louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04465773: Pupillary Response to Incremental Tetanic Stimulations Under Propofol-remifentanil TCI
Official title: Pupillary Diameter Variations in Response to Tetanic Stimulations of Incremental Intensities in Patients Under Propofol-remifentanil TCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: general anesthesia
Lead sponsor: Hôpital Armand Trousseau
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In patients under standardized steady-state general anesthesia, 6 tetanic stimulations of incremental intensities were applied to the patients. Pupillary dilation in response to these stimulations was recorded.

Detailed description: The aim of the study was to investigate a possible correlation between the intensity of a nociceptive stimulus and the magnitude of pupillary reflex dilation in patients anesthetized with propofol and remifentanil target-controlled infusion.

Anesthetic protocol: 10 minutes of steady-state general anesthesia (before extubation during a scheduled gynecological surgery) with remifentanil target concentration of 1 ng/ml, and propofol target concentration adjusted to maintain bispectral index between 45 and 55.

Study period: 6 tetanic stimulations of incremental intensities were applied to the patients: 10, 20, 30, 40, 50, 60 milliamps Pupillary dilation in response to these stimulations was recorded.

Then, propofol and remifentanil infusions were discontinued, and patients were extubated.

Eligibility criteria: Inclusion Criteria:

* Scheduled gynecological surgery requiring general anesthesia and orotracheal intubation
* written informed consent

Exclusion Criteria:

* ophthalmic disease
* neurologic disease
* preoperative chronic pain or pain medication
* medication interfering with autonomous nervous system (beta blockers, alpha agonists, metoclopramide, droperidol, atropine, catecholamines)

Primary outcomes:
measure: Pupillary diameter
timeFrame: 5 seconds before tetanic stimulation
measure: Pupillary diameter
timeFrame: 1 minute after tetanic stimulation
Secondary outcomes:
measure: Heart rate
timeFrame: 5 seconds before tetanic stimulation
measure: Heart rate
timeFrame: 1 minute after tetanic stimulation
Other outcomes:
Locations:
city: Paris
country: France
facility: Departement d'anesthesie Hopital Armand Trousseau
Study officials:
References:
Clinical trial NCT01414673: HCG Versus Spontaneous LH in Intrauterine Insemination (IUI ) Cycles
Official title: Spontaneous Triggering of Ovulation vs. Administration of Human Chorionic Gonadotropin in Patients Undergoing Intrauterine Insemination: a Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Spontaneous Triggering of Ovulation vs. Administration of Human Chorionic Gonadotropin in Patients Undergoing IUI
Keywords: IUI
HCG
Spontaneous LH
pregnancy
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2011-08-11
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We recently reported the superiority of the natural cycle to a natural cycle controlled by the administration of human chorionic gonadotropin (hCG) for planning the frozen-thawed embryo transfer cycles, demonstrating a probable negative impact of exogenous hCG on endometrial receptivity.Based on the above findings we conducted the first prospective study that assesses whether there is a difference in pregnancy rate after intrauterine insemination (IUI) in a natural cycle with spontaneous luteinizing hormone (LH) rise compared to natural cycles controlled by hCG for final ovulation.


Eligibility criteria: Inclusion Criteria:

* age ≤ 36 years,
* regular menstrual cycles,
* body mass index (BMI) between 18 and 29 kg/m²,
* basal levels of FSH (≤ 12 IU/l),
* estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle, normal hysterosalpingography (maximum 3 months prior starting the cycle).
* The use of donor sperm was also accepted as inclusion criteria.

Exclusion Criteria:

* PCOS
* endometriosis

Primary outcomes:
measure: ongoing pregnancy rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Uzbrussel
state: Laarbeeklaan 101
Study officials:
References:
citation: Kosmas IP, Tatsioni A, Fatemi HM, Kolibianakis EM, Tournaye H, Devroey P. Human chorionic gonadotropin administration vs. luteinizing monitoring for intrauterine insemination timing, after administration of clomiphene citrate: a meta-analysis. Fertil Steril. 2007 Mar;87(3):607-12. doi: 10.1016/j.fertnstert.2006.10.003. Epub 2006 Dec 14.
citation: Kyrou D, Kolibianakis EM, Fatemi HM, Grimbizis GF, Theodoridis TD, Camus M, Tournaye H, Tarlatzis BC, Devroey P. Spontaneous triggering of ovulation versus HCG administration in patients undergoing IUI: a prospective randomized study. Reprod Biomed Online. 2012 Sep;25(3):278-83. doi: 10.1016/j.rbmo.2012.05.005. Epub 2012 May 23.
Clinical trial NCT02665273: Greater Occipital Nerve Block With Bupivacaine for Acute Migraine
Official title: A Randomized, Sham-controlled Trial of Greater Occipital Nerve Block as Second Line Therapy for ED Patients With Acute Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 28
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: This is a randomized, sham-controlled study of greater occipital nerve block (GONB) using bupivacaine 0.5% for emergency department patients with acute migraine. Patients are only enrolled if they fail first line therapy with metoclopramide.

Detailed description: The investigators are testing the following hypothesis:

In a population of patients who present to an ED with acute migraine and have been treated with parenteral metoclopramide unsuccessfully, bilateral greater occipital nerve blocks with bupivicaine will provide greater rates of short-term and sustained headache freedom than bupivacaine injected intradermally.

Eligibility criteria: Inclusion Criteria:

* ED patient with acute migraine or probable migraine
* Fail first line therapy with metoclopramide

Exclusion Criteria:

* Can't obtain consent
* Concern for secondary headache
* Skull defect
* Propensity for bleeding
* Overlying infection
* Pregnancy
* Allergy, intolerance study medication

Primary outcomes:
measure: Number of Participants Who Achieve Freedom From Headache
timeFrame: 30 minutes
Secondary outcomes:
measure: Sustained Headache Relief
timeFrame: 48 hours
measure: Would Want the Same Treatment Again During a Subsequent Migraine
timeFrame: 48 hours
Other outcomes:
measure: Change in Pain Score Assessed by Verbal Pain Scale (0-10)
timeFrame: 60 minutes
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Benjamin W Friedman, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06172673: A Database for Emotion Analysis Using Physiological and Psychological Assessment by 40FY
Official title: A Database for Emotion Analysis Using Physiological and Psychological Assessment by 40FY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological Stress
Heart Rate Variability
Mental Health Services
Keywords: Contactless measurement of Heart Rate Variability
Mobile digital mental health monitoring
Psychological assessment
Lead sponsor: 40FY
Sponsor class: INDUSTRY
First posted: 2023-12-15
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We recruited Adults between the ages of 19 and 45 who can read fluently in Korean. All study participants understood the study procedures and provided written informed consent according to the Declaration of Helsinki.

Brief summary: A comprehensive study examining the physiological, emotional and psychological aspects of stress among Korean adults

Detailed description: A dataset for the analysis of affective states of Korean adults. Participants' facial and finger videos were recorded using a cell phone camera, while watching six emotion-eliciting video stimuli, each three minutes in length (two of each: neutral, positive, and negative). Participants were asked to rate their emotion and arousal in terms of arousal and valence levels. The ECG data were collected using a 1-lead ECG while watching the six emotion-eliciting video stimuli. Psychological assessments were conducted using self-administered scales measuring psychological status and personality.

Eligibility criteria: Inclusion Criteria:

* Adults over the age of 19 and under the age of 45.

Exclusion Criteria:

* Participants vulnerable to voluntary consent, such as those who have evidence of intellectual disability or traumatic brain injury
* Participants who have difficulty reading and understanding Korean.

Primary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Baseline
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline
measure: Beck Anxiety Inventory (BAI)
timeFrame: Baseline
measure: Five Factor Model of Personality Short Form Test (IPIP-NEO-120)
timeFrame: Baseline
measure: Schema Scale
timeFrame: Baseline
measure: Depression, Anxiety, and Stress Scale (DASS-21)
timeFrame: Baseline
measure: Screening for Anxiety Disorders in Adults (SCAARED)
timeFrame: Baseline, Follow-up
measure: Self-Assessment Manikin Scale (SAM)
timeFrame: Baseline
measure: Heart-rate variability indices (SDNN, RMSSD, LF, HF)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Research and Development Division, 40FY Inc.
Study officials:
affiliation: 40FY, Inc.
name: Woori Moon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04547673: To Develop and Validate a Nasoendoscopic Intelligent Diagnostic System for Nasopharyngeal Carcinoma
Official title: To Develop and Validate a Nasoendoscopic Intelligent Diagnostic System for Nasopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Otolaryngological Disease
Artificial Intelligence
Keywords: Nasopharyngeal Carcinoma
Endoscopy
Narrow-Band Imaging
White-Light Imaging
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2020-09-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at the outpatient department of otolaryngology at the First Affiliated Hospital of Sun Yat-sen University, Guangzhou, People's Republic of China, or patients at Sun Yat-Sen University Cancer Center and Kiang Wu Hospital, with risk factors including any of the following: Cantonese ethnicity, NPC family history, Epstein-Barr virus detection, any symptom of nasal obstruction, sense of peculiar smell, blood-stained nasal discharge, epistaxis, ear fullness, tinnitus, hearing loss, diplopia, headache, or cervical mass.

Brief summary: Nasopharyngeal carcinoma (NPC) occurs at a high frequency in southern China, northern Africa, and Alaska, with a reported incidence of 30 cases per 100 000 in Guangdong Province. Endoscopic examination and biopsy are the main methods used for detection and diagnosis of NPC. Early NPC patients achieve favourable prognoses after concurrent radiotherapy and chemotherapy in compassion with advanced NPC patients.

Here, the investigators focused on the utility of artificial intelligence to detect early NPC, which based on white light imaging (WLI) and Narrow-band imaging (NBI) nasoendoscopic examination. Having access to this unique population provides an unprecedented opportunity to investigate the effect of intelligent system on diverse nasopharyngeal lesions detection and develop a novel Computer-Aided Diagnosis System.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years of age

Exclusion Criteria:

* Refuse to sign the informed consent statement
* Patients who have contraindications, e.g. coagulation dysfunction, drug allergy.

Primary outcomes:
measure: Pathological diagnosis
timeFrame: baseline
Secondary outcomes:
measure: Lesion range
timeFrame: baseline
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Macao
country: China
facility: Kiang Wu Hospital
state: Macao
Study officials:
affiliation: Otolaryngology Department, First Affiliated Hospital of Sun Yat-sen University
name: Weiping Wen, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT02333773: Irreversible Electroporation(IRE) For Unresectable Portal Venous Tumor Emboli
Official title: Irreversible Electroporation(IRE) For Unresectable Portal Venous Tumor Emboli: Phase I and Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Keywords: irreversible electroporation
Portal venous tumor emboli
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Portal venous tumor emboli.

Detailed description: By enrolling patients with unresectable Portal venous tumor emboli adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous or intraoperative IRE for unresectable Portal venous tumor emboli.

Eligibility criteria: Inclusion Criteria:

* Liver cancer diagnosed by positive biopsy or non-invasive criteria,
* Liver cancer with Portal venous tumor emboli,
* Not suitable for surgical resection or transplantation,
* Child-Pugh class A,B
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

Primary outcomes:
measure: Safety (adverse effects)
timeFrame: 6 month
Secondary outcomes:
measure: Efficacy (percentage of lesions that show no sign of recurrence 12 months after IRE)
timeFrame: 12 months
measure: Voltage (A minimum and maximum range of voltage for safe and effective IRE)
timeFrame: 3 months
measure: Progress free disease (PFS)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fuda Cancer Hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT06410573: The Effect Of Self-Breast Examination Training On The Belief Of Breast Health
Official title: The Effect Of Self-Breast Examination Training Provided To Women Between 18 And 49 Years Of Age And Practice On The Belief Of Breast Health: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women of Reproductive Age
Keywords: Neoplasms
Early Detection of Cancer
Breast Neoplasms
health education
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the present research was to detect the effect of self-breast examination provided to women between 18 and 49 years of age and practice on the belief of women on their breast health.

Detailed description: The aim of this study was to investigate the effect of breast self-examination training and practice on breast health beliefs. The study was a pretest-posttest randomized controlled experimental design. Women in the experimental group of the study will be provided with the training prepared by the researcher. The presentation used in the training will include information about breast cancer, breast cancer screening programs and breast self-examination. In the presentation, the steps of breast self-examination were shown step by step using visual materials. In addition to the slide presentation about breast cancer and breast self-examination, women will be trained on breast self-examination with a breast examination model using the "show first, then do it" training technique, and the accuracy will be confirmed by asking women to do it. By using the model in breast examination, it will be determined what women do right and what they do wrong during the examination. Data will be collected with Personal Information Form and Champion Health Belief Model Scale.

Eligibility criteria: Inclusion Criteria:

* Fertility process to continue
* No communication problems
* Not having a disease that will affect perception

Exclusion Criteria:

* Having been previously diagnosed with breast cancer or receiving breast cancer treatment
* Being diagnosed with a medical mental illness and receiving treatment for this reason
* Being under active treatment in hospital due to any problem

Primary outcomes:
measure: Breast Self-Examination Training and Breast Health Beliefs
timeFrame: 1 month will be followed
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
state: Karatay
Study officials:
References:
Clinical trial NCT06591273: Efficacy and Safety of Infliximab Biosimilar in Treatment of Moderate to Severe Psoriasis; A Single-arm Clinical Trial
Official title: Efficacy and Safety of Infliximab Biosimilar in Treatment of Moderate to Severe Psoriasis; A Single-arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Moderate to Severe Chronic Plaque Psoriasis
Keywords: Infliximab biosimilar, Remsima, Plaque psoriasis, Biologics
Lead sponsor: Services Institute of Medical Sciences, Pakistan
Sponsor class: OTHER_GOV
First posted: 2024-09-19
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if Infliximab Biosimilar Remsima works to treat moderate to severe plaque Psoriasis in adults. It will also learn about the safety of the drug. The main questions it aims to answer are:

Does Infliximab-dyyb Biosimilar (Remsima) works to treat moderate to severe plaque Psoriasis in adults in reducing disease severity and relapses? What medical problems do participants have when taking Remsima?

Participants will:

be injected Infliximab Biosimilar Remsima weekly for 4 weeks and then fortnightly till 24 weeks They will be followed for efficacy and safety and lab tests at week 4, 14, 24 and 52.


Eligibility criteria: Inclusion Criteria:

* Adult Patients of moderate to severe plaque psoriasis Biologically naive patients

Exclusion Criteria:

* Patients with active or latent TB, Hepatitis B or C, HIV. Immunocompromised patients due to drugs or disease. Patients on systemic anti-psoriastic medications in last three months. Patients with personal or strong family history of heart disease. Any other medical comorbidity (hepatic or renal) or contraindication to biologic/ biosimilars.

Primary outcomes:
measure: At least 50% reduction in PASI
timeFrame: 14 weeks
measure: At least 50% reduction in DLQI
timeFrame: 14 weeks
Secondary outcomes:
measure: Maintenance of At least 50% reduction in PASI and DLQI
timeFrame: 24 weeks
measure: Maintenance of At least 50% reduction in PASI and DLQI
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Department of Dermatology, Services Institute of Medical Sciences/ Services Hospital
state: Punjab
Study officials:
affiliation: Services Institute of Medical Sciences, Lahore
name: Dr Hira Tariq, MBBS, FCPS Derma
role: PRINCIPAL_INVESTIGATOR
References: