louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02924103: Contamination Free Bacterial Swap
Official title: Danish Title: Afprøvning af indføringsrør Til Forureningsfri Podning af næsens Bihuler (Den Forureningsfri Podepind)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinusitis
Keywords: acute rhinosinusitis
staphylococcus aureus
nasal vestibule
contamination
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Region Capital Denmark
First posted: 2016-10-05
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A test of a newly designed device (Contamination free bacterial swab). This device can be used to introduce a standard bacterial swab into the nose without direct or indirect contact with the nasal vestibule.

Detailed description: Aim:

The investigators want to improved the current method for bacterial culture test in patients with possible sinusitis by reducing the risk of contamination from the nasal vestibule. The investigators will examine whether significantly fewer Staphylococcus Aureus are detected in the middle meatus when applying a new device for bacterial swab introduction. This device is designed to prevent bacterial pollution from the nasal vestibule.

More precisely, the investigators hope to reduce the frequency of Staphylococcus aureus in nasal swabs from 10-15 % to 0-5 %.

The overall objective is to avoid over-treatment with broad-spectrum antibiotics in patients with sino-nasal disease.

Design:

A comparative study in which patients serve as their own control. A bacterial swab will be introduced to both sides of the nose; on the right side using the new device, on the left side using the present day technique (visual guidance). 70 participants will be included.

Statistics:

A chi-square test will be used for comparison of frequencies.

Eligibility criteria: Inclusion Criteria:

* symptoms of upper airway disease

Exclusion Criteria:

* mental illness
* Need for interpreter

Primary outcomes:
measure: Frequency of staphylococcus aureus positive cultures
timeFrame: 1 year
Secondary outcomes:
measure: Frequency of other bacteria in cultures
timeFrame: 1 year
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Ørelæge Steffen Ørntoft
Study officials:
affiliation: Steffen Ørntoft, Ear, Nose and Throat specialist clinic
name: Steffen Ørntoft, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06965803: This Study is to Evaluate Whether Receiving Education and Glucose Monitoring With the CGM Device Will Improve Patient-reported Outcomes by Improving Patient's Satisfaction and Quality of Life (QOL) With Glucose Monitoring Device.
Official title: Continuous Glucose Monitor (CGM) Discharge Program
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes Mellitus
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 37
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: • Admitted patient with Type 1 or Type 2 diabetes.

Brief summary: The purpose of the study is to improve patient-reported outcomes by improving patient's satisfaction and quality of life (QOL) with glucose monitoring device through pre and post satisfaction survey of patient with diabetes.


Eligibility criteria: Inclusion Criteria:

* aged 18 or older
* diagnosed with Type 1 or Type 2 Diabetes who are on insulin
* able to speak and understand English language
* scheduled to receive a standard inpatient diabetes education consultation
* must not have used CGM in the six months prior to admission
* owns a smartphone
* demonstrates the ability to follow instructions and be capable of providing informed consent to participate in the program

Exclusion Criteria:

* those who are known to be pregnant. This is due to complexity of pregnancy-related changes in glucose metabolism and increased skin sensitivity, or changes in skin condition to adhesives and materials used in CGM devices.
* non-English speakers. As this is small study to evaluate which method is favorable using a survey only validated in English, enrolling non-English speakers would require additional resources/translations/personnel for evaluation and the education intervention that are not logistically possible right now.

Primary outcomes:
measure: Patient Satisfaction
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06014203: Examination of Edema After Arthroscopic Shoulder Surgery
Official title: Examination of Edema After Arthroscopic Shoulder Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Edema
Arthroscopy
Shoulder
Keywords: Edema
Shoulder arthroscopy
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for arthroscopic shoulder surgery in Gazi University Hospital, Department of Orthopedics and Traumatology

Brief summary: The investigators's aim is to examine trunk and upper extremity edema after arthroscopic rotator cuff repair and/or labrum repair surgeries. During surgery, the shoulder joint capsule is cut and the joint is entered arthroscopically. During this procedure, approximately 3-6 liters of saline fluid is injected into the joint, depending on the duration of the surgery. The given fluid accumulates out of the joint in relation to the duration of the surgery and the amount of fluid given. In this study, the investigators aim is to examine how much the extra-articular fluid collects under the skin of the upper extremity and trunk, and the change in the amount of fluid 24 hours after surgery. Examination of the amount of subcutaneous fluid may help to better understand the postoperative complications such as edema, carpal tunnel syndrome, compartment syndrome, myolysis, and dyspnea. How much edema the joint and surrounding structures are exposed to and its relationship with the duration of surgery can help to clinicians determine the safe discharge time.


Eligibility criteria: Inclusion Criteria:

* Arthroscopic shoulder surgery planned
* 18-65 years old

Exclusion Criteria:

* Frozen/stiff shoulder
* Metabolic and endocrine diseases
* Dermatological pathologies
* Hyperlaxity

Primary outcomes:
measure: Edema
timeFrame: 3 months
Secondary outcomes:
measure: Surgery time
timeFrame: 3 months
measure: Amount of the saline
timeFrame: 3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Ulunay Kanatlı
role: STUDY_DIRECTOR
References:
Clinical trial NCT00669903: Study to Asses Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of AZD0328 in Patients With Schizophrenia
Official title: A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Oral Multiple Ascending Doses of AZD0328 in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of multiple ascending doses of AZD0328 in patients with schizophrenia


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition)
* Low level of Extra-pyramidal symptoms
* No clinically significant findings on physical examination

Exclusion Criteria:

* Diagnosis of schizoaffective or schizophreniform disorders
* Any significant psychiatric or neurological disease other than schizophrenia

Primary outcomes:
measure: CogState Groton Maze Learning Task (GMLT) and One Card Learning Task (OCLT) Standardized Composite Score at Day 14
timeFrame: Baseline and Day 14
Secondary outcomes:
measure: CogState Groton Maze Learning Task (GMLT) Standardized Change Score at Day 14
timeFrame: Baseline and Day 14
measure: CogState One Card Learning Task (OCLT) Standardized Change Score at Day 14
timeFrame: Baseline and Day 14
measure: CogState Detection Task (DT) Standardized Change Score at Day 14
timeFrame: Baseline and Day 14
measure: CogState Identification Task (IT) Standardized Change Score at Day 14
timeFrame: Baseline and Day 14
measure: CogState Groton Maze Recall Task (GMRT) Standardized Change Score at Day 14
timeFrame: Baseline and Day 14
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Research Center
state: California
city: Glendale
country: United States
facility: Research Center
state: California
Study officials:
References:
Clinical trial NCT05521503: Biopsy Collection and Repository Database
Official title: Cardiac Biopsy Collection Repository and Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing evaluation of a cardiac condition or receiving a right heart catheterization with biopsy clinically indicated who are at least 18 years of age.

Brief summary: Use samples procured from patients to improve understanding of molecular, cellular, and tissue-level processes produced by a variety of cardiac diseases and therapeutic interventions.

Detailed description: This is a prospective study enrolling patients referred for or undergoing cardiovascular procedures or treatment at the University of Kentucky. The study aims to facilitate the discovery of novel diagnostic biomarkers and therapeutic targets and improve the pathophysiological understanding of cardiac conditions.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing evaluation of a cardiac condition or receiving a right heart catheterization with biopsy clinically indicated who are at least 18 years of age.

Exclusion Criteria:

* Patients without a cardiovascular or amyloidosis diagnosis, under 18 years of age.

Primary outcomes:
measure: Discover and quantify the concentration of novel diagnostic and prognostic biomarkers
timeFrame: 12/21/2021-12/31/2030
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Andrew R Kolodziej, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04433403: Pathogenic Microorganisms in Adult Severe Pneumonia Patients
Official title: A Multicenter Clinical Study on the Detection of Pathogenic Microorganisms in Adult Severe Pneumonia Patients in Liaoning Province
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pathogenic Microorganism of Serious Pneumonia
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
Collaborators: name: Chaoyang Central Hospital
name: Yingkou Central Hospital
name: Huludao central hospital
name: Dandong First Hospital
name: Fushun Mining Bureau General Hospital
name: Benxi Cental Hospital
First posted: 2020-06-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Severe pneumonia patients, aged 18 years and above, gender unlimited.

Brief summary: This study aimed to evaluate pathogenic microorganisms in adult severe pneumonia patients in different cities of Liaoning Province

Detailed description: The pathogenic microorganisms of adult patients with severe pneumonia is detected in this study. Clinical treatment does not involve , so it meets the ethical requirements. The clinical data, laboratory test results and imaging data of adult severe pneumonia patients in different hospitals in different cities are recorded. The pathogenic microorganism is detected by second-generation sequencing of lower respiratory tract sputum or alveolar lavage fluid samples, and the data were sorted out to draw the pathogenic microorganism spectrum of adult severe pneumonia in Liaoning area. It will be used to guide clinical empirical treatment.

Eligibility criteria: Inclusion Criteria:

* Meet the standard of severe pneumonia： Main standards： Requiring mechanical ventilation or septic shock requiring vasoconstrictor therapy.

Secondary standards：(only if 3 items are met) Disturbance of consciousness; respiratory rate ≥ 30 times/min; PaO2/FiO2 ≤ 250, or PaO2 \< 60mmHg; azotemia (BUN ≥ 7.12mmol / L); hypotension requires strong fluid resuscitation; infiltration of multiple lobes; leucopenia (WBC \< 4 × 109 / L); thrombocytopenia (\< 10 × 109 / L); hypothermia (T \< 36 ℃).

Exclusion Criteria:

* refuse to sign informed consent; inaccurate results due to unqualified sputum or BALF samples

Primary outcomes:
measure: Pathogenic microorganism spectrum of adult severe pneumonia in Liaoning Province
timeFrame: 2020.7-2023.12
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing hospital of China Medical University
state: Liaoning
Study officials:
References:
Clinical trial NCT03852303: Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy
Official title: OAETREAT Extra Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy: a
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: European Research Council
First posted: 2019-02-25
Enrollment: 197
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial in the Logo health zone, in Ituri province, Democratic Republic of Congo to compare seizure freedom in onchocerciasis infested epilepsy patients who ivermectin treatment once a year compared to 2 and 3 times a year. All participants also receive anti-epileptic drugs according to local guidelines for epilepsy treatment. Participants will be followed for 12 months. The primary endpoint is seizure freedom defined as no seizures during the last fourth months of the trial.

Detailed description: Randomized clinical trial in the Logo health zone, in Ituri province, Democratic Republic of Congo to compare seizure freedom in onchocerciasis infested epilepsy patients who ivermectin treatment once a year compared to 2 and 3 times a year. All participants also receive anti-epileptic drugs according to local guidelines for epilepsy treatment. Participants will be followed for 12 months.The primary endpoint is seizure freedom defined as no seizures during the last fourth months of the trial.

Eligibility criteria: Inclusion Criteria:

* Age 5 years and above
* Signed informed consent form
* Normal neurological development until onset of epilepsy
* Onset of epilepsy between ages of 5 and 18 years
* Presence of microfilaria in skin snip and/or antibodies against Ov16

Exclusion Criteria:

* Ivermectin intake the last 9 months
* Pregnancy or breastfeeding
* Known or suspected allergy to Ivermectin
* Loa Loa microfilariae in blood
* Epilepsy with known cause (e.g. severe head trauma, perinatal asphyxia, patients with a history of cerebral malaria, meningitis or encephalitis)
* Concomitant acute illness or chronic medication use
* Chronic alcohol/substance use

Primary outcomes:
measure: seizure freedom
timeFrame: month 9-12
Secondary outcomes:
Other outcomes:
Locations:
city: Rethy
country: Congo, The Democratic Republic of the
facility: Centre de Recherche en Maladies Tropicales de l'Ituri
state: Ituri
Study officials:
affiliation: Universiteit Antwerpen
name: Robert Colebunders, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02388503: The Effect of a Natural Extract on the Post-prandial Blood Glucose Response After Bread Consumption: a Dose-response of Efficacy
Official title: The Effect of a Natural Extract on the Post-prandial Blood Glucose Response After Bread Consumption: a Dose-response of Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Blood glucose
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
First posted: 2015-03-17
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to identify the minimal effective tested dose of fruit extract consumed with a bread which provides a reduction in venous post-prandial blood glucose compared to a reference bread.


Eligibility criteria: Inclusion criteria:

* Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.
* Apparently healthy males and females: no medical conditions which might affect the study measurements including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases.
* Fasting blood glucose value of subjects ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening.

Exclusion criteria:

* Use of antibiotics within 3 months before day 1; use of any other medication except paracetamol, within 14 days before day 1.
* Blood donation in the past 3 months and/or during the study.
* Reported intense sporting activities \> 10 h/week.
* Consumption of \> 14 units (female subjects) and \> 21 units (male subjects) alcoholic drinks in a typical week.
* Reported dietary habits: medically prescribed diet, slimming diet, not used to eat 3 meals a day, vegetarian.
* If female, is pregnant (or has been pregnant during the last \< 3 months) or will be planning pregnancy during the study period.
* If female, is lactating or has been lactating in the 6 weeks before screening and/or during the study period.
* Dislike, known allergy or intolerance to test products or other food products provided during the study.

Primary outcomes:
measure: Positive incremental post-prandial blood glucose area under the curve
timeFrame: 120 minutes
Secondary outcomes:
measure: Post-prandial insulin response
timeFrame: 120 minutes
measure: Post-prandial insulin response
timeFrame: 180 minutes
measure: AUC of fruit extract calculated by a non-compartmental model
timeFrame: 180 minutes
measure: AUC of fruit extract calculated by a population model
timeFrame: 180 minutes
measure: Positive incremental post-prandial blood glucose area under the curve
timeFrame: 180 minutes
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité research organisation
state: Charitéplatz 1
Study officials:
References:
Clinical trial NCT05331703: Virtual Reality Versus Mirror Therapy on Balance and Muscle Strength in Children With Hemiplegic Cerebral Palsy
Official title: Virtual Reality Versus Mirror Therapy on Balance and Muscle Strength in Children With Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rehabilitation
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Previous research has demonstrated balance deficits ranging from 28%-43% depending on the nature of the balance task in individuals with CP compared to controls (Kenis-Coskun et al., 2016). As balance is critical for underlying normal movement, improvements in static and dynamic balance are important goals in rehabilitation for ambulatory children with CP (Saether et al., 2013).

Balance deficits are among the symptoms that having a more profound impact on motor function and quality of life inn with CP children (Lai et al., 2017). Poor balance reduces the ability to perform gait-related activities and increases the risk of falling, which, in turn, limits participation in daily activities, including sports and physical activities (Usuba et al., 2015).


Eligibility criteria: Inclusion Criteria:

* Their ages will range from 6 to 10 years old.
* The degree of spasticity will range from 1+ to 2 grades according to Modified Ashworth scale (NUMANO and Günel, 2011) (Appendix II).
* They will be on level I and II on Gross Motor Function Classification System (GMFCS) (Palisano et al., 2008) (Appendix III).
* Their heights will be one meter or more.
* They will be able to follow the verbal commands or instructions.

Exclusion Criteria:

* Severe visual or auditory problems.
* Epilepsy.
* History of surgical interference in lower limbs.
* Botulinum toxin injections of the lower limbs during the previous six

Primary outcomes:
measure: Biodex balance system
timeFrame: 3 months
measure: Hand held dynamometer
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Emad Eldin
state: October
Study officials:
References: