louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06148350: Frenkel's Exercises for Sub-Acute Ischemic Stroke Patients
Official title: Regaining Balance and Quality of Life: The Impact of Frenkel's Exercises in Patients With Sub-Acute Ischemic Stroke-A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Keywords: Stroke
Disability
Exercise
Balance
Quality of Life.
Lead sponsor: Al- Shifa Physiotherapy Institute /Clinic
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This single-blinded, randomized controlled was aimed to compare the efficacy of Frenkel's and Conventional Balance Exercises in improving balance and quality of life in patients with subacute ischemic stroke. The participants of Group A received 'Frenkel's Exercises'. In contrast, Group B participants received 'Conventional Balance Exercise' interventions three days/week for 30-60 minutes for four weeks. The data was collected pre and post-treatment on the Berg Balance Scale and Stroke Specific-Quality of Life.


Eligibility criteria: Inclusion Criteria:

1. Patients aged between 35 to 75 years.
2. First-ever ischemic stroke and hemiparesis within 7 to 30 days of onset.
3. Reduced proprioception of the lower limb with a score of ≤12 on the NSA (kinesthetic and tactile sensation test),
4. Able to comprehend tasks and follow directions with a score of ≥21 points on the Mini-Mental State Examination (MMSE).
5. Able to independently perform standing motions for ≥1 minute.

Exclusion Criteria:

1. Patients with lower limb fractures within 6 months.
2. Severe pain.
3. Limited range of motion.
4. Cerebellar ataxia.
5. Medically unstable.

Primary outcomes:
measure: Berg Balance Scale
timeFrame: Baseline
measure: Berg Balance Scale
timeFrame: After 4-weeks
measure: Stroke-Specific Quality of Life Scale
timeFrame: Baseline
measure: Stroke-Specific Quality of Life Scale
timeFrame: After 4-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Al-Shifa Physiotherapy Clinic Qasimabad Hyderabad
state: Sindh
Study officials:
References:
Clinical trial NCT04869150: Does Myocardial Bridge Appear More Frequently and Diffusely on Radial Access Coronary Angiography
Official title: Cigli Training and Research Hospital Organization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Bridge of Coronary Artery
Keywords: myocardial bridge
radial access coronary angiography
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A retrospective evaluation was made of the coronary angiographies of 2600 consecutive patients who underwent radial access coronary angiography between January 2018 and February 2020

Brief summary: Although the incidence of myocardial bridge (MB) has been defined in different conventional coronary angiography (CCA) studies,the frequency of MB in radial access coronary angiography (RACA) is unknown.The aim of this study was to determine the incidence of MB in patients undergoing RACA.


Eligibility criteria: Inclusion Criteria:

* Undergoing radial access coronary angiography
* Have myocardial bridge

Exclusion Criteria:

* A history of coronary artery bypass grafting (CABG)

Primary outcomes:
measure: Does Myocardial Bridge Appear More Frequently and Diffusely on Radial Access Coronary Angiography?
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Cigli Training and Research Hospital
Study officials:
References:
Clinical trial NCT02764450: 10 Years Evaluation of Composite Restoration
Official title: Marginal Quality of Posterior Microhybrid Resin Composite Restorations Applied Using Two Polymerisation Protocols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Restoration, Permanent
Keywords: composite
restoration
polymerization
Lead sponsor: BNM Clinic and Research
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This randomised, split-mouth clinical study evaluated the marginal quality of direct Class I and Class II restorations made of microhybrid composite and applied using two polymerisation protocols,


Eligibility criteria: Inclusion Criteria:

* subjects at least 18 years old,
* require restorations due to primary caries in contralateral quadrants with opposing and adjacent tooth contact,
* having no restoration in the antagonist,

Exclusion Criteria

* allergic to resin-based materials,
* pregnant or nursing,
* periodontal disease

Primary outcomes:
measure: Number of cavity filled with problem in marginal adaptation and in marginal discoloration
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Barabanti N, Gagliani M, Roulet JF, Testori T, Ozcan M, Cerutti A. Marginal quality of posterior microhybrid resin composite restorations applied using two polymerisation protocols: 5-year randomised split mouth trial. J Dent. 2013 May;41(5):436-42. doi: 10.1016/j.jdent.2013.02.009. Epub 2013 Feb 27.
Clinical trial NCT06438250: 68Ga-JH04 PET/CT: Dosimetry and Biodistribution Studies
Official title: 68Ga-JH04 PET/CT: Dosimetry and Biodistribution Study in Patients With Various Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Malignant Neoplasm
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Drug: 68Ga-JH04
Primary purpose: DIAGNOSTIC

Brief summary: 68Ga-JH04 is a novel radiotracer targeting fibroblast activation protein (FAP). In this study, we observed the safety, biodistribution, and radiation dosimetry of 68Ga-JH04 in patients with different types of cancer.

Detailed description: Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, and showed high efficacy in tumor staging and restaging. 68Ga-JH04, a novel radiopharmaceutical targeting FAP, demostrated high stability in vitro and in vivo, and can accumulate specifically in tumors with high binding affinity, safety, and selectivity in preclinical studies. In this study, the safety, biodistribution, and radiation dosimetry of 68Ga-JH04 in patients with different types of cancer were observed to evaluate the dosimetric characteristics of 68Ga-JH04.

Eligibility criteria: Inclusion Criteria:

* Various solid tumors with available histopathological findings
* Signed informed consent

Exclusion Criteria:

* pregnant or lactational women
* who suffered from severe hepatic and renal insufficiency

Primary outcomes:
measure: safety and tolerability
timeFrame: Up to 1 week
Secondary outcomes:
measure: Human biodistribution
timeFrame: From right after tracer injection to 150 minutes at post-injection
measure: Human dosimetry
timeFrame: From right after tracer injection to 150 minutes at post-injection
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: The First Affiliated Hospital, Fujian Medical University
name: Weibing Miao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02854150: Improving Genetic Counseling for Patients With Spina Bifida Using Next Generation Sequencing
Official title: Improving Genetic Counseling for Patients With Spina Bifida Using Next Generation Sequencing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spina Bifida
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Spina Bifida patients (without age restriction), attending the genetic consultation at the National Reference Centre for Spina Bifida

Brief summary: The main objective is to improve genetic counseling in patients with Spina Bifida, by the characterization of variants in new genes using high throughput sequencing either on a panel of targeted genes or on exome in families.


Eligibility criteria: Inclusion Criteria:

* Spina Bifida patients (without age restriction), attending the genetic consultation at the National Reference Centre for Spina Bifida. These patients gave their written agreement for studying genes which could be involved in Spina Bifida.

Exclusion Criteria:

* Patients who refused to give their authorization to perform the sequencing of genes involved in Spina Bifida on their DNA

Primary outcomes:
measure: absence or low frequency (<1%) in public databases (dbSNP, Hapmap, 1000Genome)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre hospitalier universitaire de RENNES
Study officials:
References:
Clinical trial NCT04940650: COUREUR Study Myocardial Inflammation in Cyclist Part 1
Official title: Detection of Myocardial Inflammation in Cyclists After Strenuous Exercise: a Pilot Study Part 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Inflammation
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study will evaluate myocardial inflammation in cyclists after high intense and sustained exercise. Our hypothesis is that strenuous exercise in recreational cyclists may be associated with myocardial inflammation. Myocardial fibrosis in asymptomatic athletes is associated with life-threatening arrhythmic events and sudden death. Although myocarditis seems to be the most likely underlying cause, it remains unclear if strenuous and sustained physical exercise can cause myocardial inflammation with development of myocyte necrosis and possibly myocardial fibrosis in athletes.

Nineteen recreational cyclists performing "L'ETAPE DU TOUR (EDT) de France" a cycling ride (175 km, 3600 m of positive altitude difference) on July 4 2021 will be included in this study.

In part 1 of the study, each participant will complete a detailed questionnaire detailing their training history and an echocardiography at rest will be performed. All participants will have exercise testing approximately 1 week before the EDT stage to set aerobic and anaerobic gas exchange thresholds, as well as VO2max.


Eligibility criteria: Inclusion Criteria:

* Recreational cyclists performing the 'étape du tour (EDT) de France 2021 ride

Exclusion Criteria:

* presence of pre-existing cardiovascular or pulmonary diseases, hypertension, diabetes, peripheral vascular diseases, any inflammatory or auto-immune diseases and the intake of anti-inflammatory drugs.

Primary outcomes:
measure: DETECTION OF MYOCARDIAL INFLAMMATION IN CYCLISTS AFTER STRENUOUS EXERCISE: A PILOT STUDY PART 1
timeFrame: approximately 1 week before the strenuous exercise
measure: DETECTION OF MYOCARDIAL INFLAMMATION IN CYCLISTS AFTER STRENUOUS EXERCISE: A PILOT STUDY PART 1
timeFrame: approximately 1 week before the strenuous exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Hasselt University
city: Hasselt
country: Belgium
facility: Jessa Hospital
Study officials:
References:
Clinical trial NCT04888650: Assessment of the State of Health, Quality of Life and Expectations of Patients With Hereditary Angioedema
Official title: Assessment of the State of Health, Quality of Life and Expectations of Patients With Hereditary Angioedema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hereditary Angioedema
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2021-05-17
Enrollment: 314
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with HAE with or without C1 inhibitor deficiency

Brief summary: 8 years after the establishment of the therapeutic education program and 14 years after the creation of the National Reference Center for Angioedemas (CREAK), it is necessary to make an inventory in 2021 on the disease experienced by the patient with an assessment the needs and expectations of HAE patients. This assessment would make it possible to see the evolution of these needs and to adjust the price for the overall cost of children and adults in France. It may also allow a comparison of the requests expressed during a similar survey in another French-speaking region such as Quebec.

Main objective is to know the needs and the current satisfaction of the needs, with regard to the disease and the treatment of the targeted patients of hereditary angioedema (HAE)


Eligibility criteria: Inclusion Criteria:

* Patient with HAE with or without C1 inhibitor deficiency
* Patient over 15 or parents of a child under 15 with HAE

Exclusion Criteria:

* Patient opposed to the use of their data or refusing to answer the questionnaire
* Adult patients protected by law

Primary outcomes:
measure: the needs and the current satisfaction of the needs, with regard to the disease and the treatment of patients with hereditary angioedema (HAE)
timeFrame: baseline
Secondary outcomes:
measure: comparaison of results with quebec
timeFrame: baseline
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHUGA
Study officials:
References:
Clinical trial NCT01521650: Probiotics Against Pathogenic Bacteria in Connection With Anaesthesia
Official title: Probiotics for Reduction of Colonisation With Pathogenic Bacteria in the Oropharynx in Connection With Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oropharyngeal Microbiology
Keywords: Probiotics
Anaesthesia
Intubation
Pathogenic bacteria
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2012-01-31
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Longer surgical procedures require intubation and there is a potential risk of contaminating the lower airways with pathogenic bacteria from the mouth and oropharynx.

Healthy people seldom have pathogenic bacteria originating from the gastro-intestinal canal but those do occur among patients, both in those not so sick and patients with more severe problems.

For ICU patients we have seen a reduction of emerging enteric bacteria in patients given oral care with probiotics and this is a pilot study to explore the possibility of the same kind of positive effects in patients due for longer (more than 4 hours of anesthesia) procedures.

Randomisation

* No prophylaxis
* Preparation with a probiotic suspension before intubation.

Cultures

* oropharynx

  * before treatment
  * after intubation
  * before extubation
  * day 1 postoperatively
* tracheal secretions

  * after intubation
  * before extubation


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Planned interventions
* Anaesthesia \> 4 hours and requiring intubation

Exclusion Criteria:

* Ulcers in the mouth, oropharynx, oesophagus and stomach
* Current infections in the airways
* Known immuno deficiences
* Emergency cases

Primary outcomes:
measure: Differences in pathogenic bacteria in the oropharynx and lower airways
timeFrame: During hospitalization, up to 4 weeks
Secondary outcomes:
measure: White blood cells
timeFrame: During hospitalization, up to 4 weeks
measure: CRP
timeFrame: During hospitalization, up to 4 weeks
measure: Pneumonia
timeFrame: Up till 7 days postoperatively
measure: Length of hospital stay
timeFrame: time to discharged from hospital or patients death
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University Hospital
Study officials:
affiliation: Lund University
name: Bengt klarin, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stjernquist-Desatnik A, Warfving H, Johansson ML. Persistence of Lactobacillus plantarum DSM 9843 on human tonsillar surface after oral administration in fermented oatmeal gruel. A pilot study. Acta Otolaryngol Suppl. 2000;543:215-9. doi: 10.1080/000164800454422.
citation: Klarin B, Molin G, Jeppsson B, Larsson A. Use of the probiotic Lactobacillus plantarum 299 to reduce pathogenic bacteria in the oropharynx of intubated patients: a randomised controlled open pilot study. Crit Care. 2008;12(6):R136. doi: 10.1186/cc7109. Epub 2008 Nov 6.
Clinical trial NCT02595450: A Non-interventional Trial of Erlotinib (Tarceva) Metastatic Non-small Cell Lung Cancer
Official title: A Non Interventional Trial of Tarceva Metastatic Non Small Lung Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-small cell lung cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-11-03
Enrollment: 299
Sex: ALL
Minimum age (years): 35
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with locally advanced or metastatic NSCLC that are planned to receive erlotinib containing regimen according to label will be included in this trial.

Brief summary: This is a non-interventional, open label, single arm, multicenter study to assess the safety and efficacy of erlotinib in participants with non-small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* It is the physician's decision to prescribe erlotinib in participants and to document their treatment
* Participants must be candidates for receiving erlotinib for locally advanced or metastatic non-small cell lung cancer according to the product label

Exclusion Criteria:

* Participants will be excluded if safety concerns occurred
* If the participant was not compliant or if the participant would wish to stop erlotinib therapy

Primary outcomes:
measure: Progression-free Survival (PFS) Time
timeFrame: Up to 6 years
measure: Percentage of Participants With Best Overall Response
timeFrame: Up to 6 years
Secondary outcomes:
measure: Overall Survival (OS) Time
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Bludesch
country: Austria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01631955: Assessment of UTI Symptoms and Quality of Life According to Antibiotics Treatment in Acute Uncomplicated Cystitis
Official title: A Study of Quality of Life and Changes to Symptom Relief for Acute Uncomplicated Cystitis Treated With Antibiotics (Ciprobay); Prospective, Open-label, Multicenter, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Cystitis
Keywords: Acute cystitis
Antibiotics
Quality of life
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 386
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatient

Brief summary: Although Cystitis includes a clinical syndrome characterized by various combinations of dysuria (painful urination), frequency, urgency, gross haematuria, lower back and/or abdominal/suprapubic discomfort with pyuria and bacteriuria. An acute uncomplicated UTI (referred to as cystitis) has been focused microorganisms and drug-resistance. There has been little research on Clinical aspects on cystitis treatment such as bothersomeness, or the impact of symptoms on patients' quality of life (QoL). The investigators want to study for Assessment of UTI Symptoms and Quality of Life According to Antibiotics Treatment(Ciprobay) in Acute Uncomplicated Cystitis in Korean Women.


Eligibility criteria: Inclusion Criteria:

* Female outpatients (20-65 years old)
* Acute cystitis symptoms (subject-reported) for \< 1 week prior to Visit 1.

Exclusion Criteria:

* Acute cystitis symptoms for ≥ 1 week prior to Visit 1.
* Diabetes mellitus
* Congenital urinary tract abnormality
* Female subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant during the study or within 3 months after the completion of the study.
* Hypersensitivity to the active substance (Ciprobay).
* Subjects who have vaginal discharge
* Fever ( ≥ 37.5 ºC)
* Sexually transmitted diseases.
* Documented significant renal disease (sCr \> 1.5)
* Subjects who cannot consent to this study.
* Subjects who had received antimicrobial agents in the previous 4 weeks.
* Recurrent urinary tract infection defined as treatment for UTI \> 3 times in the last year.
* Use of an indwelling catheter or an intermittent self-catheterization program.
* Neurogenic bladder.

Primary outcomes:
measure: Effect on patient satisfaction and quality of life.
timeFrame: at day 5 relative to baseline
Secondary outcomes:
measure: Change in UTISA sub-category (dysuria, frequency, urgency, pain, hematuria)
timeFrame: at day 10, 21 and 28 relative to baseline
measure: Change in KHQ
timeFrame: at day 10, 21 and 28 relative to baseline
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
state: Gyeonggi-do
Study officials:
affiliation: Soonchunhyang University Hospital
name: Min-Eui Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: