louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02906228: Radiofrequency Electromagnetic Field (RF-EMF) Effects on Brain Activity During Sleep and Waking in Healthy Elderly Women
Official title: Einfluss Hochfrequenter Elektromagnetischer Felder Auf Gehirnaktivität, Schlaf Und Kognitive Leistungsfähigkeit älterer Frauen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nervous System Effects
Keywords: non-ionizing radiation
Lead sponsor: The Federal Office for Radiation Protection, Germany
Sponsor class: OTHER_GOV
Collaborators: name: Seibersdorf Labor GmbH
First posted: 2016-09-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate possible effects of radio frequency electromagnetic fields on EEG activity during sleep and on Brain function during wake (EEG in the resting state condition, slow EEG potentials, auditory evoked potentials) and cognitive performance measures in test of selective attention, divided attention and working memory in healthy elderly females (60 - 80 years).

Detailed description: To investigate possible effects of radio frequency electromagnetic fields on EEG activity during sleep and on Brain function during wake (EEG in the resting state condition, slow EEG potentials, auditory evoked potentials) and cognitive performance measures in test of selective attention, divided attention and working memory in healthy elderly females (60 - 80 years).

Subjects will be exposed with signals from mobile communication handheld devices for 7.5 h during the night and for the whole duration of the test session during the day. Exposures will be GSM (900 MHz), TETRA (400 MHz) and sham. Each subject is exposed with each exposure three times in addition to an adaptation/screening night and day to learn the test.

The results have to be discussed in the context of possible health risks resulting from RF

Eligibility criteria: Inclusion Criteria:

* healthy male subjects (age 60 - 80 years) right handedness alpha EEG as resting state EEG

Exclusion Criteria:

* acute illness severe neurological, psychiatric or internal disease CNS active medication sleep disorders drug abuse

Primary outcomes:
measure: sleep assessed by EEG power
timeFrame: during 8 h exposure
Secondary outcomes:
measure: restin g state waking EEG (Power)
timeFrame: during exposure 4 h
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Competence Center Sleep Medicine
Study officials:
affiliation: Federal Office of Radiation Protection
name: Blanka Pophof, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Danker-Hopfe H, Dorn H, Sauter C, Schmid G, Eggert T. An experimental study on effects of radiofrequency electromagnetic fields on sleep in healthy elderly males and females: Gender matters! Environ Res. 2020 Apr;183:109181. doi: 10.1016/j.envres.2020.109181. Epub 2020 Jan 24.
Clinical trial NCT01360528: Serum Folic Acid Levels in Preterm Infants
Official title: Zekai Tahir Burak Maternity and Teaching Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Very Low Birth Weight Baby
Keywords: Folic acid replacement
Folic acid
Preterm neonate
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2011-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 24
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Extremely low birth weight, Very low birth weight, Low birth weight

Brief summary: Therefore preterm infants must need folic acid replacement than term babies.

Detailed description: All babies need to different vitamin supplementation. Especially preterm infants need some vitamin supplements. Folic acid is very important structure of part of cell growing.ın theorically; preterm infants have very rapid cell reproduction capacity than term infants. Therefore preterm infants must need folic acid replacement than term babies. The investigators want to determine preterm infants folic acid levels due to gestational age whether needs folic acid replacement.

Eligibility criteria: Inclusion Criteria:

-All preterm infants

Exclusion Criteria:

-Major congenital anomaly

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital, Neonatology Unit
Study officials:
References:
citation: Oncel MY, Calisici E, Ozdemir R, Yurttutan S, Erdeve O, Karahan S, Dilmen U. Is folic acid supplementation really necessary in preterm infants </= 32 weeks of gestation? J Pediatr Gastroenterol Nutr. 2014 Feb;58(2):188-92. doi: 10.1097/MPG.0000000000000181.
Clinical trial NCT03081728: Incidence Of Hemidiaphragmatic Paralysis After Usg Guided Low Dose Interscalene Brachial Plexus Block
Official title: Incidence Of Hemidiaphragmatic Paralysis With Patient Controlled Infusion Of Low Volume Of Ropivacaine After Usg Guided Low Dose Interscalene Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2017-03-16
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: 1- block + GA 2- GA with multimodal analgesia
Primary purpose: DIAGNOSTIC

Brief summary: to put a catheter in interscalene brachial plexus USG guided and give a bolus of drug followed by 24 hours continous infusion of drug

Detailed description: to put a catheter in interscalene brachial plexus USG guided and give a bolus of drug followed by 24 hours continous infusion of drug. To see hemidiaphragmatic paralysis by seeing diaphragmatic excursion on M mode Usg subcostal approach, to see post operative pain, patient satisfaction score, complications if any

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-65 years and belonging to ASA grade I, II, III, undergoing either, shoulder surgery, (rotator cuff repair, acromioplasty, hemiarthroplasty, and total shoulder replacement) or surgery for proximal humerus fracture will be recruited for the study.

Exclusion Criteria:

* a) Patient refusal for interscalene block b) Severe respiratory disease (FEV1/FVC \<0.7 and FEV1 \< 80% of predicted) c) Allergy to amide local anaesthetic drugs d) Chronic opioid therapy e) Patients who cannot understand how to operate PCA and VAS

Primary outcomes:
measure: incidence of hemidiaphragmatic paralysis
timeFrame: 24 hours
Secondary outcomes:
measure: postoperative pain
timeFrame: 24 hours
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
Study officials:
References:
citation: Sinha SK, Abrams JH, Barnett JT, Muller JG, Lahiri B, Bernstein BA, Weller RS. Decreasing the local anesthetic volume from 20 to 10 mL for ultrasound-guided interscalene block at the cricoid level does not reduce the incidence of hemidiaphragmatic paresis. Reg Anesth Pain Med. 2011 Jan-Feb;36(1):17-20. doi: 10.1097/aap.0b013e3182030648.
citation: Renes SH, Rettig HC, Gielen MJ, Wilder-Smith OH, van Geffen GJ. Ultrasound-guided low-dose interscalene brachial plexus block reduces the incidence of hemidiaphragmatic paresis. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):498-502. doi: 10.1097/AAP.0b013e3181b49256.
citation: Fredrickson MJ, Price DJ. Analgesic effectiveness of ropivacaine 0.2% vs 0.4% via an ultrasound-guided C5-6 root/superior trunk perineural ambulatory catheter. Br J Anaesth. 2009 Sep;103(3):434-9. doi: 10.1093/bja/aep195. Epub 2009 Jul 16.
Clinical trial NCT05150028: A Virtual Intervention to Improve Medication Adherence in Pediatric Cancer: MedSupport
Official title: A Virtual Intervention to Improve Medication Adherence in Pediatric Cancer: MedSupport
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 16
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To develop a cancer center level practice intervention to promote treatment adherence and reduce outcome disparities in pediatric cancer survivors

Detailed description: To conduct a pilot study to assess the feasibility and acceptability of the Social Determinants of Adherence intervention

Eligibility criteria: Inclusion Criteria:

Parents/caregivers of pediatric patients must meet the following criteria to be eligible:

* Parents/guardians of child that has been diagnosed with any cancer.
* Parents/guardians of child with any cancer between age 0 and 18.
* Parents/guardians of child on home-based oral anti-cancer therapy or supportive care therapy.
* The clinician for the family agrees to participate in the study.

Exclusion Criteria:

* Participants will be excluded from this study if unwilling or unable to complete the assessment in English

Primary outcomes:
measure: Retention rates
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Feasibility of universal SDOA screening
timeFrame: up to 8 weeks
measure: Provider satisfaction with barrier reports
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Comprehensive Cancer Center
name: Elizabeth Bouchard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02273128: A Study to Assess the Disturbances in Calcitonin Gene in Patients With Gum Disease and Osteoporosis
Official title: Calcitonin Receptor Gene Polymorphisms in Patients With Osteoporosis and Chronic Periodontitis-An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Generalized Chronic Periodontitis
Osteoporosis
Keywords: Osteoporosis
Chronic Periodontitis
Calcitonin gene Polymorphism
Lead sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Sponsor class: OTHER
First posted: 2014-10-23
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients both male and female aged between 35-60 Years with Osteoporosis and Chronic Periodontitis.

Brief summary: Osteoporosis and Periodontitis are multifactorial diseases which share common risk factors.The aim of the present study is to ellucidate polymorphisms in Calcitonin receptor gene? in patients with Osteoporosis and Periodontitis.

Detailed description: Periodontitis is a polymicrobial inflammatory disease which includes various modifiable and nonmodifiable risk factors. The non modifiable risk factors include genetic polymorphisms like metabolism associated genetic polymorphisms ( Vitamin D and Calcitonin).

Osteoporosis is a systemic skeletal disease characterized by low bone mass and micro-architectural deterioration of bone tissue with consequent increase in bone fragility and susceptibility to fractures.

Bone loss is a common feature shared between periodontal disease and osteoporosis.

Out of all genetic factors Calcitonin gene polymorphism contributes to the development of both osteoporosis and chronic periodontitis.

Eligibility criteria: Inclusion Criteria:

* Male and Female
* Patients aged between 35.00 Year(s) to 60.00 Year(s) diagnosed with Osteoporosis and Chronic Periodontitis who are willing to participate in the study

Exclusion Criteria:

* Patients who are Systemically compromised and under medications such as steroids.
* Patients who smoke.Pregnant and lactating mothers are excluded from the study

Primary outcomes:
measure: Calcitonin gene polymorphism
timeFrame: 5 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre
state: Andhra Pradesh
Study officials:
affiliation: Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre
name: Dr.Anuradha Ankam, PG(Perio)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06045728: Telerehabilitation for Overactive Bladder Syndrome in Obese Women
Official title: Effect of Telerehabilitation on Overactive Bladder Symptoms and Metabolic Health in Obese Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overactive Bladder Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Overactive bladder syndrome(OAB) is a chronic medical condition which has a major influence on the quality of life in a significant amount of the population. The goal of this clinical trial study to identify the effect of telerehabilitation program on overactive bladder symptoms and metabolic health in obese women and to compare between the telerehabilitation group and the control group regarding overactive bladder symptoms and metabolic health in obese women.

Detailed description: overactive bladder syndrome occurs globally and affects both genders with studies indicating high prevalence in obese females. Obesity brings with it not only an increased risk of cardiovascular diseases, but also urological dysfunction including overactive bladder. Pilates exercise and diet can be used as ways for controlling overactive bladder symptoms and improving overall health of obese subjects. Integration of telerehabilitation in the clinical practice benefits both providers and patients as well decreasing healthcare costs, so the objective of this study to determine the effect of telerehabilitation on overactive bladder symptoms and metabolic health in obese women through Pilates exercise and Mediterranean diet .

Eligibility criteria: Inclusion Criteria:

* women aged 35-45 years old
* class I obesity(30-34.9kg/m2)
* women will be referred by urologist with Presence of overactive bladder symptoms confirmed by overactive bladder questionnaire
* waist circumference more than 88 cm

Exclusion Criteria:

* history of surgical treatment of urological disease
* infection of urinary tract
* oncological and neurological urinary tract disease,
* refusal to participate in the study

Primary outcomes:
measure: body mass index
timeFrame: at baseline and after 12 weeks of the intervention
measure: waist circumference
timeFrame: at baseline and after 12 weeks of the intervention
measure: overactive bladder questionnaire short form
timeFrame: at baseline and after 12 weeks of the intervention
measure: patient perception of intensity of urgency scale
timeFrame: at baseline and after 12 weeks of the intervention
measure: HOMA IR
timeFrame: at baseline and after 12 weeks of the intervention
Secondary outcomes:
measure: telehealth usability questionnaire
timeFrame: after 12 weeks of the intervention
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Online Video Programs With Patients Referred From Urologist ( Kasr Eleiny Hospital)
Study officials:
affiliation: Cairo University
name: salma I alghitany, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06258928: Early Mobilisation of the Distal Radius Fracture
Official title: Early Mobilisation of the Distal Radius Fracture Isokinetic and Functional Evaluation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Secondary Prevention
Keywords: distal radius fracture
early therapy
exercise therapy
Lead sponsor: Józef Piłsudski University of Physical Education
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a distal radius fracture DRF resulting from injury

Brief summary: The goal of this clinical trial is to demonstrate the effectiveness of early therapy in 14 patients with a distal radius fracture DRF resulting from injury, as the study group. Assess hand function of patients who underwent surgical repair of distal radius fractures using the open reduction internal fixation method (ORIF), compared to their nonoperated limb, after 6 months of early rehabilitation.

The main questions it aims to answer are:

1. Significantly faster recovery of independence from daily activities by the patient.
2. For economic reasons, patients often expect to return to work as soon as possible.

Participants will be subjected to functional examination to assess hand function of patients who underwent surgical repair of distal radius fractures using the open reduction internal fixation method.


Eligibility criteria: Inclusion Criteria:

* age range 18-60 years
* distal radius fracture
* ORIF procedure
* hand stabilisation plate (Medartis)

Exclusion Criteria:

* delayed rehabilitation protocol
* algodystrophy

Primary outcomes:
measure: DASH -Disability of the Arm, Shoulder, and Hand
timeFrame: 1 day
measure: ROM - range of motion
timeFrame: 1 day
measure: Grip strength
timeFrame: 1 day
measure: Isokinetic evaluation
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Terapia Ręki Magda Kolasińska
state: Mazowieckie
Study officials:
References:
Clinical trial NCT02339961: Evaluating Pulmonary Arterial Hypertension in Patients With Systemic Sclerosis
Official title: Evaluation of Lung Doppler Signals (LDS) in Detecting Pulmonary Arterial Hypertension in Patients With Systemic Sclerosis (SSc)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Systemic Sclerosis
Pulmonary Hypertension
Keywords: Systemic Sclerosis
Pulmonary hypertension
Lung Doppler Signals
Lead sponsor: Echosense Ltd.
Sponsor class: INDUSTRY
First posted: 2015-01-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package- the Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel). Systemic sclerosis patients often develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may provide important insight into pulmonary blood vessels characteristics by the LDS (Lung Doppler Signals) signals that are related to pulmonary hypertension. The TPD performance in detecting PAH in SSc patients will be assessed in the study.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to give signed informed consent prior to enrollment
2. Male or female, ≥ 18 years of age
3. Diagnosis of SSc according to 2013 ACR/EULAR SSc Classification Criteria (van den Hoogen 2013): Score ≥ 9.
4. Patients with RHC data available from measurement within 3 weeks prior to TPD assessment
5. No change in or initiation of PAH specific therapy between the last RHC and TPD

Exclusion Criteria:

1. People unable or unwilling to give informed consent.
2. PCWP or LVEDP \> 15 mmHg
3. Any PH etiology outside Group 1 (Dana Point, 2008)
4. Pregnant women
5. Patients having severe chest wall deformity

Primary outcomes:
measure: 1. Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC.
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Reumatology institute
name: Sara Pel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03647761: Does Wearing Tetra-Grip Improve Arm Function in Children Diagnosed With Neonatal Brachial Plexus Palsy?
Official title: Does Wearing Tetra-Grip Improve Upper Extremity Function in Children Diagnosed With Neonatal Brachial Plexus Palsy?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neonatal Brachial Plexus Palsy
Keywords: Tetra-grip
Assisting Hand Assessment
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 2
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of wearing a tetra-grip on the affected arm of children with neonatal brachial plexus palsy. Half of the participants will have tetra-grip applied to the arm, while the other half will not have it applied to the arm.

Detailed description: Tetra-grip is a tubular elastic support bandage that provides both compression and support. Previous studies have shown that by applying neoprene or athletic tape to a joint on individuals with poor proprioception or a history of joint injury, such modalities enhanced their proprioceptive recognition via stimulation of mechanoreceptors responding to skin stretch and compression during joint motion. As a result, patients have greater kinesthetic and joint position awareness of their limb.

Eligibility criteria: Inclusion Criteria:

* 3 - 7 years old
* male or female
* non-dominant upper extremity brachial plexus injury

Exclusion Criteria:

* Botox injections to the affected extremity within the past 3 months
* Severe muscle contractures of affected extremity that restricts functional use of the arm and hand
* Concurrent cerebral palsy

Primary outcomes:
measure: Assisting Hand Assessment (AHA)
timeFrame: At the end of standard OT sessions usually lasting 3 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
Study officials:
References:
Clinical trial NCT02948361: Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS
Official title: Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Volunteer Subjects
Lead sponsor: QT Ultrasound LLC
Sponsor class: INDUSTRY
First posted: 2016-10-28
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Subjects will be scanned on the QT Ultrasound Breast Scanner. For subjects that may have breast calcifications and/or mass(es) and/or other finding(s) on the QT scan image(s), standard imaging modalities (e.g., mammogram and HHUS) will be performed per ACR recommendations.

If available, subjects may provide copies of their breast imaging exams and related reports.

Demographics and medical history will be collected.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Willing and able to provide written, signed informed consent
* Willing and able to comply with all study procedures

Exclusion Criteria:

* Inability to tolerate the scan
* Present infection risk
* Allergies to device materials
* Inability to successfully "fit" breast into the investigational device
* Currently pregnant as reported by the subject
* Body weight greater than 400 lbs. (180 kg)
* Any other conditions that the Investigator determines to interfere with the conduct of the study or evaluation of results

Primary outcomes:
measure: QT Ultrasound scans
timeFrame: Scan session is 2 to 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Novato
country: United States
facility: Marin Breast Health Trial Center
state: California
Study officials:
References: