louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01394731: Analgesic Effects of Intravenous Paracetamol on Labor Pain
Official title: Analgesic Effects of Intravenous Acetaminophen on Labor Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labor Pain
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
Collaborators: name: King Abdulaziz Medical City
First posted: 2011-07-14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether intravenous paracetamol is effective in treating labor pain.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical class I-II
* term patients (≥ 37 weeks of gestation)

Exclusion Criteria:

* previous cesarean section
* hypertension, pre-eclampsia, eclampsia
* intra-uterine growth retardation
* intrauterine fetal death
* morbid obesity (body mass index ≥ 35)
* allergy to any of the study drugs

Primary outcomes:
measure: Visual analogue scale (VAS) score for pain
timeFrame: Up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City
state: Central
Study officials:
References:
Clinical trial NCT05010031: A Study of Reduced-dose Radiation in People With Metastatic Tumors With a Genetic Change
Official title: Phase II Study to Examine Precision Radiation in Patients With Pathogenic Mutations in ATM
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metastatic Cancer
Keywords: Reduced-dose Radiation
Pathogenic Mutations
ATM (ataxia telangiectasia mutated)
21-310
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm, phase II noninferiority, prospective trial
Primary purpose: TREATMENT

Brief summary: This study will test whether reduced-dose radiotherapy is an effective treatment for metastatic tumors with an ATM mutation. The researchers want to find the lowest dose of radiation that would still be effective to treat these tumors.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed malignancy with at least one metastatic lesion referred for palliative radiotherapy
* Pathogenic mutation in ATM (somatic and germline allowed)
* ECOG performance status 0-2
* Age ≥ 18 years.
* Able to provide informed consent.
* Patients at reproductive potential must agree to practice an effective contraceptive method during radiation treatments.
* Expected life expectancy of at least 6 months

Exclusion Criteria:

* Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
* Serious medical co-morbidities precluding radiotherapy.
* Pregnant or breast-feeding women.
* Lesions excluded from de-escalation include regions in which the risk of local disease progression is unacceptably high, including CNS disease and cord compression, and areas in which re-irradiation would not be feasible, including spinal cord overlap.

Primary outcomes:
measure: Treatment failure rate of irradiated lesion
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All protocol activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (All protocol activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (All protocol activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Amy Xu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05076331: Health and Aging Brain Study: Health Disparities Tau Positron Emission Tomography (PET) Scan Study
Official title: Health and Aging Brain Study: Health Disparities Tau PET Scan Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alzheimer Disease
Keywords: Alzheimer's Disease
Tau PET Scan
Health Disparities
Brain Aging
Lead sponsor: University of North Texas Health Science Center
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 3000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants of the multi ethnic "Health and Aging Brain Study Health Disparities" .Men and women age 50 and above that may or may not have cognitive impairment. .

Brief summary: The purpose of this project is to study the aging brain among participants enrolled in the Health and Aging Brain Study: Health Disparities project . There are a number of things that can influence how people think as they age, including diabetes, depression, as well as our biology. In this study, the investigators seek to study the aging brain by using brain PET scans that create detailed pictures of the brain.

Detailed description: There are a number of things that can influence how we think as people age, including diabetes, depression, as well as our biology. In this study, the investigators are using PET scans with a tracer to create detailed pictures of the brain. This information will be used to help the investigators understand how the brain ages and in the future could be used to develop better diagnostics and treatments for Alzheimer's disease and memory loss in Mexican Americans, African Americans, and non-Hispanic whites. The goal of this study is to address this disparity by enrolling ethnically diverse participants in this study.

Eligibility criteria: Inclusion Criteria:

1. Enrolled in the Health and Aging Brain Study HD: Health Disparities project
2. Provided consent to re-contact
3. Willing and capable of undergoing PET scan of the head

Exclusion Criteria:

1. Inability to provide informed consent by self or by proxy.
2. Pregnant or breast feeding women\*
3. History of alcoholism or drug dependency/abuse within the last 2 years before screening
4. Hypersensitivity to the active substance or to any of the following excipients is contraindicated: sodium dihydrogen phosphate, phosphoric acid, sodium ascorbate, ethanol (anhydrous), water for injection
5. Participants may not be in this study if they do not meet the safety criteria to undergo imaging procedures.

Primary outcomes:
measure: Health Disparities in Aging
timeFrame: Through study completion in 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center
state: Texas
Study officials:
References:
Clinical trial NCT00739531: Measuring Exhaled Nitric Oxide (eNO) Using the Apieron INSIGHT System and the Aerocrine NIOX System
Official title: Measuring the Fractional Concentration of Exhaled Nitric Oxide (eNO) Using the Apieron INSIGHT System and the Aerocrine NIOX System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
nitric oxide
eNO
FENO
Apieron INSIGHT
Aerocrine NIOX
Lead sponsor: Apieron
Sponsor class: INDUSTRY
First posted: 2008-08-21
Enrollment: 150
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 150 asthma patients recruited from the site center's population of patients.

Brief summary: Collection of quantitative data to demonstrate the accuracy (bias) and precision (repeatability) of the Apieron INSIGHT(tm) eNO Breath System as compared to the FDA cleared NIOX eNO Breath System when testing is performed by asthma patients.

Detailed description: A non-randomized, prospective study of up to 150 subjects with asthma. Patients will perform eNO testing with the Apieron INSIGHT(tm) eNO system and the NIOX eNO system at the physician's office/clinic after a short demonstration and training by a healthcare professional trained in the use of the devices. Exhaled NO testing involves inhaling to lung capacity, and then performing a controlled exhalation into a mouthpiece connected to each of the Apieron INSIGHT(tm) and NIOX systems. Patients will perform an eNO measurement with the Apieron INSIGHT(tm) system and with the FDA cleared NIOX system for the accuracy portion of the study. Patients will perform 2 sequential eNO measurements on each system for the precision part of the study. Subjects that measure eNO values over 100 ppb will be asked to repeat 2 sequential eNO measurements on each system.

Eligibility criteria: Inclusion Criteria:

* Age 5 or older
* Pre-existing diagnosis of asthma
* Non-smoker

Exclusion Criteria:

* Chronic inflammatory lung disease other than asthma
* Medical conditions that preclude hand-eye coordination

Primary outcomes:
measure: eNO using Apieron INSIGHT(tm) System and Aerocrine NIOX at 50 ml/s
timeFrame: Single point in time
Secondary outcomes:
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: The Asthma- Allergy Clinic& Research Center
state: Louisiana
city: Lake Oswego
country: United States
facility: Allergy, Asthma & Dermatology Research Center, LLC
state: Oregon
Study officials:
References:
Clinical trial NCT06358131: Propofol Versus Midazolam in Sedation for Upper and Lower Gastrointestinal Endoscopy.
Official title: Propofol Versus Midazolam in Sedation for Upper and Lower Gastrointestinal Endoscopy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Gastrointestinal Diseases
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 656
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: There has been rapid growth in the number and complexity of gastrointestinal (GI) endoscopic procedures performed during the last decade. To ensure safe and effective upper GI endoscopy, the choice of an appropriate sedative agent is crucial. Sedation usually categorized into four stages: minimal, moderate, deep and general anesthesia. The upper gastrointestinal \[GI\] endoscopy usually performed under moderate sedation Sedation usually categorized into four stages: minimal, moderate, deep and general anesthesia. The upper gastrointestinal \[GI\] endoscopy usually performed under moderate sedation. Benzodiazepines still the most common sedative agents used for conscious sedation, either solely or in combination with opioids for upper GI endoscopy. Propofol is a hypnotic drug used for induction of anesthesia with short half-life that permits rapid patient recovery and discharge. Thus, its use is for upper GI endoscopy was adopted in many endoscopy centers. So we are going to Evaluate all adverse events related to anesthesia; in patients recruited for upper and lower endoscopy and compare between propofol and midazolam based anesthesia associated adverse events.Also we are going to Evaluate patient and endoscopist satisfaction as regarding propofol and midazolam anesthesia.


Eligibility criteria: Inclusion Criteria:

Age18 to 80 American Society of Anesthesiologists (ASA) class I-II Informed consent. Patients scheduled for upper and lower endoscopy.

Exclusion Criteria:

Chronic use of drugs as benzodiazpines, neuroleptics and anticonvulsants for more than 30 days.

Hypersensitivity reactions to drugs used in the study. Psychiatric patients. Pregnancy. Being submitted to endoscopy as an emergency procedure.

Primary outcomes:
measure: Evaluate all adverse events related to anesthesia; in patients recruited for upper and lower endoscopy and compare between propofol and midazolam based anesthesia associated adverse events.
timeFrame: 2 years
Secondary outcomes:
measure: Evaluate patient and endoscopist satisfaction as regarding propofol and midazolam anesthesia.
timeFrame: 2 years
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakhlia
city: Mansoura
country: Egypt
facility: MansouraU
Study officials:
References:
Clinical trial NCT04774731: Effect of Whole Body Vibration on Walking Performance in Elderly Hemodialysis Patients
Official title: A Randomized Controlled Trial to Evaluate the Efficacy of Whole Body Vibration on Walking Performance in Elderly Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Keywords: whole body vibration
hemodialysis
gait function
Lead sponsor: Osaka University
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 98
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy of whole body vibration for 12 weeks on walking performance in elderly hemodialysis patients.

Detailed description: This is a multicenter, prospective, randomized controlled trial. Eligible subjects will be randomized in a 1:1 ratio to a whole-body vibration (WBV) group or controlled group. Patients in a WBV group will receive WBV training three times a week before initiation of dialysis sessions for 12 weeks. The primary outcome of the study will be the change in walking performance assessed by the timed up and go test.

Eligibility criteria: Inclusion Criteria:

* Undergoing maintenance hemodialysis three times a week .

Exclusion Criteria:

* Having difficulty in walking by oneself.
* Having difficulty in receiving whole body vibration training because of cognitive impairment.
* History of fracture of lower limb within 1 year.
* History of total hip arthroplasty.
* Unsuitable for participant in the trial by an attending physician.

Primary outcomes:
measure: Change in the timed up and go test
timeFrame: 12 weeks after starting intervention
Secondary outcomes:
measure: Change in the one-leg standing test
timeFrame: 12 weeks after starting intervention
measure: Change in the 30-second chair-stand test
timeFrame: 12 weeks after starting intervention
Other outcomes:
Locations:
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
Study officials:
affiliation: Department of Nephrology, Osaka University
name: Yusuke Sakaguchi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01043731: Laparoscopic Transvaginal Hybrid Anterior Resection: a Prospective Data Collection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sigmoid Diverticulitis (Hinchey I and II)
Sigmoid Diverticulosis With Two or More Attacks of Diverticulitis
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2010-01-07
Enrollment: 45
Sex: FEMALE
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: Given indication for laparoscopic anterior resection

Brief summary: Transvaginal hybrid procedures are of interest as an available NOTES-Procedure for the clinical routine. Few authors have demonstrated the feasibility and safety of such procedures (e.g. cholecystectomy) in selected patient collectives. In 2008 Lacy at al. published the experience with a transvaginal sigmoidectomy as a first in human report. The aim of this prospective data collection is to evaluate the feasibility and safety of the transvaginal hybrid anterior resection in the clinical routine.

Therefore all patients giving the informed consent to the transvaginal hybrid anterior resection will be included and assessed concerning feasibility to perform the transvaginal approach and complete the operation transvaginally.


Eligibility criteria: Inclusion Criteria:

* given informed consent
* sigmoid diverticulosis (two or more attacks)
* sigmoid diverticulitis (Hinchey I and II)

Exclusion Criteria:

* ASA IV
* emergency surgery
* liver-malfunction or coagulation disorders
* acute diverticulitis (Hinchey III and IV)
* malignancy
* acute vaginal infection
* refusal of mandatory preoperative gynecological examination
* pregnancy
* endometriosis
* previous surgery of colon and rectum
* strongly retroflexed uterus
* acute pelvic disorders, infection

Primary outcomes:
measure: Feasibility and safety of the transvaginal operation
timeFrame: 30 days
Secondary outcomes:
measure: Long-term life quality and sexual dysfunction
timeFrame: 3 year
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Department of surgery
Study officials:
affiliation: Cantonal Hospital St. Gallen
name: Andreas Zerz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01981031: A Trial to Assess the Efficacy and Safety of BioChaperone Combo and Humalog Mix 25 in Subjects With Type 1 Diabetes
Official title: Phase 1 Study to Assess the Efficacy and Safety of BioChaperone® Combo and Humalog® Mix 25 in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Adocia
Sponsor class: INDUSTRY
First posted: 2013-11-11
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: BioChaperone Combo is a liquid formulation containing both Insulin Glargine and Insulin Lispro.

The aim of this trial is to assess the efficacy and safety of BioChaperone® Combo in subjects with type 1 diabetes under a dose of 0.8 U/kg.

This trial is a phase 1 single-center, randomized, double-blinded, two-treatment, two-period cross-over, 30-hour euglycaemic glucose clamp trial in subjects with type 1 diabetes mellitus. Each subject will be randomly allocated to one single dose of 0.8 U/kg of BioChaperone® Combo and to one single dose of 0.8 U/kg of Humalog® Mix 25 on two separate dosing visits.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus for at least (or equal to ) 12 months,
* Treated with multiple daily insulin injections or insulin pump treatment for at least (or equal to) 12 months,
* Body Mass Index (BMI): 18.0-28.0kg/m2 (both inclusive)

Exclusion Criteria:

* Type 2 diabetes mellitus,
* The receipt of any investigational product within 3 month prior to first dosing,
* Clinically significant abnormalities, as judged by the investigator,
* Any systemic treatment with drugs known to interfere with glucose metabolism,
* History of alcoholism or drug/chemical abuse and any tobacco product within 5 years prior to screening
* Blood or plasma donation in the past month or more than 500mL within 3 months prior to screening

Primary outcomes:
measure: End of action of 0.8 U/kg BioChaperone® Combo (time from administration until blood glucose concentration is consistently above 8.3 mmol/L during the glucose clamp procedure)
timeFrame: from 0 to 30 hours after a single-dose administration
Secondary outcomes:
measure: Compare pharmacodynamics and pharmacokinetics profiles between BioChaperone® Combo and Humalog® Mix25
timeFrame: from 0 to 30 hours after a single-dose administration
measure: Number of Adverse Events
timeFrame: Weeks 0-10
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
References:
Clinical trial NCT02385331: Molecular Mechanism of Neutrophil Necroptosis and Its Roles in RA Pathogenesis
Official title: Molecular Mechanism of Neutrophil Necroptosis and Its Roles in RA Pathogenesis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: Neutrophils
necroptosis
apoptosis
Lead sponsor: The Third Affiliated Hospital of Southern Medical University
Sponsor class: OTHER_GOV
First posted: 2015-03-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers，age 18-65.

Brief summary: Neutrophils play a central role in innate immunity and are rapidly recruited to sites of infection and injury. Neutrophil apoptosis and necroptosis are essential for the inflammatory.This study is designed to investigate the cells and the molecular mechanisms of neutrophil necroptosis and apoptosis.

Detailed description: Necrosis has recently been demonstrated to be programmatic and energy comsuming, a process termed necroptosis.

In this project, the investigators aim to investigate the mechanisms and the effects ofneutrophil necroptosis and apoptosis: 1. to investigate the cells and the molecular mechanisms that induce neutrophil necroptosis or delay apoptosis, mainly focusing on the roles of HMGB-1,TNF-α and LPS, 2. to illustrate the effects of some molecules such as TLR, TNFR, RIP1/RIP3, Caspase8, ATP and ROS in the process of sigal transduction and membrane damage during necroptosis or apoptosis , 3. to identify the similarities and differences between traditional necrosis and necroptosis in the aspects of morphologigical changes and inflammatory cytokine release, 4. to find out the effects and mechanisms of neutrophil necroptosis or apoptosis in a rheumatoid arthritis mouse model and the therapeutic effect of blocking one or several pathways in the pathogenesis of rheumatoid arthritis.

This study will not only unravel the mechanisms of neutrophil necroptosis and apoptosis, elucidate its roles and significances in inflammation and infection, but also shed new light on anti-inflammatory and anti-infection therapy.

Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers
* age 18-65.

Exclusion Criteria:

* Don't agree with informed consent

Primary outcomes:
measure: The apopotosis and necroptosis of Neutrophils
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital of Southern Medical University
name: ew Sun, doctor
role: STUDY_DIRECTOR
References: