louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03438253: Unwanted Penile Engorgement in Pediatric Patients Under Anesthesia.
Official title: Unwanted Penile Engorgement in Pediatric Patients Under Anesthesia: A Prospective Cohort Study to Discuss the Role of Anesthetic Technique and Other Common Contributing Factors.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia; Functional
Keywords: Intraoperative penile engorgement
Anaesthesia
Urogenital surgery
Lead sponsor: Aligarh Muslim University
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 386
Sex: MALE
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Study population: All ASA grade 1 \& 2 pediatric patients having age between 2 to 12 years.

Brief summary: Penile engorgement during intraoperative period is of rare occurrence however when do happens, leads to difficulty in performing and even cancellation of elective urogenital surgery. The mechanism behind intraoperative penile engorgement is complex and involves various factors. One common myth is that penile engorgement occurs only during spinal anaesthesia and not in general anaesthesia. In this study we intend to report the incidence and management of intraoperative penile engorgement in pediatric patients undergoing urogenital operations under spinal anesthesia with/without sedation over a period of one year. The pathophysiology and role of common contributing factors leading to intraoperative penile engorgement are also discussed.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist grade1 \& 2
* Elective urogenital surgery of expected duration less than one hour

Exclusion Criteria:

* patients with local infection, coagulation abnormalities, expected duration of surgery \>1 hour and spinal anomalies.
* parents of patient not giving consent for spinal anaesthesia.

Primary outcomes:
measure: Intraoperative penile engorgement
timeFrame: sixty minutes from start of anaesthesia
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assistant Professor
name: Muazzam Hasan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03135353: Saline Sonohystrography and Office Hysteroscopy in Evaluation of Cases of Abnormal Uterine Bleeding
Official title: Comparison Between 3D Saline Infusion Sonohystrography and Office Hysteroscopy in the Evaluation of Patients With Irregular Uterine Bleeding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Disease
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 250
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: comparing the efficacy of the 3D saline infusion sonohysterography to the diagnostic office hysteroscopy in the diagnosis of the cause of abnormal uterine bleeding in females during their reproductive age


Eligibility criteria: Inclusion Criteria:

* female aged between 20 and 45 years
* with no medical disorders
* approving to participate in the study

Exclusion Criteria:

* vaginal or cervical lesions
* history or suspicion of PID
* IUD users
* bleeding disorders
* on anticoagulant therapy
* irregular use of oral contraceptive pills

Primary outcomes:
measure: effectiveness of SIS versus office hysteroscopy in the diagnosis of cause of AUB
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr el ainy hospital
Study officials:
affiliation: Cairo University
name: Dina MR Dakhly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06033053: Real-time Neurofeedback Training of Fronto-limbic Regions Functional Connectivity
Official title: Real-time Neurofeedback Training of Fronto-limbic Areas Functional Connectivity to Reduce Arousal
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotion Regulation
Healthy
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized active-sham group controlled between-subject: Group of healthy individuals will be randomly assigned to the experimental or the sham condition. The experimental group, will learn how to modulate the vmPFC-amygdala functional connectivity, while the sham group will try to modulate the functional connectivity of sham regions not involved in emotion regulation.
Primary purpose: BASIC_SCIENCE

Brief summary: This is randomized active-sham group controlled between-subject real-time fMRI neurofeedback trial aimed at modulating the ventromedial prefrontal cortex (vmPFC)-amygdala pathway to control subjective anxiety and arousal.

Detailed description: The present randomized active-sham group controlled between-subject real-time fMRI neurofeedback trial aims at determining if (1) subjects can gain volitional control over the vmPFC-amygdala pathway involved in implicit emotion regulation and arousal by means of connectivity informed neurofeedback, (2) whether the training has specific effects on the behavioral and psychophysiological arousal level, and (3) or the amygdala or the vmPFC connectivity, respectively.

The present project will determine the efficacy of the modulation of the vmPFC-amygdala functional connectivity pathway using vmPFC-amygdala upregulation (n = 25 subjects) compared to a sham control condition (targeting pathways not involved in emotion regulation, n = 20).

Eligibility criteria: Inclusion Criteria:

* age \> 18 years old
* other genders
* No past or current psychiatric or neurological or other main disorders.

Exclusion Criteria:

* Pregnant, taking oral contraceptives
* Current use of medications
* Contraindication to MRI scanning (e.g., metal implants, claustrophobia or other conditions that make them inappropriate for MRI scanning).

Primary outcomes:
measure: Functional connectivity computed from blood oxygenation level dependent (BOLD) functional magnetic resonance imaging between regions of interest.
timeFrame: 40 minutes
Secondary outcomes:
measure: Level of behavioural arousal assessed on NRS from 0 to 10
timeFrame: 10 minutes
Other outcomes:
measure: Level of behavioural anxiety assessed on NRS from 0 to 10
timeFrame: 10 minutes
Locations:
city: Chengdu
country: China
facility: University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Benjamin Becker, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04968353: Effect of Clear Aligner Attachment Design on Extrusion of Maxillary Lateral Incisors
Official title: Effect of Clear Aligner Attachment Design on Extrusion of Maxillary Lateral Incisors: a Randomized Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Lateral Incisor Malocclusion
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to test which of four clear aligner attachment types is more efficient in extruding (erupting) maxillary lateral incisors vertically into correct position during orthodontic treatment.

Detailed description: Attachments are small tooth-colored shapes that are bonded (attached) to teeth before or during treatment with clear aligners. They are like handles, giving aligners something to gently push teeth into correct positions. There are 4 different shapes of attachments that are commonly used to extrude lateral incisors (incisally-beveled, gingivally-beveled, optimized and horizontal). All 4 of these attachments are successful in extruding lateral incisors but there is not enough research evidence to know for sure which attachment would be ideal for a specific circumstance.

Eligibility criteria: Inclusion Criteria:

1. Patients 16 years or older to be treated with either Comprehensive Invisalign or Invisalign Teen,
2. Maxillary lateral incisor requiring 0.3 mm or more extrusion (as determined by ClinCheck),
3. Maxillary arch with less than 6 mm of crowding or spacing,
4. All teeth present and fully erupted (excluding third molars).

Exclusion Criteria:

1. Presence of anterior crossbite
2. Any missing teeth in the maxillary arch
3. Treatment plan includes surgery or extraction of any maxillary teeth,
4. Maxillary lateral incisors with pathology or large restorations (crowns)
5. Maxillary lateral incisors have a less than 0.3 mm of extrusion prescribed in the Tooth Movement Table on the Invisalign ClinCheck

Primary outcomes:
measure: Percent of Vertical Tooth Movement
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Steven Lindauer, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05225753: Post-operative Anemia in Lateral Fractures of the Femur.
Official title: Post-operative Anemia in Lateral Fragility Fractures of the Femur. A Prospective Observational Study in Three Different Intramedullary Nails
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femur Fracture
Keywords: fragility lateral femoral fractures
intramedullary nail
Post-operative anemia
surgical time
Blood transfusions number
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
Collaborators: name: Ospedali Riuniti di Foggia
First posted: 2022-02-07
Enrollment: 45
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Fortyfive (45) patients referring to the Orthopaedic and Trauma Unit of the local University Hospital between November 2020 and September 2021 with lateral fragility fracture were prospectively recruited.

Brief summary: It was conducted a prospective study with a series of 45 patients with lateral fragility fractures of the femur treated by three different intramedullary nails. Patients were randomized in Group A (15 patients treated by Affixus Zimmer-Biomet), Group B (15 patients treated by EBA2 - Citieffe) and Group C (15 patients treated by Proximal Femoral Nail Antirotation Synthes).

One independent observer performed seven biochemical evaluations (hemoglobin serum value) from admission to patient discharge. Surgical time and Blood transfusions number were reported for each partecipant.


Eligibility criteria: Inclusion Criteria:

* femur fractures type 31-A1, A2, A3 (Muller ME, Nazarian S, Kock P et al.);
* age more than 65 years;

Exclusion Criteria:

* patients with neurological diseases;
* finding of anemia before surgery;

Primary outcomes:
measure: Change in hemoglobin serum value
timeFrame: Preoperative, Day 0, Day 1, Day 2, Day 3, Day 5 (after surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia
Study officials:
References:
Clinical trial NCT02408653: EEG@HOME (Phase 2 of the Project, Measurements in Healthy Volunteers)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Pilipili NV
name: Imec
First posted: 2015-04-03
Enrollment: 4
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this project is the development of an EEG-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that hospital admission in the EMU can be avoided for some patients and an increasing number of patients can be examined.

In Phase 2 of the project will comprise of an EEG-registration with the different types of electrodes in healthy volunteers. For each volunteer the EEG-recording with dry electrodes will be compared to the EEG-recordings with conventionally used wet electrodes (bridge and cup electrodes). In addition each volunteer will undergo a somato-sensory evoked potential (SSEP) measurement with different types of electrodes. Analogously to the EEG-registrations, for each volunteer the SSEP measurement with the dry electrodes will be compared to the SSEP measurement with conventionally used wet electrodes (bridge and cup electrodes). Each EEG-registration will take between 5 and 10 minutes.

Minimum 2 - maximum 10 healthy volunteers will be included.

There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical evaluation of the EEG-signals. User experience will also be collected.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

Primary outcomes:
measure: EEG signal quality (visual and clinical) (scale)
timeFrame: 10 minutes
measure: EEG signal quality (technical) (signal to noise ratio)
timeFrame: 10 minutes
measure: User experience (questionnaire)
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital, Ghent
Study officials:
References:
Clinical trial NCT00144053: A Phase Ⅲ Randomized Study of Mitomycin/Vindesine/Cisplatin Versus Irinotecan/Carboplatin Versus Paclitaxel/Carboplatin With Concurrent Thoracic Radiotherapy for Unresectable Stage Ⅲ Non-Small-Cell Lung Cancer
Official title: A Phase Ⅲ Randomized Study of Mitomycin/Vindesine/Cisplatin Versus Irinotecan/Carboplatin Versus Paclitaxel/Carboplatin With Concurrent Thoracic Radiotherapy for Unresectable Stage Ⅲ Non-Small-Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Lead sponsor: West Japan Thoracic Oncology Group
Sponsor class: OTHER
First posted: 2005-09-02
Enrollment: 450
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable stage III NSCLC.


Eligibility criteria: Inclusion Criteria:

All patients had histologically or cytologically confirmed locally advanced NSCLC. All patients must not have undergone any previous therapy for NSCLC. Patients had to have measurable disease, an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and to be less than 75 years old. Adequate organ (bone marrow, renal, liver, heart, and lung) function was required. All patients gave written informed consent.

Exclusion Criteria:

The exclusion criteria consisted of pulmonary fibrosis, pleural effusion, pregnancy, lactation, active concurrent malignancies, severe drug allergies, myocardial infarction, severe heart disease, uncontrollable diabetes mellitus, and infection. -

Primary outcomes:
measure: Survival
Secondary outcomes:
measure: safety
Other outcomes:
Locations:
Study officials:
affiliation: West Japan Thoracic Oncology Group
name: Hisao Uejima, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00657553: Preemptive Strike With Bortezomib in Multiple Myeloma Patients
Official title: Preemptive Strike With Bortezomib (VELCADE) in Participants With Multiple Myeloma Still Event-free on Total Therapy 2 (UARK 98-026)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Multiple Myeloma
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2008-04-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate whether using the drug bortezomib at the start of remission will prevent relapse for a longer period of time.

Detailed description: Although advances in the treatment of multiple myeloma have led to improved remission rates, the risk for serious relapse is very high. The drug Bortezomib has been highly effective for treatment of the disease in an advanced stage such as post-transplant relapse. Due to the need of maintenance therapies, it is necessary to look to certain drugs that may prolong remission and increase the quality of life. Bortezomib, when taken at the beginning of remission, may prove to be a beneficial maintenance drug for the management of multiple myeloma.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with multiple myeloma currently or previously enrolled on UARK 98-026 and currently event-free at the time of the evaluation.
* Performance status of 0-2 based of Southwest Oncology Group (SWOG) criteria
* Previously documented platelet count \> 75,000/ul within a 35 days prior to enrollment
* Previously documented peripheral absolute neutrophil count \>1,000/ul within 35 days prior to enrollment.
* Adequate renal function
* Signed informed consent
* Female subject is post-menopausal or willing to use acceptable birth control
* Male subjects agree to use acceptable method of contraceptive

Exclusion Criteria:

* Hypersensitivity to Bortezomib, boron, or mannitol
* Female subject is pregnant or breastfeeding
* Experienced myocardial infraction within 6 months prior to enrollment
* Received other investigational new drugs within 14 days before enrollment
* Received any anti-myeloma therapy within 14 days
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study
* Diagnosed or treated for another malignancy within 3 years of enrollment

Primary outcomes:
measure: Effect of Maintenance Therapy With Bortezomib on the Length of Remission in Participants Currently Receiving Maintenance Therapy as Part of Total Therapy 2
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy
state: Arkansas
Study officials:
affiliation: UAMS
name: Bart Barlogie, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04148053: Evaluation of Immune Cell Markers in Diagnosis of Tuberculosis
Official title: Evaluation of TB-antigen Responsive T Cell Markers in Diagnosis of Tuberculosis and Extrapulmonary Tuberculosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tuberculosis Infection
Lead sponsor: Tongji University
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 500
Sex: ALL
Minimum age (years): 7
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any patients suspicious of TB infection

Brief summary: Diagnosis of active and latent pulmonary tuberculosis, as well as extrapulmonary tuberculosis, is still a major challenge of TB control in China. This observational study aims to evaluate TB-antigen responsive T cell markers in the diagnosis of tuberculosis and extrapulmonary tuberculosis and try to find new prompt and cost-effective laboratory tests for active TB screening.

Detailed description: The enrolled patients will be grouped into active or latent tuberculosis according to the bacteriological evidence of TB. The TB-antigen responsive T cell markers will be examined. The performance of each T cell marker for the diagnosis of active TB will be systematically evaluated.

Eligibility criteria: Inclusion Criteria:

* any patients suspicious of TB infection
* TB culture and Xpert test required
* Chest X-ray required

Exclusion Criteria:

* anti-TB therapy before the sample collection.

Primary outcomes:
measure: Positive rate and negative rate
timeFrame: 2-3 month after sampling
measure: Receiver operating characteristic curve
timeFrame: 2-3 month after sampling
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT03531853: OCT Technology Development to Assess Ocular Integrity and Characterize Ocular Integrity and Intraocular Scatterers
Official title: OCT Technology Development to Assess Ocular Integrity and Characterize Ocular Integrity and Intraocular Scatterers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uveitis
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to develop and demonstrate new technologies that will enable a non-contact, compact eye imaging system based on OCT to assist an early responder in acute care settings (like an emergency room) to help assess eye trauma and inflammation (swelling inside the eye).


Eligibility criteria: Inclusion Criteria:

- Pre-clinical: employees or students (over the age of 18) of the Duke Eye Center or Biomedical Engineering willing to be imaged with OCT system

- Pilot (ER): patients (over the age of 18) presenting emergently to the Duke Emergency room with traumatic eye injuries and/or suspected open globe

- Pilot (Uveitis): patients presenting to the Duke Eye Center with active uveitis and microhyphema or hyphema; patients who have independently consented to undergo vitreous tap or biopsy for their uveitis care at the Duke Eye Center

Exclusion Criteria:

- Pre-clinical: subject cannot be a direct report to any of the PIs or other key personnel of this study

- Pilot (ER): hemodynamically unstable, unable to consent

- Pilot (Uveitis): unable to consent; cornea or lens opacity/scar which would block the imaging modality

Primary outcomes:
measure: Concordance
timeFrame: Up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Anthony Kuo, MD
role: PRINCIPAL_INVESTIGATOR
References: