louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05609552: Biodistribution and Pharmacokinetics of Pretomanid in Tuberculosis Patients Using 18F-Pretomanid PET
Official title: Biodistribution and Pharmacokinetics of Pretomanid in Tuberculosis Patients Using 18F-Pretomanid PET
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tuberculosis
Keywords: PET/CT
Pretomanid
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-11-08
Enrollment: 20
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: Males and female members of all races and ethnic groups are eligible for this trial and encouraged to participate. Subjects from different groups will be enrolled concurrently.

Brief summary: This is an observational study that will examine the pretomanid pharmacokinetics (PK) in tuberculosis (TB) patients. Dynamic 18F-pretomanid PET/CT will be performed after intravenous injection of 18F-pretomanid to determine multi-compartment, noninvasive determination of pretomanid PK in TB patients.


Eligibility criteria: Inclusion Criteria:

1. Male or female ≥18 years of age at the time of consent and imaging
2. Healthy subjects OR Subjects with confirmed tuberculosis OR high suspicion of active tuberculosis by treating physician.
3. For TB patients: Imaging evidence of suspected tuberculosis infection involving the lung, and possible additional other sites of involvement.
4. For TB patients: After TB diagnosis is confirmed, patients will be eligible to participate up to 6 weeks after starting TB treatment.
5. Subject is willing to give written informed consent. Subject is willing and able to comply with the protocol for the duration of the study including undergoing scheduled visits and study procedures.
6. Screening clinical laboratory values must be within normal limits or judged not clinically significant by the investigator.
7. Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the radiotracer administration.
8. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study-related procedures.

Exclusion Criteria:

1. Inadequate venous access
2. Any medical condition that in the judgment of the investigator would make the patient inappropriate for entry into this study

Primary outcomes:
measure: Biodistribution of 18F-pretomanid
timeFrame: Up to 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Sanjay K Jain, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00594152: Anti-Nephropathic Effects of Chronic Intermittent Intravenous Insulin Therapy (CIIIT)
Official title: Anti-Nephropathic Effects of Chronic Intermittent Intravenous Insulin Therapy (CIIIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Nephropathy
Diabetic Retinopathy
Keywords: Diabetic autonomic neuropathy
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators with the goal of optimizing glycemic and blood pressure control saw type 1 diabetic patients weekly. A control group received 3-4 subcutaneous insulin injections per day; an intravenous insulin pulsed infusion group received, in addition, three one hour infusions in a pulsatile fashion over one eight hour period each week. Patients were followed for 12 months with periodic testing of renal function by repeated blood and urinary analyses; diabetes control by blood testing and diabetes impact measurement score; cardiac and autonomic function by echocardiography, 24 hour electrocardiographic testing; and visual changes with repeated fundus photography. The study hypothesis was that correction of respiratory quotient would correct the defect leading to microvascular complications of diabetes (Type 1).


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetics with proteinuria willing to be seen weekly for the evaluation of renal function

Exclusion Criteria:

* Associated active medical diseases that would not permit evaluation of stable renal disease over 18 months

Primary outcomes:
measure: Rate of loss of creatinine clearance
timeFrame: 18 months
Secondary outcomes:
measure: Quality of life assessment
timeFrame: 12 to 18 months
measure: Change in cardiac autonomic function
timeFrame: 12 to18 months
measure: Change in retinal photos
timeFrame: 12 to 18 months
measure: Change in cardiac function
timeFrame: 12 to 18 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: John A D'Elia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dailey GE, Boden GH, Creech RH, Johnson DG, Gleason RE, Kennedy FP, Weinrauch LA, Weir M, D'Elia JA. Effects of pulsatile intravenous insulin therapy on the progression of diabetic nephropathy. Metabolism. 2000 Nov;49(11):1491-5. doi: 10.1053/meta.2000.17700.
citation: Weinrauch LA, Sun J, Gleason RE, Boden GH, Creech RH, Dailey G, Kennedy FP, Weir MR, D'Elia JA. Pulsatile intermittent intravenous insulin therapy for attenuation of retinopathy and nephropathy in type 1 diabetes mellitus. Metabolism. 2010 Oct;59(10):1429-34. doi: 10.1016/j.metabol.2010.01.004. Epub 2010 Mar 1.
Clinical trial NCT01622452: Post Cardiac Surgery Neurocognitive Decline: Correlations Between Neuropsychological Tests and Functional MRI Techniques
Official title: Neurocognitive Deficits Related to Cardiac Surgery Intervention With Extracorporeal Circulation. Correlations Between Neuropsychological Tests and Functional MRI Techniques (Spectroscopy, Diffusion and Morphometry)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Cognitive Dysfunction
Keywords: Postoperative cognitive dysfunction
Cognitive decline
Valve surgery
Cardiac surgery
Diffusion Tensor Imaging
Brain Morphometry
1H-Magnetic Resonance Spectroscopy
Lead sponsor: Fondazione Toscana Gabriele Monasterio
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing elective valve surgery in Ospedale del Cuore, Fondazione G. Monasterio, Massa, Italy and matching inclusion/exclusion criteria will prospectively enter the study.

Brief summary: Postoperative cognitive decline (POCD) is a frequent complication after cardiac surgery. It is estimated that 40-70% of all cardiac patients show cognitive dysfunction during the first post-surgical week. Six weeks after surgery, this incidence decreases to 10-40% and the figure remains stable over the long-term.

The investigators will recruit 50 patients undergoing elective valve surgery and each patient will receive complete evaluation a) preoperative, one week before surgery; b) early postoperative, before hospital discharge; and c) late postoperative, 8 weeks follow up.

The investigators will apply Diffusion Tensor Imaging, 1Proton-Magnetic Resonance Spectroscopy and Morphometry studies with correlation to neuropsychological test battery to evaluate POCD.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective valve surgery in Ospedale del Cuore, Fondazione G. Monasterio, Massa, Italy will prospectively enter the study.

Exclusion Criteria:

* History of head trauma, seizures, stroke, carotid artery stenosis (\>70%)
* History of any major surgery with general anesthesia
* Preoperative MMSE score less than 23 to exclude patients with dementia and mild cognitive impairment (MCI)
* Subjects who will be unable to complete the baseline neuropsychological battery due to cognitive impairment, psychiatric disease, substance abuse, blindness, or poor knowledge of Italian language
* Any major neurological complication after CABG surgery (stroke, seizures, encephalopathy not resolving within few postoperative days)
* if any contraindications to MRI safety, indicated in local MRI safety protocol

Primary outcomes:
measure: Brain MRI microstructural/functional alteration due to cardiac surgery in association with POCD
timeFrame: 32 months
measure: Brain MRI metabolic alteration due to cardiac surgery in association with POCD
timeFrame: 32 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02684552: Non Invasive Ventilation During Physical Training in Cystic Fibrosis
Official title: Physiotherapist in Charge of the Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients with cystic fibrosis older than 18 years will performance a Bruce test with non invasive ventilation (once) after 30 minutes they perform the same test with oxygen supplementation.

Measurements: Transcutaneous level off carbon dioxide, saturation, puls and dyspnea scale.

Detailed description: measurements before and after the test: transcutaneous level off carbon dioxide, saturation, respiratory rate, dyspnea scale.

Eligibility criteria: Inclusion Criteria:

* Subjects with Cystic Fibrosis at Stockholm Cystic Fibrosis center
* \> 18 years of age
* Forced expiratory volume in one second (FEV1) between 20 and 69% of predicted value
* Developed alveolar hypoventilation at the physical performance test
* Use oxygen supplementation during aerobic training

Exclusion Criteria:

* Symptomatic upper airway infection characterized by fever less than 1 month before entering the study
* Cognitive dysfunction
* Cardio-respiratory instability
* Infection with Burkholderia cepacia complex
* Gastroesophageal reflux
* History of pneumothorax
* Massive hemoptysis.

Primary outcomes:
measure: Transcutaneous level carbon dioxide
timeFrame: 10 min measurement
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Maria Cecilia Rodriguez Hortal
city: Stockholm
country: Sweden
facility: Cecilia Rodriguez
Study officials:
affiliation: Karolinska University Hospital
name: Maria Cecilia Rodriguez Hortal, MSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04800952: Pharmacokinetics of Antibiotics in Critically Ill Patients Receiving CVVHF
Official title: Pharmacokinetics of New Licensed Antibiotics in Critically Ill Patients Receiving Continuous Venovenous Haemofiltration: An International Collaborative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis
Acute Kidney Injury
Lead sponsor: Osaka University
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The mortality in patients with sepsis and severe acute kidney injury requiring continuous renal replacement therapy (CRRT) remains high. Antibiotic therapy is a key treatment of these patients and in recent years new antibiotics have been licensed. However, data is lacking to determine the optimal dosing regimens of these antibiotics for high (Australia and other countries) and low intensity (Japan) of CRRT.

Aim To establish the appropriate dosing regimens of newly available antibiotics during CRRT can applied globally.


Eligibility criteria: Inclusion Criteria:

* Adult (age ≥18 years or older)
* Sepsis (Sepsis-3 criteria)
* Acute kidney injury requiring CRRT (KDIGO criteria)
* Eligible for intensive care without restrictions or limitations

Exclusion Criteria:

* Chronic renal failure
* Obvious or suspected pregnancy
* Intracranial bleeding

Primary outcomes:
measure: Plasma new antibiotics concentration during continuous venovenous haemofiltration (CVVHF) in critically ill patients receiving infusion of these drugs.
timeFrame: 72 hours
measure: Calculated clearances of new antibiotics during continuous venovenous haemofiltration (CVVHF) in critically ill patients receiving infusion of these drugs.
timeFrame: 72 hours
Secondary outcomes:
measure: Concentration of serum creatinine
timeFrame: through study completion, an average of 1 year
measure: length of stay in the hospital
timeFrame: up to 30 days, length of stay in the hospital will be calculated using the earliest of date that the subject is medically ready for discharge when captured, the date of discharge
measure: ICU Mortality
timeFrame: at ICU discharge assessed up to 30 days
measure: Hospital Mortality
timeFrame: at hospital discharge assessed up to 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03383952: A Clinical Study of CD19 Targeted CAR-T for Patients With CD19+ Lymphoma and Leukemia
Official title: A Phase I Trial of CD19 Targeted ICAR19 T Cells in Patients With CD19+ Leukemia and Lymphoma.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: B Cell Leukemia
B Cell Lymphoma
Lead sponsor: Immune Cell, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Weifang People's Hospital
First posted: 2017-12-27
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 T cells and the investigators will determine the safety and therapeutic effects of these cells.


Eligibility criteria: Inclusion Criteria:

CD19 positive leukemia and lymphoma，relapsed and/or refractory：

* survival\>12 weeks;
* FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin;
* LVEF≥50%;
* Creatinine\<2.5mg/dl;
* Bilirubin\<2.5mg/dl;
* ALT (alanine aminotransferase)/AST (aspartate aminotransferase)\<3 x normal;
* At least 7 days after last chemotherapy;
* provide with informed consent.

Exclusion Criteria:

* Active clinically significant CNS dysfunction
* Pregnant or breast-feeding women.
* Uncontrolled active infection including hepatitis B or C.
* HIV positive.
* Use of systemic steroids within 72 hours.
* Allogeneic lymphocyte treatments within recent 6 months.
* Any uncontrolled active medical disorder.

Primary outcomes:
measure: Measure the safety of ICAR19 CAR-T cells
timeFrame: 2 years
Secondary outcomes:
measure: Measure the anti-tumor effect of ICAR19 CAR-T cells
timeFrame: 3 years
measure: Survival time of ICAR19 T cells in vivo.
timeFrame: 5 years
Other outcomes:
Locations:
city: Weifang
country: China
facility: Weifang People's Hospital
state: Shandong
Study officials:
References:
Clinical trial NCT02860052: SB208 for the Treatment of Tinea Pedis
Official title: A Phase 2 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Dose-Ranging Study Assessing Efficacy and Safety of SB208 and Vehicle Gel in Subjects With Interdigital Tinea Pedis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tinea Pedis
Lead sponsor: Novan, Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-09
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in non immunocompromised adult subjects with interdigital tinea pedis.

Detailed description: A phase 2, multi-center, double-blind, randomized, vehicle-controlled study to be conducted in approximately 170 non immunocompromised adult subjects with interdigital tinea pedis. Subjects will apply the investigational product (IP) (SB208 or Vehicle Gel) to the interdigital areas and all affected and immediate surrounding areas of one or both feet once daily for 2 weeks, followed by a 4-week post-treatment observation period.

Eligibility criteria: Inclusion Criteria:

* Otherwise healthy male and female subjects with clinical diagnosis of interdigital t. pedis
* T.pedis provisionally confirmed at baseline by a positive KOH wet mount for segmented fungal hyphae on skin scraping from the target site

Exclusion Criteria:

* Women who are pregnant or nursing or planning on becoming pregnant
* Subjects with onychomycosis or moccasin-type t. pedis
* Subjects using topical or systemic anti-fungal agents

Primary outcomes:
measure: Fungal culture result
timeFrame: 2 weeks
Secondary outcomes:
measure: Clinical cure
timeFrame: 6 wks
measure: Mycological cure
timeFrame: 6 wks
Other outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: 6 weeks
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Instituto Dermatológico y Cirugía de Piel,
Study officials:
affiliation: Novan, Inc.
name: M Joyce Rico, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04649632: Relation Between Dose and Time to Reinjection of Botulinum Toxin-A in Patient With Poststroke Spasticity From a Real-world Healthcare Insurance Database.
Official title: Relation Between Dose and Time to Reinjection of Botulinum Toxin-A in Patient With Poststroke Spasticity From a Real-world Healthcare Insurance Database.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Stroke Spasticity
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2020-12-02
Enrollment: 451
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients selected from the database claimed within the code 313 will be included in the descriptive analyses.

Brief summary: Determining the mean/median time between botulinum toxin-A injection within the treatment of patients with spasticity after stroke in relation to the botulinum toxin dose from a healthcare insurance database in the Netherlands.


Eligibility criteria: Inclusion Criteria:

* A patient will be included if he has a diagnosis stroke within the rehabilitation setting and has received at least two injections of botulinum toxin-A: Dysport or Botox

Exclusion Criteria:

* A patient will be excluded if he has been only treated with Xeomin

Primary outcomes:
measure: Mean time to next injection per brand
timeFrame: From baseline up to end of data collection (January 2012 up to December 2016)
measure: Median time to next injection per brand
timeFrame: From baseline up to end of data collection (January 2012 up to December 2016)
measure: Dosing of botulinum toxin-A in daily practice in relation to time to next injection
timeFrame: From baseline up to end of data collection (January 2012 up to December 2016)
Secondary outcomes:
measure: Average cost per year per brand per patient
timeFrame: From baseline up to end of data collection (January 2012 up to December 2016)
measure: Exploring factors like age, gender, time since diagnosis stroke that influence dosing and time between botulinum toxin-A treatments
timeFrame: From baseline up to end of data collection (January 2012 up to December 2016)
measure: Time interval between 2 injections of the same brand
timeFrame: From baseline up to end of data collection (January 2012 up to December 2016)
Other outcomes:
Locations:
city: Hoofddorp
country: Netherlands
facility: Ipsen Facility
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00800332: Dose Finding Study With CYT003-QbG10 in Patients With House Dust Mite Allergy
Official title: Double-blind, Placebo-controlled Dose-finding Study With CYT003-QbG10 in Adult Patients With Rhinoconjunctivitis Due to House Dust Mite Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinoconjunctivitis
Allergies
Keywords: Rhinoconjunctivitis due to house dust mite allergy
Lead sponsor: Cytos Biotechnology AG
Sponsor class: INDUSTRY
First posted: 2008-12-02
Enrollment: 300
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: The purpose of the study is to test whether vaccinations with CYT003-QbG10 can improve allergy symptoms in patients with house dust mite allergy. The active treatment will be compared against placebo.


Eligibility criteria: Inclusion Criteria:

* Perennial allergic rhinoconjunctivitis due to clinically relevant allergy towards house dust mite allergens
* Further criteria as defined in the study protocol

Exclusion Criteria:

* Clinically manifested seasonal allergy/-ies which is/are expected to interfere with the patient's study treatment schedule and/or assessments
* Clinically relevant perennial allergy/-ies other than house dust mites allergy
* Contraindication to any study test or procedure
* Further criteria as defined in the study protocol

Primary outcomes:
measure: Rhinoconjunctivitis symptom and medication scores
timeFrame: Pre- / Post-Treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Paide, Tartu, Tallin, Rakvere
country: Estonia
facility: Cytos Investigator Sites
city: Fulda, Dresden, Ulm, Rodgau, Kassel, Eisenach
country: Germany
facility: Cytos Investigator Sites
city: Wiesbaden, Frankfurt/M, Leipzig, Jena, Hamburg, Dulmen
country: Germany
facility: Cytos Investigator Sites
city: N. Faliro, Hiraklion, Athens
country: Greece
facility: Cytos Investigator Sites
city: Riga, Rezekne
country: Latvia
facility: Cytos Investigator Sites
city: Vilnius, Kaunas, Klaipeda
country: Lithuania
facility: Cytos Investigator Sites
city: Galati, Cluj Napoca, Bahia Mare, Brasov, Piesti
country: Romania
facility: Cytos Investigator Sites
city: Targu Mures, Bukarest, Craiova, Iasi
country: Romania
facility: Cytos Investigator Sites
Study officials:
References:
citation: Klimek L, Willers J, Hammann-Haenni A, Pfaar O, Stocker H, Mueller P, Renner WA, Bachmann MF. Assessment of clinical efficacy of CYT003-QbG10 in patients with allergic rhinoconjunctivitis: a phase IIb study. Clin Exp Allergy. 2011 Sep;41(9):1305-12. doi: 10.1111/j.1365-2222.2011.03783.x. Epub 2011 Jun 14.