louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05805995: Effects of Vertebral Derotation on Pulmonary Functions
Official title: Impact of Vertebral Derotation on Ventilatory Functions and Chest Circumference in Adolescent Scoliosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Scoliosis Idiopathic
Keywords: lung functions, vertebral derotation, chest intervention
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The exercise group received vertebral derotation with posterior correction in addition to routine chest physiotherapy (group A).

The Control group received only posterior correction with routine chest physiotherapy (group B).
Primary purpose: TREATMENT

Brief summary: This study was conducted to determine the physiological and mechanical effects of physical training post surgical correction of adolescent scoliosis using vertebral derotation.

Detailed description: Sixty patients from both sexes with idiopathic scoliosis underwent posterior correction (fusion). They were presented with idiopathic scoliosis for 6-12 month. Their mean Cobb's angle was measured in degrees and their mean angle of rotation was measured also in degrees. Before participation all the patients were examined clinically by a chest physician to exclude any cardio pulmonary or vascular disorders which may alter the pulmonary functions. All of them did not receive any physical therapy program prior to the operation.

Patients were arranged randomly into two groups (1 and 2), each containing 30 patients. Group 1 (DRG) received posterior correction, vertebral derotation technique during posterior correction and pulmonary rehabilitation program while group 2 (NDRG) received posterior correction and the same rehabilitation program given to group 1.

Eligibility criteria: Inclusion Criteria:

* Male patients suffering from adolescent idiopathic scoliosis.
* Participant age ranged from 12- 18 years old.
* All patients had the same medical care.
* Participants have received a good explanation of the treatment and measurement device.
* Treatment was conducted surgical intervention.

Exclusion Criteria:

* Instability of patient's medical condition.
* Presence of any diseases that could affect the study results.
* Participants having respiratory, cardiac, or neurological diseases that affect pulmonary functions.

Primary outcomes:
measure: (FEV1 and MVV) were measured by using the spirometer Pulmonary functions testing
timeFrame: Five months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy -Cu
city: Giza
country: Egypt
facility: faculty of PT - cu
Study officials:
References:
citation: Kim YJ, Lenke LG, Bridwell KH, Kim KL, Steger-May K. Pulmonary function in adolescent idiopathic scoliosis relative to the surgical procedure. J Bone Joint Surg Am. 2005 Jul;87(7):1534-41. doi: 10.2106/JBJS.C.00978.
Clinical trial NCT06461195: Computer Aided Respiratory Therapy Based on Audio and Spirometry Signals
Official title: Computer Aided Respiratory Therapy Based on Audio and Spirometry Signals
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiratory Therapy
Keywords: Spirometry
Respiratory sounds
Lead sponsor: Thomas More Kempen
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: Universitair Ziekenhuis Brussel
First posted: 2024-06-14
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group interventional study acquiring spirometry data, respiration sound and physiological data in patients suffering from pulmonary disease.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to collect data: audio in the form of respiratory sounds and instructions from the therapist, spirometry data during the execution of the therapy, physiological parameters, and patient information. With the help of this data, algorithms will be developed for the automatic detection, localization, and classification of respiratory sounds, linked to the respiratory cycle using spirometric signals.

Detailed description: The study is an interventional study. Patients receive their standard respiratory physiotherapy, but in the mean time they are monitored with a stethoscope, spirometer and a wearable to measure physio-logical parameters.

It has been chosen to intervene as little as possible in the therapy to measure the respiratory sounds and breathing of the patient as accurately as possible. By recording therapy sessions with 15 patients, we expect to register several hundred events of respiratory sounds. This provides a good foundation for training an algorithm to detect and classify respiratory sounds.

Eligibility criteria: Inclusion Criteria:

* The patient has a chronic or acute respiratory condition and may need oxygen therapy
* The patient is minimally 12 years old

Exclusion Criteria:

* The patient is cognitively impaired.
* The patient has an undrained pneumothorax.
* The patient is experiencing an acute pulmonary hemorrhage.
* The patient is having an asthma exacerbation.
* The patient has an infection with Burkholderia cepatia.
* The patient is in isolation due to the risk of infection.

Primary outcomes:
measure: Respiration flow
timeFrame: 1 year
measure: Respiration volume
timeFrame: 1 year
Secondary outcomes:
measure: Heart rate
timeFrame: 1 year
measure: Skin conductivity
timeFrame: 1 year
measure: Body temperature
timeFrame: 1 year
measure: Oxygen saturation
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Filip Van Ginderdeuren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02696681: Addressing Psychosocial Comorbidities in HIV Treatment and Prevention
Official title: Addressing Psychosocial Comorbidities in HIV Treatment and Prevention: Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Depression
Mental Health
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2016-03-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Project AProaCH is an open pilot trial of a cognitive behavioral therapy (CBT) for individuals with HIV with various psychological comorbidities, which the investigators call "syndemics". Syndemics are co-occurring psychosocial problems that interact with each other and with health behavior such as HIV sexual transmission risk behavior and adherence to self care.


Eligibility criteria: Inclusion Criteria:

* HIV+ individuals
* Uncontrolled virus (plasma HIV RNA concentrations that reach detectable limits) or being diagnosed with a sexually transmitted infection (STI) (gonorrhea, chlamydia, syphilis, trichomoniasis (female only)) currently or within the past 3 months.

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania) that would interfere with study participation
* Opinion of the PI that the participant would be at risk for harm to himself or others as a result of study participation,
* Under the age of 18 or over the age of 65,
* Current CBT for a psychiatric disorder, or a course of CBT in the past year.

Primary outcomes:
measure: Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load
timeFrame: 4 months assessment
measure: Responder status as defined by the number of participants who change from a detectable to suppressed (undetectable) HIV viral load
timeFrame: 8 month assessment
Secondary outcomes:
measure: Adherence to antiretroviral therapy via real time monitoring
timeFrame: Changes over time from baseline to 8 month follow-up
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Steven A Safren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Safren SA, Harkness A, Lee JS, Rogers BG, Mendez NA, Magidson JF, Blashill AJ, Bainter S, Rodriguez A, Ironson G. Addressing Syndemics and Self-care in Individuals with Uncontrolled HIV: An Open Trial of a Transdiagnostic Treatment. AIDS Behav. 2020 Nov;24(11):3264-3278. doi: 10.1007/s10461-020-02900-7.
Clinical trial NCT02894281: Pupillometry Dynamic Measures in Patients Without Ocular or Neurological Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Optic Neuritis
Keywords: Pupillary light reflex
Multiple sclerosis
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-09
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with no optic neuritis are recruited, to be compared with a database of 22 patients already recruited in a former study (measurement of pupillary light reflex already performed in that study, for the same purpose)

Brief summary: Retrobulbar optic neuritis (NORB) is the damage to the optic nerve caused by inflammation. It causes a rapidly progressive and painful visual loss, often among young subjects. Diagnosis confirmation is important to start proper treatment, because a NORB is often the first symptom of multiple sclerosis. This diagnosis, based on a set of arguments, is difficult to define by a non-expert ophthalmologist.

The pupillary light reflex is a way to test the visual afferent pathways. If it is subject to a large inter-individual variability, the dynamics of the pupillary light reflex and its latency are more reproducible. An easy way to study the dynamics of the pupillary light reflex is to study the pupillary cycle time (PCT). In the case of NORB, elongation of the conduction in the visual afferent pathways related to demyelination plate increases the latency of the pupillary light reflex and decreases the frequency of the PCT.

Our hypothesis is that PCT dynamics measures would be a reliable indicator and easy to evaluate some pathologies affecting the integrity of the nerve. The validation of a decrease in the frequency of the PCT in NORB, compared to the frequency observed in subjects ophthalmological or neurological disease, could help developing methods to study the conduction of the visual pathways with portable devices used during the standard ophthalmologic consultation and quickly orientate patients to specialized centers.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years old
* Subject without known ocular or neurological disease
* Ametropia inferior to 3 diopters for spherical correction and inferior to 1.50 diopter for astigmatism correction
* Matched for age and sex with one of the 22 subjects of the patients' unilateral NORB database

Exclusion Criteria:

* history of disease affecting pupillary motility
* anisocoria
* patient under legal protection
* pregnant or breast feeding patient
* patient's refusal to participate in the study
* no medical insurance coverage

Primary outcomes:
measure: pupillary cycle time
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rothschild
Study officials:
affiliation: Fondation OPH A de Rothschild
name: Cedric Lamirel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00463281: CT Based Definition of a Tissue Window for Acute Stroke Thrombolysis
Official title: Observational Study of Multimodal CT in Acute Ischemic Stroke to Define a Tissue Window for Thrombolysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: stroke, ischemic
computed tomography
thrombolysis
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2007-04-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ischemic stroke patients presenting within 12 hrs from symptom onset

Brief summary: Aim of this study is to define a CT-based "tissue window" for stroke thrombolysis. Our primary hypothesis is that

1. patients with a "tissue window" (favourable non-contrast CT (NCCT) scan and an intracranial occlusion on CT angiography (CTA) or perfusion-CT-mismatch" (area of reduced cerebral blood flow (CBF) \> area of reduced cerebral blood volume (CBV)) represent a significant proportion (\> 20%)of acute stroke patients and therefore are an important target group for future interventional studies
2. patients with a "tissue window" suffer an unfavourable outcome (\> 50 % mRS =\>4 at 3 months)if the occluded artery was not recanalized.


Eligibility criteria: Inclusion Criteria:

* ischemic anterior circulation stroke
* last seen normal \< 12 hours
* stroke severity =\> 3 on the National Institute of Health Stroke Scale
* multimodal CT stroke protocol performed
* informed consent obtained

Exclusion Criteria:

* premorbid modified Rankin Scale score \> 3
* contraindications to contrast media application
* pregnancy or breast feeding
* subacute stroke \> 50 % of MCA territory
* CT evidence of non-vascular cause of stroke symptoms

Primary outcomes:
measure: modified Rankin Scale scores 0-2
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University of Dresden, Dept of Neurology
Study officials:
affiliation: University of Dresden, Dept of Neurology
name: Imanuel Dzialowski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pepper EM, Parsons MW, Bateman GA, Levi CR. CT perfusion source images improve identification of early ischaemic change in hyperacute stroke. J Clin Neurosci. 2006 Feb;13(2):199-205. doi: 10.1016/j.jocn.2005.03.030. Epub 2006 Feb 3.
citation: Parsons MW, Pepper EM, Bateman GA, Wang Y, Levi CR. Identification of the penumbra and infarct core on hyperacute noncontrast and perfusion CT. Neurology. 2007 Mar 6;68(10):730-6. doi: 10.1212/01.wnl.0000256366.86353.ff.
citation: Hill MD, Rowley HA, Adler F, Eliasziw M, Furlan A, Higashida RT, Wechsler LR, Roberts HC, Dillon WP, Fischbein NJ, Firszt CM, Schulz GA, Buchan AM; PROACT-II Investigators. Selection of acute ischemic stroke patients for intra-arterial thrombolysis with pro-urokinase by using ASPECTS. Stroke. 2003 Aug;34(8):1925-31. doi: 10.1161/01.STR.0000082483.37127.D0. Epub 2003 Jul 3.
Clinical trial NCT05559281: Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair
Official title: Evaluation of Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cleft Lip
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 22
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A cleft lip is a congenital defect resulting from failing to merge developmental processes in the Orofacial region. One of the most common complications surgeons fear after cleft lip repair is a hypertrophic scar. A cleft scar negatively affects a patient's appearance, psychology, and function. Several techniques have been proposed to improve lip scars such as steroid therapy, laser therapy, and silica gel. Despite such efforts, the results were still unsatisfactory. Botulinum Toxin injections may provide a more reliable method


Eligibility criteria: Inclusion Criteria:

* With mild to severe cleft lip deformity requiring repair.
* Neonates up to 1 year of age.
* Patients with or without cleft palate.
* Systemically healthy patients.
* Patients follow postoperative instructions provided by their legal guardians.

Exclusion Criteria:

* Patients with a syndromic type of cleft lip.
* Patients suffering from relevant systemic and metabolic diseases.
* Patients suffering from immunosuppressive diseases.
* Patients suffering from neuromuscular disorders like Myasthenia Gravis.
* Patients with special needs.

Primary outcomes:
measure: Change in cleft scar
timeFrame: 2 weeks, 3 months, 6 months
Secondary outcomes:
measure: Change in scar width
timeFrame: 2 weeks, 3 months, 6 months
measure: Change in lip height
timeFrame: 2 weeks, 3 months, 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT02067481: Effect of a Diet and Physical Activity Intervention in Breast Cancer Survivors
Official title: Effect of a Diet and Physical Activity Intervention on Body Weight and Nutritional Patterns in Overweight and Obese Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast cancer
Survivors
Weight loss
Diet
Physical activity
Lead sponsor: Institut Català d'Oncologia
Sponsor class: OTHER
First posted: 2014-02-20
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a single-arm pre-post pilot study, to assess changes in weight, quality of life and cardiorespiratory fitness after a diet and physical activity intervention in breast cancer survivors and to asses possible relation between these changes.

Detailed description: Aim:

The present study assessed changes in weight, quality of life (QoL) and cardiorespiratory fitness (CRF) during a diet and physical activity (PA) intervention in breast cancer (BC) survivors and investigated the possible relation between these changes.

Methods:

The intervention of this 12-week single-arm pre-post pilot study involved group-based sessions: one-hour weekly diet sessions delivered by a dietician and 75-minute bi-weekly PA sessions of moderate-to-high intensity led by PA monitors. This intervention, designed to promote weight loss, targeted overweight/obese women who had completed treatment less than six months before recruitment. CRF and QoL were assessed before and after the intervention and compared using paired t-tests. Linear regression models, including CRF variables, weight change and participants' characteristics, were used to assess the independent association between change in CRF and change in QoL.

Eligibility criteria: Inclusion Criteria:

* Female patients from the Catalan Institute of Oncology
* Aged 18 to 75
* Body mass index (BMI) of 25 kg•m-2 or more
* Completed chemotherapy and/or radiotherapy for breast cancer during the 6 months preceding recruitment

Exclusion Criteria:

* First cancer, tumours of stage IIIB and above
* Morbid obesity (BMI ≥40 kg•m-2)
* Any condition that could not permit to follow the diet and PA intervention offered

Primary outcomes:
measure: Weight loss
timeFrame: 3 months
Secondary outcomes:
measure: Quality of life
timeFrame: 3 months
Other outcomes:
measure: Biomarkers
timeFrame: 3 months
measure: Cardiorespiratory fitness
timeFrame: 3 months
measure: Dietary habits
timeFrame: 3 months
Locations:
city: Barcelona
country: Spain
facility: Instituto Catalá de Oncología
state: L´Hospitalet de Llobregat
Study officials:
affiliation: Institut Catalá de Oncología
name: Antonio Agudo, MsC PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05045781: Safety, Tolerability and Pharmacokinetics of Eptinezumab in Healthy Chinese Subjects
Official title: Interventional, Single-ascending-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Eptinezumab in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2021-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate how the body absorbs and get rid of eptinezumab when given directly into a vein in Chinese subjects.

Detailed description: This is an interventional, randomized, open-label, parallel-group, single-dose study investigating the safety, tolerability and pharmacokinetic properties of eptinezumab administered by intravenous (iv) infusion.

The study will consist of 20 healthy Chinese subjects, who will be randomized into two single-dose groups. The two groups will be run in parallel. In Group 1, a total of 10 subjects will receive a single iv infusion of 100 mg eptinezumab on Day 1. In Group 2, a total of 10 subjects will receive a single iv infusion of 300 mg eptinezumab on Day 1.

Safety and tolerability will be assessed throughout the study. Blood samples for plasma quantification of free eptinezumab will be collected from Day 1 to the Completion Visit (Day 84)/Withdrawal Visit.

Eligibility criteria: Inclusion Criteria:

* BMI of ≥ 19 and ≤ 25 kg/m2.
* The subject is Chinese, defined as being born in China and having four Chinese grandparents.
* The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an ECG, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria:

* The subject is pregnant or breastfeeding.
* The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.

Other inclusion and exclusion criteria may apply

Primary outcomes:
measure: AUC(0-inf) eptinezumab
timeFrame: Day 1 to Day 84
measure: Maximal observed plasma concentration (Cmax) of eptinezumab
timeFrame: Day 1 to Day 84
measure: Systemic clearance (CL) of eptinezumab
timeFrame: Day 1 to Day 84
measure: tmax
timeFrame: Day 1 to Day 84
measure: Apparent terminal elimination half-life (t½)
timeFrame: Day 1 to Day 84
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: zs-hospital Shanghai
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: