louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01663363: Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors
Official title: A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided LASIK Correction of Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4IR™ Excimer Laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myopia
Keywords: refractive
LASIK
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2012-08-13
Enrollment: 170
Sex: ALL
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 purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and effective for the correction of myopic refractive errors.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or greater
* Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
* Uncorrected visual acuity (UCVA) of 20/40 or worse
* Less than 0.75D difference between cycloplegic and manifest refraction sphere.
* Demonstration of refractive stability
* Anticipated post-operative stromal bed thickness of at least 250 microns
* Willing and capable of returning for follow-up examinations for the duration of the study.

Exclusion Criteria:

* Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
* Concurrent use of topical or systemic medications that may impair healing
* History of any medical conditions that could affect wound healing
* History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality
* Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)
* Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course

Primary outcomes:
measure: Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)
timeFrame: 6 Months
Secondary outcomes:
measure: Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better
timeFrame: 6 Months
Other outcomes:
Locations:
Study officials:
affiliation: Abbott Medical Optics
name: Kendra Hileman, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04455763: Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis
Official title: Autologous Stromal Vascular Fraction in the Treatment of Thumb Basal Joint Osteoarthritis - ReMeDY SVF -Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thumb Osteoarthritis
Keywords: Thumb Osteoarthrosis
Stromal Vascular Fraction
Lead sponsor: Töölö Hospital
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
First posted: 2020-07-02
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trial purpose is to research the outcome after thumb carpometacarpal injection with stromal vascular fraction (SVF) derived from adipose tissue. The study compares SVF injection therapy with thumb splinting vs. splinting only.

Patients with radiologically and clinically confirmed Eaton-Glickel II osteoarthritis are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo SVF injection and splinting vs. splinting only.

Baseline data is collected preoperatively and patients are followed at 1, 3 and 6 months after enrollment. The primary end-point is 6 months and the primary outcome is pain visual analogue scale and patient-rated wrist evaluation (PRWE).


Eligibility criteria: Inclusion Criteria:

* Age 40-70 years
* Eaton-Glickel II thumb CMC osteoarthrosis
* Symptom duration \> 3 months
* Pain visual analogue score \> 30 mm
* \< 3 months of treatment with thumb splinting
* American Society of Anaesthesiologists physical status (ASA) I-III
* Fluent in written and spoken Finnish

Exclusion Criteria:

* Age \<40 or \>70 years
* Eaton-Glickel I, III-IV
* Symptom duration \< 3 months
* Pain VAS \< 30 mm
* Post-traumatic osteoarthrosis of thumb CMC I
* Rheumatoid arthritis or other inflammatory joint disease
* The use of per oral corticosteroids or other immunomodulatory drugs
* Less than 6 months after another operation of the same upper limb
* Other condition of the same upper limb requiring surgery
* Malnutrition
* Neurological condition affecting upper limb function
* Heavy smoking (\> 20 cigarettes per day)
* Alcohol or drug abuse
* Previous history or active cancer
* Previous history of allergic reaction to local anaesthetic

Primary outcomes:
measure: Pain (Visual Analogue Scale)
timeFrame: 6 months
measure: Patient-Rated Wrist Evaluation (PRWE)
timeFrame: 6 months
Secondary outcomes:
measure: Global improvement
timeFrame: 6 months
measure: Grip strength
timeFrame: 6 months
measure: Key pinch strength
timeFrame: 6 months
measure: Michigan Hand Outcomes Questionnaire (MHQ)
timeFrame: 6 months
measure: Complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Töölö Hospital (Helsinki University Hospital)
Study officials:
affiliation: HUS Töölö Hospital
name: Samuli Aspinen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01977963: Genetic Study of Antithyroid Drugs Associated Agranulocytosis
Official title: Genetic Study of Antithyroid Drugs Associated Agranulocytosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Agranulocytosis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-11-07
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Agranulocytosis caused by anti-thyroid drugs

Brief summary: Thionamides, the antithyroid drugs, have been widely used to treat hyperthyroidism1. Side effects are found in 1% - 5% of the patients1. One of the most serious side effect is agranulocytosis, which occurs in 0.1% - 0.3 % of the patients1. This might lead to severe infection and sometimes mortality. The underlying mechanism is unclear. An immune phenomenon may be involved because the antigranulocyte antibodies or lymphocyte sensitized to antithyroid drugs are found in these patients6,7. The recognition of major histocompatibility complex class II peptide complexes by T lymphocytes is central to the development of immune response. According to a report in 1996, the HLA DRB1\*08032 allele is strongly associated with susceptibility to methimazole-induced agranulocytosis20.

Recently, there are new techniques for genetics study. We aimed to identify the associated genetic change of the agranulocytosis side effect of antithyroid drugs. First, we will look at the classical human Leukocyte Antigen (HLA) loci, such as HLA-A, -B, -C, -DR, -DQ and -DP. If no significant change is found in the above genes, we will consider whole exon sequencing with next-generation sequencing, Statistic analysis will include appropriate linkage analysis, association study, variation data analysis, pathway analysis. If we can identify the genetic change and perform genetic examinations before prescription, we can avoid the happening of severe side effects.


Eligibility criteria: Inclusion Criteria:

* patients with absolute neutrophil count lower than 500/mm3 caused by anti-thyroid drugs

Exclusion Criteria:

* Patients who is younger than 20 years old or older than 85 years old

Primary outcomes:
measure: Number of participants with anti-thyroid drug related agranulocytosis
timeFrame: within 2 month after taking the drug
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT01786863: Frequency of Residual Neuromuscular Blockade in the Pediatric Population
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Neuromuscular Blockade
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2013-02-08
Enrollment: 5
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery that requires them to be paralyzed

Brief summary: This study is designed to investigate the frequency of Residual Neuromuscular Blockade (RNMB) in the pediatric population.

Detailed description: The proposed study will be the first to investigate the incidence of residual postoperative neuromuscular blockade in the pediatric patient following the intraoperative use of NMBA's. If there is significant residual blockade present, it may be that these effects will lead to postoperative respiratory complications including hypoxemia, atelectasis, and prolonged oxygen requirement resulting in a prolonged stay in the post-anesthesia care unit.

Eligibility criteria: Inclusion Criteria:

1. Age less than 18 years.
2. Surgery requiring the administration of neuromuscular blocking, agents with planned extubation in the postoperative care unit (PACU).

Exclusion Criteria:

1. Neuromuscular diseases which may prolong the duration of NMBA's or exaggerate the effects of residual blockade.
2. The need for postoperative mechanical ventilation.
3. Direct admission to the Pediatric ICU, NICU or CTICU.

Primary outcomes:
measure: train-of-four (TOF) ratio
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's
state: Ohio
Study officials:
References:
Clinical trial NCT03751163: Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma
Official title: Randomized, Controlled, Double-blind Study of Oral Tranexamic Acid and Topical Hydroquinone in the Treatment of Melasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Melasma
Keywords: melasma
tranexamic acid
hydroquinone
mMASI
mexameter
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assess the effectiveness of oral tranexamic acid in combination with hydroquinone cream in the treatment of melasma.

Detailed description: Hydroquinone (HQ) is considered the gold standard depigmenting agent for melasma, nevertheless, many patients are recalcitrant to this treatment.

Recent studies have shown that tranexamic acid, a plasmin inhibitor, can prevent UV-induced pigmentation.

Eligibility criteria: Inclusion Criteria:

* moderate melasma (subject with mMASI score of 5 to 7.9),
* severe melasma (subject with mMASI score ≥ 8),
* willing to follow up for 6 months.

Exclusion Criteria:

* pregnant women,
* nursing women,
* women on exogenous hormones
* current treatment with blood thinners,
* had a history of thrombosis,
* had an abnormal kidney function,
* use of topical hydroquinone within 3 months of study enrollment,
* use of topical steroids, vitamin A analogs, chemical peels within 1 month of study

Primary outcomes:
measure: Change from Baseline mMASI Score at week 12
timeFrame: Baseline, week 2, 12, 24
Secondary outcomes:
measure: Melanin index
timeFrame: Baseline, week 2, 12, 24
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04658563: Yoga for Adolescents
Official title: The Effect of High Density Hatha Yoga Training on Physical Fitness, Respiratory Functions and Quality of Life in Healthy Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Yoga
Keywords: Yoga
physical fitness
adolescent
quality of life
sleep quality
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 28
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Purpose: Specific effects of high-density Hatha Yoga(HY) training in adolescents have not yet been clarified. Aim of our study is to investigate the effects of high-density HY education on physical fitness, pulmonary function and quality of life in healthy adolescents. Methods: 28 female adolescents will be randomly divided into two groups as yoga training and control groups. Training group will receive high-density HY training for 8 weeks, two days a week under the supervision of a physiotherapist and one day a week home program. Control group will not receive any exercise. Flexibility of individuals will be determined by sit-reach, back scratching, lateral flexion tests; muscular endurance by sit-ups, sit down-stand up on chair tests, balance by time up-go test; cardiorespiratory capacity by incremental shuttle walking test(ISWT) and respiratory functions by spirometry, quality of life will be determined by with the Quality of Life Scale for Children.


Eligibility criteria: Inclusion Criteria:

- Female adolescents between the ages of 14 and 18

Exclusion Criteria:

- Individuals with recent muscular skeletal, neuromuscular and chronic systemic diseases that could prevent exercise

Primary outcomes:
measure: Assessment of Health-Related Physical Fitness - Upper extremity flexibility
timeFrame: 8 weeks
measure: Assessment of Health-Related Physical Fitness - Lower extremity flexibility
timeFrame: 8 weeks
measure: Assessment of Health-Related Physical Fitness - Balance
timeFrame: 8 weeks
measure: Assessment of Health-Related Physical Fitness - Endurance
timeFrame: 8 weeks
measure: Cardiorespiratory endurance
timeFrame: 8 weeks
measure: Assessment of Respiratory Functions
timeFrame: 8 weeks
measure: Forced vital capacity (FVC)
timeFrame: 8 weeks
measure: First-second forced expiratory volume (FEV1)
timeFrame: 8 weeks
measure: Peak flow rate (PEF)
timeFrame: 8 weeks
measure: 25-75% of forced expiratory flow rate (FEF (25-75%)
timeFrame: 8 weeks
measure: Inspiratory capacity (IC)
timeFrame: 8 weeks
measure: Vital capacity (VC)
timeFrame: 8 weeks
measure: Assessment of quality of life
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
Study officials:
References:
Clinical trial NCT03219463: The Effects of Ginger Supplementation on Inflammation in Exercising Individuals
Official title: The Effects of Ginger Supplementation on Inflammation in Exercising Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2017-07-17
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of our graduate student research study is to observe the effects of ginger on hsCRP, IL-6, and TNF-α levels in exercising individuals based on their level of activity.

Detailed description: Participants will fill out a demographic questionnaire and a quality of life survey, (SF-36). Take a 3g supplement of ginger in powder form with meals once/day (preferably in the morning) for 8 weeks. By end of week 4 (halfway through the study), subjects will do another blood test for mid-intervention CRP, IL-6, and TNF-α values. By end of week 8, participants will do a final blood test for CRP values and fill out the SF-36 survey for post-intervention levels.

Eligibility criteria: Inclusion Criteria:

* 30 - 70 years of age
* Various levels of activity outlined by the General Physical Activities Defined by Level of Intensity by the American College of Sports Medicine (ACSM) and the Centers for Disease Control and Prevention (CDC).

  * Regular Exercisers- at least 30 minutes of moderate to vigorous activity at least 3 times per week.
  * Non-regular Exercisers- at least 30 minutes of moderate to vigorous activity 1-2 times per week.

Exclusion Criteria:

* Individuals currently taking...

  * Vit D
  * Aspirin
  * Coumadin
  * Ginger supplements more than 1x/week within the last month
  * Heparin
  * NSAIDs
  * Pain meds
* Individuals with chronic inflammatory conditions such as Cancer, CVD, Diabetes, Gastroesophageal reflux disease (GERD), Ginger allergies, Metabolic Syndrome, and/or autoimmune diseases such as Rheumatoid Arthritis

Primary outcomes:
measure: SF-36 Questionnaire
timeFrame: Change from baseline to end of 8 weeks.
Secondary outcomes:
measure: Inflammatory Bio Markers
timeFrame: A composite measurement from :1) at baseline 2) mid point (at 4weeks) and at 3) end of 8 weeks.
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda Health
state: California
Study officials:
affiliation: Loma Linda University
name: JeJe Noval, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02503163: A Long-term Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye With Sjögren's Syndrome
Keywords: Dry eye syndromes
Corneal diseases
Conjunctival diseases
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-07-20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to evaluate of the long-term safety and efficacy of KCT-0809 in dry eye patients with Sjögren's syndrome.


Eligibility criteria: Inclusion Criteria:

* Dry eye patients with Sjögren's syndrome
* Corneal and conjunctival damage

Exclusion Criteria:

* Severe ophthalmic disorder
* Punctal plugs or surgery for occlusion of the lacrimal puncta

Primary outcomes:
measure: Incidences of adverse events
timeFrame: 52 weeks
Secondary outcomes:
measure: Score of the corneal staining
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
References:
Clinical trial NCT06174363: Analgesic Efficacy of Maxigesic in Breast Cancer Surgery
Official title: Analgesic Efficacy of Maxigesic Added to Opioid Based-PCA in Patients Undergoing Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 84
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group: 0.9% saline solution/ Study group: Maxigesic
Primary purpose: OTHER

Brief summary: The present study aims to find a perioperative analgesic method that provides sufficient analgesia while reducing immune compromise in cancer surgery. This study is to investigate the analgesic effect and safety of Maxigesic inj. (a combination of acetaminophen 1000 mg and ibuprofen 300 mg), which is added to opioid-based IV-PCA in patients undergoing breast cancer surgery.


Eligibility criteria: Inclusion Criteria:

* Patient aged 20 to 70 years with ASA classification 1 to 3 undergoing breast cancer surgery (cancer resection or reconstruction)

Exclusion Criteria:

* ASA classification 4/ allergy to acetaminophen, NSAIDs, opioid/ severe liver or renal dysfunction/ pregnancy

Primary outcomes:
measure: Analgesic effect of Maxigesic
timeFrame: postoperative 30 minutes/ 6 hours/ 24 hours/ 48 hours
Secondary outcomes:
measure: Incidence of Adverse reactions (Safety)
timeFrame: postoperative 30 minutes/ 6 hours/ 24 hours/ 48 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT03723863: Occupational Therapist-Led Work Intervention in Facilitating Work Maintenance or Re-entry to the Workforce in Patients With Stage I to III Breast Cancer Undergoing Chemotherapy
Official title: The Evaluation of a Work Intervention to Facilitate Work Maintenance or Re-Entry to the Workforce for Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer Stage I
Breast Cancer Stage III
Breast Cancer Stage II
Breast Cancer Stage IIA
Breast Cancer Stage IIB
Breast Cancer Stage IIIA
Breast Cancer Stage IIIB
Breast Cancer Stage IIIc
Breast Cancer
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2018-10-30
Enrollment: 15
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: This trial studies how well occupational therapy (occupational therapist-led work intervention) works in facilitating work maintenance or re-entry to the workforce for stages I to III breast cancer patients who will be undergoing curative intent chemotherapy. Occupational therapy may help cancer patients maintain employment or successfully return to work soon after treatment.

Detailed description: Patients receive in-person occupational therapist-led work consultation.

Eligibility criteria: Inclusion Criteria:

* Stage I-III breast cancer patients who will be undergoing curative intent chemotherapy
* Working in a paid capacity (part or full-time) at time of diagnosis with the intent to maintain or return to work following treatment

Exclusion Criteria:

* Non-English speaking patients. This study requires completing online questionnaires that are written in English and will not be translated
* Patients with a psychiatric or neurological condition that impairs capacity to make decisions

Primary outcomes:
measure: Change in perceived work ability
timeFrame: Baseline up to 3 years
Secondary outcomes:
measure: Change in health related quality of life
timeFrame: Baseline up to 3 years
measure: Change in financial toxicity
timeFrame: Baseline up to 3 years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Rachel Yung
role: PRINCIPAL_INVESTIGATOR
References: