louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02585011: Effect of Local Infiltration Anesthesia With Ropivacaine on Postoperative Pain After Hip Hemiarthroplasty
Official title: Effect of Local Infiltration Anesthesia With Ropivacaine on Postoperative Pain After Hip Hemiarthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Neck Fractures
Keywords: Hemiarthroplasty
Anesthesia, Local
Pain, Postoperative
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2015-10-23
Enrollment: 123
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: At St.Olavs Hospital each year about 400 patients are treated for femoral neck fractures, 250 of them receiving hemiarthroplasty. Implementation of fast-track clinical pathways reduces morbidity and enhances recovery of patients undergoing hemiarthroplasty. One of the key prerequisites for early rehabilitation is optimized pain relief. Local infiltration anesthesia with Ropivacaine is part of a multimodal pain regimen for patients receiving hemiarthroplasty at St.Olavs Hospital, although the pain reducing effect of local Ropivacaine after hemiarthroplasty has not been investigated in clinical trials. In this study it will be investigated whether a single shot with Ropivacaine reduces acute postoperative pain and opioid requirement after hemiarthroplasty. The findings of this study will have a direct impact on patient treatment.


Eligibility criteria: Inclusion Criteria:

* scheduled for hemiarthroplasty at St. Olavs Hospital
* competent and willing to give consent
* able to be mobilized in the PACU and in the trauma ward unit.

Exclusion Criteria:

* contraindications for spinal anesthesia, Dexamethasone, Dolcontin or Acetaminophene
* receiving general anesthesia
* patients operated on with an approach different to standard direct lateral surgery
* receiving osteosyntheses
* receiving femoral block less than 4 hours before surgery

Primary outcomes:
measure: Pain sensation during mobilization in the post-anesthesia care unit.
timeFrame: 24 hours (day of surgery)
Secondary outcomes:
measure: Pain during mobilization on the day after surgery
timeFrame: 48 hours (first postoperative day)
measure: Total consumption of opioids on the first postoperative day
timeFrame: 48 hrs (first postoperative day)
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Ortopedisk forskningssenter, St.Olavs Hospital
Study officials:
affiliation: Ortopedisk forskningssenter, St.Olavs Hospital
name: Olav Foss, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT06084611: Long Term Effects of Heat and Moisture Exchangers (HMEs)
Official title: Long Term Effects of Heat and Moisture Exchangers (HMEs) (Provox® Life™) on Pulmonary Symptoms in Laryngectomized Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laryngectomy; Status
Keywords: Laryngectomy
Heat and Moisture Exchanger
HME
Pulmonary rehabilitation
Lead sponsor: Atos Medical AB
Sponsor class: INDUSTRY
Collaborators: name: Instituto de Cancer Dr Arnaldo
First posted: 2023-10-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: Assessment of long term effect of Provox Life HME use on pulmonary symptoms in laryngectomized patients.


Eligibility criteria: Inclusion Criteria:

* Total laryngectomy, irrespective of pharynx reconstruction method
* 18 years or older
* Longer than 3 months after total laryngectomy
* Longer than 6 weeks after postoperative radiotherapy

Exclusion Criteria:

* Current use of HMEs (within last 3 months)
* Medical problems prohibiting the use of HME
* Active recurrent or metastatic disease (medical deterioration)
* Recent pulmonary infections/unstable pulmonary condition
* Insufficient physical, cognitive, or mental ability required to attach, remove or operate the devices themselves
* Low tidal volumes
* Unable to understand the Participant Information and/or unable to give Informed Consent

Primary outcomes:
measure: CASA-Q Score
timeFrame: Baseline, 3 months, 6 months, 9 months
Secondary outcomes:
measure: Number of involuntary coughs per 24 hours
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Forced Expectoration
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Quality of Life by EQ-5D-5L
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Jenkins sleep evaluation questionnaire
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Questionnaire to assess Shortness of Breath
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Voice handicap Index
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Consumption of medical devices (Number of devices used)
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Study-specific questionnaire to assess number of complications and medical treatments
timeFrame: Baseline, 3 months, 6 months, 9 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Cancer Dr. Arnaldo
Study officials:
References:
Clinical trial NCT04629911: High Flow Nasal Oxygenation and Gastric Insufflation in Anesthetized Patients
Official title: The Effect of High Flow Nasal Oxygenation on Gastric Insufflation in Paralyzed Anesthetized Patients Undergoing Laryngologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Distention
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Transnasal humidified rapid-insufflation ventilatory exchange(THRIVE), or also termed high flow nasal oxygenation (HFNO) is a method of supplying heated, humidified high concentrations of oxygen via nasal cavity.

The purpose of this study is to investigate the effect of HFNO on gastric insufflation in paralyzed anesthetized patients undergoing laryngologic surgery.

Detailed description: HFNO can be used during intraoperative period. HFNO reduces the risk of desaturation and prolongs the safe apnea time, compared with conventional oxygenation.

In laryngeal microsurgery, HFNO therapy make possible to perform tubeless anesthesia, providing perfect exposure of structure of the vocal cords.

HFNO have a risk for low level of positive pressure can make gastric distension, but gastric reflux or aspiration were not occurred during rapid sequence induction for emergency operation.

The purpose of this study is to investigate the effect of HFNO on gastric insufflation in paralyzed anesthetized patients undergoing laryngologic surgery.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology physical status classification I and II
* Patients scheduled for laryngeal microsurgery under general anesthesia

Exclusion Criteria:

* gastroesophageal reflux
* gastric pathology
* pregnancy
* major cardiovascular, pulmonary, or cerebrovascular disease
* severe obesity (body mass index\>35 kg/m2)

Primary outcomes:
measure: change of gastric volume
timeFrame: before HFNO application (baseline), immediately after HFNO application
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeongki-do
Study officials:
References:
Clinical trial NCT02741011: Radiological Examination of the Mentally Handicapped Patients
Official title: Computed Tomographic Assessment of the Maxillofacial Region of Mentally Handicapped or Uncooperative Patients Under Intravenous Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Profound Mental Retardation
Keywords: Cone-Beam Computed Tomography
Mentally Handicapped
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 98
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Aim of this study is to evaluate the necessity of the radiological examinations of mentally handicapped or uncooperative patients.

Detailed description: Dental radiography has become an indispensable part of routine dental examination with the help of the technological development of radiological devices. However, medical procedures like dental treatment and medical imaging (magnetic resonance imaging-MRI, computed tomography-CT, orthopantomography- OPG, etc.) that require cooperation are usually hard to apply to mentally handicapped (MHP) or uncooperative patients (UCP). Treatments that will be done without radiological examination can be missing or incorrect.

Eligibility criteria: Inclusion Criteria:

1. Mentally Handicapped patients that radiological examination cannot performed
2. Suitable for IV sedation

Exclusion Criteria:

1. Healthy Patients
2. Patients in which the radiological examination performed

Primary outcomes:
measure: Comparison of the radiological and oral examinations in mentally handicapped patients
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02542111: A Study of Bortezomib Plus GDP in the Treatment of Refractory and Relapsed Non-GCB DLBCL
Official title: A Phase II Study of the Efficacy and Safety of Bortezomib Plus GDP in the Treatment of Refractory and Relapsed Non-GCB Diffuse Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diffuse Large B-cell Lymphoma
Keywords: diffuse large b-cell lymphoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the efficacy and safety of Bortezomib plus GDP in the treatment of non-GCB DLBCL patients.


Eligibility criteria: Inclusion Criteria:

1. Histologically proven diffuse large B-cell lymphoma non-GCB subtype. Previously treated with 1, and only 1, chemotherapy regimen including an anthracycline and excluding cisplatin, cytarabine, bortezomib and gemcitabine. Relapse after CR, less than PR or PR to previous treatment.
2. No history of stem cell transplantation, and no intention for stem cell transplantation.
3. Age between 16-75.
4. ECOG\<3.
5. At least 1 measurable tumor mass.
6. Minimum life expectancy of 3 months.
7. Written informed consent.
8. No uncontrolled CNS involvement by lymphoma:No CNS disease at time of relapse;CNS disease diagnosed at initial presentation allowed provided a complete response for CNS disease was achieved and maintained.

Exclusion Criteria:

1. Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.
2. Clinically significant active infection.
3. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.
4. Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
5. Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
6. Patients who are pregnant or breast-feeding.
7. HIV infection.

Primary outcomes:
measure: Response rate
timeFrame: Every 2 cycles during treatment and then every 3 months for 2 years
Secondary outcomes:
measure: Progression free survival
timeFrame: 1 year
measure: Overall survival
timeFrame: 1 year
measure: Safety as assessed using the CTCAE
timeFrame: Days 1 of each course and 4-6 weeks after final treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Weili Zhao, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06514911: Laparoscopic Cholodochotomy in Management of CBD Stones
Official title: Primary Closure Versus T-tube Drainage Following Laparoscopic Cholodochotomy in Management of CBD Stones
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Management of CBD Stones
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the outcomes of primary closure of cholodochotomy incision versus T-tube drainage in laparoscopic common bile duct exploration for management of CBD stones and provide evidence-based guidance to the selection of the most appropriate operative technique.


Eligibility criteria: Inclusion Criteria:

1. patients with a definitive preoperative diagnosed with CBD stones.
2. a CBD diameter of ≥1 cm.
3. patients are fit for surgery

Exclusion Criteria:

1. patients with liver cirrhosis.
2. a CBD diameter of \<1 cm
3. malignancy in the biliary tract or CBD stricture .
4. patients are not fit for surgery.

Primary outcomes:
measure: biliary leakage in the management of CBD stones
timeFrame: 3 days after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Cianci P, Restini E. Management of cholelithiasis with choledocholithiasis: Endoscopic and surgical approaches. World J Gastroenterol. 2021 Jul 28;27(28):4536-4554. doi: 10.3748/wjg.v27.i28.4536.
citation: Tan D, Zhang Y. Differences in Outcome and Comparison of Stress and Immune Status in Patients with Recurrent Common Bile Duct Stones after Biliary Tract Surgery Choosing Three Procedures (ERCP, OCBDE, and LCBDE) for Treatment. Comput Math Methods Med. 2022 Jan 5;2022:9197990. doi: 10.1155/2022/9197990. eCollection 2022.
citation: Hua J, Lin S, Qian D, He Z, Zhang T, Song Z. Primary closure and rate of bile leak following laparoscopic common bile duct exploration via choledochotomy. Dig Surg. 2015;32(1):1-8. doi: 10.1159/000368326. Epub 2015 Jan 22.
Clinical trial NCT00349011: Genetic Counseling for Menopausal Therapy Decision-Making for Women at Increased Risk for Breast Cancer
Official title: Menopausal Therapy in Women at Increased Risk for Breast Cancer: Does a Personalized Risk Assessment and Counseling Intervention Aid in Decision-Making?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: menopause
genetic counseling
breast cancer
tamoxifen
chemoprevention
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Women and Infants Hospital of Rhode Island
name: Stony Brook University
First posted: 2006-07-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the effects of a personalized menopausal therapy risk assessment and genetic counseling intervention on knowledge, risk perception, and decision-making in healthy women at increased risk for breast cancer.

Detailed description: Women with a family history of breast cancer have several menopausal therapy options, including tamoxifen, hormone therapy, alternative medications, or no treatment. This complex decision should be based on each woman's risk to develop breast cancer, menopausal symptoms, preferences, and risks for other conditions. Current models in use for menopausal therapy counseling do not include pedigree analysis, personalized risk assessment or genetic testing in this process. The purpose of this multi-center study is to determine the effects of a personalized risk assessment and genetic counseling intervention on knowledge, risk perception, and decision-making in a group of healthy women who had a first-degree relative with breast cancer. Intervention participants will be given a personalized risk assessment for breast cancer, heart disease, osteoporosis, and uterine cancer based on family history and personal health data.

Eligibility criteria: Inclusion Criteria:

* at least one first degree relative with breast cancer
* age 40 or older

Exclusion Criteria:

* currently taking a menopausal therapy
* previous cancer diagnosis (except basal cell carcinoma)
* previous diagnosis of atypical hyperplasia
* previous diagnosis of lobular carcinoma in situ (LCIS)
* known carrier of a BRCA1 or BRCA2 mutation
* personal history of heart disease
* \>10% risk of carrying a BRCA1 or BRCA2 mutation

Primary outcomes:
measure: Decisional conflict
measure: Knowledge of menopause and menopausal therapy
measure: Satisfaction with counseling intervention
measure: Medication usage
Secondary outcomes:
measure: Perceived risk of breast cancer, heart disease, osteoporosis
measure: Worry about breast cancer, heart disease, osteoporosis
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Cancer Genetic Counseling, Yale Cancer Center, Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Ellen T. Matloff, M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00612911: Cell Therapy in Dilated Cardiomyopathy: Observational Study
Official title: Cell Therapy in Dilated Cardiomyopathy: A Safety and Feasibility Study Using Autologous Bone Marrow Mononuclear Cells
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiomyopathy, Dilated
Lead sponsor: Ministry of Health, Brazil
Sponsor class: OTHER_GOV
First posted: 2008-02-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with idiopathic dilated cardiomyopathy

Brief summary: Using bone marrow mononuclear cell in 24 patients with Idiopathic dilated cardiomyopathy

Detailed description: Patients with Idiopathic dilated cardiomyopathy class II to IV NYHA with ejection fraction \<35% were selected for phase I clinical trial of bone marrow mononuclear cell delivery in the coronary arteries and followed for 6 months

Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic dilated cardiomyopathy
* Optimized therapy and for idiopathic dilated cardiomyopathy
* Left ventricular ejection fraction (Simpson) \< 35%
* Peak oxygen consumption (VO2 peak) \< 16 mL.kg-1min-1
* Functional classes II-IV of the NYHA

Exclusion Criteria:

* dilated cardiopathies of ischemic or chagasic origin
* primary valve disease
* excessive use of alcohol or illicit drugs
* pregnancy
* ventricular arrhythmias
* any co-morbidity with impact on survival

Primary outcomes:
measure: echocardiography
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: INCL - National Institute of Cardiology Laranjeiras
Study officials:
affiliation: Brazil: National Insittute of Cardiology
name: Helena F Martino
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03368911: The Effect of Reinforced Endotracheal Tube on Post-operative Hoarseness Undergoing Thyroidectomy
Official title: The Effect of Reinforced Endotracheal Tube on Post-operative Hoarseness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Voice Hoarseness
Sore Throat
Thyroidectomy
Keywords: Hoarseness
Sore Throat
Thyroidectomy
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 140
Sex: ALL
Minimum age (years): 20
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 an evaluation of the effect of the reinforced endotracheal tube on post-operative hoarseness and sore throat undergoing thyroidectomy


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist physical status 1-3
* Patients undergoing thyroidectomy under general anesthesia
* Tumor size \< 2cm
* Patient who do not have any problem in the vocal cord

Exclusion Criteria:

* Patient who is expected difficult intubation (Mallampati class 3 or more)
* Patient who has respiratory disorder
* Previous hoarseness and sore throat history
* Obesity (BMI \> 30 kg/m2)
* Recurrent laryngeal injury during operation
* Operation history of oral and laryngeal surgery

Primary outcomes:
measure: hoarseness
timeFrame: assess after 1hours after operation
measure: sore throat
timeFrame: assess after 1hours after operation
measure: hoarseness
timeFrame: assess after 24 hours after operation
measure: sore throat
timeFrame: assess after 24hours after operation
measure: hoarseness
timeFrame: assess after 48 hours after operation
measure: sore throat
timeFrame: assess after 48 hours after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hopspital
state: Jeollanamdo
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
Study officials:
affiliation: Chonnam National University Hospital
name: Seongtae Jeong
role: PRINCIPAL_INVESTIGATOR
References: