louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05075915: Transfusion and COVID-19
Official title: Transfusion and COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: COVID-19
Blood donation
Blood transfusion
Labile products
Blood platelets
Psoralen
ECMO
SARS-CoV-2
Consumption of blood products
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (≥18 years old) admitted to Strasbourg University Hospitals for suspicion of Covid-19, between February 24 and May 31 of 2019 and 2020

Brief summary: Alsace was particularly and early on affected by SARS-CoV-2 and quickly implemented a reduction in scheduled admissions and non-urgent surgical interventions, making it possible to reduce requests for labile blood products linked to non-urgent surgical procedures. as has been reported in the literature; the population containment measures also led to a major reduction in traffic - and consequently accidents on the public roads. At the same time, other demands for blood products related to activities such as onco-hematology were little affected. Finally, the blood banks have adapted their collection procedure.

To answer these questions, we propose to conduct a retrospective study over two parallel periods of 2019 and 2020 of the consumption of blood products on the one hand and the availability of stocks on the other hand.


Eligibility criteria: Inclusion criteria:

* Adults patient (≥18 years old)
* Patients admitted to Strasbourg University Hospitals for suspicion of Covid-19, between February 24 and May 31 of 2019 and 2020
* Labile blood products consumed between February 24 and May 31 of 2019 and 2020
* Subjects not having his opposition, after information, to the reuse of his data for the purposes of this research.

Non-inclusion criteria:

* Patients who expressed opposition to participating in the study
* Patients under legal protection
* Patients under guardianship or curatorship

Primary outcomes:
measure: Study of the consumption of labile blood products at Strasbourg University Hospitals, during the two covid-19 periods: from February 24 to May 31, 2019 and 2020
timeFrame: Files analysed retrospectively from from February 24 to May 31, 2019 and from February 24 to May 31, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg
name: Paul-Michel MERTES, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06642415: Effect Of High Magnification On Quality Of Life And Success After Endodontic Microsurgery: A Randomized Controlled Trial
Official title: Effect Of High Magnification On Quality Of Life And Success After Endodontic Microsurgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periapical Lesion
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of high magnification on quality of life and success after endodontic surgery: a randomized controlled trial"

Detailed description: : Residual infection in untreated canal space is one of the most common cause of post treatment apical periodontitis. The prevalence of post treatment apical periodontitis has been reported to be 60% to 80%. Endodontic microsurgery and root resection removes the inaccessible apical ramifications and ensures adequate sealing of apical communication. Magnification has been recommended for better visualization of apical terminus. Various case reports and retrospective studies have reported higher success of apical surgery when magnification devices have been used as an adjunct to periapical surgery (setzer 2010, tsesis 2006, bud 2020). However, there are very few prospective studies and there is heterogeneity in data in terms of type of magnification used and there are very few studies comparing different magnification devices.

To the best of our knowledge no randomized controlled trial has been done on the periapical surgery of maxillary anterior teeth which compares the effect of magnification by microscope versus loupes, hence the aim of this study is to assess the quality of life and success after endodontic surgery using with or without magnification.

Eligibility criteria: Inclusion Criteria:

* Patients between age of 18-55 with the diagnosis of persistent symptomatic apical periodontitis in previously treated teeth with radiographic evidence of periapical radiolucency (≥ 5 mm). (Bharathi et al 2021) Tooth with a peri radicular lesion of strictly endodontic origin and unrestorable by nonsurgical retreatment. ASA-1 patients according to the classification of the American Society of Anesthesiologists).

Exclusion Criteria:

Patients with systemic diseases (diabetes mellitus, uncontrolled hypertension grade III, hepatic/renal disease, or systemic bleeding disorders) Combined endodontic-periodontic lesions Pregnancy

-

Primary outcomes:
measure: Quality of life assessment
timeFrame: till 7 days after surgery
measure: Healing assessment
timeFrame: After 6 months and 12 months
Secondary outcomes:
measure: Pain assessment
timeFrame: till 7 postoperative days
Other outcomes:
Locations:
city: Rohtak
country: India
facility: PGIDS
state: Haryana
Study officials:
References:
Clinical trial NCT02119715: A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF in Breast Cancer Patients Receiving Chemotherapy
Official title: A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF as Supportive Therapy to Breast Cancer Patients Receiving Neoadjuvant/Adjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Neutropenia
Febrile Neutropenia
Keywords: Breast Cancer
Neutropenia
Febrile Neutropenia
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-04-22
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with breast cancer.


Eligibility criteria: Inclusion Criteria:

* Pathology diagnosis of breast cancer,Chemotherapy naïve
* ECOG performance status 0-1
* Age 18 to 70 years
* Available for at least 2 cycles of consistent neoadjuvant/adjuvant therapy
* White blood cell ≥ 4.0×109/L; absolute neutrophil count ≥2.0 × 109/L; platelet count ≥ 100 × 109/L
* Alanine aminotransferase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN
* No obvious cardiac dysfunction

Exclusion Criteria:

* Prior bone marrow or stem cell transplantation
* Received systemic antibiotics treatment within 72 h of chemotherapy
* Other disease might have influence on bone marrow function
* Radiation therapy within 4 weeks of randomization into this study
* Previous exposure or or allergic to Pegylated rhG-CSF
* Pregnancy, lactation

Primary outcomes:
measure: Incidence and the duration of grade 3/4 neutropenia in cycle 2 and the time frame of ANC recovery to 2.0×109/L
timeFrame: 6 weeks
Secondary outcomes:
measure: Incidence of the febrile neutropenia in cycle 1 and cycle 2
timeFrame: 6 weeks
measure: ANC alteration in cycle 1 and cycle 2
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: 307 Hospital Affiliated to Academy Military Medical Science
Study officials:
affiliation: 307 Hospital Affiliated to Academy Military Medical Science
name: ZeFei Jiang, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00003115: Epidural Hydromorphone Compared With Hydromorphone Infusion in Treating Patients With Prostate Cancer Undergoing Radical Prostatectomy
Official title: Spinal Effects of Epidural Hydromorphone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Prostate Cancer
Keywords: prostate cancer
pain
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2004-08-12
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SUPPORTIVE_CARE

Brief summary: RATIONALE: Giving hydromorphone in different ways may relieve the pain associated with cancer surgery.

PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of epidural hydromorphone with hydromorphone infusion in patients with prostate cancer undergoing radical prostatectomy.

Detailed description: OBJECTIVES: I. Define the duration of action of hydromorphone (spinal vs supraspinal) in patients who have undergone radical prostatectomy. II. Demonstrate that the duration of the analgesic effects of equal blood concentrations of hydromorphone is dependent on the method used to attain this concentration by comparing continuous epidural infusion with that of a continuous intravenous infusion.

OUTLINE: This is a double blinded, randomized study. After all patients have undergone radical prostatectomy, hydromorphone is administered in two different ways. Patients receive either a hydromorphone bolus injection through an epidural catheter using a patient controlled analgesia pump or a hydromorphone bolus injection through an intravenous catheter using a patient controlled analgesia pump. Infusion for both groups is stopped at 24 hours. Patients are followed every 30 minutes for 6 hours.

PROJECTED ACCRUAL: A total of 40 patients will be accrued into this study over a 3 year period.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer Not metastatic Must be undergoing radical prostatectomy

PATIENT CHARACTERISTICS: Age: 18-70 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Neurologic: No presence of an intracranial lesion associated with increased intracranial pressure Pulmonary: No chronic obstructive pulmonary disease No cor pulmonale No emphysema No kyphoscoliosis No status asthmaticus Other: No contraindications for the insertion of epidural catheter No known hypersensitivity to hydromorphone No history of alcoholism, drug abuse, mental dysfunction, or cognitive deficiencies

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified for prior surgery(ies) Other: No preoperative opioids for any reason

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
References:
Clinical trial NCT01406015: Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications
Official title: Mineralocorticoid Receptor and Obesity Induced Cardiovascular Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Keywords: Obesity
Insulin resistance
Mineralocorticoid receptor
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2011-07-29
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to find out if spironolactone, a drug that blocks the action of aldosterone, can make the blood vessels work better in people with obesity. The investigators also want to find out whether spironolactone causes changes in levels of insulin and markers of inflammation.


Eligibility criteria: Inclusion Criteria:

1. Age 18-70 years
2. Good health as evidenced by history and physical exam
3. Body Mass Index (BMI): \>30 kg/m2 and \<45 kg/m2

Exclusion criteria:

1. Medical illnesses other than treated hypothyroidism
2. Blood Pressure (BP) \>135/85 or systolic BP \<90 mm Hg
3. Hepatic disease (transaminase \> 3 times normal)
4. Renal impairment (Creatinine clearance \<60 ml/min)
5. Baseline serum Potassium (K) \>5.0 mmol/L
6. History of drug or alcohol abuse
7. Allergies to spironolactone
8. Participation in any other concurrent clinical trial
9. Women using oral contraceptives within the last 3 months

Primary outcomes:
measure: Change From Baseline in Post-ischemic Dilatation
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Change From Baseline in Para-aminohippurate (PAH) Clearance
timeFrame: Baseline and Week 6 (Prior to PAH infusion and at 50 and 60 minutes post PAH infusion)
measure: Change From Baseline in Markers of Inflammation
timeFrame: Baseline and Week 6
measure: Change From Baseline in Insulin Sensitivity Index (ISI)
timeFrame: Baseline and Week 6 (Prior to ingesting glucose and every 30 minutes for 120 minutes)
measure: Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: Baseline and Week 6 (Prior to ingesting glucose and every 30 minutes for 120 minutes)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
citation: Brown JM, Williams JS, Luther JM, Garg R, Garza AE, Pojoga LH, Ruan DT, Williams GH, Adler GK, Vaidya A. Human interventions to characterize novel relationships between the renin-angiotensin-aldosterone system and parathyroid hormone. Hypertension. 2014 Feb;63(2):273-80. doi: 10.1161/HYPERTENSIONAHA.113.01910. Epub 2013 Nov 4.
citation: Garg R, Kneen L, Williams GH, Adler GK. Effect of mineralocorticoid receptor antagonist on insulin resistance and endothelial function in obese subjects. Diabetes Obes Metab. 2014 Mar;16(3):268-72. doi: 10.1111/dom.12224. Epub 2013 Oct 31.
Clinical trial NCT06264115: Outcomes of Three Ports Versus Four Ports Laparoscopic Cholecystectomy, Sohag General Surgery Department Experience
Official title: Outcomes of Three Ports Versus Four Ports Laparoscopic Cholecystectomy, Sohag General Surgery Department Experience
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cholecystitis, Chronic
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing laparoscopic cholecystectomy

Brief summary: To compare the outcomes of three ports and four ports Laparoscopic Cholecystectomy

Detailed description: To compare the outcomes of three ports and four ports Laparoscopic Cholecystectomy Randomized clinical trial comparative study will be carried out on 50 patients underwent laparoscopic cholecystectomy in general surgical department, Sohag University. An informed written consent will be obtained from the patients. Every patient will receive an explanation of the purpose of the study and will have a secret code number. Research results will be only used for scientific purposes. Any unexpected risks appearing during the course of research will be clarified to the participants and to the ethical committee on time.

Patients will be randomly classified into two equal groups; 25 patients will be enrolled in each group using computer generated random number in closed sealed envelope.

Group I (3-ports): 25 patients undergo a three-port LC. Group II (4-ports): 25 patients undergo a four-port LC. All patients will be subjected to thorough history taking (age, sex, symptoms, and duration of symptoms) and full clinical evaluation.

Abdominal ultrasound will be done in all patients. Baseline laboratory (complete blood count and coagulation profile) will be ordered in all patients.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 75 years.
* Both sexes.
* Patient with clinical, laboratory and/or radiological evidence that is a candidate for cholecystectomy operation.

Exclusion Criteria:

* Patient's refusal.
* Bile duct stones.
* History of obstructive jaundice.
* Severe acute calculus pancreatitis.
* Severe co-morbid diseases (uncontrolled diabetes, hypertension, and severe direct hyperbilirubinemia).
* Prior surgery or adhesion.
* Radical cholecystectomy.
* Pregnancy.
* Malignancy.

Primary outcomes:
measure: Postoperative pain score
timeFrame: One year
Secondary outcomes:
measure: Operative time
timeFrame: One year
measure: length of hospital stay
timeFrame: one year
Other outcomes:
measure: Total postoperative morphine consumption
timeFrame: one year
measure: Time of first analgesic
timeFrame: one year
Locations:
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
References:
Clinical trial NCT04802915: Intraoperative Analysis of the Central Retina in ERF
Official title: Intraoperative Analysis of the Central Retina in Epiretinal Fibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epiretinal Membrane
Macular Pucker
Keywords: epiretinal membrane
internal limiting membrane
epiretinal fibrosis
macular pucker
central retina
Lead sponsor: The S.N. Fyodorov Eye Microsurgery State Institution
Sponsor class: OTHER_GOV
Collaborators: name: Makarenko Irina Romanovna
name: Zgoba Mariana Igorevna
First posted: 2021-03-17
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Changes in the retinal anatomy that occur in epiretinal fibrosis have not been sufficiently studied. It is possible that epiretinal fibrosis leads not only to traction dislocation of the macula, but also to ILM anatomical disorders.

Detailed description: Purpose: to study anatomical changes in the Central retina in epiretinal fibrosis.

Surgical treatment: standard vitrectomy 25-27G; ERM amd ILM stainig by Membrane Blue Dual; epiretinal membrane removal, ILM peeling if the divulsion of ILM was detected.

Expected results: improving the quality of epiretinal fibrosis surgery by obtaining a more detailed picture of the pathological process

Eligibility criteria: Inclusion Criteria:

* BCVA \< 0,6;

Exclusion Criteria:.

* secondary ERM, glaucoma, diabetic retinopathy, high myopia, BCVA\>0,6

Primary outcomes:
measure: ILM integrity
timeFrame: intraoperative
measure: Length and localization of the ILM dialysis
timeFrame: intraoperative
measure: ILM displacement
timeFrame: intraoperative
measure: Occurence of ILM dyalisis
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: S.N. Fedorov Nmrc "Mntk "Eye Microsurgery"
Study officials:
affiliation: The S.N. Fyodorov Eye Microsurgery State Institution
name: Pavel V Lyskin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06420115: Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects?
Official title: AOP2780 - Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer Diagnosis
Keywords: pca
needle
16 gauge
18 gauge
Lead sponsor: University Hospital Padova
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Differences in terms of diagnostic capability and side effects related to the needle caliber used for prostate biopsy sampling in patients with suspected prostate cancer

Detailed description: To assess whether a larger caliber (16G) prostate biopsy needle increases the diagnostic capability of prostate neoplasia compared to a smaller caliber (18G) needle, while keeping perioperative complications constant.

Eligibility criteria: Inclusion Criteria:

* Clinical suspicion of prostate cancer (presence of elevated prostatic specific antigen and/or suspicious digital rectal examination);
* Presence of at least one suspicious prostate lesion on MRI (Prostate Imaging-Reporting and Data System ≥ 3) according to the Prostate Imaging-Reporting and Data System v2.1 performed before Magnetic Resonance Imaging/transrectal ultrasound fusion biopsy.

Exclusion Criteria:

* Patients under active surveillance or with a previous diagnosis of prostate neoplasia prior to biopsy.
* Previous radiotherapy to the prostate for neoplasia.

Primary outcomes:
measure: Total number of random and fusion-target biopsies with presence of prostate cancer
timeFrame: When histological report available
measure: Number of random and fusion-target biopsies with clinically significant prostate cancer (defined as International Society of Urological Pathology >=2)
timeFrame: When histological report available
Secondary outcomes:
measure: Neoplasia/core ratio for each random and fusion-target biopsy
timeFrame: When histological report available
measure: Intra- and perioperative pain with 18G and 16G needles assessed using visual analog scale (VAS)
timeFrame: 30 days
measure: Number of hospitalizations at 30 and 60 days post-procedure
timeFrame: 60 days from biopsy
measure: Number of intra- and perioperative complications associated with 18G and 16G needles
timeFrame: 30 days
Other outcomes:
Locations:
city: Padua
country: Italy
facility: Urology Unit - Padua University Hospital
Study officials:
affiliation: Department of Surgery, Oncology and Gastroenterology, Urology Clinic, University of Padua, Padova,
name: Fabio Zattoni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: