louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04980521: Promoting Radon Testing Via Smartphone App: A Clinical Trial in a High Radon State
Official title: Promoting Radon Testing Via Smartphone App: A Clinical Trial in a High Radon State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: University of North Dakota
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2021-07-28
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research will compare (1) the effectiveness of a mobile radon-education app (vs. traditional brochures) and (2) that of the radon app with in-app reminders (vs. the radon app without in-app reminders and the no app use with postal reminders) to increase radon awareness and testing among North Dakotans. The prevalence of exceptionally high levels of residential radon in North Dakota (ND), coupled with public's poor understanding of this hazard, is a critical public health problem.


Eligibility criteria: Inclusion Criteria:

* The principal eligibility criterion is that participants own a smartphone.

Exclusion Criteria:

* The principal exclusion criterion is previous testing for radon within the past two years.

Primary outcomes:
measure: Ordering a Free Radon Test Kit
timeFrame: Through the study completion - 3 months
measure: Using the Radon Test Kit
timeFrame: Through the study completion - 3 months
Secondary outcomes:
measure: Change From Baseline Radon Knowledge at 3 Months
timeFrame: Change from baseline knowledge level to the completion of study at 3 months
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: University of North Dakota
state: North Dakota
Study officials:
affiliation: University of North Dakota
name: Soojung Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim S, Chiu T, Klug MG, Schmitz D, Schwartz GG. Interventions to promote home radon testing: A randomized clinical trial of a smartphone app vs. printed brochures. Cancer Med. 2023 Jan;12(2):2027-2032. doi: 10.1002/cam4.4988. Epub 2022 Jun 28.
Clinical trial NCT05820321: Effects of Dietary Nitrate Intake on Physical Performance of Middle-aged Women
Official title: Effects of Dietary Nitrate Intake on Physical Performance of Middle-aged Women: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postmenopausal; Menorrhagia
Physical Inactivity
Motor Activity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 15
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Through a randomized, crossover, triple-blind, placebo-controlled clinical trial, 15 physically inactive hypertensive women will participate a 8-day trial, each with two intervention protocols: 1) placebo and 2) beetroot; in which will ingest beet juice with or without NO3 in its composition with a 8-day washout interval.


Eligibility criteria: Inclusion Criteria:

* 50 to 65 years old
* Physically inactive
* Postmenopausal diagnosis (amenorrhea for 12 months or more);

Exclusion Criteria:

* Smoking
* Cardiac failure
* Previous history of acute myocardial infarction and/or stroke;
* Allergy or intolerance to nitrate, gluten, or milk;

Primary outcomes:
measure: Handgrip strength test (kgf)
timeFrame: up to 2 years
Secondary outcomes:
measure: Six minute walk test (distance in meters)
timeFrame: up to 2 years
measure: Arm curl test (repetitions)
timeFrame: up to 2 years
measure: Sit-to-stand test (repetitions)
timeFrame: up to 2 years
measure: 8-foot up and go test (seconds)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: Cicero Jonas Rodrigues Benjamim
state: SP
city: Ribeirão Preto
country: Brazil
facility: EEFERP - USP / Laboratório de Fisiologia do Exercício e Metabolismo
state: São Paulo
Study officials:
References:
Clinical trial NCT04421521: Acunpuncture for Fibromyalgia Syndrome
Official title: Acupuncture for Fibromyalgia Syndrome: An Observational Parallel Groups Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acupuncture
Fibromyalgia
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: patients suffering from fibromyalgia syndrome according to the criteria of the American College of Rheumatology 2010 will be enrolled. All fibromyalgic patients will be subjected to a further ambulatory visit and if an energy deficiency in the Liver and Spleen Meridians will be identified, according to the Traditional Chinese Medicine rules, acupuncture will be planned. If not, a standard therapy with analgesic drugs will be started. Acupuncture treatment will consist of six weekly sessions. Tricyclic antidepressants, anti-epileptic drugs, selective serotonin reuptake inhibitors and opioids will be used as standard strategy. Pain Scores and Fatigue Impact Scale will be assessed before any treatment and after a 28 days follow-up.


Eligibility criteria: Inclusion Criteria:

clinical diagnosis of Fibromyalgia

Exclusion Criteria:

coagulation disorders pregnancy pacemaker Implantable Cardioverter Defibrillator

Primary outcomes:
measure: Pain Score
timeFrame: 28 days after the completion of the treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03515421: Project Frazier 3 Regulatory Clinical Evaluation
Official title: Project Frazier 3 Regulatory Clinical Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Healthy Volunteers
Lead sponsor: LifeScan Scotland Ltd
Sponsor class: INDUSTRY
Collaborators: name: Institute for Diabetes-Technology GmbH
First posted: 2018-05-03
Enrollment: 379
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)

Detailed description: User performance, system use, system accuracy, user instruction for use and marketing claims evaluation of Blood Glucose Monitoring Systems.

Eligibility criteria: Summary of Inclusion Criteria

* Age - Subject is at least 12 years old.
* Informed Consent - Subject reads the appropriate Participant Information Sheet and signs the Informed Consent Form (section 12.0).
* Diabetes Diagnosis when applicable - type 1 or type 2 diabetes mellitus.
* Language - Subject reads and understands local language
* SMBG status confirmed
* Subject agrees to complete all aspects of the study

Summary of exclusion criteria

* Conflict of Interest
* Pregnancy - Subject is pregnant (as confirmed by Subject)
* User Performance Accuracy Testing - Technical Expertise

Primary outcomes:
measure: User Performance (UP) evaluation measured by blood glucose level (mg/dl) of BGMS vs reference instrument.
timeFrame: Up to 1 hour
measure: System Accuracy (SA) evaluation measured by blood glucose level(mg/dl) of BGMSs vs reference instrument.
timeFrame: Up to 1 hour
measure: System Use Evaluation questionnaire
timeFrame: Up to 15 minutes
measure: Instructions for Use Evaluation questionnaire.
timeFrame: Up to 10 days.
measure: Marketing Claims Evaluation questionnaire.
timeFrame: Up to 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Institut für Diabetes-Technologie
city: Birmingham
country: United Kingdom
facility: Diabetes Centre
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Inverness
country: United Kingdom
facility: Centre for Health Science
Study officials:
affiliation: LifeScan Scotland
name: Lorna Stewart
role: STUDY_DIRECTOR
References:
citation: Katz LB, Stewart L, Guthrie B, Cameron H. Patient Satisfaction With a New, High Accuracy Blood Glucose Meter That Provides Personalized Guidance, Insight, and Encouragement. J Diabetes Sci Technol. 2020 Mar;14(2):318-323. doi: 10.1177/1932296819867396. Epub 2019 Aug 2.
Clinical trial NCT06948721: Study of the Participation of People With Aphasia Post Stroke and Their Caregivers in Valladolid Region (Spain)
Official title: Study of the Participation of People With Aphasia Post Stroke and Their Caregivers in Valladolid Region (Spain)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stroke
Aphasia
Keywords: Aphasia post stroke
caregiver
community participation
occupational therapy
Speech Language Therapy
Lead sponsor: Centro Integral de Rehabilitación
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants in the study (people with aphasia and their caregivers) will be drawn from the registry of people treated at the companies CIRONBRAIN and CIRONLAB, which comprise the research team. Sample recruitment will also be conducted through CIRONBRAIN's social media channels, and through requests for collaboration with local disability organizations and healthcare professionals in the Valladolid region who are familiar with the project and who may be eligible for selection.

Brief summary: The objective of this study is to determine the level of community participation of people with post-stroke aphasia and their caregivers, as well as the factors that facilitate or interfere with this participation in the Valladolid region (Spain).

The main questions that this study aims to answer are:

1. What is the retained activities of the people with aphasia post-stroke?
2. What is the retained activities of the caregivers of people with aphasia post-stroke?
3. What factors influence the community participation of people with aphasia post-stroke and their caregivers?


Eligibility criteria: Inclusion Criteria:

* Chronic Stroke (stroke onset above six months).
* Aphasia post stroke.
* Residents in Valladolid Region.
* Age over 18 years.
* Ability to walk equal to or greater than 3 according to the Functional Ambulation Category (FAC).
* Informed consent acceptance.

Exclusion Criteria:

* Stroke onset below of Six months
* Age under 18 years
* Both in the case of the person with aphasia and their caregiver, presence of other pathologies that affect functional independence

Primary outcomes:
measure: Activity Card Sort
timeFrame: Baseline
Secondary outcomes:
measure: The Western Aphasia Battery (WAB)
timeFrame: Baseline
measure: Barthel Index (BI)
timeFrame: Baseline
measure: Zarit Caregiver Burden Interview (ZBI)
timeFrame: Baseline
measure: Six-Minute Walk Test (6MWT)
timeFrame: Baseline
measure: Ten-Meter Walk Test (10MWT)
timeFrame: Baseline.
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02652221: Determination of Liver Stiffness in Chronic Liver Disease Patients by Acoustic Radiation Force Imaging (ARFI) Ultrasound
Official title: Determination of Liver Stiffness in Chronic Liver Disease Patients by Acoustic Radiation Force Imaging (ARFI) Ultrasound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Liver Disease
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Siemens Medical Solutions
First posted: 2016-01-11
Enrollment: 55
Sex: ALL
Minimum age (years): 1
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A prospective, pilot study using acoustic radiation force imaging (ARFI) ultrasound (US) to quantify liver stiffness in children and young adults with chronic liver disease. ARFI results will be compared to the current clinical standard of Magnetic Resonance Elastography (MRE) and to liver biopsy when available.

Detailed description: ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness. ARFI US has been shown in a small pilot investigation in Europe in children to be reliable and rapid in estimating moderate to severe liver stiffness using histology as a reference gold standard. ARFI measures the speed of a shear wave in the examined tissue, expressed in m/s. This shear wave velocity can be mathematically converted into a liver stiffness value, which can then be used to estimate degree of liver fibrosis. The technique is non-invasive, uses no ionizing radiation, and is fast (several minutes to complete). It is possible that ARFI US will be more accurate than MRE in quantifying liver stiffness. In addition, ARFI US will ultimately be a less expensive clinical test, shorter in duration, and will not require sedation/anesthesia in younger children as MRE requires.

Eligibility criteria: Inclusion Criteria:

* Less than 25 years old with chronic liver disease

Exclusion Criteria:

* Subjects without clinically ordered MRE
* Subjects who cannot cooperate with performance of the short ARFI exam

Primary outcomes:
measure: Agreement in Measured Liver Stiffness Between ARFI and MRE
timeFrame: Within 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Andrew Trout, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07008521: UNIVERSAL EXERCISE UNIT and REBOUND THERAPY ON GENU RECURVATUM Cerebral Palsy Childeren
Official title: EFFECT OF UNIVERSAL EXERCISE UNIT VERSUS REBOUND THERAPY ON GENU RECURVATUM IN CHILDREN WITH SPASTIC CEREBRAL PALSY
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Genu Recurvatum
Keywords: genu recurvatum, Cerebral Palsy, Universal Exercise Unit, Rebound Therapy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to investigate and compare between effectiveness of Universal Exercise Unit and Rebound Therapy on genu recurvatum, muscle strength, balance, functional mobility and quality of life in spastic cerebral palsy children

Detailed description: Children will be equally assigned into three groups using simple randomization, control group, study group (A) and study group (B). Each group will consist of 20 children with spastic CP to overcome any drop out may occur.

Control group: Children in this group will receive a traditional physical therapy program.

Study group (A): Children in this group will receive a traditional physical therapy program in addition to universal exercise unit program.

Study group (B): Children in this group will receive the same traditional physical therapy program in addition to rebound therapy.

Evaluation will be carried out for each child individually before and after 3 months of treatment.

Eligibility criteria: Inclusion Criteria:

* -Children with spastic CP both hemiplegic and diplegic.
* Their ages will be ranged from 5-7 years old.
* They will have mild spasticity (grade 1 and 1+) according to Modified Ashworth scale .
* They will be in level I and II according to gross motor function classification system (GMFCS) .
* They will be able to understand orders given to them.

Exclusion Criteria:

* Subjects will be excluded if they have the following:

  1. Visual or hearing impairment.
  2. Severe limb deformities as structural genurecurvatum.
  3. Surgical interference in the lower limbs for the last 6 months.
  4. Botulinum toxin injection of the spastic lower limb muscles during the last six months.

Primary outcomes:
measure: degree of genu recurvatum
timeFrame: 10 minutes
Secondary outcomes:
measure: muscle power
timeFrame: 2 minutes
measure: balance
timeFrame: 20 minutes
measure: functional mobility
timeFrame: 20 minutes
measure: Quality of child life
timeFrame: 20 minutes administration for each child
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Cairo University
name: Nanees Essam Mohamed, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00333021: Abdominal Surgery Study Of GSK576428 (Fondaparinux Sodium)In Japanese Patients
Official title: Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism (VTE) After Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: Fondaparinux Abdominal surgery Japanese VTE
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-06-02
Enrollment: 127
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is phase 3 study for prevention of VTE in patients with abdominal surgery.


Eligibility criteria: Inclusion criteria:

* Patients aged \>=40 years undergoing the following abdominal (diaphragm to pelvic floor) surgery under general anesthesia lasting more than 45 minutes.
* General or urologic surgery
* Cancer surgery
* Gynecologic surgery
* Radical surgery for pelvic malignancy

Exclusion criteria:

* Active, clinically significant bleeding Thrombocytopenia Body weight \<40kg

Primary outcomes:
measure: Incidence of Venous thromboembolism and Major bleeding
timeFrame: Throughout entire study
Secondary outcomes:
measure: Incidence of Pulmonary embolism Incidence of Deep vein thrombosis Incidence of symptomatic Venous thromboembolism
timeFrame: Throughout entire study
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Hyogo
country: Japan
facility: GSK Investigational Site
city: Ibaraki
country: Japan
facility: GSK Investigational Site
city: Kagawa
country: Japan
facility: GSK Investigational Site
city: Kagoshima
country: Japan
facility: GSK Investigational Site
city: Kagoshima
country: Japan
facility: GSK Investigational Site
city: Nara
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
facility: GSK Investigational Site
city: Saitama
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00517621: Use of FACT-GOG/NTX Questionnaire in Peripheral Neurotoxicity & Validation of a French Version of This Questionnaire
Official title: A Multicenter Prospective Phase II Study Evaluating Peripheral Neurotoxicity by Using FACT-GOG/NTX Questionnaire in Patients With Ovarian Cancer in Relapse Treated by Paclitaxel +/- EPO. Validation of a French Version of This Questionnaire
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Neoplasms
Keywords: Peritoneal cancer
Relapse or progression
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
First posted: 2007-08-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: validation of a french version of FACT-GOG/NTX and using this questionnaire to evaluate the incidence of the peripheral neurotoxicity in patients treated for ovarian cancer with paclitaxel associated or not with EPO.


Eligibility criteria: Inclusion Criteria:

* Femal patient aged \> 18 years
* Histologically proven diagnosis of cancer of the ovary, the fallopian tube or peritoneal
* patients whose disease progresses or relapses
* patients having received at least a line of platinum-based chemotherapy
* patients whose treatment of relapse is envisaged to comprise paclitaxel
* patients who will receive EPO for treatment of their anaemia
* ECOG performans status \< 2
* life expectancy \> 16 weeks
* patient who has clearly given her consent by signing on informed consent form prior to participation

Exclusion Criteria:

* peripheral neuropathy grade \> 2
* history of ischemic cardiopathy, congestive heart failure (NYHA\>2), arrhythmia, hypertension or significant valvulopathy
* abnormal biological values
* A therapy or a serious disease which could involve a risk for the patient or interfere with the aims of the study
* patient who is pregnant, breast feeding or using inadequate contraception
* concomitant therapy by a potentially neurotoxic drug
* concomitant inclusion in another therapeutic trial which could interfere with the aims of the study
* patient who for familial, sociological, geographical or psychological condition could not be followed correctly

Primary outcomes:
measure: Validation of a french version of FACT-GOG/NTX of peripheral neurotoxicity questionnaire
Secondary outcomes:
measure: - incidence and severity of the peripheral neurotoxicity according to whether the patients are treated or not by EPO
measure: - variation of the rate of haemoglobin during chemotherapy
measure: - Incidence of the thrombo-embolic events according to whether the patients are treated or not by EPO
Other outcomes:
Locations:
city: Paris
country: France
facility: HOTEL DIEU Hospital
Study officials:
affiliation: Institut Curie Paris
name: Laure COPEL, Physician
role: PRINCIPAL_INVESTIGATOR
References: