louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05209958: The Effect of Preoperative NLR Level on Epidural Analgesia Application in Thoracotomy
Official title: The Effect of Preoperative NLR Level on Epidural Analgesia Application in Thoracotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: C23.550.767.700
C23.550.470
Keywords: Preemptive Epidural Analgesia, Neutrophil/Lymphocyte Ratio, İnflammation
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 60 female and male patients aged 18-75 years, in the ASA I-III risk group, who will undergo elective thoracotomy

Brief summary: The aim of this study is to investigate the relationship of preoperative Neutrophil/Lymphocyte Ratio (NLR) with postoperative pain and the effect of preoperative NLR level on timing of epidural analgesia in thoracotomy.

Detailed description: The study was conducted prospectively in 60 patients aged 18-75 years, ASA I-III, who underwent thoracotomy. The patients were divided into 2 groups as NLR level above 2 (Group A) (n:32) and NLR level below 2 (Group B) (n:28). Each group was divided into subgroups with equal numbers of Prempative analgesia group and control group. Local anesthetic was administered to the preemptive analgesia group (Group P) 20 minutes before the surgical incision through the epidural catheter, and to the control group (Group K) 20 minutes before the patient was awakened from the epidural catheter. NRS levels and additional analgesia needs were recorded at 2, 4, 8, 12 and 24 hours postoperatively.

Eligibility criteria: Inclusion Criteria:

* Patient graded as American Society of Anesthesiologist (ASA) physical status, I, II or III
* Patient subjected to thoracotomy operation

Exclusion Criteria:

Patient having morbid obesity,

* Patient having renal failure,
* Patient having hepatic failure,
* Patient having neuropsychiatric disease,
* Patient allergy to the study drugs

Primary outcomes:
measure: preoperative neutrophil lymphoycte ratio
timeFrame: 24 hours before the operation
measure: Postoperative opioid requiremen Postoperative opioid requirement
timeFrame: postoperative first 24 hour
Secondary outcomes:
measure: Numerical Pain Rating Scale
timeFrame: postoperative first 24 hour
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: KaradenızTU
Study officials:
References:
Clinical trial NCT06260358: Multidisciplinary Assesssment of Structured Report for Cervical Cancer Staging
Official title: Multidisciplinary Assesssment of Structured Report for Cervical Cancer Staging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with biopsy-proven cervical cancer (any FIGO stage) undergoing staging MRI afferent to the participating centers satisfying the following inclusion/exclusion criteria.

Brief summary: This study aims to validate a structured report for cervical cancer anchored to the FIGO staging system. A structured report is hypothesized to aid in uniformly applying FIGO staging, reducing staging discrepancies and improving patient care and outcomes.

Furthermore, we believe that the participation of the clinicians will improve the quality of the report to minimize the need for multidisciplinary team discussion


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old;
* Overt biopsy-proven diagnosis of cervical cancer, at any stage;
* Signed written informed consent to personal data treatment for research purposes

Exclusion Criteria:

* Age \<18 years old;
* Uncertain diagnosis of cervical cancer;
* MRI scan not according the standard acquisition protocol (ESUR guidelines);
* Patients candidate to non-standard treatments;
* Refusal to sign the written informed consent to personal data treatment for research purposes

Primary outcomes:
measure: Efficacy of a contextual structured report
timeFrame: 1 year
Secondary outcomes:
measure: Satisfaction rate with narrative and structured report
timeFrame: 1 year
measure: Comparison Single items response rate, on both narrative and structured reports
timeFrame: 1 year
measure: Differences in the single 6-to-12 items response rate between structured and narrative reports.
timeFrame: 1 year
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Advanced Radiology Center
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Evis Sala, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01412658: Clinical Safety of a Novel Milk Protein Peptide
Official title: Safety Study of Milk Peptide Supplementation in Healthy Volunteers: a Randomized Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Safety
Lead sponsor: Ambryx Biotechnology
Sponsor class: INDUSTRY
Collaborators: name: Texas A&M University
name: Baylor University
First posted: 2011-08-09
Enrollment: 73
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: A novel milk peptide has been shown in laboratory setting to have natural anti-cancer properties and extend lifespan and improve metabolism in animal models. The purpose of this study was 1.) to determine the safety dosage range and, 2.) to determine whether this novel milk peptide positively influence blood markers, metabolism and improve quality of life.

Detailed description: The study was conducted as a randomized, double-blind, placebo-controlled clinical trial in a university research setting. Healthy volunteers were randomly assigned to ingest in a double-blind and randomized manner either a placebo or milk peptides. Outcome measures were assessed at 0, 3, and 6 weeks of supplementation.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects with body mass index between 27-40.

Exclusion Criteria:

* have any metabolic disorders including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, thyroid disease or hypogonadism; a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurologic disease; if they are taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications;
* have milk allergies

Primary outcomes:
measure: Blood and Hormones
timeFrame: 6 weeks
Secondary outcomes:
measure: Psychosocial
timeFrame: 6 weeks
measure: Body Composition
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Waco
country: United States
facility: Baylor University Center for Exercise, Nutrition, and Preventive Health Research
state: Texas
Study officials:
affiliation: Texas A&M University
name: Rick Kreider, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kreider RB, Iosia M, Cooke M, Hudson G, Rasmussen C, Chen H, Mollstedt O, Tsai MH. Bioactive properties and clinical safety of a novel milk protein peptide. Nutr J. 2011 Sep 26;10:99. doi: 10.1186/1475-2891-10-99.
Clinical trial NCT02970058: Platelet-rich Plasma Use as Prophylactic of Low Back Pain Post-spinal Following Gynecological Surgery
Official title: Platelet-rich Plasma Use as Prophylactic of Low Back Pain Post-spinal Following Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Platelet-rich Plasma in Low Back Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Platelet-rich Plasma Use as Prophylactic of Post-operative Low Back Pain Following gynecological surgery.


Eligibility criteria: Inclusion Criteria:

* Elective gynecological surgery.

Exclusion Criteria:

* Spinal Pathology

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
References:
Clinical trial NCT02736058: Surgical Classification of Abnormal Placentation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adherent Placenta
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Reaching the proper pre-operative diagnosis for abnormal placentation in crucial to markedly decrease the intra-operative complications as well as the maternal morbidity and mortality. In this trial researchers aim to set up some pre-operative sonographic criteria that would help in planning the surgical procedure as well as setting up a surgical classification for the abnormally adherent placenta.


Eligibility criteria: Inclusion Criteria:

* abnormal placental site (placenta previa)

Exclusion Criteria:

* refusal to participate in the study
* cases with normal placental location ( fundal, anterior or posterior wall not reaching the lower uterine segment)

Primary outcomes:
measure: intraoperative blood loss
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr el aini hospital
Study officials:
affiliation: Cairo University
name: Ahmed M Hussein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03813758: Inter-observer and Intra-observer Variability of the Wrinkle Test
Official title: Inter-observer and Intra-observer Variability of the Wrinkle Test and the Optimum Time Need for the Test. Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wrinkle Test
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients after suture of full cut of digital nerve

Brief summary: Skin wrinkling of the fingers following immersion in warm water depends on intact sympathetic innervation. It is abolished by lesions affecting both central and peripheral sympathetic pathways. It affords a simple and reliable clinical test of sympathetic function.

Detailed description: Fingertip skin wrinkling after prolonged immersion in water is a well-recognized phenomenon, whereas a denervated digit does not exhibit normal skin wrinkling while a finger with a regenerated or repaired nerve shows at least partial reappearance of wrinkling. This is the basis for the bedside immersion-wrinkling test of autonomic digital nerve function. The exact mechanism of fingertip skin wrinkling is still subject to controversy. the purpose of this study is to examine the Inter-observer and Intra-observer Variability of the Wrinkle Test.

Eligibility criteria: Inclusion Criteria:

* patients after suture of full cut of digital nerve

Exclusion Criteria:

* other nerve injury

Primary outcomes:
measure: wrinkle test
timeFrame: 40 min
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek medical center
Study officials:
References:
Clinical trial NCT01192958: A Study to Validate a New Oral Fluid/Saliva Antibody Test for Novel H1N1v Influenza
Official title: A Study to Validate a New Oral Fluid/Saliva Antibody Test for Novel H1N1v Influenza
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: H1N1 Virus
Keywords: swine flu
novel h1n1v
novel h1n1
h1n1
Lead sponsor: Public Health England
Sponsor class: OTHER_GOV
First posted: 2010-09-01
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects from primary care who are participating in the clinical service evaluation.

Brief summary: At present influenza immunity can only be reliably confirmed by a blood test. This test is invasive for the patient. This study is intended to validate an oral fluid/saliva antibody test for the variant Swine Influenza H1N1. If such a test were available, this painless and non invasive test will improve direct clinical care to an individual as well as significantly help guide future public health management of the pandemic.


Eligibility criteria: Inclusion Criteria:

* Participants of the clinical service evaluation of novel H1N1v vaccine
* First or second blood sample for the clinical service evaluation successfully collected

Exclusion Criteria:

* Withdrawn from clinical service evaluation of novel H1N1v vaccine
* Second blood sample for the clinical service evaluation not collected.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06868758: Predictive Value of Tumor Vascular Normalization Scoring in HER-2 Positive Breast Cancer
Official title: Predictive Value of Tumor Vascular Normalization Scoring in the Response to Neoadjuvant Therapy in HER-2 Positive Breast Cancer: an Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HER2 Positive Breast Carcinoma
Neoadjuvant Therapy
Keywords: Tumor vascular normalization score
anti-HER2 antibody
Treatment efficacy
Lead sponsor: Chongqing General Hospital
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female HER2 positive breast cancer patients

Brief summary: This study aims to evaluate the predictive value of the tumor vascular normalization score for the efficacy of neoadjuvant therapy in HER-2-positive breast cancer and explore its potential as a predictive biomarker. Through longitudinal observation of HER-2-positive breast cancer patients receiving standard treatment, we will analyze the correlation between vascular normalization scores and treatment responses (including objective response rate \[ORR\] and pathological complete response \[pCR\]) to optimize individualized therapeutic strategies. Additionally, an exploratory investigation will assess the impact of ginsenoside-containing formulations (e.g., Jinxing Capsule, Shenyi Capsule, Yiqi Jianpi Oral Liquid) on tumor vasculature and neoadjuvant therapy outcomes in HER-2-positive breast cancer, providing scientific insights for complementary therapeutic interventions.


Eligibility criteria: Inclusion Criteria:

* Female breast cancer patients aged ≥18 years planned for neoadjuvant therapy.
* Histopathologically confirmed HER2-positive status (IHC 3+ or IHC 2+ with positive FISH confirmation).
* Mentally competent, no psychiatric disorders, with good compliance to treatment and follow-up.
* Voluntarily participate and provide written informed consent.

Exclusion Criteria:

* HER2-negative breast cancer.
* Pregnant, planning pregnancy, or lactating women.
* History of allergic predisposition or known/suspected allergy to study drugs.
* Participation in other clinical trials within the past 4 weeks or planned enrollment.
* Other conditions deemed ineligible by the investigator.

Primary outcomes:
measure: Correlation between VNS and Therapeutic Outcomes
timeFrame: Patients will be assessed at the third week and fifth week after initiation of anti-HER2 therapy, as well as preoperatively (prior to surgery).
Secondary outcomes:
measure: Correlation between Ginsenoside Formulation Exposure and Tumor Vascular Normalization
timeFrame: Patients will be assessed at the third week and fifth week after initiation of anti-HER2 therapy, as well as preoperatively (prior to surgery).
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing General Hospital
state: Chongqing
Study officials:
References:
Clinical trial NCT06178458: Pain Score and Opioid Consumption of Index and Previous Cesarean Delivery
Official title: Prediction of Pain Score and Opioid Consumption of Index Cesarean Delivery From Pain Score and Opioid Consumption of Previous Cesarean Delivery: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pain
Postoperative
Keywords: cesarean delivery
opioid consumption
pain score
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 416
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for cesarean delivery under spinal anesthesia with intrathecal morphine.

Brief summary: Postoperative pain after cesarean delivery is common and affects on both mothers and children.

The goals of this retrospective observational study aim to predict pain score and opioid consumption of index cesarean delivery from pain score and opioid consumption of previous cesarean delivery.

Detailed description: The authors will review the medical records of recruited participants for demographic data as well as pain scores and opioid consumption of index cesarean delivery and previous cesarean delivery.

Eligibility criteria: Inclusion Criteria:

* Patients who had at least 2 cesarean deliveries
* Patients received spinal anesthesia and intrathecal morphine for cesarean delivery
* Patients received postoperative pain control as per standard protocol

Exclusion Criteria:

* Patients with chronic pain prior to cesarean delivery
* Unable to give pain score
* Receiving general anesthesia for cesarean delivery
* Receiving postoperative pain control beyond the standard protocol
* Patients with multiple pregnancy, placenta abruption, placenta accrete, postpartum hemorrhage
* Patients with psychotic disorder

Primary outcomes:
measure: Prediction of pain score after cesarean delivery
timeFrame: January 2024 - December 2025
Secondary outcomes:
measure: Prediction of opioid consumption after cesarean delivery
timeFrame: January 2024 - December 2025
Other outcomes:
Locations:
Study officials:
affiliation: Prince of Songkla University
name: Boonsin Tangtrakulwanich, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01150058: Drug Biomarkers in Cell Samples From Patients With Acute Myeloid Leukemia
Official title: Preclinical Evaluation of Novel CD33-Targeting Therapeutics for Treatment of Acute Myeloid Leukemia (AML)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with del(5q)
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
childhood acute myeloid leukemia/other myeloid malignancies
adult acute myeloid leukemia
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-06-24
Enrollment: 40
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients With Acute Myeloid Leukemia

Brief summary: RATIONALE: Studying cell samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer

PURPOSE: This research study is studying drug biomarkers in cell samples from patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:

* To determine, in vitro, the cytotoxic activity of novel CD33-targeting immunoconjugate agents in cell samples from patients with acute myeloid leukemia (AML).
* To define the characteristics of AML cells responding to or resisting these agents.

OUTLINE: Cell samples are thawed and used for in vitro studies to determine the cytotoxic activity of novel CD33-targeting immunoconjugate agents, including gemtuzumab ozogamicin, for genotyping characterization by flow cytometry-based assays and/or western blot, and colony-forming cell assays.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia
* Cryopreserved samples available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Activity of novel CD33-targeting immunoconjugate agents
measure: Genotypic characteristics of acute myeloid leukemia cells
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Soheil Meshinchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03980158: Change in Tongue Strength and Fatigue After Upper Airway Stimulation Therapy
Official title: Change in Tongue Strength and Fatigue After Implantation of Upper Airway Stimulation System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea of Adult
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of three groups: the first group comprises of patients that have been implanted with selective hypoglossal nerve stimulation system (Inspire II Upper Airway Stimulation System, Inspire Medical Systems, Maple Grove, USA). The second group consists of confirmed OSA patients either being treated conservatively or without treatment. The test group consists of participants with no medical history for OSA and Epworth Sleepiness Scale (ESS) below 11.

Brief summary: Upper airway stimulation (UAS) is an effective surgical alternative for patients with obstructive sleep apnea (OSA) who fail continuous positive airway pressure (CPAP) therapy. This stimulation could lead to alterations in tongue strength and fatigability which could alter treatment outcome. The aim of the study is to investigate if UAS alters tongue strength and fatigability.


Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* upper airway stimulation group: Upper airway stimulation system implanted at least 4 weeks ago
* OSA group: OSA confirmed by 18-channel inpatient overnight polysomnography (PSG)
* test group: No medical history for OSA and Epworth Sleepiness Scale (ESS) below 11

Exclusion Criteria:

* history of a neuromuscular disorder
* previous tongue surgery

Primary outcomes:
measure: Tongue protrusion strength
timeFrame: Up to 60 months after implanation
measure: Tongue fatigability
timeFrame: Up to 60 months after implanation
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Ear Nose Throat
state: Bavaria
Study officials:
References:
citation: Wirth M, Unterhuber D, von Meyer F, Hofauer B, Ott A, Edenharter G, Eckert DJ, Heiser C. Hypoglossal nerve stimulation therapy does not alter tongue protrusion strength and fatigability in obstructive sleep apnea. J Clin Sleep Med. 2020 Feb 15;16(2):285-292. doi: 10.5664/jcsm.8184. Epub 2020 Jan 13.