louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04930887: Clinical Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) for the Treatment of Craniofacial Pain
Official title: Prospective, Randomized, Double-blinded, Placebo-controlled, Cross-over Trial of Endoscopically Guided Injection of Exparel (Bupivacaine) Towards the Ipsilateral Pterygopalatine Fossa for the Treatment of Craniofacial Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Craniofacial Pain
Migraine
Cluster Headache
Trigeminal Autonomic Cephalgia
Sphenopalatine Ganglion Neuralgia
Paroxysmal Hemicrania
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Exparel has a proven efficacy in providing pain relief for up to 72 hours with a single-dose administration at surgical sites. The study aims to evaluate the effectiveness of endoscopically-guided injection of Exparel (Bupivacaine) for the treatment of craniofacial pain. This study would be conducted in a prospective, randomized, double-blinded, placebo- controlled, and cross-over fashion. We aim to investigate whether the administration of Exparel (Bupivacaine) to the lateral nasal wall may positively impact craniofacial pain and functional outcomes, in patients who experience relief with the topical application of Lidocaine (routinely given prior to almost all ENT endoscopy).


Eligibility criteria: Inclusion Criteria:

* Patients with a chief complaint of craniofacial pain (migraine, cluster headache, trigeminal autonomic cephalgia, sphenopalatine ganglioneuraligia, paroxysmal hemicrania) who has Stanford Pain \& ENT clinic visit

Exclusion Criteria:

* age \<18 or \>80
* pregnant women
* economically disadvantaged (not able to afford clinic visits/treatments)
* decisionally impaired (unable to obtain informed consent)
* has allergy to bupivacaine
* unable or unwilling to participate plans to participate in another clinical study at any time during this study

Primary outcomes:
measure: Change of Pain Score
timeFrame: Baseline to day 21
Secondary outcomes:
measure: Change of Associated Symptoms
timeFrame: Baseline to day 21
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Peter H Hwang
state: California
Study officials:
affiliation: Stanford University
name: Peter Hwang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03422887: Nalbuphine and Flurbiprofen for Oculoplastic Surgery
Official title: Flurbiprofen Axetil and Nalbuphine for Postoperative Pain and Discomfort After Oculoplastic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Anesthesia
Pain
Keywords: postoperative pain
general anesthesia
postoperative discomfort
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 330
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the postoperative pain and discomfort using flurbiprofen axetil or nalbuphine administration after oculoplastic surgery under general anesthesia.

Detailed description: In this randomized controlled clinical trial, we evaluated the postoperative analgesic efficacy and adverse effects of flurbiprofen axetil combined with nalbuphine in patients undergoing oculoplastic surgery compared with a single dose of flurbiprofen axetil or nalbuphine.

Eligibility criteria: Inclusion Criteria:

* Undergoing oculoplastic surgery
* age between 16 and 75 years
* American Society of Anesthesiologists (ASA) physical status of I-II

Exclusion Criteria:

* serious coexisting disease
* body mass index (BMI) \<18.5 or \>35
* contraindications or previous adverse reactions to any of the drugs used
* females with a positive pregnancy test
* patients unable to cooperate

Primary outcomes:
measure: Pain 24 hours after recovery
timeFrame: 24 hours after recovery
Secondary outcomes:
measure: Discomfort 24 hours after recovery
timeFrame: 24 hour after recovery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Huijing Ye
role: STUDY_DIRECTOR
References:
Clinical trial NCT05807477: Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO19)
Official title: Determination of SpO2 and PR Accuracy Specifications at Rest / Accuracy of Pulse Oximeters With Profound Hypoxia NIHO 19/ Pulse Oximeter Accuracy Evaluation Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia
Lead sponsor: Nihon Kohden
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2023-04-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers. At least 10 subjects will be recruited to complete the study. Of these 3 will be dark pigmented (FItzpatrick Scale Type 4, 5 or 6). If the number of samples is less than the required 200 or if less than 3 of dark pigment subjects successfully complete the study, subjects will be added to include 3 of dark pigmented subjects and at least 200 data points.

Brief summary: The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest.

Detailed description: This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest.

Eligibility criteria: Inclusion Criteria:

* Both male and female subjects who can give written informed consent
* Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile below
* Meeting the demographic requirements

Exclusion Criteria:

* Age below 18 or over 50
* Pregnant women
* Significant arrhythmia
* Blood pressure above 150 systolic or 90 diastolic
* Carboxyhemoglobin levels over 3%
* Subjects whom the investigator consider ineligible for the study

Primary outcomes:
measure: Accuracy of Sensor Oxygen Saturation by Arms Calculation
timeFrame: 30 seconds
Secondary outcomes:
measure: Accuracy of Sensor Pulse Rate by Arms Calculation
timeFrame: 30 seconds
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Hypoxia Research Laboratory
state: California
Study officials:
affiliation: UCSF Hypoxia Research Laboratory
name: Philip Bickler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05781477: Effect of Breastfeeding Training Program and System (BMUM) for Mothers
Official title: Effect of Breastfeeding Training Program and Nurse-led Breastfeeding Online Counselling System (BMUM) for Mothers: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Lead sponsor: Kastamonu University
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of the study was to investigate effect of breastfeeding training program and nurse-led breastfeeding online counselling system (BMUM) on mothers' breastfeeding self-efficacy, breastfeeding attitudes, breastfeeding problems and postpartum depression we hypothesized that there would be differences between BG and CG groups in terms of breastfeeding self-efficacy, breastfeeding problems, postpartum depression and breastfeeding frequency. This was a randomized controlled trial. Participants were randomly assigned to the breastfeeding group (BG; n = 36), or control group (CG; n = 36). Control group will receive only standart care breastfeeding group will receive standart care and web based breastfeeding support. Breastfeeding attitudes, infant feeding attitude breastfeeding problems and postpartum depression will assessment. The assesment point will be 32-37 gestational week, postpartum 1st day, 1st week, 3 months, and 6 months.


Eligibility criteria: Inclusion Criteria:

* 18-35 years old,
* Primipara with a singleton pregnancy
* 32- and 37-weeks of gestation,
* Willingness to participate in the workshop program

Exclusion Criteria:

* Having a chronic illness
* Having pre-term labor or an abnormal fetal screening
* Had a psychiatric disorder or anxiety disorder
* Having any other high-risk complications

Primary outcomes:
measure: Breastfeeding Self efficacy change on five points between groups
timeFrame: 32-37 weeks 1st. day 1. week 3rd months 6th months
measure: Infant feeding attitude change on five points between groups
timeFrame: 32-37 weeks 1st. day 1. week 3rd months 6th months
measure: Postpartum depression change on four points between groups.
timeFrame: 1st. day 1st. week 3rd months 6th months
measure: breast problems between two groups on 1 st week
timeFrame: 1st week
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Kastamonu University
state: Kastamonu
city: Merkez
country: Turkey
facility: Şahika Şimşek Çetinkaya
state: Kastamonu
Study officials:
References:
Clinical trial NCT03817177: Application of High Flow Nasal Cannula for Prevention of Post-extubation Atelectasis in Children Undergoing Surgery
Official title: Seoul National University Hospital Department of Anesthesiology and Pain Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atelectasis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: postoperative atelectasis observation by ultrasound after application of high flow nasal cannula oxygenation

Detailed description: After surgery, postoperative atelectasis observation by ultrasound grading comparison between application of conventional nasal prong and high flow nasal cannula device

Eligibility criteria: Inclusion Criteria:

* general anesthesia

Exclusion Criteria:

* preterm
* bronchopulmonary dysplasia
* upper respiratory infection history
* respiratory disease
* cardiac surgery

Primary outcomes:
measure: lung sound score
timeFrame: 30 minutes after arrival of postanesthetic care unit
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Children's Hospital
name: Hee-Soo Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JH, Ji SH, Jang YE, Kim EH, Kim JT, Kim HS. Application of a High-Flow Nasal Cannula for Prevention of Postextubation Atelectasis in Children Undergoing Surgery: A Randomized Controlled Trial. Anesth Analg. 2021 Aug 1;133(2):474-482. doi: 10.1213/ANE.0000000000005285.
Clinical trial NCT03762577: Effects of Ground-based Walking Training in Pulmonary Hypertension
Official title: A Randomized Controlled Trial of Ground-based Walking Training for Adult Patients With Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Hypertension
Walking Training
Exercise
Balance
Quality of Life
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pulmonary Hypertension (PH) is a hemodynamic and physiopathological condition that is defined as an increase in pulmonary artery pressure ≥25 mmHg when measured at resting with symptoms such as dyspnea, fatigue, chest pain, and syncope. PH characterized by decreased exercise capacity, quality of life, peripheral muscle strength, balance, and physical inactivity. It is recommended that patients with PH should be included in cardiopulmonary rehabilitation programs in addition to medical treatment. Ground-based walking training is a safe and effective method for COPD patients. In the literature, there are no studies evaluating the effects of ground-based walking training in PH patients.

Detailed description: The aim of this project is to determine the effect of ground-based walking training on physical activity, exercise capacity, balance, peripheral muscle strength and quality of life in patients with PH.

Eligibility criteria: Inclusion Criteria:

* 18-80 years
* Diagnosed with PH
* Followed by the department of chest diseases at least six months
* Not participating in the rehabilitation program in last year

Exclusion Criteria:

* Functional group four due to WHO functional classification
* PH due to left heart diseases, PH due to lung diseases and/or hypoxia
* Treatment and medication change in the last three months
* Cooperation problems
* Patients with successful pulmonary endarterectomy operation
* Smoking
* Patients with uncontrolled cardiovascular diseases
* Patients with orthopeadic and/or neurologic disorders that could limit exercise tests
* Syncope history in recent

Primary outcomes:
measure: Endurance exercise capacity
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ozge Ertan
Study officials:
References:
Clinical trial NCT00093977: Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease
Official title: An Open-label, Single-Arm Study to Assess the Safety of Darbepoetin Alfa Manufactured by a Serum Free Bioreactor Technology in Subjects With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Disease
Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Dialysis
Anemia
Nephrology
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2004-10-11
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether darbepoetin alfa manufactured by the current "roller bottle" technology and darbepoetin alfa manufactured by a serum free process have a comparable safety profile.


Eligibility criteria: Inclusion Criteria:

* Currently diagnosed with Chronic Kidney Disease, either receiving or not receiving dialysis
* Anemic
* Currently on erythropoietic therapy
* Controlled hypertension
* Clinically stable

Primary outcomes:
measure: To determine whether darbepoetin alfa manufactured by a roler bottle technology (darbepoetin alfa RB) and darbepoetin alfa manufactured by a serum free process (darbepoetin alfa SF) have a comparable safety profile
timeFrame: Entire Study
Secondary outcomes:
measure: To characterize laboratory parameters in subjects with CKD
timeFrame: Entire Study
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Horowitz J, Agarwal A, Huang F, Gitlin M, Gandra SR, Cangialose CB. Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease. J Manag Care Pharm. 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741.
Clinical trial NCT02381977: Prevalence of Acute Critical Neurological Disease in Children: a Global Epidemiological Assessment
Official title: Prevalence of Acute Critical Neurological Disease in Children: a Global Epidemiological Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Stroke
Traumatic Brain Injury
Brain Mass
Status Epilepticus
Spinal Cord Disease
Hydrocephalus
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Laerdal Medical
First posted: 2015-03-06
Enrollment: 922
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically-ill children with acute neurologic injury

Brief summary: PANGEA is an international prospective point prevalence study to describe the epidemiology, interventions, and outcomes in children with acute critical brain disease.


Eligibility criteria: Inclusion Criteria:

1. Children aged 7 days to 17 years inclusively and admitted to an ICU (ICU can be classified as general, cardiac, trauma, etc).
2. Children with acute or acute on chronic neurologic disease that occurred just prior to hospital admission or occurred during the hospital admission.
3. Acute neurologic disease is secondary to TBI, stroke, brain mass, hydrocephalus, cardiac arrest, status epilepticus, CNS infection/inflammation, or spinal cord injury.

Exclusion Criteria:

1. Children with acute perinatal neurologic disease.
2. Children with isolated chronic brain injury and no acute neurologic disease.

Primary outcomes:
measure: Prevalence of acute brain insult
timeFrame: 4 days over a 1 year period
Secondary outcomes:
measure: Mortality
timeFrame: Hospital discharge or 3 months
Other outcomes:
Locations:
Study officials:
affiliation: 4126925164
name: Ericka Fink, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01683877: Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy
Official title: PROSPECTIVE RANDOMIZED CONPARISON OF ELECTRONIC DIATHERMY VERSUS FLOSEAL IN HEMOSTASIS AFTER LAPAROSCOPIC OVARIAN CYSTECTOMY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Ovarian Tumor
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2012-09-12
Enrollment: 128
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy in postoperative hemostasis and in sparing postoperative ovarian function between FloSeal and Electrocauterization in laparoscopic ovarian cystectomy


Eligibility criteria: Inclusion Criteria:

* Premenopausal women
* Patients who is planned to undergo laparoscopic ovarian cystectomy
* American Society of Anesthesiologists Physical Status classification (ASA PS) 1-2
* Patients with adequate bone marrow, renal and hepatic function:

WBC \> 3,000 cells/mcl Platelets \>100,000/mcl Creatinine \<2.0 mg/dL Bilirubin \<1.5 x normal and SGOT or SGPT \<3 x normal

* Patient must be suitable candidates for surgery
* Patients who have signed an approved Informed Consent

Exclusion Criteria:

* Patients with a history of pelvic or abdominal radiotherapy;
* Patients who are pregnant or nursing
* Patients who is receiving or requires hormone replacement therapy after surgery
* Patients who is undergoing hysterectomy at this time
* Patients who is undergoing unilateral or bilateral oophorectomy
* Previous history of ovarian cystectomy or oophorectomy
* Patients with contraindications to surgery
* Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
* Patient compliance and geographic proximity that do not allow adequate follow-up.
* Hormone therapy within 3 months before surgery

Primary outcomes:
measure: Hemostasis time
timeFrame: Immediately after operation
Secondary outcomes:
measure: Ovarian function after surgery
timeFrame: within 6 months after surgery
measure: Operative time
timeFrame: 1 day (Immediately after surgery)
measure: Intraoperative blood loss
timeFrame: During surgery
measure: Postoperative drainage duration
timeFrame: within 1 week after surgery
measure: Length of postoperative stay
timeFrame: within 1 month after surgery
measure: Postoperative complications
timeFrame: within 1 months after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Joo-Hyun Nam, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00461877: High-Risk HPV Infections in Women Aged 25 to 65
Official title: High-Risk HPV Infections in Women Aged 25 to 65
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Papillomavirus Infections
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2007-04-18
Enrollment: 303
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25 to 65 year old women who date online

Brief summary: The purpose of this study is to determine risk factors for HPV infections in 25 to 65 year old women who report having used internet dating websites in the past year.

Detailed description: Whether older women are susceptible to acquiring new, persistent high-risk (HR) HPV infections from new sex partners is largely unknown. This is a pilot study of predictors of HR HPV infections in two populations of women aged 25 to 44 and 45 to 65 who have used internet dating websites in the past year. 400 women will be recruited and mailed kits for self-collecting vaginal specimens for HPV DNA testing. Women will self-collect two sets of vaginal specimens four months apart, and complete sexual behavior questionnaires at the time of each self-collection. If new HPV infections associated with recent new partners are detected in these women, this pilot data will be used to develop a larger longitudinal study of the acquisition and natural history of HR HPV infections in older women. This information is important for developing guidelines for HPV vaccine implementation and cervical cancer screening guidelines in populations of older women.

Eligibility criteria: Inclusion Criteria:

* Have had sex with men
* Have used the internet to search for romantic partners in the past year (e.g. posted or responded to an ad on an internet dating website or social networking website)

Exclusion Criteria:

* Pregnant, breastfeeding, or planning a pregnancy in the next 6 months
* Hysterectomy

Primary outcomes:
measure: High-Risk HPV DNA
timeFrame: four months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Rachel L Winer, PhD
role: PRINCIPAL_INVESTIGATOR
References: