louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04964882: Gastric Insufflation During Positive Pressure Ventilation
Official title: Effect of the Peak Inspiratory Pressure and Facial Mask Holding Techniques on the Gastric Insufflation During Positive Pressure Ventilation With Facemask in Obese Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Insufflation
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: Effect of peak inspiratory pressure on the gastric insufflation is evaluated using ultrasonography during face mask ventilation in obese adults. Effect of facial mask holding techniques on the gastric insufflation is also evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients with body mass index ≥ 30 kg/m2 who are scheduled for general anesthesia

Exclusion Criteria:

* Risk of delayed gastric emptying or gastroesophageal reflux (gastroesophageal reflux disease, achalasia, history of stomach surgery, gastrointestinal obstruction, uncontrolled DM)
* Pregnancy
* Known or predicted difficult airway

Primary outcomes:
measure: Presence of gastric insufflation in the epigastric region
timeFrame: During anesthesia induction
Secondary outcomes:
measure: Cross-sectional area of the antral cross-sectional area
timeFrame: During anesthesia induction
measure: Presence of gastric insufflation in the upper esophageal region
timeFrame: During anesthesia induction
measure: Expiratory tidal volume
timeFrame: During anesthesia induction
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05015582: Perioperative Warming Measures in Cesarean Delivery
Official title: Randomized Control Trial Assessing Effectiveness of Perioperative Warming Measures in Parturients Undergoing Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypothermia; Anesthesia
Hypothermia, Newborn
Hypothermia, Sequela
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
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 to evaluate the best method for keeping patients warm during cesarean deliveries and the effect of temperature change on the patient and baby


Eligibility criteria: Inclusion Criteria:

* scheduled for elective cesarean section under neuraxial anesthesia
* singleton pregnancy

Exclusion Criteria:

* gestational age of less than 37 week
* emergency cesarean

Primary outcomes:
measure: Change in maternal core body temperature
timeFrame: preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia)
measure: Number of women with hypothermia
timeFrame: preoperative/beginning of surgery ,postoperative/end of surgery (4 hours after anesthesia)
measure: Neonate status as determined by Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score
timeFrame: 10 minutes after birth
measure: Neonate status as determined by Umbilical Artery PH
timeFrame: 10 minutes after birth
measure: Maternal Coagulopathy
timeFrame: end of surgery (4 hours after anesthesia)
Secondary outcomes:
measure: Degree of shivering (severity)
timeFrame: on arrival to Post anesthesia Care Unit (PACU) [about 4 hours after anesthesia]
measure: Number of patients that need meperidine
timeFrame: on arrival to PACU [about 4 hours after anesthesia]
measure: Degree of shivering (severity)
timeFrame: after 30 minutes in PACU
measure: Number of patients that need meperidine
timeFrame: after 30 minutes in PACU
measure: Degree of shivering (severity)
timeFrame: after administration of meperidine, if it applies (about 30 minutes in PACU)
measure: Number of patients that show Maternal thermal comfort
timeFrame: end of surgery (4 hours after anesthesia)
measure: Perioperative blood loss
timeFrame: end of surgery (4 hours ater anesthesia)
measure: Hospital Length of Stay
timeFrame: Time of admission to time of discharge (about 72 hours after surgery)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Stacy Norrell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02142582: Comparison of Different Oral Rehydration Solutions
Official title: Comparison of Different Oral Rehydration Solutions (ORS) in Short Bowel Syndrome (SBS) Patients on Home Parenteral Nutrition (HPN): A Prospective Double-blinded Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Short Bowel Syndrome
Keywords: Home Parenteral Nutrition
Compliance
Short Bowel Syndrome
Oral Rehydration Solution
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Compliance is the biggest challenge in patients with Short Bowel Syndrome (SBS) on Home Parenteral Nutrition. These patients need to hydrate themselves to meet the excess fluid loss due to their anatomy. Oral Rehydration Solution (ORS) is prescribed to all these patients. The investigators believe that taste of the standard ORS is the biggest reason why these patients are not complaint. The new ORS in the market has been prepared with this in mind. The investigators want to study if this new ORS will improve the compliance in this patient cohort.


Eligibility criteria: Inclusion Criteria

* All patients with short bowel syndrome treated by the HPN program.

Exclusion Criteria

* Participants who have do not provide written consent.
* Participants who lack the ability to provide informed consent
* Participants who are not anticipated to be on HPN for at least 6 months (determined by PrincipaI Investigator).
* Pregnant women
* Participants with pre-existing congestive heart failure, acute/ chronic kidney failure. (determined by the PrincipaI Investigator)

Primary outcomes:
measure: Number of patients who will regularly take Oral Rehydration Solution (ORS) when the newly available ORS is compared to the World Health Organisation ORS.
timeFrame: 6 months
Secondary outcomes:
measure: Changes in the electrolytes in subjects using the commercial ORS versus the WHO ORS
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ryan Hurt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00440882: Changes of Transforming Growth Factor b1 and Procollagen III in Patients With Acute Respiratory Distress Syndrome
Official title: Changes of Transforming Growth Factor b1 and Procollagen III in Patients With Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2007-02-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients whom suffered ARDS with a PaO2/FIO2 \< 200 mmHg at a positive end-expiratory pressure (PEEP) ³ 5 cm H2O and for which ARDS criteria from less than 24 hours

Brief summary: Transforming Growth Factor-b1 (TGF-b1) is involved in the development of acute lung injury and in the fibroproliferation during acute respiratory distress syndrome (ARDS). Procollagen III Peptide (PIIINP) is a validated marker of fibroproliferation. PIIINP is associated with death in ARDS patients. The simultaneous changes of TGF-b1 and PIIINP were never studied in patients with ARDS. The relationships between TGF-b1 and the outcome of ARDS are unknown.

The aim of the study is to analyse the changes of TGF-b1 and PIIINP during ARDS and to show the relationships between TGF-b1 - PIIINP and the outcomes of ARDS.

Detailed description: Primary outcome: To analyse the changes of Transforming Growth Factor b1 and Procollagen III during the acute respiratory distress syndrome.

Eligibility criteria: Inclusion Criteria:

* ARDS with a PaO2/FIO2 \< 200 mmHg at a positive end-expiratory pressure (PEEP) ³ 5 cm H2O
* ARDS criteria from less than 24 hours
* Informed consent

Exclusion Criteria:

* Pregnancy
* Chronic interstitial or fibrosis lung diseases
* Hepatic chronic disease
* Neutropenia £1 G/l
* Corticosteroid (more than 200 mg/day of hydrocortisone or equivalent, less than 2 weeks before inclusion)
* Immunosuppressive therapy within the last 30 days
* Participation in any investigational drug or devices study within 30 days prior study entry

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Sainte Marguerite
Study officials:
affiliation: AP-HM
name: Jean-Marie FOREL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06574282: Characteristics of Hypophosphatasia in Adult Patients in Rheumatology and Their Value in Developing an Algorithm to HPP-diagnosis - the COHIR Multi-center Study
Official title: The COHIR Multi-center Study - a Non-interventional, Prospective, Multi-center Investigation With Exploratory Data Analysis to Assess the Proportion of Patients With Hypophosphatasia Presenting at the Department of Rheumatology and Establishment of an Algorithm to HPP Diagnosis.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypophosphatasia
Keywords: Hypophosphatasia
Hypophosphatasemia
Musculoskeletal complaints
Genetic disorder
Rare disease
Alkaline phosphatase gene
ALP
ALPL gene
Rheumatology
COHIR study
COHIR multi-center study
COHIRnational study
Prevalence
Diagnostic Algorithm
Metabolic bone diseases
Lead sponsor: University of Bonn
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any adult patient presenting at the participating study site's rheumatology department with musculoskeletal complaints within the timeframe of the study conduct.

Brief summary: Non-interventional, prospective, multi-center investigation with exploratory data analysis to assess the proportion of patients with hypophosphatasia presenting at departments of rheumatology and to establish an algorithm to HPP diagnosis

Detailed description: Acronym: Expansion:

HPP =Hypophosphatasia COHIR ="Characteristics of Hypophosphatasia in Adult Patients in Rheumatology" ALPL =Alkaline Phosphatase

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age \> 18 years
* Clinical suspicion of hypophosphatasia
* Evidence of an abnormal ALP (ALP below LLN) within the clinical routine screening

Exclusion Criteria:

* Failure to meet the inclusion criteria listed above

Primary outcomes:
measure: Prevalence of hypophosphatasia in adult patients in rheumatology
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn
state: North Rhine-Westphali
Study officials:
affiliation: University Hospital of Bonn
name: Valentin S. Schäfer, Univ.-Prof. Dr. med. MUDr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05638282: A Study to Evaluate the Safety and Tolerability of Cendakimab in Chinese Healthy Participants
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Subcutaneous Doses of Cendakimab in Chinese Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Healthy
Chinese
Cendakimab
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-12-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the drug levels, safety, and tolerability of cendakimab in healthy male and female Chinese participants.


Eligibility criteria: Inclusion Criteria:

* Participants must be Chinese (both biological parents are ethnically Chinese).
* Body mass index (BMI) of 18.0 through 28.0 kilograms/meter squared (kg/m\^2), inclusive. BMI = weight (kg)/\[height (m)\]\^2.
* Body weight ≥ 50.0 kg.

Exclusion Criteria:

* History of clinically significant infection within 4 weeks of dosing on Day 1.
* Significant medical history/condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
* Condition(s) which may confound the ability to interpret data from the study, as determined by the investigator.

Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Maximum Observed Serum Concentration (Cmax)
timeFrame: Predose and at multiple timepoints (up to 105 days) after dosing
measure: Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC(0-T))
timeFrame: Predose and at multiple timepoints (up to 105 days) after dosing
measure: Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time (AUC(INF))
timeFrame: Predose and at multiple timepoints (up to 105 days) after dosing
Secondary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events
timeFrame: Day 1 through Day 105
measure: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
timeFrame: Screening (Days -28 to -1) through Day 105
measure: Number of Participants with Clinically Significant Changes in Vital Signs
timeFrame: Screening (Days -28 to -1) through Day 105
measure: Number of Participants with Clinically Significant Changes in Physical Examinations
timeFrame: Screening (Days -28 to -1) through Day 105
measure: Number of Participants with Clinically Significant Changes in Electrocardiograms
timeFrame: Screening (Days -28 to -1) through Day 105
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Local Institution - 0001
state: Guangdong
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06212882: Optimization of DE-CTPA Images and Diagnostic Pathway: Using Low Concentration Iodine Contrast Material
Official title: Dual-Energy CT Angiography in Suspected Pulmonary Embolism: Influence of Concentration of Contrast Materials on Image Quality and Diagnostic Performance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Embolism
Keywords: pulmonary embolism
Computed Tomography
contrast materials
Lead sponsor: Wuxi People's Hospital
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 2100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who will undergo CT pulmonary angiography due to clinical suspicion of pulmonary embolism

Brief summary: The investigators aimed to compare the image quality and diagnostic performance of DECTPA using lower concentration iodine contrast materials and using normal concentration iodine contrast materials in the evaluation of suspected pulmonary embolism.

Detailed description: All patients met the inclusion and exclusion criteria will be given written informed consensus. The enrolled patients will randomly receive one of the three injection protocols: A: 30mL Iomeprol (Iomeron 300, Bracco Imaging, Milano, Italia) injected at a flow rate of 4mL/s; B: 50mL Iomeprol (Iomeron 300, Bracco Imaging, Milano, Italia) injected at a flow rate of 4mL/s; C: 50mL Ioversol (Ioversol 350, Hengrui, Jiansun, China) injected at a flow rate of 4mL/s. A and B groups are both lower concentration iodine contrast material groups, with different total iodine loads.

Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years old
* Clinical suspicion of pulmonary embolism suggests CTPA examination (Wells score\>4 or D-2 polymer elevation)
* Patient's general physical condition tolerates CTPA examination

Exclusion Criteria:

* Allergy to iodine contrast agents
* Hyperthyroidism
* Pregnancy
* Weight greater than 80kg
* Heart failure patients, NYHA heart function level III or IV

Primary outcomes:
measure: image quality evaluation of the CTPA images of 30% participants
timeFrame: through the CTPA examinations of 30% participants finished,, an average of six month
Secondary outcomes:
measure: overall diagnostic performance for pulmonary embolism
timeFrame: CTPA examinations all participants are finished, an average of two month
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT03144882: Evaluation of Curcumin's Effect on Inflammation in Hemodialysis Patients
Official title: Evaluation of Curcumin's Effect on Inflammation in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Complication
Hemodialysis-Induced Symptom
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Programmed ingestion of turmeric has no adverse effects and reduces plasma level of hs-CRP, IL-6 and TNF-α accompanying with increases albumin levels in hemodialysis patients. Turmeric can be considered as an effective anti-inflammatory supplement in hemodialysis patients.

Detailed description: Hemodialysis patients over 18 years were recruited after fulfilling the inclusion criteria.Seventy-one hemodialysis patients were randomized into two groups: the trial group (n =35 ) and the controls (n =36 ); a randomization numeric table was used for allocation sequence . Trial group received turmeric and control group received placebo for 12 weeks. Biochemical determinations included levels of serum albumin (Alb), potassium (K) ,blood urea nitrogen (BUN), serum creatinine (Cr), IL-6 level, TNF- α , and liver function tests and hs-CRP at the start and end of the study were measured.

Eligibility criteria: Inclusion Criteria:• Males or females undergoing maintenance hemodyalisis,

* Age ≥18 year
* Clinically stable and receiving adequate hemodialysis defined by a single pool Kt/V≥1.20 or no less than 3 dialysis sessions per week with a total dialysis time ≥12 hour per week for at least 3 month before enrollment,
* Diabetic patients must be willing to commence insulin therapy if deemed necessary for plasma glucose control.

Exclusion Criteria:

* Active malignant disease (defined as less than 5 year since receiving a diagnosis of being malignancy-free)

  * Critical illness as defined by the need for respiratory or circulatory support (in an intensive care unit)
  * Active vasculitis
  * Severe congestive heart failure (New York Heart Association class IV)
  * Severe chronic systemic infectious or inflammatory disease
  * Liver disease (defined as serum alanine aminotransferase or aspartate aminotransferase levels greater than three times the upper limit of normal)
  * Known or suspected allergy to trial product(s) or related products
  * Treatment with immunosuppressive agents or receipt of any investigational drug within one month preceding screening
  * Recent or current use of anti-inflammatory corticosteroids agents
  * A scheduled renal transplantation within the trial period

Primary outcomes:
measure: Mean Interlukin-6 Levels
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03003182: A Study of Nasopharyngeal Carcinoma From Guangdong
Official title: A Prospective Cohort Study of Nasopharyngeal Carcinoma to Establish Prognostic Models, to Discover Toxicity Associated Predictors and to Validate Randomized Trials in Clinical Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-12-26
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes patients with nasopharyngeal carcinoma in all stages.

Brief summary: This prospective cohort study aims to establish prognostic models, to discover toxicity associated predictors and to validate randomized trials in clinical practice.


Eligibility criteria: Inclusion Criteria:

* histological confirmed nasopharyngeal carcinoma;
* scanned by magnetic resonance imaging from calvaria vertex to clavicles before treatment;
* pretreatment Epstein-Barr virus deoxyribonucleic acid copy number is available;
* irradiated with intensity-modulated radiotherapy;

Exclusion Criteria:

* finishing anticancer therapy in two or more hospitals;
* pregnancy or lactation;
* diagnosed with other sort of cancer before or during the treatment.

Primary outcomes:
measure: overall survival
timeFrame: 3-years
Secondary outcomes:
measure: Number of participants with treatment-related acute adverse events as assessed by CTCAE v4.0
timeFrame: 30-days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
citation: Yang SS, Wu YS, Pang YJ, Xiao SM, Zhang BY, Liu ZQ, Chen EN, Zhang X, OuYang PY, Xie FY. Development and validation of radiologic scores for guiding individualized induction chemotherapy in T3N1M0 nasopharyngeal carcinoma. Eur Radiol. 2022 Jun;32(6):3649-3660. doi: 10.1007/s00330-021-08460-1. Epub 2022 Jan 6.