louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04060186: Postoperative Balloninflation After Evacuation of cSDH
Official title: Balloninflation After Evacuation of Chronical Subdural Haematoma for Reduction of Hematoma Recurrrence: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Subdural Hematoma
Keywords: Recurrence rate of cSDH
Outcome
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2019-08-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this prospective, randomized, multicenter trial shall patients with chronic subdural hematoma (cSDH) recruited, who were surgically treated. Initially, we would divide the patients randomized into two groups: Patients with supervised blow-maneuver and without. After surgical treatment of cSDH with insertion of a subdural drain, one group would perform a supervised blow maneuver ("Valsalva maneuver") every hour for five minutes from 10:00 to 20:00. In the other group, the standard care would be performed. The subdural drain would be explanted 2days after operation and a postoperative CT scan would routinely be performed. After hospital discharge, the patient would be rechecked in an ambulant setting and would receive CT scan as clinical standard. Recurrence of hematoma is defined as recurrent hematoma which should be reoperated. After 3 and 6 months we would evaluate the outcome of patients.


Eligibility criteria: Inclusion Criteria:

* age over 18 years
* surgically treated cSDH
* patients with an operatively implanted subdural drainage

Exclusion Criteria:

* age under 18 years
* Admission in critical clinical state, e.g. already to light unresponsive pupils for about 2 hours
* conservative treatment of cSDH
* patients without an operatively implanted subdural drainage
* patient cannot be consented
* participation in other clinical trials

Primary outcomes:
measure: Recurrence Rate
timeFrame: 3 Months
Secondary outcomes:
measure: Neurological Functional Outcome
timeFrame: 6 Months
Other outcomes:
Locations:
city: Frankfurt Niederrad
country: Germany
facility: University Hospital
state: Hessen
Study officials:
References:
Clinical trial NCT04116086: Using PSMA PET-CT as a Diagnostic Tool for Detection of Prostatic Cancer at an Early Stage
Official title: Using PSMA PET-CT as a Diagnostic Tool for Detection of Prostatic Cancer at an Early Stage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-10-04
Enrollment: 50
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One investigator will interpret the PSMA PET-CT and another one will interpret MRI, both in a blinded and independent fashion and before the biopsy. At the end of the study, these 'blind' PSMA PET-CT and MRI reports will be compared to each other and to the actual fusion biopsy results. In the event that a high correlation is found between the diagnostic imaging results to those of the fusion biopsies, it would suggest that PSMA PET-CT could give the option to be performed instead of the need for biopsy in men who present with high levels of PSA and prompt treatment accordingly.
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is the evaluation of the possible role of PSMA PET-CT in early detection of prostate cancer, reducing rate of unnecessary prostate biopsies, and in cases of prostate cancer, correct staging of the disease and corresponding management.

Detailed description: The aim of the study is the evaluation of the possible role of PSMA PET-CT in early detection of prostate cancer, reducing rate of unnecessary prostate biopsies, and in cases of prostate cancer, correct staging of the disease and corresponding management.

Consequently, use of PSMA PET-CT in patients with suspicious PSA changes may improve our knowledge whether the prostate tumor is clinically significant or not (for the development of PSMA PET-CT with 68 Ga ligand allows to visualize prostate cancer with aggressive patterns), and improve clinical decision making for performing prostate biopsy or selecting patients for observation only.

In light of the above, we are of the opinion that this proposed study has the potential to significantly alter the medical practice of how prostate cancer is diagnosed, which even today suffers from real clinical dilemma.

Eligibility criteria: Inclusion Criteria:

1. Men aged 40-75
2. With or without suspicious DRE,
3. Were referred by their treating physicians for prostate cancer biopsy based on either an elevated PSA result, a suspicious DRE exam, or both
4. 4 \< PSA ≤ 10 ng/ml

   -

   Exclusion Criteria:
5. A previous diagnosis of prostate cancer
6. Underwent previous prostate biopsy
7. Previous radiation to pelvis for any reason

   -

Primary outcomes:
measure: Prostate Cancer Diagnosis
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT06348186: Fascial Tissue Response to Manual Therapy: Implications in Long COVID-19
Official title: Fascial Tissue Response to Manual Therapy: Implications in Long COVID-19
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19
Keywords: Long COVID
Manual Therapy
Fascia
Rehabilitation
Lead sponsor: University of the State of Santa Catarina
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa e Inovação do Estado de Santa Catarina
First posted: 2024-04-04
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of two or groups, typically an intervention group (fascia-focused manual therapy) and a control group. Participants are randomly allocated. Participants and outcomes assessor are blinded.
Primary purpose: TREATMENT

Brief summary: According to the World Health Organization (WHO), as of mid-September 2022, more than 21 million Brazilians have recovered from COVID-19. However, post-infection symptoms continue to appear months after the end of the acute infection, a syndrome called long COVID. Therefore, the aim of this study is to investigate the responses of fascia-focused manual therapy in participants with long COVID.

Detailed description: Participants reported to have long COVID, of both sexes, aged between 20 and 80 years, from the community, outpatient clinics and hospitals will be evaluated. The treatment of participants will be carried out at the CEFID-UDESC Physiotherapy School Clinic, where they will undergo assessment of the biomechanical and viscoelastic properties of tissues, postural control, pain and quality of life. For normality analysis, the Shapiro-Wilk test will be applied, and according to the distribution of the data, parametric or non-parametric tests will be used. Pre- and post-assessment and treatment data will be compared using descriptive statistics and Student's t-test with a significance level of p=0.05 for parametric data or Wilcoxon for non-parametric data.

Eligibility criteria: Inclusion Criteria:

* Participants diagnosed with long COVID, of both sexes, aged between 20 and 80 years, from the community, outpatient clinics and hospitals.

Exclusion Criteria:

* Participants with suspected deep vein thrombosis; Participants with neurological disorders.

Primary outcomes:
measure: Functioning and disability
timeFrame: 6 weeks
measure: Biomechanical and tissue viscoelastic properties
timeFrame: 6 weeks
Secondary outcomes:
measure: Work capacity
timeFrame: 6 weeks
measure: Level of Quality of life
timeFrame: 6 weeks
measure: Upper limb dysfunctions
timeFrame: 6 weeks
measure: Balance
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Florianópolis
country: Brazil
facility: Santa Catarina State University
state: Santa Catarina
Study officials:
References:
Clinical trial NCT04538586: Influence of the COVId-19 Pandemic on STRESS, and Screening Procedures (COVISTRESS Screening)
Official title: Influence of the COVId-19 Pandemic on STRESS, and Screening Procedures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19 Screening
Keywords: COVID-19
Screening
Stress
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People screened for COVID-19

Brief summary: Coronavirus has caused containment of more than a third of the world's population. Some countries have used a major screening strategy. Screening procedures, such as waiting (or resulting) for the test, can be stressful and can attract the most stressed people. However, there is currently no data on the relationship between stress and screening for SARS-CoV2

Detailed description: This is an observational study by REDCap questionnaire® via a flyer deposited in the waiting room of the COVID screening centres. No incentive to complete the questionnaire will be made. The self-survey will assess stress and its relationship to SARS-CoV2 screening procedures, socio-demographic factors or lifestyle habits. This Screening questionnaire includes 31 questions.

Eligibility criteria: Inclusion Criteria:

* All volunteers who are screened

Exclusion Criteria:

* None

Primary outcomes:
measure: Stress measures
timeFrame: Day 1
Secondary outcomes:
measure: Screening
timeFrame: Day 1
measure: Sociodemographic characteristics
timeFrame: Day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Univeristy Hospital, Clermont-Ferrand
Study officials:
References:
citation: Delamarre L, Tannous S, Lakbar I, Couarraze S, Pereira B, Leone M, Marhar F, Baker JS, Bagheri R, Berton M, Rabbouch H, Zak M, Sikorski T, Wasik M, Nasir H, Quach B, Jiao J, Aviles R, Covistress Network, Clinchamps M, Dutheil F. The Evolution of Effort-Reward Imbalance in Workers during the COVID-19 Pandemic in France-An Observational Study in More than 8000 Workers. Int J Environ Res Public Health. 2022 Jul 26;19(15):9113. doi: 10.3390/ijerph19159113.
Clinical trial NCT04577586: Negative Oral Contrast Agents Utilization in PET/CT Studies
Official title: Negative Oral Contrast Agents Utilization in PET/CT Studies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PET/CT
Oral Contrast
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients in our institution who prepared for PET-CT with administration of oral contrast material

Brief summary: To compare the performance of different negative oral contrast agents in bowel distension in patient referred for PET/CT studies for various causes aiming for identification of ideal oral contrast agent(OCA).

Detailed description: Evaluation of gastrointestinal pathology depends on adequate bowel distention, which optimizes resolution of the bowel wall and contents. Traditionally, high-attenuation oral Contrast material in the form of iodine solutions or barium suspensions has been used to obtain bowel distension in MDCT examinations

Traditional high-contrast oral agents like iodine solutions, and barium suspensions which due to overcorrection problems in PET-CT interpretation lowers the accuracy of diagnosis. Negative oral contrast agents like water, air, fat containing agents used with 12.5% corn oil and polyethylene glycol has been used in radiological studies. Milk with 4% fat content has also been tested out in radiological studies and found to be effective. As it is more easily available, palatable, and acceptable especially, by children it needed to be tested in the visualization of the GIT in the PET-CT studies compared to other negative contrast agents.

Eligibility criteria: Inclusion Criteria:

* all patients referred to our unit for PET/CT study for various causes

Exclusion Criteria:

* Patients with GIT disease.
* Pregnancy and lactation.
* Severely ill patients.

Primary outcomes:
measure: compare the performance of different negative oral contrast agents in PET/Ct studies
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
citation: Meyer SA, Gawde S. Utility of negative oral contrast (milk with 4% fat) in PET-CT studies. Indian J Nucl Med. 2012 Jul;27(3):151-5. doi: 10.4103/0972-3919.112719.
citation: Koo CW, Shah-Patel LR, Baer JW, Frager DH. Cost-effectiveness and patient tolerance of low-attenuation oral contrast material: milk versus VoLumen. AJR Am J Roentgenol. 2008 May;190(5):1307-13. doi: 10.2214/AJR.07.3193.
Clinical trial NCT04685486: Virtual Reality for Pain Management in Burn Patients
Official title: Virtual Reality for Pain Management in Burn Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Keywords: Virtual Reality
Pain Management
Anxiety
Depression
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized proof-of-concept study to assess the efficacy of Virtual Reality (VR) vs standard of care in 50 adult patients in the New York Presbyterian Burn Unit. The participants who are randomized to receive the virtual reality intervention will also receive opioids, which is the standard of care and is known to be effective. Participants will be randomly assigned to two groups. The first group will receive VR during their painful procedure (e.g., wound dressing changes, physical therapy etc.) in addition to the standard of care. The other group will receive standard of care (and no VR).


Eligibility criteria: Inclusion Criteria:

* 8 years and older
* Patients with a burn injury and is in the Burn Unit at New York Presbyterian
* Awake, alert, ambulatory
* The burn comprises less than 15% total body surface area (TBSA)
* The patient does not require conscious sedation such as ketamine for staple removal or wound dressing changes
* The patient is able to give informed consent

Exclusion Criteria:

* Diagnosis of a cognitive disorder, psychotic disorder or bipolar I as determined by self-report from previous diagnosis
* Current opioid abuse

Primary outcomes:
measure: Change in Pain
timeFrame: Peri-procedural: 30 minutes before to two hours after the painful event.
measure: Change in narcotic dose
timeFrame: Peri-procedural: 30 minutes before to two hours after the painful event.
Secondary outcomes:
measure: Change in narcotic dose
timeFrame: Day 1 of hospitalization to last day of hospitalization (approximately 15 days)
measure: Change in anxiolytics dose
timeFrame: Day 1 of hospitalization to last day of hospitalization (approximately 15 days)
measure: Change in Anxiety Symptoms
timeFrame: Peri-procedural: 30 minutes before to two hours after the painful event.
measure: Change in Depressive Symptoms
timeFrame: Peri-procedural: 30 minutes before to two hours after the painful event.
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: JoAnn Difede, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04337086: Effect of T4K Versus Twin Block in Developing Class II Division I Malocculsion
Official title: The Effect of T4K Versus Twin Block in Developing Class II Division I Malocculsion (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Appliances
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2020-04-07
Enrollment: 20
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate and compare the effect of myofunctional trainer T4K versus twin block functional appliance on the dentoalveolar changes in children with class II division I malocclusion

Detailed description: This study was a parallel arm randomized comparative clinical trial including 20 healthy children age ranged from 9-12 years showing Angle's class II division I malocclusion due to mandibular retrusion. Preoperative photographs, radiographs and study casts were taken, children were randomly assigned into two groups according to the appliance used; Group 1: T4k, and Group II: twin block. Follow up was done every 4 weeks for 9 months. Postoperative cephalometric X ray, study casts and photographs were retaken for measurements and comparison.

Eligibility criteria: Inclusion Criteria:

* Angle's class II division I malocclusion due to mandibular retrusion depending on clinical judgement and confirmed with the lateral cephalometric X-ray.
* Parental written consent was secured.

Exclusion Criteria:

* Patients with mandibular shifts.
* Patients with severe crowding.
* Patients with anterior open bite.
* Patients with posterior crossbite.
* Patients with any peri-oral habits.
* Patients who had received any previous orthodontic or orthopaedic treatments.

Primary outcomes:
measure: Dento-alveolar changes
timeFrame: baseline
measure: Dento-alveolar changes
timeFrame: 9 months
measure: Overjet
timeFrame: baseline
measure: Overjet
timeFrame: 9 months
measure: Overbite
timeFrame: baseline
measure: Overbite
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Pharos University in Alexandria.
name: Yasmine El Hamouly, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Hanan A Ismaiel, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Azza A ElHousseiny, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Laila M El Habashy, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06740786: Efficacy and Safety of Dapagliflozin in Preventing Atrial Fibrillation Recurrence After Catheter Ablation
Official title: Efficacy and Safety of Dapagliflozin in Preventing Atrial Fibrillation Recurrence After Catheter Ablation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: Hefei Binhu Hospital
name: The First People's Hospital of Hefei
name: Second People's Hospital of Hefei City
name: The Second People's Hospital of Anhui Province
First posted: 2024-12-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Atrial fibrillation (AF) is a common arrhythmia, particularly prevalent in the elderly population. Catheter ablation is a common treatment for AF, but post-ablation recurrence of arrhythmias remains a significant clinical challenge. Dapagliflozin, an SGLT2 inhibitor primarily used for the treatment of type 2 diabetes, has shown potential in the field of cardiology, particularly for treating heart failure patients. Some studies suggest that dapagliflozin may reduce cardiac workload, improve heart function, and could even help in the management of atrial fibrillation. Therefore, this study aims to explore whether dapagliflozin can reduce the recurrence of arrhythmias following atrial fibrillation catheter ablation.


Eligibility criteria: Inclusion Criteria:

- Age: Patients aged 18 years and older. Presence of type 2 diabetes or heart failure. Diagnosis of Atrial Fibrillation: Confirmed atrial fibrillation through ECG or Holter monitoring.

First-time Catheter Ablation: Patients undergoing their first atrial fibrillation catheter ablation.

Voluntary Participation: Patients willing to participate and sign informed consent.

Exclusion Criteria:

- Presence of urinary tract infection Pregnancy or Breastfeeding: Women who are pregnant, breastfeeding, or planning to become pregnant.

Allergy to Dapagliflozin or Similar Drugs: History of allergic reactions to dapagliflozin or other SGLT2 inhibitors.

Other Contraindications to Dapagliflozin: Any other contraindications for dapagliflozin use.

Kidney Function: eGFR \< 45 ml/min/1.73m², with severe kidney disease.

Primary outcomes:
measure: The recurrence of atrial arrhythmias
timeFrame: Within 12 months, beyond the 3-month blanking period.
Secondary outcomes:
measure: The recurrence of atrial fibrillation
timeFrame: Within 12 months, beyond the 3-month blanking period.
measure: changes in quality of life at 12 months as assessed by Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire
timeFrame: 12 months post-ablation.
measure: Atrial Fibrillation Burden
timeFrame: after 1 year post-ablation
measure: Number of participants with adverse events
timeFrame: 12 months post-ablation.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00108186: Celecoxib Treatment for Lung Cancer
Official title: Celecoxib-Mediated Inhibition of T Regulatory Cells in Human Lung Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Non-Small-Cell Lung Carcinoma
Keywords: cyclooxygenase 2
lung cancer
lymphocytes
non small cell
therapeutics
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of California, Los Angeles
name: City of Hope Medical Center
First posted: 2005-04-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This proposal evaluates cyclooxygenase 2 (COX-2) inhibition as a means to decrease T regulatory cell activities and thus augment immune responses against lung cancer. The broad goal focuses on understanding how COX-2 expression regulates the malignant phenotype in non small cell lung cancer in an effort to foster an informed approach for the use of COX-2 inhibitors in prevention and therapy for lung cancer.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed and surgically resectable non small cell lung cancer and subjects must be ineligible for or refuse, neoadjuvant therapy

Exclusion Criteria:

Hypersensitivity to celecoxib or NSAIDs, previous history of GI bleeding or ulceration, chronic or concurrent use of steroids and renal insufficiency

Primary outcomes:
measure: Measure bio-markers; safety measures
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West LA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West LA
name: Steven Dubinett, MD
role: PRINCIPAL_INVESTIGATOR
References: