louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03767127: Oxygen Extraction-guided Transfusion in Critically Ill Patients
Official title: Red Blood Cell Transfusion Decision Based on Arterial-venous Oxygen Difference Can Reduce Mortality in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Critical Illness
Keywords: transfusion
intensive care medicine
90-day mortality
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 177
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: Unselected critically ill patients admitted to intensive care unit

Brief summary: Anemia is common in intensive care unit (ICU) patients and often appears early in the ICU course. The optimal management red blood cells RBC transfusion in critically ill patients remains controversial and clinical studies in this field have usually been based on transfusion thresholds. In the "TRICC" Trial, patients assigned to a restrictive transfusion strategy (transfusion if Hb\<7 g/dL) had similar mortality to patients transfused if Hb\<10 g/dL. Notably, none of the large RCT tried to focus on a personalize RBC transfusion protocol, i.e. a transfusion protocol which address the individual need for transfusion basing on physiological approach. We therefore hypothesized that patients with high extraction of oxygen could benefit more of RBCs transfusion regardless their hemoglobin levels.


Eligibility criteria: Inclusion Criteria:

* Hemoglobin level \<10 g/dL during the first 72 hours of ICU

Exclusion Criteria:

* Acute bleeding
* Hemoglobin level less than 7 g/dL

Primary outcomes:
measure: 90-day mortality
timeFrame: after 90 days from study enrollment
Secondary outcomes:
measure: Acute kidney injury
timeFrame: 7 days after study inclusion
measure: Length of ICU stay
timeFrame: from ICU admission to discharge, up to 8 weeks
measure: Variation in Sequential Organ Failure Assessment (SOFA) score
timeFrame: 5 days
measure: Days of vasopressor
timeFrame: 28 days after study inclusion
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Università di Ferrara
Study officials:
References:
citation: Fogagnolo A, Taccone FS, Vincent JL, Benetto G, Cavalcante E, Marangoni E, Ragazzi R, Creteur J, Volta CA, Spadaro S. Using arterial-venous oxygen difference to guide red blood cell transfusion strategy. Crit Care. 2020 Apr 20;24(1):160. doi: 10.1186/s13054-020-2827-5.
Clinical trial NCT03353727: Orthoptic Rehabilitation for Low Vision People With Innovative Mechanisms (Eye Tracker and Tactile Device)
Official title: Orthoptic Rehabilitation for Low Vision People With Innovative Mechanisms (Eye Tracker and Tactile Device)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Low Vision
Keywords: Orthoptic rehabilitation
low vision
eye tracker
tactile device
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2017-11-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This project is working on orthoptic rehabilitation for low vision people. The aim of the project is to assess the interest and integration of this rehabilitation device used at home, in low-vision private practice and at the hospital. It leads to develop and evaluate an innovative device to integrate and adjust monitoring of patients according to their need and their progress, to create new interactions with the patient, enabling the orthoptist to stay in touch with his patient at home between rehabilitation sessions and to obtain a more fine and objective analysis of the exercises done by the patient.

Using an eye tracker and a digital tactile screen with data uploads allows the practitioner to observe the progress objectively. It also leads the patient to a better understanding of his/her visual behavior and of the effects of rehabilitation. Therefore, it will be easier to adopt better strategies.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from visual impairment, with a need for visual rehabilitation
* Visual acuity (≤1.3 logMAR)
* Good knowledge of French language
* Informed consent of research

Exclusion Criteria:

* Medical treatment that may interfere with the study
* Degenerative diseases or any other diseases that may interfere with the study.
* Mini-Mental State Examination Score without visual item ≤ 20/25
* Pregnancy and lactation.

Primary outcomes:
measure: score assessing the feasibility of the rehabilitation
timeFrame: 18 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
city: Paris
country: France
facility: Fondation Hospitalière Sainte Marie
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
affiliation: Centre Hospitalier National d'Ophtalmologie des Quinze Vingts, Paris
name: Jean-François Girmens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02204527: Supplementation of Vitamin D in Patients With Type 2 Diabetes and Hypertension
Official title: Supplementation of Vitamin D in Patients With Type 2 Diabetes and Hypertension: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Keywords: hypertension
diabetes mellitus
vitamin D
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
First posted: 2014-07-30
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was a randomized, double-blind, placebo-controlled clinical trial on 40 outpatients with hypertension and type 2 diabetes were recruited.

Patients were allocated into two equal groups of 20 by computer-generated randomly permutated codes. the subjects were randomly assigned to 1 of 2 groups: Group 1 received a single dose (100.000 IU) of oral supplementation with cholecalciferol (vitamin D3). Group 2 received matching placebo capsules containing microcrystalline cellulose.
Primary purpose: TREATMENT

Brief summary: In patients with type 2 diabetes, the effects on blood pressure of vitamin D has been shown to be variable. Thus, the goal of this proposal is to evaluate the effect of vitamin D supplementation in patients with type 2 diabetes and hypertension


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* hypovitaminosis D
* hypertension

Exclusion Criteria:

* pregnant or lactating
* patients using vitamin D supplementation
* using drugs that interfere on vitamin D metabolism (corticosteroids, anticonvulsants)
* illicit drug use
* diseases such as chronic renal failure (serum creatinine greater than 2.0 mg/dl)
* liver cirrhosis
* alcoholism
* dementia
* malignant disease that compromises the 5-year survival,
* digestive tract (malabsorption) diseases
* BMI\> 40 kg / m2

Primary outcomes:
measure: Ambulatory Blood pressure monitoring
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: HCPA, Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
References:
citation: de Paula TP, Moreira JSR, Sperb LF, Muller MEP, Steemburgo T, Viana LV. Efficacy of single-dose cholecalciferol in the blood pressure of patients with type 2 diabetes, hypertension and hypovitaminoses D. Sci Rep. 2020 Nov 12;10(1):19611. doi: 10.1038/s41598-020-76646-6.
Clinical trial NCT06946927: A Phase Ib Study of JMKX001899 in Combination With Other Therapies in Advanced NSCLC Harboring KRAS G12C Mutation
Official title: A Phase Ib, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of JMKX001899 in Combination With Other Therapies in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With KRAS G12C Mutation.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: NSCLC (Advanced Non-small Cell Lung Cancer)
Lead sponsor: Jemincare
Sponsor class: INDUSTRY
First posted: 2025-04-27
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a phase 1b, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of JMKX001899 in combination with IN10018 or in combination with chemotherapy or in combination with IN10018 and chemotherapy in subjects with locally advanced or metastatic NSCLC with KRAS G12C mutation.


Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV NSCLC disease.
2. Known KRAS G12C mutation, and negative results for other driver genes with approved targeted therapies.
3. Measurable disease according to RECIST 1.1.
4. An Eastern Cooperative Group (ECOG) performance status of 0 or 1.
5. Adequate organ function.

Exclusion Criteria:

1. Subjects with carcinomatous meningitis or spinal cord compression; or with other evidence indicating that central nervous system (CNS) metastases or leptomeningeal metastases are not yet controlled.
2. Prior chemotherapy, radiotherapy, immunotherapy or treatment with an investigational agent within 4 weeks of receipt of study drug (within 6 weeks for nitrosoureas, mitomycin C; within 2 weeks of small molecule targeted therapies, traditional medicine with anticancer indication).
3. History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
4. Gastrointestinal (GI) tract disease causing the inability to take oral medication or affect drug absorption.

Primary outcomes:
measure: Recommended Phase II dose (RP2D)
timeFrame: approximately 1 year
measure: adverse events
timeFrame: Through study completion, approximately 2.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT06876727: Efficacy and Safety of Antiplatelet Therapy After Endovascular Aortic Repair
Official title: A Target Trial Emulation for Efficacy and Safety of Antiplatelet Therapy After Endovascular Aortic Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysms (AAA)
Endovascular Aneurysm Repair (EVAR)
Keywords: Abdominal Aortic Aneurysms (AAA)
Endovascular Aneurysm Repair (EVAR)
Single antiplatelet therapy
Dual antiplatelet therapy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 8325
Sex: ALL
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: All patients who underwent EVAR for AAA and were successfully discharged and prescribe any antiplatelet therapy.

Brief summary: This study was a target trial emulation using the National Health Claims database established by the Korean National Health Insurance Service (K-NHIS). 8,325 patients were included.

Detailed description: Among these patients, any patients who were prescribed SAPT or DAPT at the date of discharge from the index hospitalization for standard EVAR were defined as being in the SAPT group (N=4,162) and the DAPT group (N=4,163), respectively.

Eligibility criteria: Inclusion Criteria:

* All patients who underwent EVAR for AAA and were successfully discharged

Exclusion Criteria:

* Patients who had experienced a myocardial infarction
* Patients who had experienced a stroke
* Patients who had experienced percutaneous coronary intervention
* Patients who had history of peripheral disease
* Patients who had major bleeding event within 1 year of admission
* Those prescribed non-vitamin K antagonist oral anticoagulant or warfarin
* Patients who did not prescribe any antiplatelet therapy

Primary outcomes:
measure: Major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: 1 year after EVAR
measure: Major or clinically relevant non-major bleeding
timeFrame: 1 year after EVAR
measure: Re-intervention or surgery for AAAs
timeFrame: 1 year after EVAR
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03130127: Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis
Official title: Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis: A Prospective Non-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Liver Cirrhosis
Portal Hypertension
Variceal Hemorrhage
Bleeding
Esophageal and Gastric Varices
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Terlipressin is the mainstay drug for the treatment of acute variceal bleeding in liver cirrhosis. According to the drug instructions, intravenous bolus infusion is the standard approach of terlipressin. It remains unclear about whether or not continuous infusion of terlipressin should be considered.

Detailed description: Although intravenous bolus infusion of terlipressin is the standard approach, continuous infusion of terlipressin is preferred in clinical practice. The present study is a pilot non-randomized controlled trial to explore the feasibility and safety of continuous infusion of terlipressin for the treatment of acute variceal bleeding in liver cirrhosis.

Eligibility criteria: Inclusion Criteria:

1. A diagnosis of liver cirrhosis;
2. Child-Pugh B or C;
3. Acute gastroesophageal variceal bleeding;
4. Written informed consents. -

Exclusion Criteria:

1. No liver cirrhosis;
2. Child-Pugh class A;
3. Acute upper gastrointestinal bleeding unrelated to varices;
4. Use of somatostatin or octreotide. -

Primary outcomes:
measure: 5 day treatment failure
timeFrame: 5 days (120 hours)
Secondary outcomes:
measure: Six-week mortality
timeFrame: 6 weeks
Other outcomes:
measure: Adverse events related to terlipressin [Safety]
timeFrame: 5 days after treatment
Locations:
Study officials:
affiliation: General Hospital of Shenyang Military Area
name: Xiaozhong Guo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01434927: The Clinical Acceptability of Unsedated Colonoscopy
Official title: Unsedated Colonoscopy: An Option For Some But Not For All
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonoscopy
Lead sponsor: Valduce Hospital
Sponsor class: OTHER
First posted: 2011-09-15
Enrollment: 964
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all consecutive 18-80 year-old outpatients presenting to undergo open-access colonoscopy for routine indications were considered eligible to enter the study.

Brief summary: The study was aimed to prospectively evaluate the acceptance rate of unsedated colonoscopy, in a setting where routine sedation for colonoscopy is standard practice and to characterize the subset of patients willing to try and potentially completing an unsedated procedure.

Detailed description: Patients were offered to undergo colonoscopy without routine premedication. In case of both acceptance and refusal, a brief questionnaire recording demographics (gender, age, level of education) and clinical features was prospectively recorded in a standard data sheet by one of the four endoscopists at enrollment. Clinical features recorded for each patient included: indication to the procedure, history of abdominal surgery or irritable bowel syndrome, presence of pain as main symptom, chronic use of sedative medications, level of patient's anxiety (none, mild, moderate or severe), main concern about the examination and reason for willing to attempt unsedated procedure.

Eligibility criteria: Inclusion Criteria:

* adult outpatients

Exclusion Criteria:

1. previous colorectal surgery
2. indication to a bi-directional endoscopy
3. indication to a partial examination
4. patients' refusal or inability to provide informed consent and
5. advanced heart, lung, liver or renal disease (American Society of Anesthesiology risk class III-IV)

Primary outcomes:
measure: ODDS ratio for unsedated colonoscopy acceptance
timeFrame: up to 8 months
Secondary outcomes:
measure: Acceptance rate of unsedated colonoscopy
timeFrame: up to 8 months
measure: ODDS ratios for unsedated colonoscopy completion
timeFrame: up to 8 months
Other outcomes:
Locations:
city: Como
country: Italy
facility: Vadluce Hospital
Study officials:
affiliation: Valduce Hospital
name: Franco Radaelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06394427: Neoadjuvant Chemoimmunotherapy in Stage IIIA- N2IIIB Non-small Cell Lung Cancer
Official title: Influence of Neoadjuvant Chemoimmunotherapy on Treatment Response in Stage IIIA- N2IIIB Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non-small Cell Lung Cancer Stage ⅢA
Non-small Cell Lung Cancer Stage IIIB
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: locally advanced NSCLC meeting the above crateria

Brief summary: to explore the impact of preoperative neoadjuvant immunotherapy on perioperative outcomes and long-term prognosis of locally advanced NSCLC in the real world


Eligibility criteria: Inclusion Criteria:

* Confirmed as primary lung cancer through cytology or histological examination;

  * ECOG score of 0 or 1; ③ 18 years old or above;

    * Received imaging examination, with a preliminary clinical staging of stage III;

      * Received genetic testing and tested negative for EGFR mutations, ALK or ROS-1 fusion; ⑥ Accepting preoperative neoadjuvant immunotherapy combined with chemotherapy; ⑦ Receive surgical treatment after completion of neoadjuvant therapy; ⑧ The postoperative specimens were sent to the pathology department of our hospital for pathological testing, and a complete pathological report is available.

Exclusion Criteria:

* Patients with combined small cell lung cancer; ② Patients with severe liver/kidney dysfunction, cardiovascular disease, or systemic immune disorders;

  * Accept other neoadjuvant treatments; ④ Patients participating in any clinical trial.

Primary outcomes:
measure: major pathological remission
timeFrame: one month
measure: pathological complete remission
timeFrame: one month
measure: survival time
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00220376: Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP584) for the Treatment of Overactive Bladder Syndrome
Official title: Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP584) for the Treatment of Overactive Bladder Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder Syndrome
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will provide long-term data on safety, satisfaction and maintenance on therapy of fesoterodine (SPM 907) in subjects with overactive bladder syndrome.

Subjects completing the 12 week treatment period of SP584 had the opportunity to participate if eligibility was confirmed. They received fesoterodine 8mg with the option to reduce the dose to 4mg during scheduled visits, and to increase again to 8mg, a procedure which can be followed on an annual basis.

The primary variables are long-term safety and tolerability, measured by observation and assessment of adverse events and duration on therapy. Further safety variables include the assessment of laboratory parameters, changes in ECG, physical exams and measurement of residual urine.

Secondary efficacy variables included various parameters derived from micturition diaries and the evaluation of Quality of Life questionnaires


Eligibility criteria: Inclusion Criteria:

* Overactive Bladder Syndrome

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: RTP
country: United States
facility: Schwarz
state: North Carolina
Study officials:
affiliation: UCB Pharma
name: Brooke Derby
role: STUDY_DIRECTOR
References:
Clinical trial NCT07015827: Effect of Locally Produced Mango Variety on Glycemic Index
Official title: Effect of Locally Produced Mango Variety on Glycemic Index
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Glycemic Index and Glycemic Load
Keywords: Glycemic index
posprandial glucose response
glycemic load
Lead sponsor: Rehman Medical Institute - RMI
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This randomized trial aims to assess the glycemic index (GI) of locally available mango varieties in healthy adult participants, using glucose as the reference food. The study will evaluate the postprandial blood glucose response elicited by selected mango varieties and compare it to the response produced by a standard glucose . The objective is to determine whether certain mango varieties have a lower glycemic impact, which may be relevant for dietary planning and public health recommendations.

Detailed description: This randomized trial aims to assess the glycemic index (GI) of locally available mango varieties in healthy adult participants, using glucose as the reference food. The study will evaluate the postprandial blood glucose response elicited by selected mango varieties and compare it to the response produced by a standard glucose . The objective is to determine whether certain mango varieties have a lower glycemic impact, which may be relevant for dietary planning and public health recommendations.

Eligibility criteria: Inclusion Criteria:

* Healthy non-diabetic adults
* Normal fasting blood glucose levels
* Willingness to provide informed consent

Exclusion Criteria:

Diagnosis of diabetes mellitus or impaired glucose tolerance

* Gastrointestinal, metabolic, or endocrine disorders
* Current use of medications affecting blood glucose
* Pregnant or lactating women
* Smoking or alcohol consumption

Primary outcomes:
measure: Glycemic Index (GI) of Mango Varieties
timeFrame: 0 to 120 minutes after consumption of test food
Secondary outcomes:
measure: Peak Blood Glucose Level
timeFrame: 0 to 120 minutes after consumption
Other outcomes:
Locations:
Study officials:
References: