louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03094897: Clinic Study of 18F-Al-NOTA-MATBBN in Cancer Diagnostics
Official title: Phase 1 Study of 18F-Al-NOTA-MATBBN in Cancer Diagnostics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Breast Neoplasms
Prostatic Neoplasms
Keywords: Breast Neoplasms,Prostatic Neoplasms
Lead sponsor: Wuxi No. 4 People's Hospital
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether 18F-Al-NOTA-MATBBN is safety and effective for cancer diagnosis.

Detailed description: Observe radiation dose to healthy volunteers and patients; the correlation between integrin level and tumor/metastases uptake.

Eligibility criteria: Inclusion Criteria:

1. Volunteers or patients with age more than 18 yeas;
2. The patients have been diagnosed with cancer or suspected with cancer;
3. It must fulfill the ethical requirements and subjects have signed an informed consent.

Exclusion Criteria:

1. Pregnancy or nursing mothers;
2. Having drugs or alcohol dependence;
3. Hypersensitive to the active or inactive ingredients of the study drug;
4. Having attended other drug clinical trials within three months;
5. Cardiac functional insufficiency;
6. Hepatic and renal function insufficiency;
7. Hypertensive patients with serious complications;
8. Endangering the safety of life.

Primary outcomes:
measure: Standardized uptake value of 18F-Al-NOTA-MATBBN in malignant lesions
timeFrame: 1 day
Secondary outcomes:
measure: Adverse events collection
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
affiliation: Department of Nuclear Medicine, Affiliated Hospital of Jiangnan University (Wuxi 4th People's Hospital)
name: chunjing Yu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Honer M, Mu L, Stellfeld T, Graham K, Martic M, Fischer CR, Lehmann L, Schubiger PA, Ametamey SM, Dinkelborg L, Srinivasan A, Borkowski S. 18F-labeled bombesin analog for specific and effective targeting of prostate tumors expressing gastrin-releasing peptide receptors. J Nucl Med. 2011 Feb;52(2):270-8. doi: 10.2967/jnumed.110.081620. Epub 2011 Jan 13.
Clinical trial NCT00914797: Terbutaline Concentrations in Blood and Urine
Official title: Blood and Urinary Concentrations of Terbutaline in Asthmatics and Elite Athletes With Asthma: Comparison Between Inhalation vs. Oral Administration.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Doping
Beta agonist
Terbutaline
Pharmacokinetics
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Hormone Laboratory, Aker University Hospital, Oslo, Norway
First posted: 2009-06-05
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to assess the blood and urine concentrations of terbutaline and to evaluate the difference between inhaled and oral terbutaline in order to distinguish treatment with terbutaline from doping with terbutaline in a doping control.

Detailed description: To investigate the serum and urine concentrations of terbutaline and evaluate the difference between inhaled terbutaline (2 mg) and oral terbutaline (10 mg) in order to distinguish doping with terbutaline from anti-asthmatic treatment with terbutaline.

To investigate the above mentioned in three groups: healthy men, male asthmatic subjects and male elite athletes with asthma.

Eligibility criteria: Inclusion Criteria:

* Physician-diagnosed asthma with positive reversibility or challenge test.
* Informed consent.
* Age between 18 - 45 years.
* Sex: male.
* Asthma classified as mild to moderate according to GINA guidelines.
* Used beta-2-agonist in minimum 12 months.

Exclusion Criteria:

* Smokers or ex-smokers with a smoking history of 10 pack years or more.
* Respiratory tract infections within the last 2 weeks prior to visit 1 and 2.
* Subjects with other chronic diseases than asthma and allergy.
* Allergy towards the study medicine.
* Use of beta-2-agonist 6 days prior to study day.

Primary outcomes:
measure: Terbutaline concentrations in serum and urine
timeFrame: baseline, 4, 8, and 12 hours after medicine administration
Secondary outcomes:
Other outcomes:
Locations:
city: Kobenhavn NV
country: Denmark
facility: Bispebjerg Hospital, Respiratory Research Unit
Study officials:
affiliation: Bispebjerg Hospital, Respiratory Research Unit
name: Jimmi Elers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01914497: Dipole Density Mapping of Typical Atrial Flutter
Official title: Dipole Density Right Atrial Mapping and Assessment of Therapy In Cavotricuspid Isthmus Flutter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Flutter
Lead sponsor: Acutus Medical
Sponsor class: INDUSTRY
First posted: 2013-08-02
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Study to determine the feasibility of the Acutus Medical System in obtaining data to create Dipole Density Maps of electrical activation in the right atrium in patients with typical atrial flutter.


Eligibility criteria: Inclusion Criteria:

1. Be aged 18 to 75 years
2. Be scheduled for ablation of typical atrial flutter (cavotricuspid isthmus dependent)
3. Be able and willing to give informed consent

Exclusion Criteria:

1. Have any of the following:

   1.1 Patients with implanted prosthetic, artificial, or repaired cardiac valves in the chamber being mapped.

   1.2 Patients with permanent pacemaker or ICD leads in the chamber being mapped. 1.3Patients with hypercoagulopathy or an inability to tolerate anticoagulation therapy during an electrophysiology procedure.
2. Require treatment in the left atrium and/or a require a transseptal puncture to access the left atrium during the index procedure
3. Have had a myocardial infarction within the prior two months
4. Have had cardiac surgery within the prior three months
5. Have an intracardiac thrombus
6. Have clinically significant tricuspid valve regurgitation or stenosis
7. Have had any cerebral ischemic event (including transient ischemic attacks) in the prior six months
8. Be pregnant or nursing
9. Be currently enrolled in any other clinical investigation

Primary outcomes:
measure: Incidence of device-and procedure-related adverse events
timeFrame: 7 days
measure: The number of patients in which offline construction of pre- and post-treatment activation maps can be completed
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Stephan Willems, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03288597: Explore the Clinical Value of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in Neuroendocrine Neoplasms
Official title: A Prospective Exploration in the Clinical Value of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in Neuroendocrine Neoplasms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuroendocrine Tumors
Keywords: positive rate
SUVmax
relationship
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2017-09-20
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: Neuroendocrine neoplasmes

Brief summary: 68Ga-DOTANOC and 18F-FDG PET/CT have important values in the staging and clinical treatment of neuroendocrine tumors. Retrospective studies suggest that the positivite rates and SUVmax of dual imaging associated with pathological findings and prognosis. The study was designed to confirm thet clinical values of dual imagings for neuroendocrine tumors.


Eligibility criteria: Inclusion Criteria:

1. sign written informed consent form
2. age ≥ 18 years
3. pathologically confirmed neuroendocrine, Ki67\>=10%;
4. ECOG 0-1;
5. No prior antitumor treatment with chemotherapy targeting regimens for neuroendocrine carcimomas, no more than 2 systematic treatment for neuroendocrine tumors;
6. Unresectable disease;
7. At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded) (routine CT scan \>=20mm, spiral CT scan \>=10mm, no prior radiation to measurable lesions);
8. Predicted survival \>=3 months;
9. Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women;
10. Sexually active males or females willing to practice contraception during the study until 30 days after end of study.

Exclusion Criteria:

1. In the process of antitumor therapy with effective response;
2. Refuse to accept PET/CT;
3. Pregnant or nursing, or sexually active males or females refuse to practice contraception during the study until 30 days after end of study;
4. Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons；

Primary outcomes:
measure: The correlation between the positive rate and SUVs of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT and treatment response
timeFrame: 3 years
Secondary outcomes:
measure: The correlation between positive rate and SUV of PET/CT and prognosis
timeFrame: 3 year
measure: Compare SUVmax, tumor/liver ratio as a prognostic marker
timeFrame: 3 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04957797: Anatomic and Biomechanical Investigation on ACL: A Cadaveric Study
Official title: Anatomic and Biomechanical Investigation on Anterior Cruciate Ligament: A Cadaveric Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Nine matched-paired fresh frozen human cadaveric knees were randomly distributed into two groups: Flat-tunnel (FLT) group and round-tunnel (ROT) group. One knee from each pair was reamed with flat tunnel, while the contralateral knee was reamed with round tunnel.
Primary purpose: TREATMENT

Brief summary: The present study was aimed to investigate the kinematics differences between round-tunnel (ROT) and flat-tunnel (FLT) techniques and compare the influence to the anterior root of lateral meniscus (ARLM ) in anterior cruciate ligament (ACL) reconstruction when using hamstring graft.

Detailed description: Nine matched pairs of fresh-frozen cadaveric knees were evaluated for the kinematics of intact, ACL-sectioned, and either ROT or FLT reconstructed knees. The graft bundles for FLT technique were separately tensioned. A 6 degrees of freedom robotic system was used to assess knee laxity: (1) 134-N anterior tibial load at 0°, 15°, 30°, 60°, and 90°of knee ﬂexion. (2) 10-Nm of valgus torque followed by 5-Nm of internal rotation torque simulates a pivot-shift test at 15°, 30°. (3) 5-Nm internal and external rotation torques at 0°, 15°, 30°, 60°, and 90°. (4) 10-Nm varus and valgus torques at 15°, 30°. Coverage of ACL tibial footprint and areas of ARLM attachment before and after reaming were measured using three-dimensional isotropic MRI scanning.

Eligibility criteria: Inclusion Criteria:

* intact knee with no previous injures

Exclusion Criteria:

* those with ligamentous injury or a limited range of motion

Primary outcomes:
measure: simulated pivot-shift test
timeFrame: within 1 hour after surgery
measure: simulated KT-2000 arthrometer
timeFrame: within 1 hour after surgery
measure: internal and external rotation
timeFrame: within 1 hour after surgery
measure: varus and valgus
timeFrame: within 1 hour after surgery
measure: average percentage of ACL tibial footprint coverage
timeFrame: within 1 hour after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university third hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: yingfang ao, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01185405: Voriconazole Plasma Level in Intensive Care Unit (ICU) Patients
Official title: Prediction and Adjustment of Voriconazole Plasma Level in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Invasive Fungal Infection
Keywords: Voriconazole
Therapeutic drug monitoring
Intensive care unit
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2010-08-20
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Voriconazole, a newer triazole-derivative, has become the drug of choice for many invasive fungal infections, including invasive Aspergillosis. Recently, therapeutic drug monitoring of voriconazole has been issued because of wide variations and unpredictability of voriconazole blood concentration. The objective of this study is 1) to characterize the pharmacokinetics of voriconazole in ICU patients on voriconazole prophylaxis or treatment, and 2) to develop and evaluate the prediction and adjustment models for voriconazole plasma levels.

Detailed description: Patients will be randomly assigned into 2 groups: conventional adjustment group (CA group) and early adjustment group (EA group). Voriconazole plasma levels will be measured on day 1 (both peak and trough levels), day 3, day 5, day 10, and day 14 (all trough levels). For CA group patients, voriconazole dosage will be adjusted according to the trough levels of day 5 (steady-state level). Predefined dose adjustment protocol will be used (\< 1 µg/ml: 50% increase, 1\~5.5 µg/ml: no change, \> 5.5 µg/ml: 50% decrease). For EA group patients, voriconazole dosage will be adjusted according to the each measurements of voriconazole levels from day 1. Adjusted dosage will be calculated using the NONMEN software. The target range of trough level is between 1.0 µg/ml and 5.5 µg/ml. The appropriateness of voriconazole level (day 5, day 10, and day 14), mortality, ICU stay, and the frequency of voriconazole-related adverse events will be compared. CYP2C19 polymorphism will be analyzed for all patients.

Eligibility criteria: Inclusion Criteria:

* Patients who received voriconazole

Exclusion Criteria:

* Patients allergic to azole(s)

Primary outcomes:
measure: Appropriateness of voriconazole trough level
timeFrame: Day 3, day 5, day 10, and day 14
Secondary outcomes:
measure: Mortality
timeFrame: 2 week, 4 week, 8 week, 12 week, and 24 week
measure: Voriconazole-related adverse event
timeFrame: 1 week, 2 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Sang-Ho Choi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04744805: Mask-associated Dry Eye Symptoms in China
Official title: Mask-associated Dry Eye Symptoms: an Online Survey of 6262 Chinese Persons
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dry Eye Syndromes
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 6262
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: An online survey of persons focused on face mask usage

Brief summary: To review the relationship of increased face mask usage arising from lockdown measures instituted during the COVID-19 pandemic with dry eye symptoms on Chinese people, and make recommendations for mitigating potential detrimental effects on dry eye symptoms.


Eligibility criteria: Inclusion Criteria:

* age \>=8 years mental health

Exclusion Criteria:

* eye diseases mental or systemic diseases

Primary outcomes:
measure: time of face mask wear
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tianjin Eye Hospital
name: Yan Wang, director
role: STUDY_DIRECTOR
References:
citation: Fan Q, Liang M, Kong W, Zhang W, Wang H, Chu J, Fang X, Song Y, Gao W, Wang Y. Wearing face masks and possibility for dry eye during the COVID-19 pandemic. Sci Rep. 2022 Apr 13;12(1):6214. doi: 10.1038/s41598-022-07724-0.
Clinical trial NCT00625105: Using Heart Rate Variability Biofeedback to Improve Attention and Memory in PTSD+ Combat Veterans
Official title: Using Heart Rate Variability Biofeedback to Improve Attention and Memory in PTSD+ Combat Veterans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PTSD
Lead sponsor: William Jennings Bryan Dorn VA Medical Center
Sponsor class: FED
Collaborators: name: Congressionally Directed Medical Research Programs
First posted: 2008-02-28
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study will test the effectiveness of Heart Rate Variability (HRV) Biofeedback as a therapeutic tool in the reduction of everyday memory problems routinely experienced by combat veterans with Posttraumatic Stress Disorder (PTSD). The study is innovative in three ways: (1) through its investigation of the clinical use of a novel PTSD treatment technology, (2) by focusing on the understudied aspect of the daily functioning of PTSD veterans, and, (3) by investigating a heretofore untested application of biofeedback for PTSD induced deficits in attention (ATTN) and immediate memory (IM). Though HRV Biofeedback has proven successful for several applications in the general population, the idea that deficits in ATTN/IM in combat veterans with PTSD can be remedied by normalization of HRV has not yet been tested empirically. HRV is functionally incorporated into attentional processes, essentially operating as an index of autonomic flexibility and the ability to self-regulate in response to stimulation from the environment. Low HRV occurs in patients with PTSD, General Anxiety Disorder, and Coronary Artery Disease, and is correlated with negative affect and hostility. HRV Biofeedback training has been shown to be effective in increasing HRV in these groups of patients, as well as improving psychological well-being and physiological function in patients with Depression, Fibromyalgia, and Cardiovascular Disease. Therefore, the interrelationship between HRV and ATTN/IM problems in PTSD+ Combat veterans warrants further investigation. If HRV Biofeedback significantly improves ATTN/IM in these subjects, then it can be offered to VA clinicians treating combat PTSD as an effective new treatment tool.


Eligibility criteria: Inclusion Criteria:

* OIF/OEF veterans with PTSD

Exclusion Criteria:

* Neurologic disorder
* Active substance abuse

Primary outcomes:
measure: Heart rate variability
timeFrame: completion
measure: Attention and immediate memory
timeFrame: completion
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Dorn VA Medical Center
state: South Carolina
Study officials:
References:
Clinical trial NCT05754905: High-resolution CE-MRA of Children's Hip Joint
Official title: High-resolution Contrast-enhanced Magnetic Mesonance Angiography of Children's Hip Joint
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip
Vessels; Anomaly
Magnetic Resonance
Three-dimensional Water-selective Cartilage (3D-WATSc)
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with hip disease from 2021-2022 in Children's Hospital of Chongqing Medical University

Brief summary: The goal of this observational study is to learn about the feasibility of enhanced three-dimensional water-selective cartilage (3D-WATSc) sequence in displaying the vessels of children's hip by magnetic resonance. The main questions it aims to answer are:

* Could the images of enhanced 3D-WATSc sequence show the healthy side hip joint vessels in children?
* Could the images of enhanced 3D-WATSc sequence show the vascular disease of the suffering side hip joint in children?

Participants with unilateral hip disease will undergo the magnetic resonance examination including enhanced 3D-WATSc sequence. The pelvic plain film and magnetic resonance images will be collected and analysed.

Researchers will compare the images of of the normal side with the images of the abnormal side to see if the enhanced 3D-WATSc sequence images could show the vascular disease of the suffering side hip joint in children?


Eligibility criteria: Inclusion Criteria:

* Children aged 6 months-14 years who are diagnosed as hip disease after screening by pediatric orthopedic surgeon in Children's Hospital of Chongqing Medical University during the study period. The hip disease contain developmental dysplasia of the hip, Perthes disease, infection of the hip, inflammation of the hip, fracture of the hip, and Meyer's dysplasia.

Exclusion Criteria:

* patients with bilateral hip joint disease; patients with claustrophobia;Patients with metal implants (such as pacemaker implantation)

Primary outcomes:
measure: The medial circumflex femoral artery (MCFA) and lateral circumflex femoral artery (LCFA) of the bilateral hip joint
timeFrame: 1 day (Magnetic resonance examination end time)
measure: The branches of the MCFA and/or LCFA around the bilateral femoral neck
timeFrame: 1 day (Magnetic resonance examination end time)
measure: The vessels of secondary ossification center and/or cartilaginous vascular canal in bilateral femoral head
timeFrame: 1 day (Magnetic resonance examination end time)
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Children's Hospital of Chongqing Medical University
name: Yuxi Su, M.D.
role: STUDY_CHAIR
References: