louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05788016: Developing an Opioid Taper Intervention Before Total Joint Arthroplasty
Official title: Developing and Testing an Opioid Taper Intervention Before Total Knee Arthroplasty: Phase 2 Intervention Development
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthritis Knee
Arthritis Hip
Chronic Pain
Keywords: Opioids
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2023-03-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to develop an pharmacist-led preoperative opioid taper intervention for patients undergoing total knee or hip replacement who are on chronic opioids before their surgery. The main questions it aims to answer are:

* Is the intervention feasible and acceptable to patients?
* Does the intervention result in a decrease in opioid dose during the preoperative period?

Participants will meet with a clinical pharmacist, who will provide some basic education on pain and opioids, and will propose an opioid taper schedule. The pharmacist will then follow-up with the participant by phone each week until surgery to assess progress and adjust the taper as necessary.


Eligibility criteria: Inclusion Criteria:

* decided to pursue primary, unilateral total knee or hip arthroplasty with planned surgery date in 4-8 weeks
* currently taking between 20 and 90 MME of oral opioids, and that dose has been stable for at least 3 months
* have a reliable telephone number for contact
* speaks English

Exclusion Criteria:

* Taking opioid medications that include:

  * Buprenorphine
  * Methadone
  * Long-acting formulations of opioid pain medications (e.g., extended-release oxycodone and extended-release morphine)
  * Transdermal formations of opioid pain medications (e.g., fentanyl patches)

Primary outcomes:
measure: Acceptability
timeFrame: From enrollment until approximately 2 weeks after surgery
Secondary outcomes:
measure: Study Recruitment Rate
timeFrame: From enrollment until approximately 2 weeks after surgery
measure: Study Retention Rate
timeFrame: From enrollment until approximately 2 weeks after surgery
measure: Taper Efficacy
timeFrame: From enrollment until the time of surgery
measure: Perioperative Pain
timeFrame: From enrollment until approximately 2 weeks after surgery
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Hospital-Highlands
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Kevin R Riggs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01114516: Multifactorial Approach to Emergent Cerclage
Official title: Role in Emergent Cerclage of Indomethacin and Antibiotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Insufficiency
Keywords: cervical insufficiency
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2010-05-03
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Though cervical insufficiency is a common cause of second trimester pregnancy loss, the placement of an emergent cerclage in these patients is thought to improve perinatal outcomes. It is unknown whether the use of tocolytics and antibiotics prolongs pregnancies complicated by need for emergent cerclage.

The objective is to determine whether administration of peri-operative antibiotics and indomethacin to patients receiving emergent cerclages for cervical insufficiency increases latency period to delivery compared with patients receiving emergent cerclage alone.


Eligibility criteria: Inclusion Criteria:

* GA 16+0 to 23+6 weeks
* Singleton gestation
* Presence of cervical dilation as diagnosed on digital examination
* Intact membranes

Exclusion Criteria:

* Age \<18 years
* Allergy to NSAIDs
* Renal disease
* Allergy to penicillins AND clindamycin
* Currently on antibiotics or indomethacin for any reason
* HIV positive
* Pregnancies complicated by fetal congenital anomalies
* Preterm premature rupture of membranes
* Fever of 100.4 degrees Fahrenheit or higher
* Any patient having received a therapeutic cerclage during the current pregnancy

Primary outcomes:
measure: Gestational Latency Achieved Between Cerclage Placement and Time of Delivery
timeFrame: 24 weeks
Secondary outcomes:
measure: Gestational Latency of More Than 28 Days
timeFrame: 28 days postpartum
measure: Gestational Age at Delivery
timeFrame: 24 weeks
measure: Neonatal Morbidity and Mortality
timeFrame: 1 year
measure: Birthweight
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Prentice Women's Hospital
state: Illinois
Study officials:
References:
citation: Miller ES, Grobman WA, Fonseca L, Robinson BK. Indomethacin and antibiotics in examination-indicated cerclage: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1311-1316. doi: 10.1097/AOG.0000000000000228.
Clinical trial NCT02905916: The Efficacy and Safety of PEG-rhG-CSF in Neutropenia After Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mammary Cancer
Lymphoma
Bone Tumour
Gynecological Tumors
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of the trail is to evaluate the efficacy and safety of PEG-rhG-CSF in primary prophylaxis and secondary prophylaxis of neutropenia after chemotherapy.


Eligibility criteria: Inclusion Criteria:

1. Patients with age between 18 and 70 years.
2. Breast cancer, lymphoma, bone tumor or Gynecologic tumor patients.
3. With multi-cycle chemotherapy.
4. With III/IV degree neutropenia after the last cycle of chemotherapy and plans to use the same regimen in the subsequent cycles.FN risk of the chemotherapy regimens is ≥20%，or 10%≤FN risk\<20% and has high risk factors associated with FN.
5. KPS score≥ 70.
6. Expected to survive more than 3 months.
7. No hematologic system disease and ANC≥1.5×10E9/L, PKT≥80×10E9/L, Hb≥ 75g/L, WBC≥3×10E9/L, and no bleeding tendency.
8. Written informed consent are acquired. -

Exclusion Criteria:

1. With infection or systemic antibiotic therapy 72h before chemotherapy.
2. With any abnormal hematopoietic function.
3. Received transplantation within 3 months.
4. Suffered from other malignant tumor or brain metastases.
5. TBIL, ALT,AST \> 2.5×ULN; if it were caused by liver metastases, TBIL, ALT,AST \>5×ULN.
6. Cr \>1.5 ×ULN.
7. Sensitive to the product or other genetically engineered biological products from Escherichia coli strains.
8. Mental or nervous system disorders.
9. Refused to accept contraceptive measures.
10. Other situations that investigators consider as contra-indication for this study.

    -

Primary outcomes:
measure: Incidence of febrile neutropenia (FN)
timeFrame: 30days after PEG-rhG-CSF administration
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jun Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01706016: Local Treatment by Thermic Destruction of Primitive Breast Cancer
Official title: Local Treatment by Thermic Destruction of Primitive Breast Cancer. Phase II: Feasibility and Effectiveness, Standardization of Procedures.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2012-10-15
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Demonstrate the effectiveness of laser in the treatment of cancerous lesions by determinating with histological analysis of the specimen the percentage of tumor cells remaining in the area treated by the laser


Eligibility criteria: Inclusion Criteria:

* Noninflammatory unilateral and unifocal breast cancer
* Size \</= 20mm (ultrasound measure)
* Histological confirmation of cancer by biopsy grade status hormone and HER2.
* Good delineation of the lesion on ultrasound.
* Minimum distance of 5 mm between the tumor and the skin between the tumor and muscle.
* Age between 18 and 80
* ECOG performance status 0 or 1

Primary outcomes:
measure: Effectiveness of laser treatment
timeFrame: 28 days after initial diagnosis
Secondary outcomes:
measure: Life quality
timeFrame: D-0 and before the surgery
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
state: Nord
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Val De Marne
city: Paris
country: France
facility: Hopital Lariboisière
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Jean Remy GARBAY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02124616: National Registry for Egyptian Pediatric Neuromuscular Diseases
Official title: National Registry for Egyptian Pediatric Neuromuscular Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Muscular Atrophy
Muscular Dystrophy
Muscle Diseases
Myasthenic Syndromes
Polyneuropathies
Keywords: spinal muscular atrophy
Muscular dystrophy
Muscle diseases
myasthenic syndromes
Polyneuropathies
Myopathies
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children from birth to 18 years of age with inherited or acquired neuromuscular diseases.

Brief summary: Our aim is to establish multi-center national Egyptian database of information for inherited and acquired neuromuscular diseases in infants and children from 0 to 18 years of age.

Detailed description: Aims: An open-ended multi-center, national Egyptian study to collect and analyze data for children with Neuromuscular Diseases (NMD) inherited NMD (spinal muscular atrophy (SMA), Duchenne/Becker and congenital muscular dystrophies (DMD/BMD, CMD), congenital myopathies, and congenital myasthenic syndromes) and acquired NMD (neuropathies, myasthenia gravis and myositis).

Participants: Eligible infants and children with inherited and acquired neuromuscular diseases.

DESIGN: This study is a prospective cohort study.

Outcome measures: Motor development assessment, respiratory and cardiac examination.

Eligibility criteria: Inclusion Criteria:

* Weakness, hypotonia.
* Nerve conduction study and electromyographic confirmation of lower motor neuron affection.

Exclusion Criteria:

* Chromosomal diseases.
* Malformations and deformations.

Primary outcomes:
measure: Functional motor ability
timeFrame: 1 year
Secondary outcomes:
measure: Cardio-pulmonary function
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University
state: Abassia
Study officials:
affiliation: Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University
name: Sahar MA Hassanein, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01117116: Sub-Sensitivity to Long-Acting Bronchodilators (LABA)
Official title: Sub-Sensitivity to Long-Acting Bronchodilators (LABA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to look at whether Advair® and SYMBICORT® have different effects on airway constriction by means of methacholine challenge testing.


Eligibility criteria: Inclusion Criteria:

* 20 subjects males or females 18-65 years of age with physician diagnosed asthma Diagnosis of asthma \> 12 months Currently on 2 puffs SABA bid. Baseline percent FEV1 of greater than 60% and less than or equal to 100% 12% reversibility in the previous 12 months 12% reversibility at Screening Visit Positive MTC (≤ 8mg/ml) at the end of 2 week Run-In Currently symptomatic with ACT score less than 19 at the end of run in on ICS ≥ 200 and ≤ 400 ug/day Non-smoker or ex-smoker with \< 10 pk year who stopped \> 1 year ago

Exclusion Criteria:

* Asthma exacerbation, significant airflow obstruction, or respiratory infection between Visits 0 and 2. Patients who fail screening because of one of these events may be re-screened once (at least 4 weeks after recovery from the event).

Pre-existing lung disease other than asthma, including active infections Clinically significant medical disease that is uncontrolled despite treatment or is likely in the opinion of the investigator to require a change in therapy during the study Noncompliance or inability to participate in all assessments. Current smoker or former smoker with a lifetime smoking history of ≥ 10 pack-years. A current smoker is defined as someone who has smoked one or more cigarettes per day (or marijuana or a pipe or cigar) for \>/= 30 days within the 24 months prior to Visit 1.

Any individual who smokes (cigarettes, marijuana, pipe, or cigar) occasionally, even if for \< 30 days in the 24 months Prior to Visit 1, must agree to abstain from all smoking from the time of consent through completion.

History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator.

Participation in another interventional clinical trial (including a trial of an approved drug or an interventional study that does not include medication) within 30 days or 5 half-lives of the investigational agent, whichever is longer.

Women with a positive urine pregnancy test.

Primary outcomes:
measure: Improvement in PC20
timeFrame: Study Completion
Secondary outcomes:
measure: Changes in FEV1
timeFrame: Study Completion
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
affiliation: National Jewish Health
name: Rohit K Katial, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01479816: Urinary Continence Index for Prediction of Urinary Incontinence in Older Women
Official title: Urinary Continence Index for Prediction of Urinary Incontinence in Older Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Keywords: continence
index
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2011-11-24
Enrollment: 702
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women 55 years and older

Brief summary: This study will analyse existing data to establish a clinically useful index to predict those women who are more likely to become incontinent. This would create significant opportunities for focused prevention and early intervention strategies.


Eligibility criteria: Inclusion Criteria:

* Women

Exclusion Criteria:

* Men

Primary outcomes:
measure: Index Estimation for Urinary Incontinence Prediction
timeFrame: 2 years
Secondary outcomes:
measure: Predictive Reliability of Urinary Incontinence Index and its Validation
timeFrame: 3 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Oakland University
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Ananias Diokno, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03982316: Telehealth Behavioral Migraine Management
Official title: Telehealth Behavioral Migraine Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-06-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project aims to develop the protocol and obtain feasibility and acceptability information for Telehealth Behavioral MIgraine Management in a single-arm pre-post pilot study. The investigator and study team aim to recruit 20 people with migraine from the Montefiore Headache Center in the Bronx NY. Participants will receive the 12-week protocol including a mobile app headache diary, an online patient manual with interactive vignettes, 4 50-minute telehealth sessions, and 3 15-minute check-ins.


Eligibility criteria: Inclusion Criteria:

* Physician diagnosis of migraine
* Current self-reported symptoms meeting the International Classification for Headache Disorders -- 3 criteria for migraine
* Self-reported between 4 and 20 headache days/month
* Aged 18-65
* Can read English
* Capacity to consent

Exclusion Criteria:

* Psychiatric illness that would interfere with study participation
* Meeting criteria for probable medication overuse headache

Primary outcomes:
measure: Feasibility of TeleBMM
timeFrame: Week 0 through Week 12
Secondary outcomes:
measure: Patient-rated satisfaction
timeFrame: Post-treatment survey at Week 12
measure: Quality of Life (Migraine Specific)
timeFrame: Change from Pre-treatment (Week 0) to Post-treatment (Week 12)
measure: Headache frequency
timeFrame: Slope change from Week 0 to Week 12
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Yeshiva University/Albert Einstein College of Medicine
name: Elizabeth K Seng, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02268916: Physical Activity and Participation
Official title: Veterans With Diabetes Mellitus: Improving Physical Activity and Participation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
physical activity
participation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2014-10-20
Enrollment: 104
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: The purpose of the study is to investigate if the investigators can improve physical activity and social participation level among Veterans with diabetes.

Detailed description: Physical activity is the cornerstone of good diabetes management, and yet effective physical activity intervention is not available. The investigators developed a lifestyle intervention based on individual's home activity patterns. The goal of the study is to test the efficacy of this intervention among Veterans with diabetes in a randomized-controlled trial. In addition to physical activity, the investigators will also assess if the intervention will improve social participation among Veterans.

Eligibility criteria: Inclusion Criteria:

* Veterans
* Aged 60 years or older
* Has Type 2 diabetes mellitus
* Able to operate accelerometer
* Competent to consent to the study
* No dementia diagnosis
* Ambulatory with or without assistive device
* English-speaking
* Community living (i.e., not a nursing home resident)
* Not physically active on a regular basis (less than 150 minutes of moderate or vigorous physical activity per week)

Exclusion Criteria:

* Medically unstable
* Hospitalized within the last 6 months
* 2 or more days of complete bed rest in the last month
* hemiplegia or limb amputation
* Self-reported illness or conditions that would impair the cooperation with the study team or the ability to complete the study
* work involved in shift schedule
* current enrollment of a physical activity program
* replacement of hip or knee within the last 6 months.
* Parkinson's disease
* frequent falls

Primary outcomes:
measure: Physical Activity
timeFrame: 6 months
measure: Social Participation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: Physical Function
timeFrame: 6 months
measure: Physical Function
timeFrame: 6 months
measure: Physical Function
timeFrame: 6 months
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Pearl G. Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: