louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04575246: Predictors and Outcomes of Intraoperative Hypothermia in Patients Undergoing Knee Arthroplasty
Official title: Predictors and Outcomes of Intraoperative Hypothermia in Patients Undergoing Total Knee Arthroplasty: A Retrospective Cross-sectional Study From a Developing Country
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Arthroplasty, Total
Hypothermia
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults greater than 18 years undergoing total knee arthroplasty from January 2016 to December 2017 at Aga Khan University were included in this study. A standardized proforma was used to collect data from online patient data system about patients' preoperative, intraoperative and postoperative details. Preoperative data included age, gender, and comorbid conditions. Intraoperative data was collected from the surgical and anaesthesia records and included surgical site, American Society of Anesthesiologists (ASA) Level, duration of surgery, preoperative body temperature, intraoperative body temperature and duration of surgery. Postoperative data included post-operative body temperature and whether the patient developed any surgical site infection.

Brief summary: The study is designed to retrospectively assess the risk factors associated with intra-operative hypothermia in patients undergoing total knee arthroplasty from January 2016 to December 2017 at Aga Khan University and also understand it's impact on post-operative outcomes.


Eligibility criteria: Inclusion Criteria:

* All adults greater than 18 years who underwent total knee arthroplasty.

Exclusion Criteria:

* Any patient below 18 years

Primary outcomes:
measure: Surgical Site Infection (SSI)
timeFrame: 2016-2017
measure: Post-operative hypothermia
timeFrame: Within an hour after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ukrani RD, Arif A, Sadruddin A, Hasan O, Noordin S. Intraoperative hypothermia in patients undergoing Total knee arthroplasty: a cross-sectional study from a developing country. BMC Musculoskelet Disord. 2021 May 31;22(1):504. doi: 10.1186/s12891-021-04390-7.
Clinical trial NCT02187146: The Effects of Serum Vitamin D and IVF Outcome
Official title: The Effects of Serum Vitamin D and IVF Outcome: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Vitamin D Insufficiency
Infertility
Keywords: Vitamin D
Infertility
IVF
ART
Lead sponsor: University of Birmingham
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 504
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing IVF, ICSI and FET treatment cycles at the Birmingham Womens Fertility Centre

Brief summary: The purpose of this study is to investigate whether an association exists between serum vitamin D levels and IVF treatment outcome


Eligibility criteria: Inclusion Criteria:

* All patients undergoing IVF, ICSI or FET treatment at Birmingham Womens Fertility Centre

Exclusion Criteria:

* None

Primary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: 7 weeks after embryo transfer
Secondary outcomes:
measure: Biochemical pregnancy rate
timeFrame: 2 weeks after embryo transfer
measure: Miscarriage rate
timeFrame: 20 weeks after embryo transfer
measure: Live birth rate
timeFrame: 42 weeks after embryo transfer
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Womens NHS Foundation Trust
state: West Midlands
Study officials:
References:
citation: Chu J, Gallos I, Tobias A, Robinson L, Kirkman-Brown J, Dhillon-Smith R, Harb H, Eapen A, Rajkhowa M, Coomarasamy A. Vitamin D and assisted reproductive treatment outcome: a prospective cohort study. Reprod Health. 2019 Jul 15;16(1):106. doi: 10.1186/s12978-019-0769-7.
Clinical trial NCT05546346: Clinical Application of Wearable Magnet Tracking System for Capsule Endoscopes
Official title: Clinical Application of Wearable Magnet Tracking System for Capsule Endoscopes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Capsule Endoscopes
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The investigators developed a wearable magnet tracking system, which provided a non-invasive and high accuracy method for capsule endoscopes localization. Data fusion from multiple sensors expanded positioning range and proposed localization algorithm overcame shortcomings of existing systems. This clinical trial was conducted to verify effectiveness and stability of the tracking system.


Eligibility criteria: Inclusion Criteria:

* aged between 18 and 75
* agree to give written informed consent

Exclusion Criteria:

* dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or postabdominal radiation
* congestive heart failure, renal insufficiency, under therapeutic anticoagulation, in poor general condition (American Society of Anesthesiologists class III/IV), claustrophobia, metallic parts, a pacemaker or other implanted electromedical devices, or artificial heart valves
* pregnancy or suspected pregnancy
* exclusion criteria for standard magnetic resonance imaging examination such as the presence of surgical metallic devices, even though its low magnetic field technically would not interferewith such devices
* currently participating in another clinical study

Primary outcomes:
measure: The duration of time
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT00612846: Study Investigating the Best Method of Treatment of Bile Duct Stones in Higher Risk Patients
Official title: A Randomised Clinical Trial to Compare Endoscopic Sphincterotomy and Subsequent Laparoscopic Cholecystectomy With Primary Laparoscopic Bile Duct Exploration During Cholecystectomy in Higher Risk Patients With Choledocholithiasis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Choledocholithiasis
Higher Risk Patients
Keywords: Common Bile Duct Calculi
Choledocholithiasis
Endoscopic sphincterotomy
Cholecystectomy, laparoscopic
Laparoscopic bile duct exploration
Lead sponsor: North Bristol NHS Trust
Sponsor class: OTHER
First posted: 2008-02-12
Enrollment: 91
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the trial is to compare two operations which are used to treat bile duct stones. The hypothesis of the study is that there is no difference between endoscopic sphincterotomy followed by laparoscopic cholecystectomy or laparoscopic bile duct exploration during laparoscopic cholecystectomy in the treatment of bile duct stones in higher risk patients.


Eligibility criteria: Inclusion Criteria:

* Gallbladder stones
* At least strong evidence of bile duct stones (abnormal LFTs and dilated bile duct)
* Higher risk (\>70yrs, \>60yrs with co-morbidity, \>50 with BMI\>40)

Exclusion Criteria:

* Not fit for general anaesthesia
* Cholangitis requiring emergency ERCP
* Previous upper GI surgery making ERCP impossible

Primary outcomes:
measure: Bile duct clearance
timeFrame: Peri-operative
Secondary outcomes:
measure: Morbidity and mortality
timeFrame: 30 day or directly relating to intervention
measure: Post-operative stay
timeFrame: Post-operative stay
measure: Procedures per patient
timeFrame: Interventions required to acheive duct clearance
measure: Conversion to open surgery
timeFrame: Peri-operative
Other outcomes:
Locations:
Study officials:
affiliation: North Bristol NHS Trust
name: Michael H Thompson, MD, FRCS
role: STUDY_DIRECTOR
References:
Clinical trial NCT00350246: Long-term Effects of Laser Refractive Surgery
Official title: Long-term Effects of Laser Refractive Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myopia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2006-07-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine if there are short- and long-term postoperative differences in visual and corneal outcomes between different laser refractive surgical procedures.

Detailed description: We will measure postoperative differences in visual acuity, contrast sensitivity, corneal light scatter, density of keratocytes and subbasal nerves, corneal sensitivity, corneal topography and wavefront between PRK performed with epithelial removal by a laser or by a rotary brush and between LASIK performed by using a microkeratome or by using a femtosecond laser. Measurements will be made at baseline and at intervals over 5 postoperative years in 21 LASIK patients, 20 PRK patients, and 20 unoperated controls.

Eligibility criteria: Myopia 1-10 diopters No other ocular abnormalities except presbyopia

Primary outcomes:
measure: keratocyte density at 5 years
measure: nerve density at 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: William M. Bourne, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel SV, McLaren JW, Kittleson KM, Bourne WM. Subbasal nerve density and corneal sensitivity after laser in situ keratomileusis: femtosecond laser vs mechanical microkeratome. Arch Ophthalmol. 2010 Nov;128(11):1413-9. doi: 10.1001/archophthalmol.2010.253.
citation: Calvo R, McLaren JW, Hodge DO, Bourne WM, Patel SV. Corneal aberrations and visual acuity after laser in situ keratomileusis: femtosecond laser versus mechanical microkeratome. Am J Ophthalmol. 2010 May;149(5):785-93. doi: 10.1016/j.ajo.2009.12.023. Epub 2010 Mar 15.
Clinical trial NCT01256346: Electrocardiography Versus Pulse Oximetry for Newborn Heart Rate Determination
Official title: A Comparison of Electrocardiography Versus Pulse Oximetry for Determination of Initial Heart Rate in Preterm Newborns: A Pilot Study.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prematurity
Keywords: Premature
baby
heart rate
resuscitation
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2010-12-08
Enrollment: 0
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Thirty babies believed to be of 24-32 weeks gestational age who are to be born at the University of Oklahoma Health Sciences Center.

Brief summary: The goal of this study is to compare the time required for accurate heart rate measurement of the preterm newborn when using pulse oximetry versus electrocardiography leads.


Eligibility criteria: Inclusion Criteria:

* Gestational age of 24-32 weeks

Exclusion Criteria:

* Babies with open abdominal defects

Primary outcomes:
measure: Time until accurate heart rate.
timeFrame: To be determined
Secondary outcomes:
measure: Intermeasurement accuracy
timeFrame: To be determined
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Douglas Dannaway, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kamlin CO, Dawson JA, O'Donnell CP, Morley CJ, Donath SM, Sekhon J, Davis PG. Accuracy of pulse oximetry measurement of heart rate of newborn infants in the delivery room. J Pediatr. 2008 Jun;152(6):756-60. doi: 10.1016/j.jpeds.2008.01.002. Epub 2008 Mar 6.
citation: Kamlin CO, O'Donnell CP, Everest NJ, Davis PG, Morley CJ. Accuracy of clinical assessment of infant heart rate in the delivery room. Resuscitation. 2006 Dec;71(3):319-21. doi: 10.1016/j.resuscitation.2006.04.015. Epub 2006 Sep 20.
citation: O'Donnell CP, Kamlin CO, Davis PG, Morley CJ. Feasibility of and delay in obtaining pulse oximetry during neonatal resuscitation. J Pediatr. 2005 Nov;147(5):698-9. doi: 10.1016/j.jpeds.2005.07.025.
citation: Owen CJ, Wyllie JP. Determination of heart rate in the baby at birth. Resuscitation. 2004 Feb;60(2):213-7. doi: 10.1016/j.resuscitation.2003.10.002.
citation: Petrozzino JJ, Heldt GP, Rich WD, Finer NN. Use of ECG for initial newborn heart rate assessment: a pilot/feasibility study. J Investig Med. 2008;56(1):263-7.
citation: Vento M, Aguar M, Leone TA, Finer NN, Gimeno A, Rich W, Saenz P, Escrig R, Brugada M. Using intensive care technology in the delivery room: a new concept for the resuscitation of extremely preterm neonates. Pediatrics. 2008 Nov;122(5):1113-6. doi: 10.1542/peds.2008-1422. No abstract available.
Clinical trial NCT06175546: Daily Duration of Compression Treatment in Patients With Symptomatic Chronic Venous Disease
Official title: Determination of Duration of Wearing Compression Hosiery Necessary to Reduce Subjective Symptoms of Chronic Venous Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Venous Insufficiency
Varicose Veins of Lower Limb
Keywords: Chronic venous disease
Compression treatment
Compression socks
Treatment duration
Regimen
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 80
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: Aim of study is to investigate the optimal duration and daily regimen of compression treatment in patients with chronic venous disease


Eligibility criteria: Inclusion Criteria:

* Symptomatic chronic venous disease
* C0-C4 according to CEAP-classification

Exclusion Criteria:

* C5-C6 according to CEAP-classification
* Intolerance to compression socks
* Patient's unwillingness to use compression socks
* Inability to use compression socks

Primary outcomes:
measure: Leg discomfort related to CVD measured with 10-cm visual analogue scale (VAS)
timeFrame: Day 0, Day 7, Day 14, Day 21, Day 28
measure: Quality of life (QoL) was measured by ChronIc Venous Insufficiency Quality of Life (CIVIQ-20)
timeFrame: Day 0, Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Pirogov Russian National Research Medical University
Study officials:
References:
Clinical trial NCT06237946: Early-stage Ovarian Clear Cell Carcinoma (OCCC) Patients at Risk of Recurrence
Official title: A Retrospective, Open-label, Biomarker Study for Early-stage Ovarian Clear Cell Carcinoma (OCCC) Patients at Risk of Recurrence
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: FIGO Stage IC2 to II Ovarian Clear Cell Carcinoma
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Chang Gung Memorial Hospital
name: Tokyo University
name: Samsung Medical Center
First posted: 2024-02-02
Enrollment: 272
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A cohort of 272 women with a diagnosis of FIGO stage IC2, IC3, IIA and IIB of OCCC, diagnosed between 2011 and 2021. Patients were received platinum-based adjuvant therapy following debulking surgery will be included for the study. Adjuvant therapy was given according to the NCCN guideline and Institutional Tumor Board.

Brief summary: The goal of this observational study is to determine the risk of recurrence in early-stage OCCC (Ovarian Clear Cell Carcinoma) patients who received postoperative adjuvant treatment.

Participants were received platinum-based adjuvant therapy following debulking surgery will be included for the study.

Detailed description: This is a retrospective, global multicenter, single-arm, study for early-stage OCCC (Ovarian Clear Cell Carcinoma) patients at risk of recurrence following the first-line treatment. This study is planned to enroll 272 patients eligible for participation from two study sites in Taiwan, one in Korea, and one in Japan. The study will use archival Formalin-Fixed Paraffin-Embedded (FFPE) samples from patients who have received adjuvant therapy following debulking surgery. The study is designed to identify OCCC patients at risk for relapse and apply clinical stratification by IHC staining of 3 selected markers (CD45, CD8, tryptase) to prepare as clinical assays.

Eligibility criteria: Inclusion Criteria:

* Women aged ≥20 years old.
* Participant with histologically confirmed OCCC of stage IC2, IC3, IIA and IIB by International Federation of Gynecology and Obstetrics (FIGO) 2014 system.
* Participant has received platinum-based regimens for 3 to 6 cycles combined with paclitaxel, gemcitabine, cyclophosphamide, or bevacizumab adjuvant therapy following debulking surgery.
* Formalin-fixed paraffin-embedded (FFPE) tissue samples available.

Exclusion Criteria:

* Absence of histological confirmation of the diagnosis.
* Unusable sample or biologically deteriorated.

Primary outcomes:
measure: Presence of recurrence
timeFrame: up to 24 months
Secondary outcomes:
measure: 2-year PFS
timeFrame: up to 24 months
measure: 5-year OS
timeFrame: up to 60 months
measure: Outcomes for adjuvant treatment with paclitaxel-based chemotherapy
timeFrame: up to 60 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03549546: Expression of the Inhibitory Receptors on Lymphocytes T Cells After Lung Cancer Surgery.
Official title: Expression of the Inhibitory Receptors on Lymphocytes T Cells After Lung Cancer Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Surgery
Keywords: Lymphopenia
Lung cancer surgery
TIM-3
PD-1
CTLA-4
lymphocytes
CD4
CD8
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Postoperative pneumonia is one of the most common complications after lung cancer surgery and associated with a morbidity and mortality. Postoperative lymphopenia has been recently identified as one of risk factors for postoperative pneumonia. According to recent studies in polytrauma, cancer or septic shock, T cells dysfunction may be related to high expression of inhibitory receptors on lymphocytes.

Detailed description: This study will investigate prospectively TIM-3, PD-1 and CTLA4 expression on lymphocytes T cells before and after lung cancer surgery. Patients ≥ 18 years with no history of immunosuppressive state will be included.

Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18 years undergoing lung cancer surgery by thoracoscopy

Exclusion Criteria:

* Patient under guardianship/curatorship
* Patient who received of radiotherapy or chemotherapy in the last 6 months
* Patient under immunosuppressive treatment or dose of corticoids over 10 mg/day prednisolone or equivalent
* Patient with history of malignant blood disease or auto-immune disease
* Patient suffering from HIV infection and
* Patients with pre-operative infection
* Patient with an empiric antibiotic therapy introduced at operating room

Primary outcomes:
measure: PD-1, TIM-3, CTLA4 on CD4/CD8 lymphocytes
timeFrame: Days 0, 1, 3
Secondary outcomes:
measure: functionality of CD4/CD8 lymphocytes and production of IF gamma, TNF and IL-2
timeFrame: Days 0, 1, 3
measure: pneumonia
timeFrame: Days 3
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Guillaume Dupont, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06949046: Effects of a Nursing-led Communication Using Mobile Health Information in Breast Cancer Patients Undergoing Concurrent Chemotherapy
Official title: Effects of a Nursing-led Communication Support Program Using Mobile Health Information on Physical and Mental Status in Breast Cancer Patients Undergoing Concurrent Chemotherapy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Keywords: breast cancer
chemotherapy
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Breast cancer is the most common malignant tumor among women. Side effects from initial chemotherapy include sleep disorders, anxiety, depression, and reduced quality of life. Mental health distress is also a major issue in cancer care. This study integrates mobile health information with a nurse-led communication support plan, aiming to improve patients' physical and mental outcomes during chemotherapy.

Detailed description: The objective of this study is to explore the effects of a nursing-led communication support program using mobile health information on physical and mental state in breast cancer patients undergoing initial chemotherapy.

Eligibility criteria: Inclusion Criteria:

breast cancer initial chemotherapy

Exclusion Criteria:

Patients whose cancer has recurred without undergoing the first course of chemotherapy

Primary outcomes:
measure: Effects of a nursing-led communication support program using mobile health information on physical and mental status in breast cancer patients undergoing concurrent chemotherapy: a randomized controlled trial
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
References: