louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04366557: The Influence of the Body Posture Correcting Therapy on Pelvic Floor Muscles Function
Official title: The Influence of the Body Posture Correcting Therapy on Pelvic Floor Muscles Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence,Stress
Lead sponsor: Józef Piłsudski University of Physical Education
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants divided into two groups (the study and the control)
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the influence of the body posture correcting therapy on pelvic floor muscles function and urinary incontinence problem.

Detailed description: This randomized, controlled study was aimed to asses influence of a six week global posture correction therapy on pelvic floor muscles function and urinary incontinence problem. Participants were randomly divided into two groups. All subjects overcame assessment of pelvic floor muscles (sEMG, manometry and digital) and completed questionnaire about urinary incontinence problem and general health condition connected with lower tract symptoms. Both groups had a pelvic floor education (what is it, where are the pelvic floor muscle, how to correct contract them etc.) Additionally, the study group had a six week therapy focused on body posture correction. Therapy consisted of manual therapy (once per week) and correction exercises.

Eligibility criteria: Inclusion Criteria:

* stress urinary incontinence (confirmed by a medical examination)
* female
* age between 25 and 45 years old

Exclusion Criteria:

* gynecological, spinal, and abdominal surgery (excluding cesarean delivery)
* menopause
* spinal and pelvis injuries
* chronic diseases of the circulatory and respiratory system
* neurlogical accidance

Primary outcomes:
measure: Change in Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF)
timeFrame: 6 week (post-treatment)
measure: Change in Oswestry Disability Index (ODI)
timeFrame: 6 week (post-treatment)
measure: Change in King's Health Questionnaire (KHQ)
timeFrame: 6 week (post-treatment)
measure: Change in sEMG of the pelvic floor muscles
timeFrame: 6 week (post-treatment)
measure: Change in manometry of the pelvic floor muscles
timeFrame: 6 week (post-treatment)
measure: Change in digital palpation of the pelvic floor muscles using PERFECT shame
timeFrame: 6 week (post-treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: The rehabilitation clinic PROFEMED
Study officials:
References:
Clinical trial NCT01405157: A Bioequivalence Study Comparing Methylprednisolone Suspension To Methylprednisolone Tablets Under Fasting Conditions
Official title: Phase 1, Open-label, Randomized, Single-dose, 2-treatment, Crossover Be Study Comparing Constituted Methylprednisolone Powder For Oral Suspension 4 Mg/ml To Methylprednisolone 16 Mg Tablet Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Therapeutic Equivalency
Keywords: bioequivalence study
methylprednisolone
suspension
tablets
fasting
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-07-29
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A study to determine whether a new formulation of methylprednisolone suspension is bioequivalent to methylprednisolone tablets under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects between the ages of 21 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight \> 45 kg (99 lbs).

Exclusion Criteria:

* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive uring drug screen.

Primary outcomes:
measure: AUCinf (area under the concentration time curve to infinity)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
measure: Cmax (maximum concentration)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Secondary outcomes:
measure: AUClast (area under the concentration time curve to last time point)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
measure: Tmax (time at maximum concentration)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
measure: Half-life
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 10, 12, 16, 24 hours post dose
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06679257: Liquid BiopsiEs for LuNg AllogRaft Damage ClassificatiOn - LEONARDO
Official title: Liquid Biopsies for Lung Allograft Damage Classification
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Transplant Failure and Rejection
Lung Transplant Infection
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2024-11-07
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly lung transplanted patients within scandinavia

Brief summary: LTx has the shortest survival of all solid organ transplants. The complex and time-demanding diagnostics of allograft dysfunction are a significant reason for this.

The current study aims overarchingly to improve survival after lung transplantation (LTx) through precise and fast diagnostics. The specific aim is to develop direct-to-clinical implementation biomarkers for the most important aspects of long-term survival after LTx. An in-house-developed PCR-based cell-free-DNA methodology (cf-DNA) will be used for allograft damage and combined with specific other biomarkers to identify damage type. The current clinical golden standard for damage identification will be performed at every sampling instance.

The research will be a single-centre prospective observational cohort study. The control samples at all time points will consist of the samples without allograft damage. Blood will be drawn at fixed time points and clinical events. All analyses will be performed at a separate lab, blinded to the patient's status.

.


Eligibility criteria: Inclusion Criteria:

* Luing Transplanted and followed up within the reach of the study paricipating centres.

A good understanding to read and write within the languages in which the consent is provided.

Exclusion Criteria:

* Not Lung Transplanted or not followed up within the reach of the study paricipating centres.

No good understanding to read and write within the languages in which the consent is provided.

Primary outcomes:
measure: Damage distinction
timeFrame: One month, three months, one year, three years, five years
Secondary outcomes:
measure: Damage detection Limit
timeFrame: One month, three months, one year, three years, five years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03886857: Segmental Mechanisms of Transcutaneous Spinal Cord Stimulation for Spasticity Control
Official title: Carry-over Effects of Transcutaneous Spinal Cord Stimulation for Spasticity Control on Inhibitory Circuits of the Spinal Cord: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Klinikum Floridsdorf
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
First posted: 2019-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of the pilot study is to gain first insights into the interaction of transcutaneous spinal cord stimulation with the altered activity of intraspinal circuits associated with spinal spasticity. The main goal is to evaluate the validity of the chosen measures and to generate a data base for statistical planning of a subsequent clinical study.


Eligibility criteria: Inclusion Criteria:

written informed consent prior to participation

for participants with intact CNS:

• no previous neurological or musculoskeletal disorders

for participants with spinal cord injury:

* Spinal cord injury due to trauma
* ≥ 12 months post-spinal cord injury
* complete or incomplete spinal cord injury classified as grade C or D on the American Spinal Injury Association Impairment Scale (AIS)
* neurological level of spinal cord injury: C3-T10
* preserved tendon and cutaneo-muscular reflexes in the lower limbs

Exclusion Criteria:

* other neuromuscular diseases, e.g., amyotrophic lateral sclerosis (ALS), Parkinson's disease, Guillain-Barré syndrome, muscular dystrophy
* active implants (e.g., cardiac pacemaker, drug pump)
* passive implants at vertebral level T10 or caudal (e.g., metal screws/plates for surgical stabilization of spinal fractures)
* active infections or diseases, pressure sores
* dermatological issues at the stimulation site
* malignant diseases
* heart insufficiency (NYHA III-IV)
* potential pregnancy (pregnancy test to be conducted in women of child bearing age before application of transcutaneous spinal cord stimulation)

Primary outcomes:
measure: Postsynaptic inhibition
timeFrame: pre-intervention to 2 hours post-intervention
Secondary outcomes:
measure: Presynaptic inhibition
timeFrame: pre-intervention to 2 hours post-intervention
measure: H_max/M_max
timeFrame: pre-intervention to 2 hours post-intervention
measure: Low-frequency depression
timeFrame: pre-intervention to 2 hours post-intervention
measure: Evaluation of lower-limb spasticity
timeFrame: pre-intervention to 2 hours post-intervention
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Vienna
country: Austria
facility: Klinik Floridsdorf
Study officials:
affiliation: Medical University of Vienna
name: Ursula Hofstoetter, Prof., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00954057: Pilot Study to Determine Safety and Efficacy of Orbital Injections of LIPO-102 in Patients With Symptomatic Exophthalmos Associated With Thyroid-related Eye Disease (TED)
Official title: A Single-masked, Placebo Controlled, Multi-center Pilot Study to Determine the Safety and Efficacy of Orbital Injections of a Fixed Dose of LIPO-102 in Patients With Symptomatic Exophthalmos Associated With Thyroid-related Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thyroid-Related Eye Disease
Keywords: TED
Lead sponsor: Neothetics, Inc
Sponsor class: INDUSTRY
First posted: 2009-08-06
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot study to determine the safety and efficacy of orbital injections of LIPO-102.


Eligibility criteria: Inclusion Criteria:

* Male or Non pregnant female
* Symptomatic exophthalmos
* Inactive Thyroid Eye Disease
* Signed informed consent

Exclusion Criteria:

* Known hypersensitivity to study drugs
* Treatment with an investigational agent within 30 days of first dose
* History of Thyroid Eye Disease less than 6 months
* Previous decompression surgery
* Glaucoma

Primary outcomes:
measure: Safety: physical examinations, laboratory tests, VISA activity score, AE assessments
timeFrame: 8 weeks treatment and 1 week follow up
Secondary outcomes:
measure: Efficacy: change in proptosis, VISA activity score, VAS for Eye Appearance Satisfaction
timeFrame: 8 weeks treatment and 1 week follow up
Other outcomes:
Locations:
city: Adelaide
country: Australia
city: Brisbane
country: Australia
city: Melbourne
country: Australia
city: Sydney
country: Australia
city: Auckland
country: New Zealand
Study officials:
References:
Clinical trial NCT03143257: Ambispective Clinical Evaluation of Sophono™
Official title: Ambispective Clinical Evaluation of Sophono™
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conductive Hearing Loss
Single-Sided Deafness
Mixed Hearing Loss
Lead sponsor: Medtronic Surgical Technologies
Sponsor class: INDUSTRY
First posted: 2017-05-08
Enrollment: 71
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject population for this study includes male and female patients 5 years of age and older who have received the Sophono implant. Subjects will be recruited from Investigators who have implanted Sophono systems or from other non-investigator physician referrals. Subjects are expected to represent a population diagnosed with conductive hearing loss (CHL), single-sided deafness (SSD), and mixed hearing loss (HL).

Brief summary: Study to accumulate post-market clinical evidence for the safety and effectiveness of the Sophono Alpha 2 and Alpha 2 Maximum Power Output (MPO) systems in subjects diagnosed with conductive hearing loss, single-sided deafness and mixed hearing loss who currently have or have had the Sophono implant.


Eligibility criteria: Inclusion Criteria:

* Any subject who currently has or who has had the Sophono implant (including those who have been explanted)
* Has or has had Sophono implant for 3 months or longer

Exclusion Criteria:

* Subject has implant but is unable or unwilling to perform audiologic testing
* Subject is currently participating in another clinical study and has not been approved for concurrent enrollment by the Study Sponsor

Primary outcomes:
measure: Safety Outcome Measure: Proportion of Adverse Events (AEs) Related to Sophono Implant
timeFrame: From Implantation to Study Visit, up to 6 years
measure: Gain in Sensitivity to Sound in Decibels (dB) Resulting From Sophono Alpha 2 Maximum Power Output (MPO) Processor
timeFrame: 1 day
Secondary outcomes:
measure: Compare the Effectiveness of the Sophono Alpha 2 Processor to the Alpha 2 MPO Processor
timeFrame: 1 day
measure: Percentage of Participants Satisfied After System Use
timeFrame: 1 day
measure: Assess QOL After System Use
timeFrame: 1 day
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Macias Otology
state: Arizona
city: Gainesville
country: United States
facility: UF Health ENT and Allergy
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children's Specialty Care
state: Florida
city: New York
country: United States
facility: Park Avenue Otology/Neurotology
state: New York
city: Raleigh
country: United States
facility: Carolina Ear & Hearing Clinic
state: North Carolina
city: Pittsburgh
country: United States
facility: Pittsburgh Ear Associates
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06510257: Safety and Efficacy Reconyl for Cough With/Without Sore Throat
Official title: Safety and Efficacy of Reconyl for Cough With/Without Sore Throat: A Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cough
Keywords: Cough with sore throat
Cough without sore throat
Reconyl
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
Collaborators: name: Fakultas Kedokteran Universitas Indonesia
First posted: 2024-07-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a prospective, randomized, double-blind and placebo-controlled study to find out if reconyl may relieve the acute cough with/without sore throat.

Detailed description: Reconyl is a mixed extract from 4 Indonesian herbs, Vitex trifolia (Legundi), Zingiber officinale var. Amarum (Jahe Gajah), Abrus precatorius (Saga), and Phaleria macrocarpa (Mahkota Dewa), which have been known traditionally to relieve cough, respiratory congestion, and sore throat.

There will be two parallel groups of 30 subjects per group (a total of 60 subjects) planned to be enrolled in this study.

The investigational product: tablets @ 225 mg of Reconyl. Dose administration: One tablet of Reconyl or Placebo, given 3 times daily, for 3 days.

Eligible subjects will be instructed to perform a daily self-assessment on the cough symptoms over the 3 days of treatment, in the Subject Diary. Subject shall return to the study clinic 3 days ± 24 hours after the first dose, for completion of the subject's participation in the study.

Eligibility criteria: Inclusion Criteria:

1. Healthy men or women aged 18 to 60 years with cough with/without sore throat with a maximum onset of 3 days.
2. Signing the informed consent.

Exclusion Criteria:

1. Body temperature of \> 37.3˚C and/or refuse to follow health protocol for COVID-19
2. Known hypersensitivity to herbal drugs
3. Pregnant or lactating women
4. Have received any anti-inflammatory or cough-alleviating drugs within the past 24 hours
5. Presence of vomiting or diarrhea within the past 24 hours and still ongoing at the start of study
6. Severe illness, e.g. severe hypertension, any other chronic infections or diseases that may induce cough, such as: pulmonary tuberculosis, gastrointestinal reflux diseases (GERD)

Primary outcomes:
measure: Cough score
timeFrame: Day 0, Day 1, Day 2, Day 3
measure: Visual Analogue Scale (VAS)
timeFrame: Day 0, Day 1, Day 2, Day 3
measure: Adverse events
timeFrame: Day 0, Day 1, Day 2, Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Imeri Fkui
state: DKI Jakarta
city: Depok
country: Indonesia
facility: Klinik Satelit Makara UI Depok
state: Jawa Barat
Study officials:
affiliation: Department Pharmacology & Therapeutics Faculty of Medicine Universitas Indonesia
name: Dewi S Rosdiana, Dr,MD,MKes
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04085757: Optimal Timing of Dinoprostone Administration Prior to Office Hysteroscopy
Official title: Determining the Optimal Time Interval Between Vaginal Dinoprostone Administration and Diagnostic Office Hysteroscopy in Nulliparous Women: A Randomized Double-Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dinoprostone Timing
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine whether dinoprostone administered 10 hours before office hysteroscopy can relieve pain more effectively compared with dinoprostone administered 3 hours before office hysteroscopy.


Eligibility criteria: Inclusion Criteria:

* Nulliparous patients who have an indication for office hysteroscopy

Exclusion Criteria:

* Parous patients, menopausal patients and patients with cervical pathology, and previous cervical surgery will be excluded from the study. Moreover, patients with severe vaginal bleeding, allergy to dinoprostone

Primary outcomes:
measure: Intensity of pain
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: faculty of medicine Cairo university
city: Giza
country: Egypt
facility: Tertiary referral hospital
Study officials:
affiliation: Cairo University
name: AHMED SAMY
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rund NMA, El Shenoufy H, Islam BA, El Husseiny T, Nassar SA, Mohsen RA, Alaa D, Gad Allah SH, Bakry A, Refaat R, Gehad MA, Kotb MMM, Osman OM, Ashour ASA, Ali AS, Taher A, Kholaif K, Hashem AT, Elsallamy AAH, Nour DA, Dahab S, Talaat B, Almohammady M. Determining the Optimal Time Interval between Vaginal Dinoprostone Administration and Diagnostic Office Hysteroscopy in Nulliparous Women: A Randomized, Double-blind Trial. J Minim Invasive Gynecol. 2022 Jan;29(1):85-93. doi: 10.1016/j.jmig.2021.06.021. Epub 2021 Jul 1.
Clinical trial NCT01003457: Ultrasonographic Bladder Wall Thickness and Different Forms of Detrusor Overactivity
Official title: Ultrasonographic Bladder Wall Thickness and Different Forms of Detrusor Overactivity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Detrusor Overactivity
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2009-10-28
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all women with urinary dysfunction

Brief summary: In the last decade, several authors proposed ultrasound measurement of Bladder wall thickness (BWT) for the screening of the voiding dysfunction and of the detrusor overactivity (DO). The aims of the investigator prospective study were:

* to compare the ultrasonographic measurement of BWT in women with DO vs women with other urodynamic diagnosis in a very large population.
* to verify whether the BWT in women with DO can be different in the clinically or urodinamically different forms of DO.


Eligibility criteria: Inclusion Criteria:

* All women referred to our Urogynecology Unit from January 2005 to December 2008 for symptoms of OAB, stress urinary incontinence or mixed incontinence and sottoposte a prove urodinamiche complete were included in this prospective study

Exclusion Criteria:

* The investigators excluded women with documented recurrent urinary tract infections
* Previous antimuscarinic treatment
* Previous pelvic surgery
* Neurological disease
* Vaginal prolapse \> I stage
* Symptoms or clinical and/or urodynamic signs of voiding dysfunction
* Patients included in other ongoing clinical trials during the same study period.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Varese
country: Italy
facility: University of Insubria
Study officials:
References:
citation: Serati M, Salvatore S, Cattoni E, Soligo M, Cromi A, Ghezzi F. Ultrasound measurement of bladder wall thickness in different forms of detrusor overactivity. Int Urogynecol J. 2010 Nov;21(11):1405-11. doi: 10.1007/s00192-010-1194-1. Epub 2010 Jun 10.