louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00264407: Neural Changes in the Aging Auditory System
Official title: Age-Related Hearing Loss: Presbycusis & Its Neural Bases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Progesterone
Estrogens
Hearing
Psychoacoustics
Auditory Perceptual Disorders
Keywords: Hearing Loss, Central
Presbycusis
Hearing Loss, Sensorineural
Hearing Loss, Cochlear
Hearing Loss, Bilateral
Sex Steroid Hormones
Estradiol
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Rochester Institute of Technology
name: National Institute on Aging (NIA)
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2005-12-12
Enrollment: 126
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: The purpose of this study was to determine the effects of hormone replacement therapy (HRT) on hearing in post-menopausal women.

Detailed description: Background: Female hormone influences on the development and aging of the auditory system are not completely understood. The present study retrospectively analyzed and compared hearing abilities among post-menopausal women taking hormone replacement therapy (HRT), treated with estrogen and progesterone (E+P); estrogen alone (E), and a third (control - NHRT) group, matched for age, who did not receive any HRT.

Methods: 126 subjects, (60-86 yr), N=32, E+P; N=31, E; N= 63, NHRT; matched for age and health status participated. All had relatively healthy medical histories, absence of significant noise exposure, middle ear problems, major surgeries or current/heavy smoking. Hearing tests included pure tone audiometry (PTA), tympanometry, distortion-product otoacoustic emissions (DPOAEs), transient otoacoustic emissions (TEOAEs) and hearing-in-noise-test (HINT). The latter is a test for speech perception in background noise: the major complaint of hearing-impaired persons.

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Eligibility criteria: Inclusion Criteria:

* Healthy middle ears

Exclusion Criteria:

* ototoxic medications
* serious medical health problems
* neurological conditions
* Meniere's disease or labyrinthitis
* those who failed cognitive screening tests (Mini-Mental Test)
* current/heavy smokers
* conductive hearing loss
* history of noise damage and/or audiograms signifying noise damage
* poor speech discrimination scores (80% or less)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: International Center Hearing & Speech Research - NTID - RIT
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester Medical School
name: Robert D Frisina, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03467607: A Feasibility Study of a Low Tidal Volume Ventilation Strategy in One Lung Ventilation
Official title: A Feasibility Study of a Low Tidal Volume Ventilation Strategy in One Lung Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Tidal Volume Ventilation
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel assignment
Primary purpose: PREVENTION

Brief summary: A study of two ventilatory strategies for low tidal volume ventilation compared to a control group to elucidate if low tidal volumes of 3ml/kg or 4ml/kg were feasible for one lung ventilation.

Detailed description: This study investigated the feasibility of low tidal volume ventilation for one lung ventilation.

45 patients were recruited - 15 patients in each of three groups, 3ml/kg, 4ml/kg or usual care.

Outcomes studied were length of stay, 30 day mortality, unplanned ICU admission, evidence of respiratory failure or requirement for non-invasive ventilation, chest x-ray infiltrates and requirement for antibiotics.

Eligibility criteria: Inclusion Criteria:

* ASA I-III lung resection surgery requiring one lung ventilation

Exclusion Criteria:

* ASA IV or above under 18 or over 80 years of age pregnancy previous lung lobectomy or pneumonectomy requirement for massive transfusion during the case BMI \> 35

Primary outcomes:
measure: Radiological evidence of injury to the ventilated lung
timeFrame: post operatively up to 6 weeks post operatively
measure: unplanned ICU admission
timeFrame: up to 6 weeks post operatively
measure: Requirement for non-invasive ventilation
timeFrame: up to 6 weeks post operatively
measure: Hospital acquired pneumonia
timeFrame: up to discharge at 6 weeks post operatively
Secondary outcomes:
measure: length of hospital stay
timeFrame: until patient discharge at 6 weeks post operatively
measure: length of icu stay
timeFrame: until patient discharge at 6 weeks post operatively
measure: 30 day mortality
timeFrame: 30 days post operatively
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St James's Hospital Dublin
Study officials:
affiliation: University of Dublin, Trinity College
name: Ignacio Martin-Loeches, md
role: STUDY_CHAIR
References:
Clinical trial NCT00679107: A Prospective Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions
Official title: A Prospective, Randomized, Controlled, Multicenter, Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Lumbar Spondylolisthesis
Keywords: Degenerative Disc Disease
Lead sponsor: Olympus Biotech Corporation
Sponsor class: INDUSTRY
First posted: 2008-05-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will explore the use of OP-1 Putty in conjunction with surgical treatment for the treatment of spinal decompression and lumbar spinal fusion.

Detailed description: It is postulated that the addition of OP-1 Putty to autogenous bone will prove beneficial in the treatment of patients requiring decompression and lumbar spinal fusion. The Investigational system is intended to stimulate bone growth. It is indicated as an adjunct or a replacement for autograft in spinal fusion.

Eligibility criteria: Inclusion Criteria:

1. The subject has a diagnosis of Degenerative Lumbar Spondylolisthesis of Grade I or II with Spinal Stenosis demonstrated by medical history, physical examination a n d radiographic imaging.
2. The subject is a candidate for decompression and spinal fusion with the use of autograft from the iliac crest.
3. The subject requires one level lumbar fusion (L-3 to S-1).
4. The subject has a preoperative Oswestry Disability Index of 30-100.

Exclusion Criteria:

1. The subject has active spinal and/or systemic infection.
2. The subject is morbidly obese.
3. The subject has a known sensitivity to any component of the OP-1 Putty.
4. The subject has spinal instability measured on flexion / extension radiographs of greater than 50% translation of the vertebrae and greater than or equal to 20 degrees of angular motion.
5. The subject uses tobacco or nicotine or is prescribed steroids such as cortisone.

Primary outcomes:
measure: Safety, by comparison of the complications and neurological status within the OP-1treatment groups and the control group (autograft alone).
timeFrame: 6 weeks; 3, 6, 9, 12, and 24 months
Secondary outcomes:
measure: Efficacy, by comparison of overall fusion success and time to fusion along with pain / function outcome within the OP-1 treatment groups and the control group (autograft alone).
timeFrame: 6 weeks; 3, 6, 9, 12, and 24 months
Other outcomes:
Locations:
city: New Haven
country: United States
state: Connecticut
city: Chicago
country: United States
state: Illinois
city: Royal Oak
country: United States
state: Michigan
city: Akron
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04898907: Study Developed to Evaluate the Effect of ANG-3777 on QT/QTc Interval
Official title: A Single Part, Four-Way Crossover, Randomized, Partially-Blinded Study to Evaluate the Effect of Intravenous ANG-3777 on Baseline-Adjusted QT/QTc Interval in the Fasted State in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Angion Biomedica Corp
Sponsor class: INDUSTRY
Collaborators: name: Quotient Sciences
First posted: 2021-05-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of ANG-3777 on placebo-corrected change from baseline, QT/corrected QT (QTc) interval, following single intravenous (IV) doses in healthy volunteer adults.


Eligibility criteria: Inclusion Criteria:

1. Healthy males or non-pregnant, non-lactating healthy females
2. Aged 18 to 55 years inclusive at the time of signing informed consent
3. Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
4. Weight ≥50 kg and ≤100 kg at screening and admission
5. Must be willing and able to comply with all study requirements
6. Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures
7. Must agree to use an adequate method of contraception

Exclusion Criteria:

1. Subjects who have received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose. However, in no event, shall the time between last receipt of IMP and first dose be less than 30 days.
2. Subjects who are study site or sponsor employees, or are immediate family members of a study site or sponsor employee
3. Evidence of current SARS-CoV-2 infection
4. History of any drug or alcohol abuse in the past 2 years
5. Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit, or 5 oz glass of wine)
6. A confirmed positive alcohol urine test at screening or admission
7. Current smokers and those who have smoked within the last 12 months or current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
8. A confirmed positive urine cotinine test at screening or admission.
9. Positive drugs of abuse test result

Primary outcomes:
measure: Change from baseline in corrected QT interval by Fridericia's formula for ANG-3777 at the therapeutic and supra-therapeutic dose levels compared to placebo
timeFrame: Day 1, Day 5, Day 9 and Day 13
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Quotient Sciences
state: Florida
Study officials:
affiliation: Quotient Sciences - Miami, Inc.
name: Jeffrey Levy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03687307: What Are the Three Dimensional Soft Tissue Changes That Occur After Orthognathic Surgery for Skeletal Class II Patients? Pre-test Post-test Quasi Experimental Study
Official title: What Are the Three Dimensional Soft Tissue Changes That Occur After Orthognathic Surgery for Skeletal Class II Patients? Pre-test Post-test Quasi Experimental Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Orthognathic Surgery
Keywords: class II,
soft tissue changes
CBCT
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with class 2 skeletal deformity, over 18 years and younger than 40

Brief summary: the aim of the study is to establish reference data that could be used for the creation of more accurate three dimensional prediction of soft tissue outcome.

Detailed description: in this study, 15 skeletal class 2 orthognathic patients will be selected. CBCT and proface will be done preoperatively. after the surgery and 6 months later the imaging investigations will be repeated to investigate the soft tissue changes that have resulted due to the bone movement.

Eligibility criteria: Inclusion Criteria:

* Patients with class II skeletal deformity
* Patients must be over 18 years of age to allow for growth cessation
* Patients must not have any systemic condition which contraindicates general anaesthesia

Exclusion Criteria:

* o patients with cleft palate

  * patients with syndromes affecting their craniofacial structure
  * patients with facial scars
  * patients with severe facial asymmetry

Primary outcomes:
measure: 3D soft-tissue changes (linear)
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of soft tissue change to hard tissue change
timeFrame: 6 months
measure: Is the esthetic outcome as expected/imagined?
timeFrame: 6 months
measure: 3D soft-tissue changes (angular)
timeFrame: 6 months
measure: 3D soft-tissue changes (volumetric)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06449807: Effects of Crossover Point Exercise on Depression, Anxiety and Stress in Chinese Postmenopausal Women
Official title: Effects of Crossover Point Exercise on Depression, Anxiety and Stress in Chinese Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health
Keywords: Mental health
Sleep quality
Exercise
Body composition
Body image
Lead sponsor: Beijing Sport University
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 80
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To analyze the effects of the Crossover Point (COP) Exercise Program on Chinese postmenopausal women.

Detailed description: This is a randomized clinical trial of single-blind with 2 arms (control group and experimental group), in which a pre-treatment-posttest design has been used.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women without incapacitating chronic disease or contraindications to exercise
* baseline mental health
* no severe chronic diseases or exercise contraindications
* ability to understand the research details and voluntarily sign the informed consent form.

Exclusion Criteria:

* Women with undetermined menopause；
* BMI \<18.5 kg/m2 or BMI \>28 kg/m2
* uncontrolled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>110 mmHg)
* life-threatening illness with a prognosis of \<5 years
* currently receiving estrogen therapy
* currently taking medication that may affect psychological testing
* contraindications to exercise

Primary outcomes:
measure: DASS-21 (Depression Anxiety Stress Scale-21)
timeFrame: At the beginning-at three months.
Secondary outcomes:
measure: Body Mass Index (BMI )
timeFrame: At the beginning-at three months.
measure: Body Image States Scale (BISS)
timeFrame: At the beginning-at three months.
measure: Body Appreciation Scale-2 (BAS-2)
timeFrame: At the beginning-at three months.
measure: The Meaning in Life Questionnaire (MLQ)
timeFrame: At the beginning-at three months.
measure: The Subjective Happiness Scale (SMS)
timeFrame: At the beginning-at three months.
measure: Body composition
timeFrame: At the beginning-at three months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: School of Sports Medicine and Rehabilitation, Beijing Sport University
Study officials:
References:
Clinical trial NCT04953507: Evaluation of T2, T3 Sympathectomy for Postmastectomy Pain Syndrome by Pulse Oximeter
Official title: Evaluation of T2, T3 Sympathectomy for Postmastectomy Pain Syndrome by Thermal Radiofrequency Versus Chemical Neurolysis Using Perfusion Index Derived Pulse Oximeter
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the efficacy of T2, T3 sympathetic block using thermal radiofrequency versus chemical neurolysis in postmastectomy pain syndrome using perfusion index derived from pulse oximetry.

Detailed description: Postmastectomy pain is a chronic pain condition with neuropathic nature. Several drugs and methods are used for its management. This study was designed to compare the efficacy of both thermal radiofrequency and chemical neurolysis in management of postmastectomy pain through using perfusion index derived from pulse oximetry.

Eligibility criteria: Inclusion Criteria:

* Female patients with postmastectomy pain syndrome
* ≥ Age 18 years
* ASA II-III

Exclusion Criteria:

* patient refusal
* coagulation defects
* abnormal kidney or liver functions
* local infection at site of injection
* bone metastases
* severe cardiorespiratory disease

Primary outcomes:
measure: Perfusion index trend
timeFrame: procedure time
Secondary outcomes:
measure: Visual analogue score
timeFrame: 6 weeks
measure: Opioid consumption
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Walaa Y Elsabeeny
Study officials:
affiliation: Assistant Professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University
name: Walaa Y Elsabeeny, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04943107: Effect of Antihypertensive Drugs on Glaucoma Patients
Official title: Effect of Antihypertensive Drugs on Glaucoma Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatient from ophthalmology and cardiology clinic

Brief summary: It has been reported that among Asian non-glaucomatous, antihypertensive medications were associated with retinal nerve fiber layer and ganglion cell-inner plexiform layer thickness. In order to explore whether antihypertensive medications would influence the neuropathy among glaucomatous population, we designed a cross-sectional observational study to analyze the retinal status among glaucoma patients with use of antihypertensive medication.

Detailed description: we designed a cross-sectional obeservational study to analyze the retinal status among glaucoma patients with use of hyertensive medication.

Eligibility criteria: Inclusion Criteria:

* age no less than 18 years

  * best corrected visual acuity better than decimal 0.3

Exclusion Criteria:

* secondary glaucoma

  * secondary hypertension
  * glaucoma-related operation history
  * pregnancy or lactation period
  * uncooperative with retinal examination
  * severe opacity with refracting media in eye
  * severe retinal diseases and neuropathy
  * congenital retinal optic nerve abnormality
  * other systemic diseases that influence hypertension and glaucoma assessment

Primary outcomes:
measure: retinal nerve fiber layer thickness
timeFrame: within 3 months from recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of College of Medicine, Zhejiang University
name: Kaijun Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05056207: PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema
Official title: PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lymphedema
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This research study is to learn about breast cancer patients' opinions about screening for lymphedema (a side effect of breast cancer treatment in which the arm can become heavy, painful, and/or swollen) and their satisfaction with the lymphedema screening program.

Detailed description: Primary Objectives:

* To determine the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer for reducing the cumulative incidence of grade lymphedema among breast cancer patients after ALND compared to routine screening. Secondary Objectives:
* To estimate the direct costs associated with the Lymphedema Screening Initiative
* To determine the association of the Initiative on patient productivity
* To determine patient satisfaction with the Lymphedema Initiative in the context of their cancer care
* To determine patient understanding of lymphedema-associated symptoms
* To determine patient self-reported compliance with treatments and measures to prevent lymphedema
* To determine the incidence of breast cancer-related lymphedema among a cohort of breast cancer patients treated with ALND To analyze clinical and pathological features associated with the development of lymphedema

Eligibility criteria: Inclusion Criteria:

a Cohort A:

* Breast cancer patients with a baseline (preoperative perometer measurements) who have undergone axillary lymph node dissection
* English speaker
* Patients who participate in Cohort A will be eligible for enrollment in Cohort

b Cohort I:

* Breast cancer patients who have undergone axillary lymph node dissection who have a clinic visit in the Nellie B. Connally Breast Center approximately 12 months (+/- 4 months) following axillary lymph node dissection
* English speaker

c Cohort II:

* Breast cancer patients who have undergone axillary lymph node dissection who are having a follow-up visit in the Nellie B. Connally Breast Center within 0-6 months following surgery who intend to continue follow-up care at MD Anderson
* English speaker

Exclusion Criteria:

Inability to complete a self-administered questionnaire

Primary outcomes:
measure: To establish the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Simona Shaitelman
role: PRINCIPAL_INVESTIGATOR
References: