louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05339997: Evaluation of Respiratory Function and Functional Capacity in Pediatric Patients With Chronic Kidney Disease (CKD)
Official title: Evaluation of Respiratory Function and Functional Capacity in Pediatric Patients With Chronic Kidney Disease (CKD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Chronic Renal Disease
Chronic Renal Failure
Keywords: pediatric chronic kidney disease
pulmonary function
functional capacity
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients aged 5-18 years with stage 1-5 chronic kidney disease

Brief summary: Chronic kidney disease (CKD) is defined as a permanent abnormality in kidney structure or function that persists for more than 3 months (for example, glomerular filtration rate \[GFR\] \<60 mL/min/1.73 m2 or albuminuria ≥30 mg/24 hours) and, it effects the 8% to 16% of the population worldwide.In pediatric patients with CKD, exercise capacity begins to decline in stage 3 of the disease and progressively decreases in stage 5, in dialysis and transplant patients (4, 5). Reduction in respiratory muscle strength and six minute walk test (6MWT) is observed in patients with CKD treated with hemodialysis (HD).The aim in present study is to evaluate the relationship between functional capacity and respiratory functions in stage 1-5 pediatric chronic kidney disease patients.

Detailed description: The aim of this study is to evaluate functional capacity with six minutes walk test (6MWT), respiratory functions with spirometer and the correlation between functional capacity and respiratory functions in pediatric CKD patients.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 5-18, having stage I-V chronic kidney disease,
* Having chronic kidney disease for at least 6 months,
* Not having visual and hearing impairment

Exclusion Criteria:

Presence of mental retardation,

* Insufficient Turkish communication, Inability to communicate,
* Having metabolic-neurological problems,
* Presence of cardiomyopathy, angina pectoris,
* Presence of orthopedic problem that will prevent standing and walking
* Cerebrovascular disease
* Patients will not be included in the study in the presence of metastatic carcinoma.

Primary outcomes:
measure: 6 minute walk test
timeFrame: during the procedure
Secondary outcomes:
measure: pulmonary function test
timeFrame: during the procedure
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Mehmet Ali Aydınlar University
Study officials:
affiliation: Acıbadem Mehmet Ali Aydınlar University
name: Irmak Çavuşoğlu, MSc
role: STUDY_DIRECTOR
affiliation: Acıbadem Mehmet Ali Aydınlar University
name: Elif Esma Safran, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT06892197: Comparing Hydrocortisone and Prednisolone for Community Acquired Pneumonia (CAP)
Official title: Comparing Hydrocortisone and Prednisolone for Community Acquired Pneumonia (CAP)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Community Acquired Pneumonia (CAP)
Lead sponsor: Copenhagen Respiratory Research
Sponsor class: NETWORK
First posted: 2025-03-24
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a cluster randomized controlled trial. It consists of two arms, in which patients will be randomized to receive treatment with either Hydrocortisone or Prednisolone.
Primary purpose: TREATMENT

Brief summary: The goal of this cluster randomized controlled trial is to determine the optimal treatment for community aquired pneumonia (CAP). The study compares the effects and side effects of hydrocortisone and prednisolone in patients above 18 years old diagnosed with severe CAP. The main question is whether there is a difference in all cause mortality within thirty days.

Participants will be randomized to receive treatment with either hydrocortisone or prednisolone.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Diagnosis of severe CAP for who the physician in charge decides for corticosteroid therapy for severe CAP.

Exclusion Criteria:

* Admitted \>24 h
* Pregnant or breastfeeding women
* Active tuberculosis or fungal infection
* Pneumonia caused by influenza
* Intolerance to either study drug

Primary outcomes:
measure: All-cause mortality
timeFrame: 30 days
Secondary outcomes:
measure: All-cause mortality
timeFrame: 90 days
measure: All-cause infections
timeFrame: 90 days
measure: Need for vasopressor treatment
timeFrame: 30 days
measure: Need for mechanical ventilation
timeFrame: 30 days
measure: Admission to ICU
timeFrame: 30 days
measure: Daily amount of insulin administered to the patient by day 7 or discharge from hospital
timeFrame: 7 days
measure: Gastrointestinal bleeding
timeFrame: 30 days
measure: Blood glucose levels
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: COP:RESP
name: Jens-Ulrik Stæhr Jensen, MD, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00794105: Observation of Gas Exchange in the Middle Ear
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Normal Middle Ears.
Otitis Media Ears.
Keywords: Gas
Middle ear
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2008-11-19
Sex: ALL
Minimum age (years): 8
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated as a routine treatment in the outpatient or patients admitted for treatment of sudden hearing loss.

Brief summary: Observation of fluid behavior over a perforated eardrum.

A comparison of the behavior of the gas in normal vs. different kinds of otitis media ears.

Detailed description: Fluid present in middle ears is observed during the regular treatment of patients.

The observation in made during the treatment and not as an additional activity. The fluid is either a steroids solution or sterile normal saline or ear's mucus discharge, all in perforated eardrums, either as a part of their intra-tympanic treatment for sudden hearing loss, or traumatic perforation \[considered as the normal ears\] compared to otitis media ears.

The observation is made on bubble formation over the perforation. The time length of the inspection is about 1 minute, under the microscope, during the treatment.

Eligibility criteria: Inclusion Criteria:

* Patients having perforated eardrum.

Exclusion Criteria:

* Non cooperative patients.

Primary outcomes:
measure: Creation of air bubbles.
timeFrame: one year.
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Otolaryngology Dept., Shaare Zedek Medical Center
Study officials:
References:
Clinical trial NCT03596697: A Study in Healthy Volunteers
Official title: A Randomized, Partially-blinded, Placebo-controlled, Ascending Sequential Dose Groups, Single Dose Study of the Safety, Tolerability and Pharmacokinetics of CRV431, Alone and In Combination With Tenofovir Disoproxil Fumarate in Healthy Subjects, With a Pilot Study of Multiple Ascending Sequential Doses in Healthy Volunteer Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis B
Infectious Disease
Liver Diseases
Keywords: CRV431
Hepatitis B Virus
Hepatitis Virus
Lead sponsor: Hepion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-24
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is three part study that will, in part one assess the safety, tolerability, and PK of a single dose of CRV431 in healthy volunteers. The second part of the study will be a single dose drug-drug interaction study in healthy volunteers with CRV431 co-treated with TDF. The third part of the study will assess the safety, tolerability, PK, and preliminary signal for antiviral efficacy and identification of clinically-relevant biomarkers of CRV431 with TDF in stable HBV patients.


Eligibility criteria: Inclusion Criteria:

* Capable of giving written informed consent
* Willing and able to complete all study requirements
* Healthy male or female between 18 and 55 years of age (inclusive);
* Body mass index 16 to 32 kg/m2 (inclusive);

Exclusion Criteria:

* Positive test for HCVAb or HIVAb. For healthy subjects only: positive test for HBsAg
* Current or history of abuse of alcohol or illicit drugs
* Received an investigational drug, vaccine or medical device within 90 days prior to first dose of study drug.

Additional Exclusion Criteria for HBV Pilot Subjects Only:

* Evidence of significant liver fibrosis or cirrhosis
* History of NAFLD or NASH
* Positive test for HDV

Primary outcomes:
measure: Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events
timeFrame: 56 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion, Inc
state: Arizona
city: Lincoln
country: United States
facility: Celerion, Inc
state: Nebraska
city: San Antonio
country: United States
facility: Pinnacle Clinical Research
state: Texas
Study officials:
affiliation: ContraVir Pharmaceutical, Inc.
name: Jill Greytok
role: STUDY_DIRECTOR
References:
Clinical trial NCT01345097: A Short Metaphyseal Fitting Total Hip Arthroplasty in Young and Elderly Patients
Official title: A Short Metaphyseal Fitting Total Hip Arthroplasty in Young and Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteonecrosis
Osteoarthritis
Keywords: short, metaphyseal-fitting femoral stem
cementless anatomical femoral stem
young patient
elderly patient
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2011-04-29
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators determined whether

1. new short, metaphyseal-fitting cementless anatomical femoral stem provides major functional improvements
2. radiographically secure implant fixation is achieved with this new stem
3. the bone content is preserved at the baseline level or above at the final follow-up
4. these procedures are associated with early failure and complications.

Detailed description: To attempt reduction of stress shielding and thigh pain as well as to improve survivorship, a new short, metaphyseal-fitting cementless anatomical femoral stem was developed. The question arises as to whether it is possible to obtain rigid fixation of the stem without diaphyseal fixation in the young as well as in the elderly patients. The purpose of this study was to determine the clinical and radiographic results of the new short, metaphyseal-fitting cementless anatomical femoral stem in the young as well as in the elderly patients.

Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of hip joint requiring total hip arthroplasty

Exclusion Criteria:

* Neurologic disorders affecting motor function of lower extremity foot and ankle disorders limiting ambulation of the patient
* Patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism
* Multi-systemic inflammatory arthritis which debilitates patients other than hip joint.

Primary outcomes:
measure: Harris hip score
timeFrame: At least 5 years after surgery
Secondary outcomes:
measure: Improvement in the Range of Motion
timeFrame: At least 5 years after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hosptial
Study officials:
affiliation: Ewha Womans University Mokdong Hospital
name: Young-Hoo Kim, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00557297: NIS for Patients Using Symbicort Turbuhaler for Maintenance and Reliever Therapy in a Single Inhaler
Official title: NIS for Patients Using Symbicort Turbuhaler for Maintenance and Reliever Therapy in a Single Inhaler
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: asthma
SMART
inhaled
glucocorticosteroid
reliever
maintenance
single inhaler
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-11-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL

Brief summary: The aim of this non-interventional study is to ensure that patients in routine clinical practice follow given treatment instructions and to evaluate the number of reliever inhalations as well as the number of patient/days with more than 8/12 total inhalations at any day. If the number of reliever inhalations and thus the received inhaled glucocorticosteroid dose is not excessive, the safety conclusions from the clinical studies can be extrapolated to real life for better acceptance of SMART (Symbicort Maintenance and Reliever Therapy).


Eligibility criteria: Inclusion Criteria:

* Persistent asthma
* Prior Symbicort Turbuhaler maintenance and reliever therapy in a single inhaler

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aluksne
country: Latvia
facility: Research Site
city: Aozkraukle
country: Latvia
facility: Research Site
city: Balvi
country: Latvia
facility: Research Site
city: Cesis
country: Latvia
facility: Research Site
city: Gulbene
country: Latvia
facility: Research Site
city: Jekabpils
country: Latvia
facility: Research Site
city: Jumprava
country: Latvia
facility: Research Site
city: Kekava
country: Latvia
facility: Research Site
city: Kraslava
country: Latvia
facility: Research Site
city: Kuldiga
country: Latvia
facility: Research Site
city: Liepaja
country: Latvia
facility: Research Site
city: Limbazi
country: Latvia
facility: Research Site
city: Livani
country: Latvia
facility: Research Site
city: Madona
country: Latvia
facility: Research Site
city: Ogre
country: Latvia
facility: Research Site
city: Preili
country: Latvia
facility: Research Site
city: Rezekne
country: Latvia
facility: Research Site
city: Salacgriva
country: Latvia
facility: Research Site
city: Saldus
country: Latvia
facility: Research Site
city: Talsi
country: Latvia
facility: Research Site
city: Valniera
country: Latvia
facility: Research Site
city: Ventspils
country: Latvia
facility: Research Site
Study officials:
References:
Clinical trial NCT05463497: To Evaluate the Pharmacokinetic Drug Interactions, Safety and Drug Tolerance in Healthy Volunteers
Official title: A Randomized, Open-label, Multiple-dose, 2x3 Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction of JW0201 and C2103 or C2104 After Oral Administration in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2022-07-19
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A randomized, open-label, multiple-dose, 2x3 crossover clinical trial
Primary purpose: OTHER

Brief summary: A randomized, open-label, multiple-dose, 2x3 crossover clinical trial to investigate the pharmacokinetic drug interaction of JW0201 and C2103 or C2104 after oral administration in healthy adults

Detailed description: 1. To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2103 compared to the case of each single administration in healthy adults.
2. To evaluate the pharmacokinetic characteristics, safety, and drug tolerance of combined administration JW0201 and C2104 compared to the case of each single administration in healthy adults.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Subjects does not meet the Inclusion Criteria

Primary outcomes:
measure: Cmax,ss
timeFrame: up to 12hour(or 24hour) after administration
measure: AUCτ,ss
timeFrame: up to 12hour(or 24hour) after administration
Secondary outcomes:
measure: Cmin,ss
timeFrame: up to 12hour(or 24hour) after administration
measure: Tmax,ss
timeFrame: up to 12hour(or 24hour) after administration
measure: CLss/F
timeFrame: up to 12hour(or 24hour) after administration
measure: Vdss/F
timeFrame: up to 12hour(or 24hour) after administration
measure: fluctuation
timeFrame: up to 12hour(or 24hour) after administration
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospita
state: Jeollabuk-do
Study officials:
affiliation: Jeonbuk National University Hospita
name: Min-Gul Kim, PI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02530697: The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil
Official title: The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: An Open-label, Randomized Clinical Trial in Brazil
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Leishmaniasis
Keywords: Leishmaniasis
Mucocutaneous
Miltefosine
Pentoxifylline
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2015-08-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mucocutaneous leishmaniasis is endemic in the central region of Brazil and other countries worldwide. The standard treatment with meglumine antimoniate has a high rate of important adverse effects. This interventional study consists in a randomized clinical trial to access efficacy and safety of the association of miltefosine and pentoxifylline compared to meglumine antimoniate and pentoxifyline.


Eligibility criteria: Inclusion Criteria:

* Mucosal and/or cutaneous leishmaniasis, not treated or at least 6 months without any treatment to leishmaniasis;
* For patients with cutaneous lesions: duration of disease longer then a 1 month and shorter then 4 yeas; 1 to 3 lesions; larger lesions from 10mm to 50mm;
* Ages between 18 and 80 years old;
* Fertile female patients should use at least two contraceptive methods (hormonal and barrier);
* Agree to participate in the study and sign the informed consent term.

Exclusion Criteria:

* Use of any leishmanicidal drugs six months prior;
* Clinical or laboratorial evidences of electrocardiographic disorders;
* Renal, hepatic, cardiac diseases, uncontrolled diabetes or AIDS;
* Hypersensitivity to meglucamine antimoniate;
* Pregnancy or lactation;
* Fertile females that do not agree to use contraceptive methods;
* Patients that do not agree to the informed consent term.

Primary outcomes:
measure: Cure
timeFrame: 90 days
measure: Failure
timeFrame: 90 days
measure: Relapse
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Hospital Universitário de Brasília
state: DF
Study officials:
References:
Clinical trial NCT01449097: Adductor-Canal-Blockade Versus the Femoral Nerve Block Effect on Muscle Strength and Mobilization in Healthy Volunteers
Official title: Comparison of the Efficacy of the Adductor-Canal-Blockade Versus the Femoral Nerve Block on Muscle Strength and Mobilization in Healthy Volunteers: a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Muscle Strength
Healthy Volunteers
Keywords: Adductor-Canal-blockade,
human volunteers,
US-guided nerve block
femoral nerve block
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-10-07
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus the femoral nerve block versus placebo on muscle strength in healthy volunteers. The investigators hypothesize that the Adductor-Canal-Blockade results in a lesser reduction of the quadriceps muscle strength compared to the femoral nerve block.


Eligibility criteria: Inclusion Criteria:

* written informed consent
* ASA 1
* BMI \> 18 og \< 25

Exclusion Criteria:

* Can not cooperate to the exam
* Do not speak or understand Danish
* Drug allergy
* Alcohol or drug abuse
* Daily consumption of analgetics on prescription
* Any drug intake within the last 48 hours
* Neuromuscular defects in the femoral nere, the obturator nerve or the muscles of the thigh.
* Previous surgery or trauma to the lower limb
* Diabetes Mellitus
* Intake of steroids, except steroids for inhalation
* Physical exercise within the last 24 hours prior to Day 1 and 2 of the study

Primary outcomes:
measure: the difference in quadriceps muscle strength between the Adductor-Canal-Blockade and placebo
timeFrame: 0-6 hours
Secondary outcomes:
measure: The difference in quadriceps muscle strength between the Adductor-Canal-Blockade and the femoral nerve block
timeFrame: 0-6 hours
measure: The difference in quadriceps muscle strength between the placebo and the femoral nerve block
timeFrame: 0-6 hours
measure: The difference in adductor muscle strength between the groups
timeFrame: 0-6 hours
measure: The difference in mobilization between the groups
timeFrame: 0-6 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Pia Jæger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.