louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05572866: Impact of COVID-19 Pandemic on Hepatopancreatobiliary Surgical Services in Singapore
Official title: Before and After- Impact of COVID-19 Pandemic on Hepatobiliary and Pancreatic Surgical Services in Singapore: Retrospective Quantitative Study 2019-2022
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Surgery
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 1089
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who underwent gallbladder, hernia, liver or pancreas resection surgeries during the periods of January to June of 2019/2020/2021/2022.

Brief summary: This paper is intended to report our observational study in evaluating the impact of the COVID-19 pandemic on Tan Tock Seng Hospital hepatopancreatobiliary unit's surgical workload from January to June across 2019 to 2022, corresponding to the pre-pandemic baseline to its peak and the gradual normalization of hospital services as Singapore entered the transition phase to COVID-19 resilience.

Detailed description: This paper is intended to report our observational study in evaluating the impact of the COVID-19 pandemic on Tan Tock Seng Hospital hepatopancreatobiliary unit's surgical workload from January to June across 2019 to 2022, corresponding to the pre-pandemic baseline to its peak and the gradual normalization of hospital services as Singapore entered the transition phase to COVID-19 resilience.

A comparative audit of the unit's surgical workload for the months of January-June across 2019 to 2022, which corresponded to pre-COVID-19, the height of the pandemic, and a gradual normalization of surgical services. Operations performed by the unit were collected from the surgeons' electronic case logs. These operations were sorted based on the Singapore Ministry of Health's table of surgical procedures, which assigns charge codes to different procedures. The retrospective data across the 4 years were compared and analysed.

No patient contact or identifiers were retrieved, stored or disseminated and thus exempt from ethics board review.

Eligibility criteria: Inclusion Criteria:

* all patients who underwent gallbladder, hernia, liver or pancreas resection surgeries during the periods of January to June of 2019/2020/2021/2022.

Exclusion Criteria:

* anyone who does not fall within the inclusion criteria

Primary outcomes:
measure: Number of surgeries done under general anaesthesia by the hepatopancreatobiliary unit
timeFrame: 2019-2022
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Vishalkumar G Shelat, MMed, FRCS
role: STUDY_DIRECTOR
References:
Clinical trial NCT04597866: Treatment of Complex Regional Pain Syndrome, a Long-term Follow-up
Official title: Treatment of Complex Regional Pain Syndrome, a Qualitative Interview Study and a Case Series With Long-term Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complex Regional Pain Syndromes
Chronic Pain
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with CRPS 1 or 2, diagnosed according to the Budapest criteria that has received in-patient treatment at Uppsala University Hospital, comprised of graded exposure therapy in vivo, in combination with methods targeting cortical reorganisation.

Brief summary: Complex regional pain syndrome, CRPS, is an uncommon but often very disabling chronic pain syndrome characterized by, beside pain: sensory disturbances, peripheral autonomic changes and inflammatory features. The diagnosis is subdivided in CRPS type 1 where no nerve injury has been identified, and CRPS type 2 when a major nerve injury has been verified.

A combination of exposure in vivo, a form of behaviour therapy where the patient is gradually confronted with avoided movements and activities, and interventions directly targeting a hypothesized cortical reorganisation is an interesting novel approach for treating CRPS.

The present study consists of (1) a qualitative interview study with 10-15 subjects that has received this form of treatment, in order to better understand their experience and effects of the treatment, and (2) a case series with long-term follow-up of 3-5 subjects that received the treatment för 5-8 years ago, in order to study the long term effects of the treatment.


Eligibility criteria: Inclusion Criteria:

* Has participated in multimodal treatment for CRPS at Uppsala University Hospital

Exclusion Criteria:

* Other serious physical or mental condition

Primary outcomes:
measure: Diagnosis
timeFrame: 1 day
measure: Subjective experience
timeFrame: 1 day
Secondary outcomes:
measure: Level of pain
timeFrame: 1 day
measure: Subjective experience of quality of life
timeFrame: 1 day
measure: Global impression of change
timeFrame: 1 day
measure: Acceptance of pain
timeFrame: 1 day (0-156, higher scores mean a better outcome)
measure: Fear of pain
timeFrame: 1 day (0-52, lower scores mean a better outcome)
measure: Pain catastrophizing
timeFrame: 1 day (0-52, lower scores mean a better outcome)
measure: Avoidance of activities
timeFrame: 1 day (0-100, lower scores mean a better outcome)
measure: Neglect of the affected limb
timeFrame: 1 day (0-36, lower scores mean a better outcome)
measure: Subjective experience of quality of life 2
timeFrame: 1 day
measure: Subjective experience of quality of life 3
timeFrame: 1 day
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Uppsala University
name: Kristoffer Bothelius, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02469766: Treatment of Upper Ureteric Stones
Official title: A Comparison Between Flexible Ureteroscopy, Semirigid Ureteroscopy and Extracorporeal Shockwaves Lithotripsy (SWL) in The Management of Proximal Ureteric Stones. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ureteric Stones
Keywords: ureteral stones
ureter
ureteroscopy
flexible
SWL
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-06-11
Enrollment: 240
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to compare the success and complication rates of ureteroscopy, and shockwaves lithotripsy for treatment of upper ureteric stones ≤1 cm.

Detailed description: This study will be conducted to compare the success and complication rates of Flexible, Semi-rigid URS, and SWL approaches for proximal ureteric stones with size ≤1 cm.

Eligibility criteria: Inclusion Criteria:

* Radio-opaque stones
* less than or equal 1 cm

Exclusion Criteria:

* Active UTI
* Coagulopathy
* Pregnancy
* Ureteric stricture

Primary outcomes:
measure: Stone free rate
timeFrame: 3 months
Secondary outcomes:
measure: Complication rate
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
state: Dakhlia
Study officials:
affiliation: Mansoura University
name: Ahmed M Shoma, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05627466: US Expanded Access Program for Magrolimab in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Official title: Expanded Access Program for Magrolimab
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Relapsed/Refractory Acute Myeloid Leukemia
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2022-11-25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The goal of this expanded access program is to provide rapid access to magrolimab free-of-cost material, to treat patients in the United States suffering from relapsed or refractory acute myeloid leukemia (AML).


Eligibility criteria: Key Inclusion Criteria:

* Individuals with confirmation of acute myeloid leukemia (AML) according to WHO 2016 classification who are refractory or relapsed, ineligible for all known drugs with proven efficacy, and ineligible for existing clinical studies; and the treating physician has assessed that the potential benefits of magrolimab outweigh the risks.
* Eastern Cooperative Oncology Group performance status score of 0 to 3.
* Treating physician plans to administer magrolimab in combination with azacitadine/venetoclax or magrolimab in combination with azacitadine alone, following the indication-specific combinations described in the protocol.

Key Exclusion Criteria:

* Known hypersensitivity to magrolimab, azacitidine, venetoclax, their metabolites, or formulation excipients, if applicable to planned treatment regimen.
* Prior treatment with cluster of differentiation (CD)47 or signal regulatory protein alpha (SIRPα)-targeting agents.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02439866: Outcomes of Steroid and Oxygen Therapy Versus Placebo Therapy in Non-arteritic Anterior Ischemic Optic Neuropathy
Official title: The Effect of High Dose Steroid and Normobaric Oxygen Therapy on Recent Onset Non-arteritic Anterior Ischemic Optic Neuropathy(NAION); a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients diagnosed with NAION within 14 days of onset were included. Patients were randomized into 3 groups. Group 1 or control consisted of 30 patients who received gelatinous capsules filled with sugar as placebo. Group 2 or steroid consisted of 30 patients received methylprednisolone (Solu-Medrol, Pharmacia Pharmaceutical Company, Belgium) 500 mg twice a day for 3 days followed by 2 weeks of oral prednisolone 1mg/kg/day. Thirty patients in group 3 or oxygen received 100% normobaric oxygen with face mask in sitting position, at a flow rate of 5 liters per minute for 1 hour twice a day for two weeks Functional and structural outcomes were assessed at 1 and 6 months following treatment. Best corrected visual acuity was the main outcome measure, and mean deviation index of visual field test and peripapillary retinal nerve fiber layer thickness were secondary outcome measures.


Eligibility criteria: Inclusion Criteria:

* Patients with recent onset ( within 2 weeks) of non-arteritic ischemic optic neuropathy

Exclusion Criteria:

* the presence of glaucoma, or any other ocular, neurologic, or systemic disease that may influence visual acuity and visual field; abnormal results in laboratory assessments, including an abnormally elevated erythrocyte sedimentation rate and positive serum C-reactive protein;
* a history of previous ocular surgery;
* a history of prior treatment of any type for NAION;
* systemic condition such as diabetes mellitus and poorly controlled hypertension

Primary outcomes:
measure: Best corrected visual acuity using Snellen chart
timeFrame: until 6 months
Secondary outcomes:
measure: Visual field mean deviation index using the Humphrey Visual Field Analyzer
timeFrame: until 6 months
Other outcomes:
Locations:
city: Tahran
country: Iran, Islamic Republic of
Study officials:
References:
Clinical trial NCT00836966: Sampling Biomarkers in Meniscus Injury to the Knee
Official title: Diagnostic Utility of Cytokine Biomarkers in the Evaluation of Acute Knee Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cartilage Diseases
Lead sponsor: Scuderi, Gaetano J., M.D.
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2009-02-04
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 68 patients with knee pain \< 6 months with either acute or insidious onset who failed conservative management and elected arthroscopy. Adult volunteers with no history of knee pain.

Brief summary: The diagnosis of clinically-significant meniscal tears of the knee remains challenging, and it is unknown why only some injuries become painful. The limitations of diagnostic magnetic resonance imaging result in arthroscopy that is not always beneficial. Elucidation of biochemical pathways underlying pain in this condition may aid patient selection for surgery and provide pharmacotherapeutic targets. Cytokines may be involved in pain following meniscus injury and diagnostic cytokine assay may help physicians differentiate patients that may benefit from arthroscopy from those that may not.

Detailed description: Lavage of the operative and contralateral knee for comparison was performed under anesthesia prior to arthroscopy by the infusion of sterile saline into the knee joint followed by the immediate withdrawal into the syringe. Sixteen asymptomatic control subjects also contributed knee samples. The concentrations of 17 inflammatory cytokines/chemokines were measured using a multiplexed immunoassay panel. Pre-operative magnetic resonance imaging findings and cytokine assay results were compared to "gold-standard" intraoperative findings.

Eligibility criteria: Inclusion Criteria:

* Adult patients with knee pain \< 6 months with acute onset who had failed conservative treatment and elected for arthroscopic management. Indications for surgery included the presence of mechanical symptoms on history, a physical examination positive for McMurray's maneuver or joint line tenderness or both32, absence of severe joint space narrowing on plain radiography1 33, and the presence of grade III signal changes on MRI35 in an anatomic location consistent with the history and physical examination.

Exclusion Criteria:

* Less than 18 years old.
* Recent (within three months) intra-articular corticosteroid injection and past or current medical history of autoimmune disease (i.e. rheumatoid arthritis).
* In addition, no patients involved in a worker's compensation claim or personal injury litigation were enrolled in the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Gaetano J Scuderi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00233766: Evaluation of Two Reduced Sirolimus Doses in Treatment of de Novo Coronary Artery Lesions (REDOX)
Official title: An Evaluation of Two Reduced Sirolimus Doses on the BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions(REDOX)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Coronary Artery Disease
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2005-10-06
Enrollment: 60
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: The objective of this study is to assess the performance and safety of two reduced sirolimus doses on the Bx VELOCITY Balloon-Expandable stent, mounted on the Raptorâ rapid exchange (RX) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.


Eligibility criteria: Inclusion Criteria:

1. Male or non-pregnant female patient minimum 18 years of age
2. No significant (\>50%) untreated stenoses proximal or distal to the target lesion that will not be treated during the procedure and may require revascularization or impede runoff;
3. Target lesion is 18mm in length (visual estimate);
4. Target lesion is 3.0mm and 3.5mm in diameter (visual estimate);
5. Target lesion stenosis is \>50% and \<100% (visual estimate);

Exclusion Criteria:

1. A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;
2. Ejection fraction 30%;
3. Stent placement of target lesion covers a side branch \>2.0mm in diameter;

Primary outcomes:
measure: Late loss measured by quantitative coronary angiography at four-months and twelve-months post-procedure.
timeFrame: four-months and twelve-months post-procedure
measure: NIH volume as measured by intravascular ultrasound (IVUS) at four-months and twelve-months post-procedure.
timeFrame: four-months and twelve-months post-procedure
measure: Volumetric plaque burden as measured by IVUS at four-months and twelve months post-procedure.
timeFrame: four-months and twelve months post-procedure
measure: Four and twelve month target vessel failure (TVF).
timeFrame: Four and twelve month
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paolo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
Study officials:
affiliation: Instituto Dante Pazzanese de Cardiologia
name: J. E. Sousa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nakamura M, Abizaid A, Hirohata A, Honda Y, Sousa JE, Fitzgerald PJ. Efficacy of reduced-dose sirolimus-eluting stents in the human coronary artery: serial IVUS analysis of neointimal hyperplasia and luminal dimension. Catheter Cardiovasc Interv. 2007 Dec 1;70(7):946-51. doi: 10.1002/ccd.21272.
Clinical trial NCT02079766: 18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy
Official title: 18F-AV-1451 and Florbetapir F 18 PET Imaging in Subjects With Repetitive Brain Trauma at High Risk for Chronic Traumatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Traumatic Encephalopathy
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-03-06
Enrollment: 41
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will explore the use of flortaucipir as a biomarker for chronic traumatic encephalopathy (CTE) and examine the relationship between clinical presentation and tau deposition.


Eligibility criteria: Inclusion Criteria:

* Male subjects consented and currently enrolled in the Diagnosing and Evaluating Traumatic Encephalopathy Using Clinical Tests (DETECT) or the Long-Term Consequences of Repetitive Brain Injury in Athletes study protocols
* Can tolerate up to two PET imaging sessions
* Have the ability to provide informed consent for study procedures

Exclusion Criteria:

* Claustrophobia
* Current clinically significant cardiovascular disease or clinically significant abnormalities on screening ECG
* History of risk factors for Torsades de Pointes or are taking drugs known to cause QT-prolongation
* Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer that the investigator believes would affect study participation or scan results
* Have had a non-study related radiopharmaceutical imaging or treatment within 7 days prior to study PET imaging sessions

Primary outcomes:
measure: Flortaucipir Visual Read as CTE Biomarker
timeFrame: Baseline scan
measure: Relationship Between Clinical Presentation and Tau Deposition (Subjects at High Risk of CTE Only)
timeFrame: baseline scan
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute
state: Arizona
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Avid Radiopharmaceuticals, Inc.
name: Chief Medical Officer
role: STUDY_CHAIR
References:
citation: Stern RA, Adler CH, Chen K, Navitsky M, Luo J, Dodick DW, Alosco ML, Tripodis Y, Goradia DD, Martin B, Mastroeni D, Fritts NG, Jarnagin J, Devous MD Sr, Mintun MA, Pontecorvo MJ, Shenton ME, Reiman EM. Tau Positron-Emission Tomography in Former National Football League Players. N Engl J Med. 2019 May 2;380(18):1716-1725. doi: 10.1056/NEJMoa1900757. Epub 2019 Apr 10.
Clinical trial NCT04731766: Effect of Using Different Varnishes on Dentin Hypersensitivity; Na Fluoride and Nano-silver Fluoride
Official title: Effectiveness of Using Nano-Silver Fluoride Varnish Versus Sodium Fluoride Varnish in Management of Cervical Dentin Hypersensitivity in Adult Patients: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dentin Hypersensitivity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 42
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 2 different varnishes will be used to test their effectiveness in controlling teeth hypersensitivity in adult patient.

Detailed description: In-vivo part:

Each varnish will be applied separately on different teeth according to the manufacturer's instructions and the VAS will be measured according to a specific timeline: T0 (baseline, before application of varnish), T1 (1 week after application), T2 (4 weeks after application) and T3 (4 weeks after application).

In-situ part:

Dentin specimen will be prepared from extracted teeth from the orthodontic department in our college, sterilized and prepared.

it will be bonded to an orthodontic wire and bonded to upper first molar. Dentinal occlusion will be measured using scanning electron microscope following the same timeline.

Eligibility criteria: Inclusion Criteria:

* Patients consulting in one of the Qasr Einy, faculty of dentistry outpatient clinics.
* Males or females.
* Patient's age range 25-50 years.
* Patients complaining of hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bi-cuspids, and first molars with exposed cervical dentine) with teeth scoring Bpain (VAS score: greater than or equal to 3) during application of stimulus (airblast and tactile sensitivity test).
* Tooth with exposed root surface, complaining from hypersensitivity (VAS score; greater than or equal to 3).
* Patients accept the 2-months follow-up period.
* Provide informed consent.

Exclusion Criteria:

* • Patients participating in another dental study that may alter the results of this study.

  * A medical condition that could hinder the accuracy of pain reporting (e.g., pain disorders).
  * Any chronic medical condition that requires the regular use of anti-inflammatory pain medications.
  * Patients used or applied a desensitizing varnish within the last four weeks.
  * Patients with dental problems; chipped teeth, defective restorations, fractured Un-displaced cuspids or deep dental caries.
  * Lack of patient's approval and compliance.

Primary outcomes:
measure: change in dentin Hypersensitivity
timeFrame: 1 week, 4 weeks & 8 weeks
Secondary outcomes:
measure: change in dentinal Tubule Occlusion
timeFrame: 1 week, 4 weeks * 8 weeks
Other outcomes:
Locations:
Study officials:
References: