louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05298319: The 90% Effective Flow of High Flow Nasal Oxygenation (HFNO) During Sedated Bronchoscopy
Official title: The 90% Effective Flow of High Flow Nasal Oxygenation During Deeply Sedated Bronchoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Keywords: high flow nasal oxygenation
hypoxemia
bronchoscopy
effective flow
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients undergoing sedated bronchoscopy were randomized into six groups (10 Liters/minute \[L/min\], 20 L/min, 30 L/min, 40 L/min, 50 L/min, 60 L/min). The primary outcome was the incidence of hypoxemia.

Detailed description: It's a double-blind, randomized trial. The patients'demographic information, such as sex, weight, height, smoking status, present illness and history of past illness, were collected. After successful peripheral intravenous access, all patients, before sedation, received 20 min nebulization with lidocaine via a nebuliser facemask. The basic oxygen saturation, heart rate, and blood pressure of the patients were recorded by the investigators.Patients in the HFNO group received humidified oxygen at different rates via a high-flow nasal cannula (AIRVO2, New Zealand). After sedation with propofol and sufentanil, continuous electrocardiography and pulse oximetry were recorded, and the blood pressure of the patients was monitored throughout the procedure. . After bronchoscopy, patients were transferred to the post anesthesia care unit (PACU) if their vital signs were stable.

Eligibility criteria: Inclusion Criteria:

* (1) undergoing sedated bronchoscopy
* (2) 18 to 70 years of age;
* (3) American Society of Anaesthesiologists (ASA) class: I-III

Exclusion Criteria:

* (1) severe cardiac disease, including aortic stenosis, mitral stenosis, hemodynamic instability caused by severe arrhythmia, and acute myocardial infarction or cardiac surgery within the last 6 months;
* (2) severe hypoxemia (SpO2 \< 90% without oxygen supply on admission), caused by interstitial lung disease, end-stage chronic obstructive pulmonary disease (COPD) or other diseases;
* (3) upper respiratory tract infection or lung infection;
* (4) refusal to participate in this study.

Primary outcomes:
measure: the incidence of hypoxemia
timeFrame: during bronchoscopy
Secondary outcomes:
measure: jaw thrust maneuver
timeFrame: during bronchoscopy
measure: increase of flow rate
timeFrame: during bronchoscopy
measure: bag-mask ventilation
timeFrame: during bronchoscopy
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT05510219: Safety Analysis of Intravenous Rapid Infusion of Obinutuzumab in Patients With B-cell Non-Hodgkin's Lymphoma in China
Official title: Safety Analysis of Intravenous Rapid Infusion of Obinutuzumab in Patients With B-cell
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Obinutuzumab
Rapid Infusion
Intravenous Infusion Reaction
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study was a prospective, single-arm, open-label, phase IV clinical trial that included patients with B-cell non-Hodgkin's lymphoma who visited the Department of Hematology, Jiangsu Provincial People's Hospital . All patients were treated with the standard infusion regimen of obinutuzumab in cycle 1, and for patients who did not develop severe infusion-related reactions (IRRs) in cycle 1, a rapid 90-min obinutuzumab infusion regimen was used from cycle 2 onward while recording any occurrence of infusion reactions in different treatment cycles.
Primary purpose: TREATMENT

Brief summary: This study aimed to analyze the safety of 90-min intravenous rapid infusion of obinutuzumab in patients with B-cell non-Hodgkin's lymphoma and to provide evidence for the applicability of rapid infusion regimens in chemotherapy in China.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of B-cell lymphoma and with indications for obinutuzumab treatment
* No significant organ damage
* ECOG score of 0-2;
* Life expectancy ≥ 6 months
* Informed consent

Exclusion Criteria:

* Pregnant or lactating
* Serologically tested positive for human immunodeficiency virus or hepatitis B virus infection but had not received treatment
* Severe hepatic or renal insufficiency
* Severe cardiovascular disease.

Primary outcomes:
measure: change from baseline infusion-related reactions at cycle 6
timeFrame: at the end of cycle 6(each cycle is 21~28 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
Study officials:
affiliation: Jiangsu Provincial People's Hospital
name: JianYong Li, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00205218: Validation of Methods to Estimate Body Fat
Official title: Validation of Methods to Estimate Body Fat
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to evaluate various methods for estimating body composition in human subjects. Each subject is evaluated by several methods that are then compared to a criterion value. We hypothesize that the prediction method will yield the same result as the criterion value. The risks to subjects are minimal and all techniques are routinely performed.


Eligibility criteria: Inclusion Criteria:

* healthy male and female (pre-menopausal) volunteers

Exclusion Criteria:

* post-menopausal and pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Randy Clark
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02114619: Comparative Study of Different I-131 Doses in Graves' Disease
Official title: The Effect of Different Calculated Doses of I-131 in Treatment of Patients With Grave's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Graves' Disease
Keywords: radioiodine therapy
Graves' disease
Hyperthyroidism
calculated dose
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Radioactive iodine (RAI) administration is an effective and completely established treatment modality in hyperthyroidism including Graves' disease. Despite the long experience with radioiodine for hyperthyroidism, controversy remains regarding the optimal dose of iodine that is required to achieve long-term euthyroidism. The fixed activity administration method does not optimize the therapy, giving often too high or too low radiation to the gland, but the optimal dose per gram of thyroid mass in calculated activity administration method is also under much debates. This prospective study has been designed in order to compare the effect of different calculated doses of radioiodine on Graves' disease treatment outcome.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 hyperthyroid patients (Graves'disease)

Exclusion Criteria:

* Pregnancy or lactation

Primary outcomes:
measure: change of thyroid related hormones blood level from baseline at 1,3,6 and 12 month
timeFrame: 1,3,6,12 month
Secondary outcomes:
measure: Rate of hypothyroidism status at 1, 3,6 and 12 month post RAI therapy
timeFrame: 1,3,6,12 month
Other outcomes:
measure: Change of thyroid volume
timeFrame: 1,3,6 and 12 months
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Nuclear Medicine Research Center, Ghaem Hospital
state: Khorasan-Razavi
Study officials:
affiliation: Nuclear Medicine Research Center
name: Narjess Ayati, MD, FEBNM
role: STUDY_DIRECTOR
References:
Clinical trial NCT05325619: Evaluation of the Rate of Consultations in Gynecological Emergencies Under "Non-urgent" Management
Official title: City-hospital Network: Evaluation of the Rate of Consultations in Gynecological Emergencies Under Non-emergency Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Disease
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 809
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-pregnant or pregnant patients \< 14 weeks' gestation, admitted to the gynecological emergency department of the Paris Saint-Joseph Hospital between 01/02/2021 and 30/04/2021

Brief summary: The difference between the demand and the current medical supply poses a real public health problem in terms of the organization of health care systems.

For several years in France, there has been an increase in the number of consultations in emergency services, particularly gynaecological ones. The two causes put forward are a change in user behavior with an increase in requests for rapid but "non-urgent" care and the inadequacy of the supply of care in the private sector.

Few studies have been carried out concerning gynaecological emergencies, unlike general emergencies.

The aim of this study is to measure the frequency of consultations in gynaecological emergencies for non-emergency reasons.

The interest of this study is therefore mainly on the optimization of the care system with the emphasis on the city-hospital network in the management of these patients.


Eligibility criteria: Inclusion Criteria:

* Patient whose age is ≥ 18 years
* Patient not pregnant or pregnant \< 14 SA
* Patient admitted for gynecological emergency care at Paris Saint-Joseph Hospital between 01/02/2021 and 30/04/2021
* French-speaking patient

Exclusion Criteria:

* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patient objecting to the use of her data for this research

Primary outcomes:
measure: Rate of gynecological emergency room visits for non-urgent reasons
timeFrame: Month 2
Secondary outcomes:
measure: Optimization of patient care not requiring urgent care
timeFrame: Month 2
measure: Hospitalization rate
timeFrame: Month 2
measure: Surgical management rate
timeFrame: Month 2
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Marie Charlotte Marie Charlotte, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01601119: Impact of Disease Modifying Therapies (DMTs) and Associated Support Services in Relapsing Multiple Sclerosis (RMS) Patients
Official title: The Impact of Disease Modifying Therapies (DMTs) and Associated Support Services on Patient Reported Experience Measures (PREMs) and Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Multiple Sclerosis
Keywords: Multiple Sclerosis
Patient reported outcome
Patient reported experience
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono Limited, UK
First posted: 2012-05-17
Enrollment: 545
Sex: ALL
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: Patients in the UK newly diagnosed with RMS (and naive to previous DMT) and receiving a DMT that can be self-administered

Brief summary: The objective is to establish the impact of current disease modifying therapies (DMTs) and associated support services on Patient Reported Experience Measures and Patient Reported Outcomes in relation to the treatment and management of Relapsing Multiple Sclerosis in the United Kingdom (UK).


Eligibility criteria: Inclusion Criteria:

* Relapsing Multiple Sclerosis patients aged 18 years or over.
* Naive to previous DMT therapy and not yet started treatment with a disease modifying therapy.

Exclusion Criteria:

* Participating in an MS-related clinical trial.
* Unwilling to provide electronic online consent.
* Any disability that may impair them from being able to complete the online questionnaire.
* Do not have regular access to the Internet.
* Unable to complete the baseline questionnaire before they receive their first DMT injection.

Primary outcomes:
measure: Treatment Satisfaction
timeFrame: 96 weeks
Secondary outcomes:
measure: Work Productivity
timeFrame: 96 weeks
measure: Health Related Quality of Life
timeFrame: 96 weeks
measure: Health Related Quality of Life EuroQoL (EQ-5D)-5L Questionnaire
timeFrame: 96 weeks
measure: Device satisfaction
timeFrame: 96 weeks
measure: Evaluation of support services
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Merck KGaA Communication Center for locations
country: United Kingdom
facility: Please contact the
Study officials:
affiliation: Merck Serono Limited, UK
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06327919: Effects of Probiotic Supplementation With Weight Reducing Plan in Patients With Food Addiction and Weight Regain After Bariatric Surgery
Official title: Effects of Probiotic Supplementation With Weight Reducing Plan on Anthropometric Measures, Body Composition, Eating Behavior, and Related Hormone Levels in Patients With Food Addiction and Weight Regain After Bariatric Surgery: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Regain After Bariatric Surgery and Food Addiction
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effects of probiotic supplementation with a weight loss program and cognitive behavioral therapy (CBT) on anthropometric measures, eating behavior, food addiction, and related hormone levels in patients with food addiction and weight regain after bariatric surgery, 50 patients who referred to obesity clinic with weight regain (regaining ≥10% nadir weight) after bariatric surgery (at least 18 months), and food addiction will be randomly allocated to receive a weight loss program and CBT plus either probiotic, or placebo for 12 weeks. At the first and the end of the intervention, anthropometric measurements, eating behavior, food addiction, leptin, serotonin, and oxytocin will be assessed and compared between groups.


Eligibility criteria: Inclusion Criteria:

* BMI ≥25 kg/m2; willingness to participate in the study; not having diseases such as cancer, thyroid, diabetes, renal or liver (except fatty liver); non-pregnant or lactating or menopause or professional athlete; not use of any antibiotics in the last three weeks and any protein or probiotic supplement in the last month

Exclusion Criteria:

* taking antibiotic; using probiotic supplements/products or protein supplements; using weight-loss or appetite-suppressing medications; pregnancy; consuming less than 90% of the supplements prescribed during the study; following less than 90% of diet or physical activity for more than 10 days; participants who refuse to continue the study

Primary outcomes:
measure: Weight
timeFrame: 12 weeks
measure: BMI
timeFrame: 12 weeks
measure: Waist circumference
timeFrame: 12 weeks
measure: Fat mass
timeFrame: 12 weeks
measure: Food addiction
timeFrame: 12 weeks
Secondary outcomes:
measure: Eating behavior
timeFrame: 12 weeks
measure: Leptin
timeFrame: 12 weeks
measure: Serotonin
timeFrame: 12 weeks
measure: Oxytocin
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Azita Hekmatdoost
state: Middle East
city: Tehran
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
Study officials:
References:
Clinical trial NCT04955119: Fusion Imaging Contrast-enhanced Ultrasound LI-RADS
Official title: Fusion Imaging Contrast-enhanced Ultrasound LI-RADS in Patients With High-risk Hepatocellular Carcinoma With Focal Liver Lesions Invisible on Conventional Ultrasound: a Multi-center Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Tianjin Third Central Hospital
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital, School of Medicine, Zhejiang University
First posted: 2021-07-08
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: CEUS LI-RASD apply to lesion visible at precontrast ultrasound but not the lesion invisible. Fusion imaging can use to invisible lesions at precontrast ultrasound in clinical practice. Thus, our aim is to explore the application value of CEUS LI-RADS in contrast-enhanced fusion imaging for focal liver lesions that are not visible on conventional ultrasound in high-risk patients with hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

Patients at risk for HCC(Cirrhosis or Chronic hepatitis B viral infection or Current or prior HCC) Suspicious lesions detected by CECT/MRI but not visible on conventional ultrasound and US-CECT/MRI fusion imaging Patients sign the informed consent.

Exclusion Criteria:

Patients without risk of HCC(With cirrhosis due to congenital hepatic fibrosis or With cirrhosis due to a vascular disorder such as hereditary hemorrhagic telangiectasia, Budd-Chiari syndrome, chronic portal vein occlusion, cardiac congestion, or diffuse nodular regenerative hyperplasia) Patients without a successful registration or lesions can be seen on conventional ultrasound after successful registration Pregnancy or lactation Patients with pretreat lesion Patients don't sign the informed consent.

Primary outcomes:
measure: Positive predictive value
timeFrame: 6 months
Secondary outcomes:
measure: The sensitivity and specificity of CEUS LR-5
timeFrame: 6 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Third Central Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT04067219: SkIn, Muscle and Bone Aging Determinants in HIV Infected-patients.
Official title: Determinants of Skin, Muscle and Bone Aging in HIV-1 Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-1-infection
Marker; Structural
Keywords: Alterations
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 246
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: this study consists of the study of markers of skin, muscular, neurocognitive and bone aging in HIV infected adults and to compare the frequency of these signs to the general population of same gender and age.

Detailed description: Nowadays, the elevated frequency of cancers as well as cardiovascular, neurocognitive and bone diseases seems to denote a process of accelerated aging in the treated HIV-infected population of western countries, who are 40 to 50 years old in median. Markers of age-related alterations should be compared to the distribution among the general population whenever possible, to disentangle the effect of HIV and "normal" ageing or ageing due to other conditions. Common mechanisms should be better understood, more specifically those related to the impact of tobacco, antiretroviral treatments, and nutritional components. For markers of skin, muscle, neurocognitive function and bone ageing, the distribution of the general population is available and, in addition, alteration of these markers might have common mechanisms, such as insufficiency in 25 hydroxy vitamin D or nutritional parameters. Therefore, a joint study of these three organs seems particularly relevant.

This aim is to study markers of skin, muscular, neurocognitive and bone aging in HIV infected adults and to compare the frequency of these signs to the general population of same gender and age.

Eligibility criteria: Inclusion Criteria:

* HIV-1 infected patients included in the TISSOS-VIH substudy of the ARNS CO3 Aquitaine Cohort or who had a DXA measurement of the lumbar spine, femoral neck, and total body between 2004 and 2011 at the University Hospital of Bordeaux,
* \> 18 years
* Affiliated to the medical insurance
* Having had at least one DXA measurement prior to the SIMBAD study visit
* Written informed consent for the SIMBAD study

Exclusion Criteria:

* Hepatitis C virus co-infection
* Pregnancy

Primary outcomes:
measure: Proportion of patients with an alteration in bone, muscle, neurocognitive or skin parameters
timeFrame: At the earliest at the inclusion visit and within a 9-month window after inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Bordeaux
name: Patrick MERCIE, Pr
role: PRINCIPAL_INVESTIGATOR
References: