louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03588208: Progressive Resistance Training for Fibromyalgia
Official title: Evaluation of the Effectiveness of a Progressive Resistance Training Program for Patients With Fibromyalgia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Pain
Function
Quality of life
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 60
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients in the experimental group underwent a progressive resistance training program, performed twice a week for 12 weeks. The charge intensity was progressively increased from 40% to 80% of 1 repetition maximum. The following muscle groups were worked: trunk flexors and extensors, elbow flexors and extensors, knee flexors and extensors, hip abductors and adductors and shoulder abductors. In addition to strength training, the experimental group also conducted a structured education program in one hour class once a week for five weeks. Patients in the control group performed the same education program.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology;
* Feminine gender;
* Age between 18 and 65 years;
* Pain between 3 and 8 cm in the Numerical Pain Scale (END);
* Have not changed treatment for fibromyalgia in the past three months;
* Agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

* Cognitive deficit that does not allow the understanding of the evaluation instruments;
* Other diseases that make it impossible to perform the exercises;
* Physical activity started or changed in the last three months;
* Physical therapy in the last six months;
* In litigation.

Primary outcomes:
measure: Change in pain
timeFrame: Baseline and after 6 and 12 weeks
Secondary outcomes:
measure: Change in Health related quality of life
timeFrame: Baseline and after 6 and 12 weeks
measure: Change in Generic quality of life
timeFrame: Baseline and after 6 and 12 weeks
measure: Change in Functional capacity
timeFrame: Baseline and after 6 and 12 weeks
measure: Change in strength
timeFrame: Baseline and after 6 and 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05245708: Effects of Oxytocin on Reinforcement Learning and Interoception
Official title: The Modulatory Effects of Oxytocin on Reinforcement Learning and Interoceptive Processing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: oxytocin
learning
interoception
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main aim of the study is to investigate whether intranasal oxytocin has effects on reinforcement learning under dynamic environment and interoceptive processing based on behavioral and electroencephalogram (EEG) responses.

Detailed description: A double-blinded, placebo-controled, between-subject design is employed in this study. In a randomized order, a total of 80 healthy males are instructed to self-administrated intranasal spray of oxytocin or placebo. (1) Participants first complete a probabilistic reward learning task 45 minutes after treatment with behavioral (response time and accuracy) and EEG data (ERP components such as FRN, ERN and P300) being collected during this task. (2) A resting-state recording and a heartbeat counting task are conducted following the learning task with ECG and EEG data being collected. Personality traits of subjects are assessed using validated Chinese version questionnaires including the Beck Depression Inventory (BDI-II), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), the Cognitive Flexibility Inventory(CFI), Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), Behavioral Inhibition System and Behavioral Activation System Scale (BIS/BAS). Subjects are asked to complete Positive and Negative Affect Schedule (PANAS) when they just arrive, before and after the tasks.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects without any past or present psychiatric or neurological disorders.

Exclusion Criteria:

* History of brain injury medical or mental illness.

Primary outcomes:
measure: Behavioral index in the learning task: chioce accuracy
timeFrame: 45-65 minutes after treatment administration
measure: Behavioral index in the heartbeat counting task: interoceptive accuracy
timeFrame: 65-75 minutes after treatment administration
Secondary outcomes:
measure: ERP components in the learning task: ERN, FRN, P300, N2pc
timeFrame: 45-65 minutes after treatment administration
measure: ERP components in the heartbeat counting task: heartbeat-evoked potential (HEP)
timeFrame: 65-75 minutes after treatment administration
Other outcomes:
Locations:
city: Chengdu
country: China
facility: University of Electronic Science and Technology of China (UESTC)
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Yao Shuxia, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01291108: Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-02-08
Enrollment: 125
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: This study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution compared with bimatoprost ophthalmic solution (Lumigan®) as monotherapy and adjunctive therapy in patients with primary open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary open-angle glaucoma or ocular hypertension in each eye
* Requires bilateral treatment with an IOP-lowering medication
* Best corrected visual acuity of 20/100 or better in each eye

Exclusion Criteria:

* Use of oral, intramuscular, intravenous or topical ophthalmic corticosteroids within 2 months
* Inability to fast for up to 10 hours
* Prior refractive laser surgery (eg, LASIK, radial keratectomy, photorefractive keratectomy)
* Intraocular surgery or IOP-lowering laser surgery (eg, laser trabeculoplasty) within 6 months
* Current or anticipated use of artificial tears or any ocular medications aside from study medications during study
* Anticipated wearing of contact lenses during study

Primary outcomes:
measure: Change From Baseline in Average Eye IOP
timeFrame: Baseline, Day 57
Secondary outcomes:
measure: Change From Baseline in Worse Eye IOP
timeFrame: Baseline, Day 57
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06666608: Bone Stimulator for Spondylolysis
Official title: The Efficacy of Bone Stimulator in Treatment and Return-to-Sport for Spondylolysis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spondylolysis
Symptomatic Spondylolysis
Athletes
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 48
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective study aims to investigate the effectiveness of bone stimulator therapy as adjunct treatment of spondylolysis in athletic populations. By evaluating its impact on pain reduction, functional improvement, osseous bony union and return-to-sport time, the investigators seek to provide valuable insights into the role of bone stimulation therapy as a potential treatment modality for this challenging condition.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 16 to 40 years of age diagnosed with symptomatic spondylolysis by one of the investigators
* Patients who plan to attend prescribed physical therapy
* Patients who participate in a regular sport whether that be professional, collegiate or recreational

Exclusion Criteria:

* Any condition which in the investigator's opinion, would interfere with the subject's ability to comply with study instructions
* Patients with contraindications to bone stimulator therapy
* Patients with pacemaker and implantable cardioverter defibrillator
* Patients with previous spine surgery
* Patients with metabolic bone conditions
* Patients who use nicotine products
* Vulnerable populations
* Non-English speaking services

Primary outcomes:
measure: Time to Return to Sport After Diagnosis of Spondylolysis and Bone Healing
timeFrame: Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline
Secondary outcomes:
measure: Level of pain
timeFrame: Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline
measure: Level of pain
timeFrame: Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline
measure: Effect on Daily Life
timeFrame: Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline
Other outcomes:
measure: Physical Therapy Attendance
timeFrame: Baseline visit, 6 weeks after baseline, 12 weeks after baseline, 6 months after baseline
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Mark Prasarn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00745108: Tibolone Endometrium Study (Study 32972)(P06470)
Official title: A Multinational, Multicenter, Randomized, Double-blind, Parallel Group, Active Controlled, Comparative Trial, to Assess the Endometrial Histological Profile Following Treatment With Tibolone (Org OD14) Versus Conjugated Estrogen (CE) Plus Medroxyprogesterone Acetate (MPA) in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Women
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-09-03
Enrollment: 32
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Tibolone has been registered for the treatment of climacteric symptoms and for the prevention of postmenopausal osteoporosis. This is a 2-year study to further confirm the endometrial safety of tibolone in comparison with CE/MPA.


Eligibility criteria: Inclusion Criteria:

* Healthy postmenopausal women, 45 to 65 years of age with an intact uterus. Women must have been postmenopausal for less than 15 years, have an atrophic or inactive endometrium, and a body mass index of 18 - 32 kg/ m2 (inclusive).

Exclusion Criteria:

* Final diagnosis of the endometrial biopsy as 'no tissue' or 'tissue insufficient for diagnosis'.
* Double layer endometrial thickness \> 6 mm as assessed by transvaginal ultrasonography (TVUS).
* Any previous or current unopposed estrogen administration or tamoxifen citrate.
* Any unexplained vaginal bleeding following the menopause.
* Women with abnormal Pap smear test results (PAP IIb and higher)
* Previous use of raloxifene hydrochloride for longer than one month.

Primary outcomes:
measure: Endometrial biopsy and histological examination
timeFrame: At 1 year and 2 year.
Secondary outcomes:
measure: Double-layer endometrial thickness by transvaginal ultrasonography (TVUS), vaginal bleeding from a Bleeding Episode Log.
timeFrame: TVUS: at 1 year and 2 year; Vaginal bleeding: daily recording
Other outcomes:
Locations:
Study officials:
References:
citation: Archer DF, Hendrix S, Ferenczy A, Felix J, Gallagher JC, Rymer J, Skouby SO, den Hollander W, Stathopoulos V, Helmond FA; THEBES Study Group. Tibolone histology of the endometrium and breast endpoints study: design of the trial and endometrial histology at baseline in postmenopausal women. Fertil Steril. 2007 Oct;88(4):866-78. doi: 10.1016/j.fertnstert.2006.12.052. Epub 2007 Jun 4.
Clinical trial NCT06508008: Rapid and Safe Sputum Suction Method Validation
Official title: Verification of the Effect of Intermittent Negative Pressure Sputum Suction Through Oral Pharyngeal Ventilation Tube in Comatose Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sputum
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 900
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 600 comatose patients admitted to the hospital in China from June 2024 to June 2028 were randomly divided into groups A and B. Group A used intermittent negative pressure suction through oral and pharyngeal ventilation, while group B used continuous negative pressure suction through regular oral and nasal suction.

Detailed description: Research content: (1) Selection and placement methods of oropharyngeal ventilation tubes, studying the application effects of different models and sizes of oropharyngeal ventilation tubes in critically ill patients, exploring the best placement method to improve the efficiency and safety of sputum suction operations. (2) The norms and techniques of sputum suction, the steps, techniques, and precautions of sputum suction, the depth, strength, time of insertion, and when to interrupt negative pressure, in order to minimize damage to the patient's respiratory mucosa. (3) Evaluation of patient comfort and tolerance, assessing the tolerance and potential adverse reactions of critically ill patients during oral pharyngeal intubation for sputum suction, providing a basis for optimizing sputum suction. (4) Evaluation of sputum suction effect, comparing blood oxygen saturation, respiratory distress, sputum sounds, and other indicators before and after sputum suction to evaluate the effectiveness of sputum suction.

Eligibility criteria: Inclusion Criteria:

* 1. Clinical diagnosis of stroke; 2. Clinical diagnosis of comatose;

Exclusion Criteria:

* 1. Clinical diagnosis of multiple organ failure; 2. Clinical diagnosis of multiple organ bleeding;

Primary outcomes:
measure: Blood oxygen saturation before and after sputum aspiration
timeFrame: Not exceeding 1 day
measure: Suctioning time
timeFrame: Not exceeding 2 minute
measure: Degree of airway bleeding
timeFrame: Not exceeding 30 minute
Secondary outcomes:
measure: Patient family satisfaction
timeFrame: Not exceeding 1 day
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
affiliation: Ethics Committee of Nantong University Affiliated Hospital
name: Tao Zhang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01997008: Optimizing Resilience and Coping in HIV Via Internet Delivery
Official title: Optimizing Resilience and Coping in HIV Via Internet Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Disease
Depression
Affect
Psychological Stress
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a feasibility/pilot test of a set of positive affect skills provided online to HIV positive people with elevated depressive symptoms - a Center for Epidemiological Studies Depression Scale D (CES-D) score \> 10. The investigators will test the feasibility of recruitment, retention and acceptability of these skills in an online delivery format, determine feasibility and acceptability of daily emotion assessments via text messaging and assess efficacy of these skills for improving psychological well-being this population.


Eligibility criteria: Inclusion Criteria:

* HIV +
* 18 or older
* Score of CES-D depression scale \>10
* Daily internet access
* Smart phone ownership

Exclusion Criteria:

-

Primary outcomes:
measure: Acceptability of ORCHID content
timeFrame: 5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content.
measure: Retention of participants in online delivery format.
timeFrame: 5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content.
measure: Feasibility of an online delivery format.
timeFrame: 5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content.
Secondary outcomes:
measure: Determine acceptability of multiple daily emotion assessments using text messaging.
timeFrame: 5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content.
Other outcomes:
measure: Assess preliminary efficacy of the ORCHID intervention for improving psychological well-being in people living with HIV who have elevated depressive symptoms.
timeFrame: 5 weeks post enrollment. May be slightly more or less for intervention participants depending on time taken to complete online content.
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Judy Moskowitz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moskowitz JT, Hult JR, Duncan LG, Cohn MA, Maurer S, Bussolari C, Acree M. A positive affect intervention for people experiencing health-related stress: development and non-randomized pilot test. J Health Psychol. 2012 Jul;17(5):676-92. doi: 10.1177/1359105311425275. Epub 2011 Oct 21.
Clinical trial NCT06318208: Pulmonary Function in Non-hospitalized Adults and Children After Mild COVID-19
Official title: Pulmonary Function in Non-hospitalized Adults and Children After Mild COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2 Infection
Keywords: mild COVID-19
LCI
lung function
non-hospitalized COVID-19
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 110
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: SARS-Covid -2 Infection 1 months before investigation

Brief summary: The study investigates whether patients with mild SARS-CoV-2 infection, who stayed at home during their infection and weren't hospitalized, have any persisting sequelae in pulmonary function.

Therefore, 110 patients, aged 6-60 years, were recruited by telephone 4-12 weeks after laboratory-confirmed positive PCR and invited for a lung function testing. Every patient with abnormalities in pulmonary function was invited to a follow-up 3 months after the first appointment to assess changes in lung function values.

Patients with a pre-existing lung disease and smokers within the last five years were excluded beforehand.

Additionally to lung function testing we did a throat swab at each appointment to analyse via Multiplex PCR whether the patients had any other respiratory infection at the time of the pulmonary function testing.

Detailed description: 110 patients, 90 adults and 20 children, were recruited. The lung function included LCI, FEV1, FVC and DLCO (Hb corrected). Additionally we did a throat swab at each appointment to analyse via Multiplex PCR whether the patients had any other respiratory infection at the time of the test.

Eligibility criteria: Inclusion Criteria:

* SARS-CoV-2 Infection, non-hospitalized during infection

Exclusion Criteria:

* Smoking, existing lung disease (COPD, Asthma bronchiale)

Primary outcomes:
measure: Pulmonary function
timeFrame: 4.3 - 11.3 weeks after positive PCR for SARS-CoV-2
Secondary outcomes:
measure: Changes in pulmonary function
timeFrame: 11.0 - 16.7 weeks after the first lung function testing
measure: Sociodemographic factors
timeFrame: 9 months
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: Kinder- und Jugendklinik Universitätsmedizin Rostock
Study officials:
affiliation: UMR Kinder- und Jugendklinik
name: Manfred Ballmann, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04569708: Sleep Spindles and Memory in Rolandic Epilepsy
Official title: Auditory Stimulation Effect on Spindles and Sleep Dependent Learning in Rolandic Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rolandic Epilepsy
Rolandic Epilepsy, Benign
Centrotemporal Epilepsy
Centrotemporal; EEG Spikes, Epilepsy of Childhood
Epilepsy; Seizure
Epilepsy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Boston University
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2020-09-30
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators are recruiting children with Rolandic epilepsy and children without epilepsy (aged 4 years old and above) for a non-invasive brain imaging study using Magnetic Resonance Imaging (MRI), Magnetoencephalography/Electroencephalography (MEG/EEG), and experimental tasks. The investigators hope to determine the brain circuits and brain rhythms affected in these children and ultimately identify new treatment options for childhood epilepsy patients.

Detailed description: This is a prospective study of epilepsy biomarkers in a total of 100 subjects of ages 4-18. Participants will spend about 5 hours at the Massachusetts General Hospital (MGH) Athinoula A. Martinos Center for Biomedical Imaging. They will undergo training on a memory task concurrent with EEG/MEG recordings. During the EEG, subjects will wear headphones that will deliver a quiet pink noise stimulus intermittently during a nap. The auditory stimulus will be calibrated in volume to not cause arousals. After napping, subjects will undergo cognitive testing and memory task testing.

Eligibility criteria: Inclusion Criteria:

1. Ages 4-18 years
2. Diagnosed with childhood epilepsy with centrotemporal spikes (CECTS) or Rolandic epilepsy by child neurologist
3. Has EEG with sleep activated centrotemporal spikes
4. Has had at least 1 focal motor or generalized seizure

Exclusion Criteria:

1. Has abnormal brain MRI
2. Has other unrelated neurological disease
3. Unable to have an MRI/MEG

   1. Claustrophobic
   2. History of frequent vomiting
   3. Permanent metal in body, braces
   4. Over MRI weight limit: 350lbs

Primary outcomes:
measure: Spindle Density
timeFrame: 1-5 hours
measure: Memory performance
timeFrame: 1-5 hours
Secondary outcomes:
Other outcomes:
measure: Spindle-slow oscillation coupling
timeFrame: 1-5 hours
Locations:
city: Charlestown
country: United States
facility: Athinoula A. Martinos Center Biomedical Imaging
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Catherine Chu, MD
role: PRINCIPAL_INVESTIGATOR
References: