous Heparin Injection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Pain
Bruising
Keywords: subcutaneous injection heparin
injection duration
bruising pain
decrease pain
decrease bruising
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 90
Sex: ALL
Minimum age (years): 53
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Subcutaneous heparin injection is one of the most frequent nurses' clinical care. This study aimed to Identify and compare the effects of four different injection duration on pain and bruising associated with subcutaneous injection of heparin in 90 patients. Four injection methods were used for them:

A: 10s injections duration

B: 10s injection duration and waiting 10s before withdrawing the needle

C: 15s injection duration and waiting 5s before withdrawing the needle

D: 5s injection duration and waiting 15s before withdrawing the needle.

Bruising was measured by a flexible millimeter ruler 48h after each injection; and pain was measured by pain visual analogue scale immediately after the injection. Data will be analyzed by SPSS.


Eligibility criteria: Inclusion Criteria:

* Inclination to participate in the study; filling out the form of conscious satisfaction
* Ability to answer the questions and determining the rate of pain
* Not being affected by blood clotting difficulties, tissue damages, injuries, and bruises in the site of injection.

Exclusion Criteria:

* Death,
* Discharge

Primary outcomes:
measure: decrease pain
timeFrame: up to 6 months
measure: bruising
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00162474: Determinants of Warfarin Metabolism
Official title: Correlation Between Phenotypic Activity of CYP2C9 and Genetic Polymorphism in CYP2C9 and Warfarin Metabolism.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Healthy Volunteers
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-13
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The anticoagulant effect of warfarin varies greatly among individuals. Some of this variability is attributed to differences in the activity of CYP2C9, the predominant enzyme involved in the metabolism of S-warfarin.

The present study is designed to define the differences in warfarin metabolism among healthy individuals carrying different CYP2C9 genotypes. In addition, the study will define the correlation between the phenytoin metabolic ratio, a marker of CYP2C9 activity in vivo, and warfarin metabolism.


Eligibility criteria: Inclusion Criteria:

* Age range of 20-50 years old
* The absence of significant disease states

Exclusion Criteria:

* Known hypersensitivity to warfarin or phenytoin
* The presence of significant disease states
* Regular use of drugs (including birth control pills)

Primary outcomes:
measure: Warfarin oral clearance
timeFrame: 2 weeks
measure: Formation clearance of CYP2C9 mediated warfarin metabolites
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Yoseph Caraco, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shaul C, Blotnick S, Muszkat M, Bialer M, Caraco Y. Quantitative Assessment of CYP2C9 Genetic Polymorphisms Effect on the Oral Clearance of S-Warfarin in Healthy Subjects. Mol Diagn Ther. 2017 Feb;21(1):75-83. doi: 10.1007/s40291-016-0247-7.
Clinical trial NCT00588874: Age Related Changes in Calciotropic Hormones and Their Impact on Male Osteoporosis
Official title: Pilot Study to Assess the Skeletal Effects of Age-related Changes in Calcium and Vitamin D Metabolism in Men
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Bone Density
Keywords: male osteoporosis
male osteopenia
calciotropic hormones
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2008-01-09
Enrollment: 24
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy men 50 yrs of age and older, without a known history of metabolic bone disease or renal insufficiency

Brief summary: The purpose of this pilot study is to generate preliminary data regarding the skeletal effects of age-related changes in calcium and vitamin D metabolism in older men.


Eligibility criteria: Inclusion Criteria:

* healthy men age 50 yrs and older

Exclusion Criteria:

* smokers
* known history of metabolic bone disease, known history of hypogonadism or renal insufficiency.

Primary outcomes:
measure: Bone density of hip and spine
timeFrame: measured after screening evaluation
Secondary outcomes:
measure: calciotropic hormones, including calcium, PTH and vitamin D metabolites
timeFrame: measured after screening evaluation
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation
state: Connecticut
Study officials:
affiliation: Yale University
name: Barbara I Gulanski, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06432374: Written Exposure Therapy for Nurses
Official title: Open Pilot of Written Exposure Therapy for Nurses Experiencing Work-Related Posttraumatic Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Posttraumatic Stress Disorder
Depressive Symptoms
Burn Out
Anxiety
Work Related Stress
Keywords: Nurses
Written Exposure Therapy
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2024-05-29
Enrollment: 10
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: Nurses often experience elevated levels of stress, overwork, and trauma in the workplace, leading to posttraumatic stress disorder (PTSD), depression, burnout, and even nurse turnover. While effective therapies for PTSD exist, barriers to treatment arise from nursing culture, such as workplace stigma about mental health problems, fear that psychological status may impact performance evaluations, and demands of shiftwork. There is a pressing need for scalable evidence-based interventions tailored to nursing culture to effectively address PTSD and related mental health issues. The study aimed to assess the feasibility, safety, and acceptability of a tailored evidence-based treatment, Written Exposure Therapy (WET), for nurses experiencing work-related traumatic stress.

This single-arm open pilot study with pre- and post-intervention assessments, included participants from two nursing schools' alumni. Eligibility criteria included nurses screening positive for work-related trauma with a report of at least two PTSD symptoms. Participants engaged in a self-administered, asynchronous, five-week online writing session, facilitated by WET-trained nurses. Outcomes measures (PTSD, depression, anxiety, burnout, and intention to quit) were assessed at baseline, post-intervention, and 5-weeks follow-up.


Eligibility criteria: Inclusion Criteria:

* Work-related trauma
* Posttraumatic stress disorder

Exclusion Criteria:

* Current substance abuse
* Current suicidality
* Current psychiatric treatment with psychotherapy or psychotropic medications other than selective serotonin (and norepinephrine) reuptake inhibitors (SSRI/SNRI).

Primary outcomes:
measure: Posttraumatic stress disorder
timeFrame: Baseline, immediately post-intervention, and 5 weeks follow-up
Secondary outcomes:
measure: Depression
timeFrame: Baseline, immediately post-intervention, and 5 weeks follow-up
measure: Anxiety
timeFrame: Baseline, immediately post-intervention, and 5 weeks follow-up
measure: Professional Quality of Life
timeFrame: Baseline, immediately post-intervention, and 5 weeks follow-up
measure: Intention to Quit
timeFrame: Baseline, immediately post-intervention, and 5 weeks follow-up
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT05706974: Looking At Bile Duct Cancer Patient Experience Patterns in Medical Trials
Official title: Prospective Evaluation of Clinical Study Experiences of Patients With Bile Duct Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bile Duct Cancer
Keywords: bile duct
bile duct cancer
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Bile duct cancer patients who are actively considering participating in an observational medical study, but have not yet completed enrollment and randomization.

Brief summary: Clinical trials can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical trials, both positive and negative.

The goal is to identify the obstacles and challenges that prevent participation in bile duct cancer clinical trials, as well as the reasons for withdrawal or discontinuation.

The insights gained from this study will ultimately benefit those with bile duct cancer who may be invited to participate in medical research in the years to come.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Signed written informed consent
* Patient has been diagnosed with bile duct cancer

Exclusion Criteria:

* Woman pregnant or susceptible to the being
* Inability to perform regular electronic reporting
* Inclusion in another investigational clinical trial

Primary outcomes:
measure: Number of bile duct cancer patients who decide to enroll in a clinical study
timeFrame: 3 months
measure: Rate of bile duct cancer patients who remain in a clinical study to completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Norton RA, Foster EA. Bile duct cancer. CA Cancer J Clin. 1990 Jul-Aug;40(4):225-33. doi: 10.3322/canjclin.40.4.225.
citation: Ebata T, Hirano S, Konishi M, Uesaka K, Tsuchiya Y, Ohtsuka M, Kaneoka Y, Yamamoto M, Ambo Y, Shimizu Y, Ozawa F, Fukutomi A, Ando M, Nimura Y, Nagino M; Bile Duct Cancer Adjuvant Trial (BCAT) Study Group. Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer. Br J Surg. 2018 Feb;105(3):192-202. doi: 10.1002/bjs.10776.
citation: Xiang YJ, Sun JX, Wu JY, Wang K, Feng JK, Wei YG, Zhou JY, Zhang ZB, Zhang YQ, Qin YY, Yan ML, Cheng SQ. Recurrence hazard rate in patients with hepatocellular carcinoma and bile duct tumor thrombus: a multicenter observational study. HPB (Oxford). 2022 Oct;24(10):1703-1710. doi: 10.1016/j.hpb.2022.04.007. Epub 2022 Apr 22.
Clinical trial NCT04221074: Ultrasound Guided Modified Pectoral Plane Block Versus Erector Spinae Plane Block During GA in Gynecomastia Surgery
Official title: Ultrasound Guided Modified Pectoral Plane (PECS II )Block Versus Erector Spinae Plane (ESP) Block for Perioperative Analgesia of Surgical Treatment of Gynecomastia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecomastia, Adolescent
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-01-09
Enrollment: 46
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pain of breast surgery is due to chest wall scar and arm in some cases like carcinoma or due to nerve injury.It is neuropathic or nociceptive pain.Its severity is depending on the extent of surgery and the radiotherapy if needed.

Previous studies proved that local nerve block procedures improved the immediate postoperative pain and decreased the incidence of postoperative pain chronicity .

Also effective control of pain suppresses the surgical stress response minimizes the anaesthestic needs intraoperatively and decreases the opioid needs postoperatively .

Pectoralis nerve(pecs) II block and erector spinae plane (ESP) block are novel procedures that may provide good intraoperative and postoperative analgesia in patients undergoing surgical treatment of gynecomastia.


Eligibility criteria: Inclusion Criteria:

* Male gender .
* Age : 18 - 25 years old .
* Physical status : ASA I - II .
* Body mass index(BMI) :20-30 kg/m2
* Surgical treatment of Gynecomastia .
* Duration of surgery : 60 -120 min

Exclusion Criteria:

* Patient refusal .
* History of opioid abuse or chronic analgesic use .
* Coagulopathy .
* Allergy to study drugs .
* Infection in the injection sites.
* Uncooperative patients.

Primary outcomes:
measure: intraoperative analgesia
timeFrame: 60-120 minuets
measure: intraoperative analgesia
timeFrame: 60-120 minuets
measure: intraoperative analgesia
timeFrame: 60-120 minuets
Secondary outcomes:
measure: postoperative analgesia
timeFrame: 24 hours
measure: postoperative analgesia
timeFrame: 24 hours
measure: postoperative analgesia
timeFrame: 24 hours
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig university
Study officials:
References:
Clinical trial NCT02443974: Bracing to Treat Knee Osteoarthritis in Elderly
Official title: Effectiveness of Knee Bracing in Elderly With Knee Osteoarthritis: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Osteoarthritis (OA) is highly prevalent in the elderly, with the knee being the most commonly affected joint in this population. Knee braces are often used to prevent common problems in knees during daily activities. The purpose of these devices is to decrease pain and improve functionality. In the literature some studies have tested the effectiveness of unloader brace for valgus or varus. However, the braces most used in the investigators' clinical setting and the less costly ones have not been described in quality studies in the literature. There are only few studies on this subject and they are methodologically inadequate. There are no studies that compared the effectiveness between the knee brace with metal hinges (no alignment) and knee brace without metal hinges. Objective: To evaluate the effectiveness of knee braces on pain, function and quality of life in the elderly with knee OA. Methods: Elderly with knee OA, both genders, with pain scale 3-7cm on a 10cm pain numeric scale were included. Of the 222 patients screened, 120 met the eligibility criteria and were randomized to the groups: without metal hinges, with metal hinges or control group. The groups without and with metal hinges received knee brace and were instructed to use it in daily activities, every day, during three months. Assessment for pain (NPS), function (WOMAC and Knee Lequesne) and quality of life (SF-36) were done at baseline and after 45, 90 and 180 days by a blinded assessor.


Eligibility criteria: Inclusion Criteria:

* pain in numerical pain scale between 3 and 7cm;
* Knee ligamentous instability

Exclusion Criteria:

* fibromyalgia and neurologic disease;
* knee or hip replacement
* surgery scheduled in the following 6 months
* start physical activity or received joint injection in the past three months
* need to use walking aids or brace in knee

Primary outcomes:
measure: Change in pain measured by a numeric pain scale
timeFrame: Baseline, after 45, 90 and 180 days
Secondary outcomes:
measure: Change in function measured by Lequesne and WOMAC questionnaires
timeFrame: Baseline, after 45, 90 and 180 days
measure: Change in quality of life measured by SF-36 questionnaire
timeFrame: Baseline, after 45, 90 and 180 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
References:
Clinical trial NCT01617174: Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer
Official title: Observational Longitudinal Study of Pain in Men With Metastatic Castrate-Resistant Prostate Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Keywords: prostate
pain assessment
12-110
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: Johns Hopkins University
First posted: 2012-06-12
Enrollment: 0
Sex: MALE
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: Eligible patients will be recruited from 3 different collaborating sites: MSKCC, John Hopkins, and OHSU. MSKCC will enroll approximately 200 patients, and John Hopkins and OHSU will each enroll approximately 100 patients; 400 participants will be enrolled in total. MSKCC is the coordinating site for this study.

Brief summary: The first goal of this study is to learn more about the experience of pain and other symptoms in men being treated for advanced prostate cancer. The second goal of the study is to identify reliable ways of measuring pain which will be used in future clinical trials of treatments for advanced prostate cancer.


Eligibility criteria: Inclusion Criteria:

* The subject must be ≥ 18 years old on the day of consent.
* The subject is able to understand written and spoken English.
* The patient must have histologically or cytologically confirmed prostate adenocarcinoma.
* The subject must have castration-resistant prostate cancer (CRPC).
* The subject must have metastatic disease involving bone, seen on radiographic imaging (bone scan, CT scan, PET scan, or MRI).
* The subject must be in a castrate state (e.g., currently receiving androgen deprivation therapy or have had an orchiectomy).
* The subject must be starting any line of systemic treatment post-androgen deprivation/antiandrogen therapy, with any of the following: chemotherapy (e.g., docetaxel, paclitaxel, carboplatin, cabazitaxel, or mitoxantrone); abiraterone acetate; MDV3100; ketoconazole; a clinical trial.
* The subject owns or has regular access to a telephone (cellular or land line).
* The subject is willing and able to self-report pain and analgesic use via an automated telephone system.
* The subject is willing and able to provide informed consent.

Exclusion Criteria:

* The subject has small cell or predominantly neuroendocrine differentiated prostate tumor.

Primary outcomes:
measure: pain score
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Michael Morris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06956274: Ostomy Readmission Reduction Program
Official title: Ostomy Readmission Reduction Program
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ostomy - Ileostomy or Colostomy
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be identified from our outpatient clinic during surgical consultations.

Brief summary: The purpose of this study is to reduce complications like peristomal skin issues, stoma-related problems, dehydration, and other preventable factors that can lead to re-hospitalization within the first 30 days after surgery.


Eligibility criteria: Inclusion Criteria:

* Elective operations involving an ileostomy or a colostomy
* Individuals 18 years old or older are included

Exclusion Criteria:

* Individuals under age 18
* Pregnant patients
* Emergency operations
* Patients with existing pre operative ostomies

Primary outcomes:
measure: Readmission to hospital within 30 Days of Surgery
timeFrame: 30 Days Post Surgery
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: From index surgery to discharge (up to 30 days postoperatively)
measure: Incidence of Acute Kidney Injury (AKI)
timeFrame: From index surgery through 30 days postoperatively
measure: Incidence of Peristomal Skin Complications
timeFrame: From index surgery through 30 days postoperatively
measure: Incidence of Stoma-Related Leakage
timeFrame: From index surgery through 30 days postoperatively
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Surgery Group LA
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Yosef Nasseri, MD
role: PRINCIPAL_INVESTIGATOR
References: