louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00498264: Effectiveness of Physical Exercise in Women With Fibromyalgia
Official title: Effectiveness of Physical Exercise on Decrease of Pain in Patients With Fibromyalgia:Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Fibromyalgia
Keywords: Exercise
Rehabilitation
Strength exercise
Aerobic exercise
Pain
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: University of Santo Amaro
First posted: 2007-07-10
Enrollment: 90
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fibromyalgia (FMS) is a syndrome expressed by chronic widespread body pain which leads to reduced physical function and frequent use of health care services. Exercise training is commonly recommended as a treatment.

The purpose of this study is to determine whether a supervised resistance muscular exercise (RME) and walking program (WP) are effective in the treatment of FMS on decrease of pain.

The practical of the RME reduces the pain of participants with FMS.

Detailed description: This study will evaluate and compare the effectiveness of a supervised resistance muscular exercise (RME) , walking program (WP)and control group (just observation) in women with FMS during 16 weeks, on decrease of pain.

Participants will undergo an assessment including medical some questionnaires to assess their FMS symptoms at baseline, after 8 weeks, 16 weeks and 28 weeks.

Eligibility criteria: Inclusion Criteria:

* Criteria diagnosis according ACR 1990
* Wash-out of medication specific for fibromyalgia for 1 month
* Only paracetamol 750mg will be allowed during the period of study.

Exclusion Criteria:

* Alterations that against indicate the practical one of physical activity evaluated previously in clinical and rheumatology evaluation

Primary outcomes:
measure: Decrease of pain and use of specific medicine for fibromyalgia
timeFrame: 16 weeks
Secondary outcomes:
measure: Improvement on phsysical function assessment throughout of 6 minute walk test and specific questionnaire: FIQ (Fibromyalgia Impact questionnarie) and SF-36 (Quality of life)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Santo Amaro - Ambulatory of Special Conditions
Study officials:
affiliation: Federal University of São Paulo
name: Andrea H Kayo, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kayo AH, Peccin MS, Sanches CM, Trevisani VF. Effectiveness of physical activity in reducing pain in patients with fibromyalgia: a blinded randomized clinical trial. Rheumatol Int. 2012 Aug;32(8):2285-92. doi: 10.1007/s00296-011-1958-z. Epub 2011 May 19.
Clinical trial NCT05056064: Efficacy of Swallowing Function After Early Postoperative Oral Exercise Among Patient With Oral Cavity Cancer Underwent Flap Reconstruction
Official title: Efficacy of Swallowing Function After Early Postoperative Oral Exercise Among Patient With Oral Cavity Cancer Underwent Flap Reconstruction: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Cavity Cancer
Keywords: Dysphagia
oral cancer
oral exercise
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2021-09-24
Enrollment: 90
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: Efficacy of swallowing function after early postoperative oral exercise among patient with oral cavity cancer underwent flap reconstruction: A randomized controlled trial


Eligibility criteria: Inclusion Criteria:

* patient with CA tongue and tumor size 2 cm

Exclusion Criteria:

* previous treatment
* history of head and neck cancer

Primary outcomes:
measure: Efficacy swallowing function
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
References:
Clinical trial NCT03566264: Study of the Sudden Heart Failure Participant Population in the US
Official title: Characterizing the Acute Decompensated Heart Failure (ADHF) Patient Population in the United States (US)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Decompensation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-06-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will be participants hospitalized with ADHF who do not have a coincident myocardial infarction and who have at least 6 months of activity in the database prior to the hospitalization

Brief summary: An observational study using data from a large US electronic health record database to find participants hospitalized with ADHF who do not have a concurring heart attack


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older on the index date
* At least 6 months of activity in the database
* An inpatient visit with at least one of the following ICD-9 or ICD-10 diagnosis codes (ICD-9 diagnosis codes: 428.xx, 785.51 or ICD-10 diagnosis codes: I50.xx, R57.0) in the primary or secondary position OR mention of "heart failure" on the admission record

Exclusion Criteria:

* An average LVEF ≥ 40 during the hospitalization
* Any code for myocardial infarction (ICD-9 diagnosis code: 410.xx, ICD-10 diagnosis code: I21.xx) or related terms such as "myocardial infarction", "mi", "infarct" or "heart attack" occurring during the index hospitalization

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Incidence of comorbid events among hospitalized ADHF participants
timeFrame: In the 30 days after discharge
measure: Incidence of participants hospitalized with ADHF
timeFrame: Up to 66 months
measure: Incidence of participants hospitalized with ADHF
timeFrame: In the 30 days after discharge
measure: Incidence of comorbid events among hospitalized ADHF participants
timeFrame: Up to 66 months
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Bristol-Myers Squibb
state: New Jersey
city: Princeton
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06898164: The Influence of Axial Length on Visual Quality Following SMILE Surgery in Patients with High Myopia
Official title: The Influence of Axial Length on Visual Quality Following SMILE Surgery in Patients with High Myopia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Quality
Axial Length
High Myopia
Keywords: Axial length
High myopia
SMILE
Higher-order aberration
visual quality
Lead sponsor: Tongji University
Sponsor class: OTHER
Collaborators: name: Shanghai 10th People's Hospital
First posted: 2025-03-27
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 113 high myopic patients (202 eyes) of Shanghai's Tenth People's Hospital were enroled in this prospective, non-randomized study conducted from July 2021 to September 2023.

Brief summary: This retrospective study aimed to investigate the subjective and objective visual outcomes following Small Incision Lenticule Extraction (SMILE) surgery in high myopic patients with varying axial lengths (AL).

Detailed description: The study enrolled 113 highly myopic patients (202 eyes) who underwent SMILE surgery at Shanghai's Tenth People's Hospital. Patients were classified into three groups based on the axial length before surgery: Group A (AL \< 26 mm, 62 eyes), Group B (26 mm ≤ AL \< 27 mm, 88 eyes), and Group C (AL ≥ 27 mm, 52 eyes). Preoperative and postoperative evaluations included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), equivalent spherical error(SE), and corneal high order aberration. Subjective visual quality was assessed using the Quality of Vision (QoV) questionnaire.

Eligibility criteria: Inclusion Criteria:

* manifest refraction spherical equivalent refraction exceeding -6.00D;
* stable myopia for a duration of at least 2 years;
* corrected distance visual acuity of at least 20/25;
* annual myopic spherical equivalent increment less than - 0.50 D.

Exclusion Criteria:

* a history of moderate to severe dry eye as well as any ocular or systemic disease.

Primary outcomes:
measure: Subjective visual quality
timeFrame: 12 months
Secondary outcomes:
measure: Refractive results
timeFrame: 12 months
Other outcomes:
measure: Ocular high-order aberrations
timeFrame: 12 months
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT06261164: Population Pharmacokinetic Model of Amikacin and Vancomycin in Critically Ill Patients
Official title: Development and Use of a Population Pharmacokinetic Model of Amikacin and Vancomycin for the Optimization of Dosing Regimens in Critically Ill Patients on Different Modalities of Extracorporeal Hemoadsorption
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Lead sponsor: University Clinical Centre of Republic of Srpska
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult critically ill patients with a diagnosis of SIRS, sepsis and/or septic shock who are hospitalized in the Department of Medical Intensive Care Medicine

Brief summary: The object of the scientific research is the characterization of the pharmacokinetic profile and the investigation of factors of pharmacokinetic variability of amikacin and vacnomycin in critically ill patients with a diagnosis of sepsis-like condition (SIRS), hospital-acquired sepsis and/or septic shock and who are on extracorporeal therapy with Cytosorb® and Oxiris® adsorbents.


Eligibility criteria: Inclusion Criteria:

* diagnosis of SIRS, sepsis and/or septic shock,
* older than 18 years, who are being treated with amikacin and/or vancomycin,
* length of use of adsorbent at least 12 hours.

Exclusion Criteria:

* contraindication for hemodiafiltration with adsorbents,
* patients under the age of 18,
* terminal cancer patients.

Primary outcomes:
measure: Development of population pharmacokinetic model
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Banja Luka
country: Bosnia and Herzegovina
facility: Department of Medical Intensive Care Medicine
Study officials:
affiliation: University Clinical Centre of Republic of Srpska
name: Nikolina Spiric, MPharm
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01937364: Preventing Alcohol Withdrawal With Oral Baclofen
Official title: Preventing Alcohol Withdrawal With Oral Baclofen: A Randomized, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alcoholism
Alcohol Withdrawal
Lead sponsor: Essentia Health
Sponsor class: OTHER
First posted: 2013-09-09
Enrollment: 17
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is determine if the medication baclofen can prevent the symptoms of Alcohol Withdrawal Syndrome (AWS) in hospitalized patients who may be at risk for AWS. This medication is most often used for patients who have spasticity of their muscles due to a neuromuscular disease. In several European studies, and in an earlier study at Essentia Health (NCT00597701), baclofen has been found to have a significant effect on the severity of symptoms of AWS.


Eligibility criteria: Inclusion Criteria:

* Adults (\>21) admitted to inpatients units of 1 of 3 Essentia Health hospitals
* Patient placed on AWS watch protocol by admitting physicians.

Exclusion Criteria:

* Unable to provide informed consent
* Unable to take swallow oral medications (tube-fed patients are to be excluded)
* Admitted for AWS or with Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) score \>8 at baseline
* No alcohol intake for ≥ 48 hours or AUDIT score \<12 at baseline
* Baclofen use at baseline
* Baclofen sensitivity
* Hospital discharge anticipated in within 48 hours
* Pregnant or breast feeding (urine pregnancy test required of women of child-bearing potential)
* Other active drug dependence (except tobacco)

Primary outcomes:
measure: Moderate or Severe Alcohol Withdrawal Syndrome
timeFrame: 72 hours
Secondary outcomes:
measure: Severity of Alcohol Withdrawal Symptoms as Measured on the CIWA-Ar Scale and Assessed at 24, 48, and 72 Hours After Enrollment
timeFrame: 72 hours
measure: Peak and Total Benzodiazepine Dose Required
timeFrame: 72 hours
Other outcomes:
Locations:
city: Duluth
country: United States
facility: St. Mary's Medical Center
state: Minnesota
city: Fargo
country: United States
facility: Essentia Health Innovis Hospital
state: North Dakota
Study officials:
affiliation: Essentia Health
name: Jeffrey E Lyon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06543264: Efficacy of Cryotherapy in Managing Chemotherapy-Induced Peripheral Neuropathy in Children With Leukemia
Official title: Efficacy of Cryotherapy in Managing Chemotherapy-Induced Peripheral Neuropathy in Children With Leukemia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to assess the efficacy of cryotherapy in controlling Peripheral Neuropathy in cancer children

Detailed description: Peripheral neuropathy is a serious condition characterized by symmetrical, distal damage to the peripheral nerves that may be caused by several classes of drugs, including chemotherapeutic agents. Chemotherapy-induced peripheral neuropathy (CIPN) is an adverse effect estimated to occur in up to 40% of patients undergoing chemotherapy, with its incidence increasing in patients being treated with multiple agents. Pharmacists play a pivotal role in the prevention and management of CIPN by recommending evidence-based pharmacologic and non pharmacologic strategies appropriate for the individual patient.Peripheral neuropathy (PN) is a systemic disease characterized by symmetrical, distal damage to the peripheral nerves that negatively impacts patient quality of life (QOL). Prolonged symptoms associated with PN can cause pain, interfere with functional ability (e.g., dressing, driving, house-work), and disrupt emotional health.

Eligibility criteria: Inclusion Criteria:

1. Their age will ranging from eight to seventeen years.
2. Children participated in this study will from both sexes.
3. Children receiving chemotherapy as medical treatment protocol
4. All children have polyneuropathy caused by chemotherapy.

Exclusion Criteria:

1. Children with Epilepsy.
2. Children with blood clotting disorder.
3. Children have Open wounds / broken skin
4. Children with severe cardiac disease
5. Uncooperative patients.

Primary outcomes:
measure: Nerve conduction studies (NCS)
timeFrame: nerve conduction velocity for sensory ulnar nerve at day 0
measure: Nerve conduction studies (NCS)
timeFrame: nerve conduction velocity for sensory ulnar nerve at day 90
measure: Nerve conduction studies (NCS)
timeFrame: nerve conduction velocity for sensory sensory median nerve at day 0
measure: Nerve conduction studies (NCS)
timeFrame: nerve conduction velocity for sensory sensory median nerve at day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Qina,
country: Egypt
facility: South Valley University, Faculty of Physical Therapy
Study officials:
affiliation: South Valley University
name: Nehad A. Abo-zaid, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01052064: Transcranial Magnetic Stimulation in Children With Attention Deficit Hyperactivity Disorder (ADHD). A Safety Study
Official title: Therapy With rTMS in Children With Attention Deficit and Hyperactivity Disorder. Phase 1 Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Children
ADHD
rTMS
Safety
Lead sponsor: International Center for Neurological Restoration, Cuba
Sponsor class: OTHER
First posted: 2010-01-20
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Low frequency repetitive Transcranial Magnetic Stimulation(rTMS) is a safe and tolerable procedure in children with Attention Deficit Hyperactivity Disorder(ADHD); it also could be a complement to the treatment of patients with poor symptomatic control to conventional treatment.

Detailed description: Attention Deficit Hyperactivity Disorder is a common disorder in the infancy; the majority of ADHD have good clinical response to amphetamines alone or in association with antiepileptic drugs. It is described that some patients(10-30%) with ADHD do not respond to conventional pharmacological and psycho- pedagogical treatment; in those patients non invasive brain stimulation methods could be a supplementary option for symptomatic control. There are not many published papers describing the effects of rTMS in persons younger than 18 years; so the first step to extent its use in pediatric population should be to obtain evidences about its tolerance and safety.

Eligibility criteria: Inclusion Criteria:

* Ages eligible for Study: 7years to 12 years
* Genders Eligible for Study: Both

Exclusion Criteria:

* History of convulsions
* Co-morbidity with other psychiatric or neurologic disease

Primary outcomes:
measure: Incidence of adverse events
timeFrame: week 1,during treatment
Secondary outcomes:
measure: EEG changes in epileptiform or basal activity after treatment compared with the baseline
timeFrame: last day of treatment
Other outcomes:
Locations:
city: Havana
country: Cuba
facility: International Center for Neurological Restoration
Study officials:
affiliation: International Center of Neurological Restoration
name: Lázaro Gómez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03384264: Effect of Suspension Training in the Elderly
Official title: Changes in Phase Angle and Handgrip Strength Induced by Suspension Training in Older Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of Suspension Training
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2017-12-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aimed to analyze the effects of a 12-week suspension exercise training programme on handgrip strength (HG) and anthropometric and bioelectrical impedance parameters in older adults.


Eligibility criteria: Inclusion Criteria:

non-hypertensive and not receiving hormonal replacement therapy,

Exclusion Criteria:

performing any regular physical exercise more than once a week over the 6 months preceding the beginning of the study

Primary outcomes:
measure: Phase angle
timeFrame: 12 weeks
measure: Body composition
timeFrame: 12 weeks
measure: Handgrip strength
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06246864: Evaluation of the Effects on the Skin of Different Materials Used in Orogastric Tube Detection in Premature Babies
Official title: Evaluation of the Effects on the Skin of Different Materials Used in Orogastric Tube Detection in Premature Babies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neonatal Skin Conditions
Keywords: premature
skin care
Hydrocolloid dressing
hypoallergenic patch
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 32
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control experimental trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: While medical adhesives provide fixation of devices and catheters in neonatal intensive care, they can cause disruption of skin integrity when removed. Therefore, when detecting medical devices, it is important to choose products that will not harm babies' skin and to use different occlusive dressings (polymer foams, hydrogel dressings, hydrocolloid dressings).

This study aims to compare the effectiveness of different types of patches (Hydrocolloid dressing and Hypoallergenic Flexible Patch) used in the detection of oragastric catheter (OG) in preterm babies hospitalized in the neonatal intensive care unit in preventing skin damage.

Detailed description: Many interventions are applied to premature babies in neonatal intensive care units due to the developing technologies in recent years. Babies in neonatal intensive care need many devices to maintain their vital functions and monitor the treatment process. The medical adhesive materials to be selected are important in determining the medical devices used in neonatal intensive care units, especially premature babies.

This study aims to compare the effectiveness of different types of patches (Hydrocolloid dressing and Hypoallergenic Flexible Patch) used in the detection of oragastric catheter (OG) in preterm babies hospitalized in the neonatal intensive care unit in preventing skin damage.

Eligibility criteria: Inclusion Criteria:

* A newborn is a baby born between 32-36 weeks of gestation
* No medical adhesive tape should be applied to the newborn's lips beforehand.
* The newborn does not have any skin diseases
* OG will be inserted into the newborn for the first time
* Having a newborn receiving respiratory support with non-invasive mechanical ventilation, hood or free oxygen

Exclusion Criteria:

* The newborn is not a baby born between 32-36 weeks of gestation
* Applying medical adhesive tape on the newborn's lips beforehand
* The newborn has any skin disease
* OG has been inserted into the newborn before and detected.
* Supporting and detecting the newborn's breathing by intubating it

Primary outcomes:
measure: Newborn Skin Condition Score
timeFrame: The patch will be removed 24 hours after orogastric detection and a skin evaluation will be performed immediately.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: