louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05227456: Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study
Official title: Failed Endometrial Ablation Treatment With Implantable Progesterone (FEAT) Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Abnormal Uterine Bleeding
Dysmenorrhea
Keywords: abnormal uterine bleeding
pain
dysmenorrhea
endometrial ablation
Lead sponsor: Saskatchewan Health Authority - Regina Area
Sponsor class: OTHER
Collaborators: name: University of Saskatchewan
First posted: 2022-02-07
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the efficacy of an implantable etonogestrel device in reducing hysterectomy rate in patients with a failed endometrial ablation.

Detailed description: The researchers aim to determine whether use of etonogestrel implant in patients with failed endometrial ablation significantly decreases hysterectomy rate. Changes in pelvic pain and vaginal bleeding will be assessed. Time to hysterectomy will be examined.

The researchers hypothesize that treatment of failed endometrial ablation with etonogestrel implant will decrease pelvic pain and vaginal bleeding resulting in a significantly decreased need for hysterectomy.

Eligibility criteria: Inclusion Criteria:

* Previous endometrial ablation
* Pelvic pain and/or vaginal bleeding seeking treatment

Exclusion Criteria:

* Previous or current VTE
* Liver tumour, benign or malignant, or active liver disease
* Undiagnosed abnormal genital bleeding
* Known or suspected breast cancer
* Uncontrolled hypertension
* Allergy to component of etonogestrel implant
* Lack of patient consent

Primary outcomes:
measure: Hysterectomy
timeFrame: Occurrence of hysterectomy will be documented any time during the 3 year follow up period
Secondary outcomes:
measure: Vaginal bleeding
timeFrame: PBAC score will be documented at baseline and 3, 6, 12, 18, 24, 30, and 36 months
measure: Pelvic Pain
timeFrame: VAS will be documented at baseline and 3, 6, 12, 18, 24, 30, and 36 months
measure: Time to Hysterectomy
timeFrame: Time of hysterectomy will be documented any time during the 3 year follow up period
Other outcomes:
Locations:
city: Regina
country: Canada
facility: Saskatchewan Health Authority
state: Saskatchewan
Study officials:
affiliation: Obstetrician Gynecologist
name: Sarah N Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02802956: A Preliminary Feasibility Efficacy of Participation in Daily Life Promotion Program
Official title: National Taiwan University Hospital, Taiwan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Life participation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy of Participation in Daily Life Promotion Program for Patients with Chronic Stroke

Detailed description: The purpose of this three-year research project is to develop an intervention program to promote participation in daily life for patients with chronic stroke and to evaluate its efficacy.

Eligibility criteria: Inclusion Criteria:

* Patient with stroke after 6 months.
* Must be able to follow orders and no other cognition impairment, Mini Mental State Examination scale must \>20.

Exclusion Criteria:

* Clinical diagnosis of Dementia or Psychosis.
* Clinical diagnosis of Musculoskeletal disorders or Nervous system diseases.
* Patient with Congestive Heart Failure, Hypertension, Atrial fibrillation.
* Could not communication with others.
* Foreigner.

Primary outcomes:
measure: Stroke Impact Scale(SIS)
timeFrame: one year
Secondary outcomes:
measure: Postural Assessment Scale for Stroke patients(PASS)
timeFrame: one year
measure: Action Research Arm Test(ARAT)
timeFrame: one year
measure: Fugl-Meyer Assessment(FMA)
timeFrame: one year
measure: self-rated abilities for health practice scale
timeFrame: one year
measure: WHO Quality of Life-BREF (Taiwan version)
timeFrame: one year
measure: Taiwan Instrumental Activities of Daily Living(TIADL)
timeFrame: one year
measure: Barthel Index
timeFrame: one year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Test2
Study officials:
affiliation: National Taiwan University Hospital
name: I MING HSIAO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00124956: Doxorubicin Pharmacokinetic (PK) Study
Official title: Impact of Body Composition on Pharmacokinetics of Doxorubicin in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Cancer
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Glaser Pediatric Research Network
name: Elizabeth Glaser Pediatric AIDS Foundation
First posted: 2005-07-29
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This protocol is designed to obtain detailed information on the impact of body composition on the pharmacokinetic behavior of doxorubicin after a single intravenous dose in children 21 years of age or younger. There is no efficacy component. Approximately 9 children will be enrolled at Children's Hospital Boston. The information gained from this study could be very important in developing dosing strategies for doxorubicin in the obese patient population.


Eligibility criteria: Inclusion Criteria:

* Eligible patients will be \> 1 and ≤ 21 years old.
* All patients must be receiving chemotherapy that includes doxorubicin administered as an infusion of any duration \< 24 hours, on either a 1-day or 2-day schedule. This includes bolus and all short infusion schedules.
* All patients or their parents/legal guardians will provide informed consent/assent (as required by law) indicating their awareness of the investigational nature and the risks of this study according to the informed consent process.

Exclusion Criteria:

* Women who are known to be pregnant or lactating
* Patients with significant uncontrolled systemic illness
* Serum glutamic oxaloacetic transaminase (SGOT/AST), serum glutamic pyruvate transaminase (SGPT/ALT) \> 3 times the upper limit of normal tested within 14 days prior to infusion
* Bilirubin \> the upper limit of normal tested within 14 days prior to infusion
* Patients whose dose of doxorubicin is based on ideal body weight
* Patients who weigh \< 12 kilograms at time of screening

Primary outcomes:
measure: To evaluate the relationship between obesity and doxorubicin pharmacokinetics in children
Secondary outcomes:
measure: To explore the relationship between PK parameters and the patients' characteristics (age, gender, and ethnicity) and to correlate between PK parameters and DXA data (fat mass, lean tissue mass, and bone mineral content)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital, Boston
state: Massachusetts
Study officials:
affiliation: Dana Farber Cancer Insitute
name: Holcombe Grier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02353156: Posthemorrhoidectomy Pain Management With Electronic Bidet or Sitz Bath
Official title: Single Blind, Randomized Controlled, Multicenter Study to Evaluate the Efficacy and Convenience of Electronic Bidet With Very Low Force Flow Fountain System for Pain Control and Wound Healing After Operation for Anal Disease, Compared to Conventional Sitz Bath
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hemorrhoid
Keywords: Hemorrhoidectomy
postoperative pain
Sitz bath
Electronic bidet
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Daehang Hospital
name: Coway Co
First posted: 2015-02-02
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigator will perform a randomized clinical trials to compare the effect of pain management and wound healing after hemorrhoidectomy between warm sitz bath and electronic bidet.

Detailed description: After hemorrhoidectomy, the patients should take warm sitz bath for relieving pain and inducing wound healing. Electronic bidet is a device for cleansing the anus after defecation, and some patients are using the bidet for sitz bath. Thus, the investigator perform this study for comparing the effect of pain and wound management after hemorrhoidectomy between sitz bath and electronic bidet

Eligibility criteria: Inclusion Criteria:

* the patients who undergo hemorrhoidectomy

Exclusion Criteria:

* previous history of anal surgery
* Crohn's anal disease
* perianal complex abscess or fistula
* uncontrollable medical disease
* Tb
* HIV
* malignancy
* immunocompromised
* pregnancy
* breast feeding
* NSAID allergy

Primary outcomes:
measure: pain score
timeFrame: 1 week
Secondary outcomes:
measure: wound healing
timeFrame: 4 week
measure: convenience
timeFrame: 4 week
measure: urinary difficulty
timeFrame: 4 week
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University College of Medicine
name: Kyu Joo Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ryoo S, Song YS, Seo MS, Oh HK, Choe EK, Park KJ. Effect of electronic toilet system (bidet) on anorectal pressure in normal healthy volunteers: influence of different types of water stream and temperature. J Korean Med Sci. 2011 Jan;26(1):71-7. doi: 10.3346/jkms.2011.26.1.71. Epub 2010 Dec 22.
Clinical trial NCT00774956: Shoulder Training: Muscle Recruitment Patterns and the Effect of an Exercise Program
Official title: Shoulder Training: Muscle Recruitment Patterns and the Effect of an Exercise Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2008-10-17
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the muscle recruitment pattern and the effect of a 6 week shoulder exercise training program in healthy persons and subjects with shoulder impingement


Eligibility criteria: Inclusion Criteria:

* current reported history of shoulder pain localised at the glenohumeral joint diagnosed as impingement
* two positive shoulder impingement tests
* pain reproduction during two of three additional categories of clinical tests
* the subject is able to perform pain-free arm elevations with a resistance of 0.5 kg

Exclusion Criteria:

* cervical and periscapular pain
* positive labral injury tests
* history of shoulder surgery

Primary outcomes:
measure: Muscle recruitment pattern
timeFrame: After 6 weeks of training
Secondary outcomes:
measure: Shoulder pain and functional ability in the patient group
timeFrame: After 6 weeks of training
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Ghent
Study officials:
affiliation: University Ghent
name: Guy Vanderstraeten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Ann Cools, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01497756: Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)
Official title: Feasibility Trial of the Circumferential Abdominal Pelvic Pressure Device (CAPP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2011-12-22
Enrollment: 10
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A group of midwives and obstetric nurses have been trained to use circumferential abdominal pelvic pressure (CAPP) to treat postpartum hemorrhage. As part of the training follow up any use of a CAPP device will be monitored to identify complications.

Detailed description: Providers will be surveyed twice at 4 and 8 months using open ended methods.

Eligibility criteria: Inclusion Criteria:

* Any patient receiving CAPP during study period.

Exclusion Criteria:

* None (CAPP is only clinically indicated for obstetric hemorrhage post delivery.

Primary outcomes:
measure: Usage
timeFrame: Eight months
Secondary outcomes:
measure: Side Effects
timeFrame: Eight months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Mark Hauswald, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02542956: Comparison of Local Anesthetic Infusion Pump Versus DepoFoam Bupivacaine for Pain Management
Official title: Prospective, Randomized, Controlled Comparison of Local Anesthetic Infusion Pump Versus DepoFoam Bupivacaine For Pain Management After Abdominoplasty and TRAM Flap Breast Reconstruction.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pain
Keywords: Tummy tuck (abdominoplasty)
Breast Surgery
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 0
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: The purpose of this study is to identify the best pain management for patients undergoing abdominoplasty after massive weight loss or transverse rectus abdominis myocutaneous (TRAM) flap for breast reconstruction. The investigator is conducting this study to compare the effectiveness of a continuous infusion pain pump versus a locally injectable long-acting anesthesia (DepoFoam bupivacaine) versus standard injectable anesthesia (bupivacaine) for post surgical pain control. These drugs and devices are approved by the FDA (Food and Drug Administration) for the purpose of pain control after surgery, and have been used for this purpose before.

Detailed description: The purpose of this study is to identify the best pain management for patients undergoing abdominoplasty after massive weight loss or transverse rectus abdominis myocutaneous (TRAM) flap for breast reconstruction. The investigator is conducting this study to compare the effectiveness of a continuous infusion pain pump versus a locally injectable long-acting anesthesia (DepoFoam bupivacaine) versus standard injectable anesthesia (bupivacaine) for post surgical pain control. These drugs and devices are approved by the FDA (Food and Drug Administration) for the purpose of pain control after surgery, and have been used for this purpose before.

Eligibility criteria: Inclusion Criteria:

* Undergoing abdominoplasty or TRAM flap breast reconstruction

Exclusion Criteria:

* A medical condition that could interfere with study participation
* Body weight less than 50 kg
* Participating in another study involving an investigational medication

Primary outcomes:
measure: Recurrence of Pain
timeFrame: 30 minute to 72 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Donna Tepper, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01547156: Mobile Sipoo - Telemonitoring With Combined With Active Assistance Technology
Official title: Mobile Sipoo a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Hypertension
Keywords: patient decision support
telemonitoring
self-management
remote patient monitoring
active assistance technology
selfcare
Lead sponsor: VTT Technical Research Centre of Finland
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 56
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mobile Sipoo is a randomized controlled trial aiming to improve selfcare and outcomes of diabetes and hypertensive patients by introducing a remote patient monitoring system supported with automatic patient decision support. The feedback system is coupled with back-office health coaching.

Detailed description: Self-monitored data from blood pressure meters (SMBP), glucometers (SMBG), scales and pedometers are transferred by mobile phone terminals to a tethered personal health record (PHR) integrated with the provider EHR. The PHR application includes tools to display of self-monitoring data.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of diabetes or hypertension made at least 6 months prior to inclusion to study.
* For hypertensive patients: Blood pressure over 140/90 mmHg (systolic and diastolic separately) treated or untreated
* Diabetes patients: Glycohemoglobin A1c over 6.5% but lower that 11%
* use of diabetes medication

Exclusion Criteria:

* Patients who decline to participate
* Patients specifically excluded by the health centre physician
* Patients unable to co-operate, expected poor study compliance (IT illiterate) or reluctance to perform self monitoring
* Pregnancy
* Patients with a life expectance of less than one year
* Patients with major elective surgery planned within 6 months or patient has had major surgery within last 2 months.
* Patients with psychiatric disorders (depression), abuse of alcohol or narcotics complicating or disabling participation in the study

Primary outcomes:
measure: Change in blood pressure
timeFrame: 9 months
measure: Change in Hba1c(for diabetes patients)
timeFrame: 9 months
Secondary outcomes:
measure: Achieving the desired target range
timeFrame: 9 months
measure: Adverse effects
timeFrame: 9 months
measure: Hypoglycemia
timeFrame: 9 months
measure: Change in body weight
timeFrame: 9 months
measure: Change in BMI
timeFrame: 9 months
measure: Change in medication
timeFrame: 9 months
measure: Change in FÍNSIK scores
timeFrame: 9 months
Other outcomes:
Locations:
city: Sipoo
country: Finland
facility: Sipoo Health Care Centre
Study officials:
References:
Clinical trial NCT01528956: Studying Genes in Samples From Younger Patients With Adrenocortical Tumor
Official title: Using New Approaches for Genomics Studies in Pediatric Adrenocortical Tumors: Whole Genome Sequencing; Deep Sequencing; miRNA; methDNA and SNP 6.0
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenocortical Carcinoma
Keywords: adrenocortical carcinoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-02-08
Enrollment: 10
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled on COG-ARAR0332

Brief summary: RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies genes in samples from younger patients with adrenocortical tumor.

Detailed description: OBJECTIVES:

* To perform whole-genome sequencing, deep sequencing, micro RNA analysis, methylation status, copy number variation analysis, and single-nucleotide polymorphisms (SNPs) analysis in pediatric adrenocortical tumors and compare those results to those of the same patient's normal cells.

OUTLINE: Archived tumor and blood samples are analyzed for whole-genome sequencing, deep sequencing, micro RNA , methylation status, copy variation, and single-nucleotide polymorphisms. Results are then compared with patients' normal cells.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Banked tumor and blood samples obtained from patients enrolled on COG-ARAR0332 in North America and Brazil

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Identification of genetic factors affecting adrenocortical tumors
measure: Comprehensive catalog of altered genes in adrenocortical samples
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Gerard Zambetti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00230256: Treatment Outcomes and Quality of Life After IMRT Treatments of Head and Neck Cancers
Official title: Treatment Outcomes and Quality of Life After IMRT Treatments of Head and Neck Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-30
Enrollment: 61
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 who complete radiation therapy for H\&N cancers at Stanford University

Brief summary: The purpose of the research study is to evaluate effectiveness and the quality of life, specifically the risk of dry mouth, after radiation treatment for head and neck cancers.


Eligibility criteria: Inclusion Criteria:Patients who complete radiation therapy for H\&N cancers at Stanford University

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Quynh-Thu Le
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03805256: Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cancer
Official title: Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cnacer
Lead sponsor: Second Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target population comprises all adult patients aged 18 years and older who present with pulmonary nodules.The study sample will include 60 subjects.

Brief summary: Mutation-positive peripheral blood ctDNA became mutation-negative after surgical removal of the cancer tissue. All subjects in the control group were negative for ctDNA mutations。


Eligibility criteria: Inclusion Criteria:Patients with pulmonary nodules who underwent curative-intent resection were able to enter the study -

Exclusion Criteria:Patients who received any invasive examination or treatment prior to resection or had a history of malignancy; patients who do not attend follow up after surgery; blood samples that were contaminated; and biopsies that exhibited advanced lung cancer in pathology。

-

Primary outcomes:
measure: The potential value of ctDNA in the diagnosis of NSCLC
timeFrame: Half a year
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Jianping Gong
state: Jiang Su
Study officials:
affiliation: Second Affiliated Hospital of Soochow University
name: Jianping Gong, Doctor
role: STUDY_DIRECTOR
References: