louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06600932: Evaluation of TMS Visual Outcome
Official title: Effects of Transcranial Magnetic Stimulation on Visual Outcome in Patients After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cataract Surgery Experience
Lead sponsor: Shanghai High Myopia Study Group
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if transcranial magnetic stimulation (TMS) can improve the visual outcomes in patients after cataract surgery. The main question it aims to answer is:

• Does TMS improve the visual outcome in patients after cataract surgery? Researchers will compare TMS to the sham-controlled treatment (exposure to recorded sounds of pulses without real magnetic stimulation) to see if TMS works to improve the visual outcomes of patients after cataract surgery.

Participants will

* Undergo TMS treatment or a sham-controlled treatment for consecutive 5 days.
* Visit the clinic once every 2 weeks for checkups and tests.


Eligibility criteria: Inclusion Criteria:

* Post cataract surgery
* Best-corrected visual acuity less than 0.1logMAR

Exclusion Criteria:

* Diagnosed with cognitive impairment or mental disorders and unable to cooperate with treatment;
* Diagnosed with significant opacity of refractive media that affects observation of visual function;
* History of epileptic seizures;
* Long term use of psychotropic drugs；
* Metal implants in the body.

Primary outcomes:
measure: Visual acuity
timeFrame: From enrollment to the end of treatment at 2 weeks
Secondary outcomes:
measure: Visual field
timeFrame: From enrollment to the end of treatment at 2 weeks
Other outcomes:
measure: Visual quality
timeFrame: From enrollment to the end of treatment at 12 weeks
Locations:
city: Shanghai
country: China
facility: Eye and Ear, Nose Throat Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Eye and ENT Hospital of Fudan University
name: Xiangjia Zhu
role: STUDY_CHAIR
affiliation: Eye and ENT Hospital of Fudan University
name: Jiaqi Meng
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye and ENT Hospital of Fudan University
name: Yinglei Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye and ENT Hospital of Fudan University
name: Yating Tang
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye and ENT Hospital of Fudan University
name: Xin Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06691932: At-the-Breast Vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)
Official title: At-the-Breast Vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Feeding
Exclusive Breastfeeding
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-11-18
Enrollment: 240
Sex: ALL
Minimum age (years): 0
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 240 mother/infant dyads exclusively feeding HM to healthy infants between 1-5 months postpartum: 120 mothers primarily feeding ATB (ATB Group) and 120 mothers predominantly feeding expressed HM (Express Group)

Brief summary: The purpose of this study is to define human milk (HM) as an ecosystem which investigators will then combine into temporal models of milk dynamics to accurately describe HM chronobiology. This study addresses 4 crucial public health gaps: 1) how breast milk changes over time and over the day, 2) how milk dynamics are related to infant sleep patterns, 3) how milk dynamics are related to infant microbiome dynamics, and 4) how all these relationships differ between infants fed directly at-the-breast vs pumped milk. These fundamental insights have been unknown until now, so that families who feed pumped breast milk are completely underserved. These results are critical to optimizing infant feeding and health outcomes for all infants receiving breast milk.


Eligibility criteria: Inclusion Criteria:

* Lactating mothers between 20-40 years old at enrollment

  o 120 mother/infant dyads who primarily feed HM ATB (average \>75% of feeds,
* pumping no more than one time per day)

  o 120 mother/infant dyads who predominantly feed expressed HM (average \>75% of feeds)
* All races and ethnicities may enroll
* Singleton infant delivered after 37 weeks
* Infant between the ages of 0-1 months at the time of enrollment.
* No serious health complications in mother or infant

Exclusion Criteria:

* Non-English-speaking subjects as study personnel only speak English
* Lactating moms who will be feeding both ATB and expressed HM (over 25% of the time in either feeding mode)
* Infant supplementation with formula ≥10 oz before sample collections begin, and/or no more than 16 oz during active participation/ sample collections.

Primary outcomes:
measure: Infant Sleep Latency
timeFrame: Baseline, 2 months and 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT01595932: Efficacy and Tolerability of α-galactosidase in Treating Gas-related Symptoms in Children
Official title: Efficacy and Tolerability of α-galactosidase in Treating Gas-related Symptoms in Children. A Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gas Pain Related Intake
Keywords: irritable bowel syndrome (IBS)
bloating
abdominal distension
flatulence
α-Galactosidase
Lead sponsor: Azienda Policlinico Umberto I
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 52
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the efficacy and tolerability of α-galactosidase in pediatric patients with predominant gas-related symptoms.

Detailed description: Most patients with functional gastrointestinal disorders complain of gas-related symptoms which can negatively affect quality of life, even in pediatric age.

Dietary and life-style changes, administration of simethicone, activated charcoal and probiotics may reduce intestinal gas but often results are unsatisfactory.

Literature shows that α-galactosidase is effective to reduce gas production and related symptoms in adults.

Eligibility criteria: Inclusion Criteria:

* pediatric out-patients with gas-related disturbances at least once per week over the last 12 weeks.

Exclusion Criteria:

* suspected episodes of hypersensitivity or allergy;
* chronic organic disorders (by clinical history, physical examination, laboratory tests);
* use of drug affecting the GI motility during the previous 4 weeks;
* inability of the parent to comprehend the full nature and purpose of the study and unwillingness to co-operate with the Investigator.

Primary outcomes:
measure: Efficacy
timeFrame: 5 weeks of observation
Secondary outcomes:
measure: Clinical tolerability
timeFrame: treatment: 2 weeks
measure: Efficacy
timeFrame: 5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks)
measure: Efficacy
timeFrame: 5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks)
Other outcomes:
Locations:
Study officials:
References:
citation: Di Nardo G, Oliva S, Ferrari F, Mallardo S, Barbara G, Cremon C, Aloi M, Cucchiara S. Efficacy and tolerability of alpha-galactosidase in treating gas-related symptoms in children: a randomized, double-blind, placebo controlled trial. BMC Gastroenterol. 2013 Sep 24;13:142. doi: 10.1186/1471-230X-13-142.
Clinical trial NCT03729232: Japanese Catheter Ablation Registry
Official title: Japanese Catheter Ablation Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Catheter Ablation
Cardiac Arrhythmias
Keywords: Catheter Ablation
Cardiac Arrhythmias
Registry
Complication
REDCap
Lead sponsor: National Cerebral and Cardiovascular Center, Japan
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 400000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients

Brief summary: Japanese Cather Ablation (J-AB) Registry is a voluntary nationwide registry, performed by Japanese Heart Rhythm Society, collaborated with the National Cerebral and Cardiovascular Center. The objectives of this registry are to observe and describe developments in the catheter ablation treatment of arrhythmia in Japan and to provide reliable information on the type of activity performed and the facilities available in Japanese arrhythmia units.

Detailed description: Japanese Cather Ablation (J-AB) Registry is a nationwide, multicenter, observational registry, performed by Japanese Heart Rhythm Society, collaborated with National Cerebral and Cardiovascular Center.

This study is a voluntary nationwide registry and data are collected prospectively using a Research Electronic Data Capture (REDCap) system. Detailed data collection including antiarrhythmic medication is also performed at every September. The acute success rate at discharge and the complications associated with ablation procedure will be collected in all cases. Major bleeding events are defined according to Bleeding Academic Research Consortium criteria. Based on the provided information, the annual incidence and predictive factors for outcome will be investigated by the event assessment committee.

Eligibility criteria: Inclusion Criteria:

* Patients treated with catheter ablation in Japan

Exclusion Criteria:

* Patients who refused to consent

Primary outcomes:
measure: Number of patients with recurrence of targeted arrhythmia
timeFrame: Through discharge from hospital, approximately up to 1 weeks
Secondary outcomes:
measure: Number of deaths
timeFrame: Through discharge from hospital, approximately up to 1 weeks
measure: Number of patients with treatment-related complications
timeFrame: 3 months
Other outcomes:
Locations:
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
state: Osaka
Study officials:
affiliation: The Jikei University School of Medicine
name: Teiichi Yamane, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cerebral and Cardiovascular Center, Japan
name: Kengo Kusano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01606332: Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis
Official title: Indwelling Interscalene Nerve Catheters in Surgical Management of Idiopathic Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frozen Shoulder
Lead sponsor: OAD Orthopaedics
Sponsor class: OTHER
First posted: 2012-05-25
Enrollment: 40
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: In patients who undergo shoulder manipulation for idiopathic adhesive capsulitis, a postoperative indwelling analgesic pain catheter will improve patient outcomes by decreasing shoulder pain and improving range of motion compared to a single-dose interscalene block.

Detailed description: Shoulder manipulation under anesthesia to treat idiopathic adhesive capsulitis is performed only when conservative treatment fails to remedy the condition.

It is common practice to use an interscalene nerve block as anesthesia for this surgical intervention. This randomized prospective study is designed to evaluate the effects of two different anesthesia methods on patient's post-surgical rehabilitation after manipulation. Forty patients scheduled for surgery will be entered into this study. Patients will be randomly assigned to receive a single-doseinterscalene block or a single-dose interscalene block and an indwelling nerve catheter which will provide a continuous infusion of local anesthetic. Patients with the continuous infusion of local anesthetic will receive the additional anesthesia for 24 hours. Patient's range of motion will be evaluated pre-op, intra-op and post-operatively at 10 days, 4,8,16 weeks and 6 months

Eligibility criteria: Inclusion Criteria:

* Males and Females over the age of 18 with a diagnosis of idiopathic adhesive capsulitis
* Failed conservative treatment for a minimum of 4 months
* Patient had 3 sequential office visits with no clinical improvement

Exclusion Criteria:

* Adhesive capsulitis following a surgical procedure and/or fracture

Primary outcomes:
measure: Improvement in shoulder function as demonstrated by increased range of motion
timeFrame: 10 days, 4, 8, 16 weeks and 6 months
Secondary outcomes:
measure: Decrease in shoulder pain
timeFrame: 10 days, 4, 8, 16 weeks and 6 months
Other outcomes:
Locations:
city: Warrenville
country: United States
facility: OAD Orthopaedics
state: Illinois
Study officials:
affiliation: OAD Orthopaedics
name: Aaron A Bare, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04444232: Cancer Communication Within Hispanic Social Networks
Official title: Cancer Communication Within Social Networks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Carcinoma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-06-23
Enrollment: 57
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This trial examines cancer communication within Hispanic social networks. Hispanics have the lowest colorectal cancer screening rate of any major ethnic group and health interventions are crucially needed among Hispanics. Patient decision aids are health communication interventions designed to provide patients with targeted health information and have shown to improve colorectal cancer screening rates among Hispanics. The goal of this study is to investigate, in a sample of Hispanics, how a colorectal cancer decision aid aimed at increasing individuals' colorectal cancer screening behavior has effects on their alters' intention to get screened for colorectal cancer.

Detailed description: OUTLINE:

Participants view an educational video on cancer and cancer screening options over 12 minutes. Participants also complete a phone survey over 10-15 minutes before attending the video session and 2 months after the video session.

Eligibility criteria: Inclusion Criteria:

* Self-identify as "Hispanic" or "Latino"
* Have no family history of CRC
* Have no personal history of pre-cancerous (adenomatous) colonic polyps
* Have not had either an annual fecal occult blood test (FOBT) within the past year or colonoscopy within the last 10 years (defined as up-to-date with CRC screening by current United States \[U.S.\] Preventive Services Task Force recommendations)
* Have at least two family members, friends, or co-workers who are ages 50-75
* Alters will be eligible if they are ages 50-75

Primary outcomes:
measure: Patients' communication with their families, friends, and co-workers about colorectal cancer (CRC) screening
timeFrame: Up to 6 months
measure: Alters' intent to become screened for CRC in the next six months
timeFrame: Up to 6 months
Secondary outcomes:
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: Linda Ko
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04787432: Salutogenic Frailty Prevention Program for Women Aged 55 Years and Over
Official title: The Effect of Salutogenic Model Based Frailty Prevention Program on Development of Frailty and Sense of Coherence in Women Aged 55 Years and Over
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frailty
Frailty Syndrome
Salutogenesis
Sense of Coherence
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 84
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Frailty is a condition of reduced the capacity in multiple body systems and causing adverse outcomes because of decreasing the ability to cope with stressors. Female sex, the changes of the body imposed by ageing, and coping strategies for stressors are causal mechanisms in the development of frailty. This project is designed with the salutogenic model that is focused on the concepts of health, stress, and coping. The aim of this project is to assess the effect of Salutogenic Frailty Prevention Program on promoting sense of coherence and preventing the development of frailty in women aged 55 years and over


Eligibility criteria: Inclusion Criteria:

* Willing to participate in the study
* Woman aged 55 years and over
* Pre-frail (Total FRAIL scale score 1 or 2)
* Has Internet access

Exclusion Criteria:

* To be semi-dependent and dependent according to the Katz Daily Activities Activity Scale
* To have any cognitive, psychiatric and neurological disorders
* To have any surgical operation in the past 3 month
* Communication barrier (due to hearing/vision impairment)

Primary outcomes:
measure: Change in Sense of Coherence
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Change in FRAIL scale
timeFrame: Baseline, 3 months, 6 months, 9 months
Secondary outcomes:
measure: Change in The World Health Organisation- Five Well-Being Index (WHO-5)
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Change in health-related quality of life
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Change in EQ-VAS
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Change in number of falls
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Change in fear of fall
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Change in number of emergency admissions
timeFrame: Baseline, 3 months, 6 months, 9 months
Other outcomes:
Locations:
Study officials:
References:
citation: Yas MA, Secginli S. Salutogenic Model-Based Frailty Prevention Program for Pre-Frail Women Aged 55 Years and Over (SAFRAPP): A Study Protocol for a Randomized Controlled Trial. Res Theory Nurs Pract. 2022 Apr 1;36(2):215-232. doi: 10.1891/RTNP-2021-0098.
Clinical trial NCT01109732: Physical Activity, Function and Quality of Life in Patients After Endovascular Treatment
Official title: Physical Activity, Function and Quality of Life in Patients After Endovascular Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Disease
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Oslo University College
First posted: 2010-04-23
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate how systematic physical training after endovascular treatment influence the durability of the endovascular treatment and how it effects physical function, quality of life and future cardiovascular events.


Eligibility criteria: Inclusion Criteria:

* 55 years old or older
* successful endovascular
* living in Oslo or in the close area being able to come to physical training classes at the hospital

Exclusion Criteria:

* endovascular treatment on study-leg last 2 years
* other reasons for reduced walking function than peripheral arterial disease

Primary outcomes:
measure: Time to potential occlusion
timeFrame: 1 year
Secondary outcomes:
measure: 6 Minutes Walk Test
timeFrame: 1 year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Astrid Bergland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03926832: Prevalence of Obstructive Sleep Apnea Syndrome in Sarcoidosis and Impact of CPAP Treatment on Associated Fatigue Status
Official title: Prevalence of Obstructive Sleep Apnea Syndrome in Sarcoidosis and Impact of CPAP Treatment on Associated Fatigue Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoidosis
Sleep Apnea, Obstructive
Fatigue
Keywords: CPAP
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Sarcoidosis is a multisystemic granulomatous disease that affects individuals worldwide without known pathogenesis, and the role of comorbidities has not been fully assessed in the scientific literature. An increased incidence of Obstructive Sleep Apnea Syndrome (OSAS) has been described in Sarcoidosis although this association has not been explained yet and no data is available about the effect of treatment with Continuous Positive Airway Pressure (CPAP) in Sarcoidosis. Also, patients affected by Sarcoidosis usually experience a state of physical and mental weariness called fatigue and reported in approximately 60-80% sarcoid patients and thought to be a consequence of inflammatory mediators but the high prevalence of OSAS could be a remarkable bias in clinical evaluation because fatigue is also strongly associated with sleep disorders.

Thus, there is a real need for assessing not only the real prevalence of OSAS in Sarcoidosis but also the effect of CPAP treatment on fatigue status experienced by sarcoidotic patients.


Eligibility criteria: Inclusion Criteria:

* Subjects with a definite diagnosis of sarcoidosis according to international ATS and WASOG guideline

Exclusion Criteria:

* Ongoing CPAP treatment
* Psychiatric disorders

Primary outcomes:
measure: Prevalence of Obstructive Sleep Apnea
timeFrame: Day 1
Secondary outcomes:
measure: Impact of Continuous Positive Airway Pressure (CPAP) treatment on fatigue associated status
timeFrame: Day 1, month 3 of CPAP treatment
measure: Impact of Continuous Positive Airway Pressure (CPAP) treatment on daytime sleepiness
timeFrame: Day 1, month 3 of CPAP treatment
measure: Compliance to CPAP treatment
timeFrame: 3 month post CPAP treatment
measure: Baseline evaluation of fatigue status
timeFrame: Day 1
measure: Baseline evaluation sleepiness
timeFrame: Day 1
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Luca Richeldi, MD, PhD
role: STUDY_DIRECTOR
References: