louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04733846: Treatment of Corneal Wounds Emergencies During the COVID-19 Shutdown: Absorbable 10-0 Vicryl Sutures as a Valuable Strategy.
Official title: Treatment of Corneal Wounds Emergencies During the COVID-19 Shutdown: Absorbable 10-0 Vicryl Sutures as a Valuable Strategy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Trauma
Keywords: Corneal
penetrating injury
lamellar laceration
COVID
polyglactin
Vicryl
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had an emergency eye surgery in the Saint-Etienne University Hospital from 18/03/2020 to 05/12/2020

Brief summary: Vicryl (polyglactin) 10-0 resorbable suture is rarely used, little known to ophthalmologists but may offer therapeutic and practical advantages in eligible cases of corneal trauma, particularly during a COVID-19 pandemic.

This has imposed new sanitary restrictions : limited access to the operating room in ophthalmology only for functional emergencies and a drastically reduced capacity for external consultations in favor of teleconsultation. The aim of this study is to evaluate the Vicryl 10-0 (polyglactin 910) resorbable monofilament suture in corneal trauma, rather than classic Nylon 10-0: structural and functional results, and adaptation of postoperative follow-up during a sanitary crisis period.


Eligibility criteria: Inclusion Criteria:

* Corneal penetrating injury and/or lamellar laceration

Exclusion Criteria:

* Corneal Penetrating injury trauma requiring necessarily ONLY Nylon 10-0
* Traumatism requiring necessarily a cryopreserved human amniotic membrane (for example)
* Traumatism eligible for biological glue (long-axis wound \< 2 mm)

Primary outcomes:
measure: change visual acuity (Snellen scale) from baseline and 2, 6, 12 and 18 months after the intervention
timeFrame: Months: 0, 2, 6, 12, 18
measure: change Visual acuity (Parinaud scale) from baseline and 2, 6, 12 and 18 months after the intervention
timeFrame: Months: 0, 2, 6, 12, 18
Secondary outcomes:
measure: Astigmatism (diopter)
timeFrame: Months: 0, 2, 6, 12, 18
measure: Number of postoperative external consultations
timeFrame: Months: 0, 2, 6, 12, 18
measure: Adverse events
timeFrame: Months: 0, 2, 6, 12, 18
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Thibaut GARCIN, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00816946: District-based Mainstreaming Nutrition Project in Rural Pakistan
Official title: Scaling up Evidence-based Nutrition Interventions to Address Maternal and Child Health Outcomes in Pakistan: a District-based Demonstration Project in Rural Sindh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: malnutrition
growth
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: National Lady Health Workers Programme, Government of Pakistan
First posted: 2009-01-05
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to provide evidence regarding the feasibility of integrating an enhanced maternal and child care health education package into the existing curricula of the National Program for Family Planning and Primary Health Care (LHW Program) and evaluating the feasibility of scaling-up as well as the impact on birth outcomes, nutritional status, morbidity patterns and overall survival patterns at the community level.

Detailed description: This project aims to do the following:

* To evaluate the operational feasibility of integrating an enhanced health education and nutrition package into the existing curriculum of the National Program for FP/PHC (LHW Program)
* Impact of the implementation of the full package of evidence-based nutrition interventions on the nutrition status, morbidity patterns and overall survival patterns in the district

Eligibility criteria: Inclusion Criteria:

* Live born infants and young children from all registered pregnancies within participating villages and catchment population
* pregnant women
* Consent given by at least one of the parents

Exclusion Criteria:

* Children born with congenital malformations or serious birth injury
* Suspected non-compliance (mobile and poorly motivated parents).
* Failure to give consent

Primary outcomes:
measure: mother pregnancy weight gain in 3rd trimester
timeFrame: at time of enrollment, 2 weeks before delivery
measure: mothers Hb level
timeFrame: at time of enrollment, 2 weeks before delivery
measure: child's birthweight
timeFrame: at birth
Secondary outcomes:
measure: young child's growth
timeFrame: 0, 3, 6, 12, 18 mths, at end of study
measure: dietary diversity of CF
timeFrame: 6 mths, 9mths, 12mths, 18 mths
Other outcomes:
Locations:
city: Naushero Feroze
country: Pakistan
facility: AKU-Peds Naushero Feroze Site Office
state: Sindh
Study officials:
References:
Clinical trial NCT01907646: Role of Bladder Training During Post-operative Hospital Stay After Radical Hysterectomy in Patients
Official title: Role of Bladder Training During Post-operative Hospital Stay After Radical Hysterectomy in Patients: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uterine Cervical Neoplasms
Keywords: bladder training, radical hysterectomy,gynaecologic cancer
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 111
Sex: FEMALE
Minimum age (years): 27
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the impact and the outcome of bladder training during post-operative hospital stay after radical hysterectomy, mainly after neoadjuvant concurrent chemo-radiation therapy for locally advanced cervical cancer.


Eligibility criteria: Inclusion Criteria:

- Women who underwent Querleu-Morrow class B2 and class C1 RH were enrolled in this randomized prospective study.

Exclusion Criteria:

-All the patients with preoperative urinary dysfunctions were excluded by study. Other exclusion criteria were surgery of lower urinary tract and psychiatric disease.

Primary outcomes:
measure: clean intermittent self-catheterization
timeFrame: three days
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of the Sacred Heart
Study officials:
References:
Clinical trial NCT01910246: Cardiovascular Effects of Metformin on Obesity
Official title: Cardiovascular Effects of Metformin on Obesity With Subclinical Myocardial Dysfunction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Insulin Resistance
Keywords: Metformin
Insulin Resistance
Cardiac Function
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2013-07-29
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It has been shown that asymptomatic obese adolescents can demonstrate abnormal regional myocardial contraction, with preserved global cardiac function. Metformin has been shown to decrease cardiovascular mortality in patients with type 2 diabetes and insulin resistance, but the mechanism of cardiovascular protection is unknown.

The purpose of this study is to evaluate the reversibility of subclinical cardiovascular abnormalities in obese adolescents with insulin resistance after a six-month course of Metformin. The investigators hypothesized that the beneficial effects of Metformin will be progressive and sustained after six months of therapy.


Eligibility criteria: Inclusion Criteria:

* Adolescents 12 to 17 years old under clinical care at the UCSF WATCH clinic
* Body mass index\> 95th percentile for age and gender according to the Centers for Disease Control and Prevention 2000 growth charts for the United States
* Insulin resistant after 6 months of healthy diet and exercise
* Able to understand the assent form

Exclusion Criteria:

* Patients with known cardiac disease
* Patients with contraindications to metformin as listed below:

  * Renal disease or renal (serum creatinine levels ≥1.5 mg/dL for males, and ≥1.4 mg/dL for females;
  * Known hypersensitivity to Metformin;
  * Acute or chronic metabolic acidosis;
* Patients with contraindications to MRI including:

  * Cardiac pacemaker;
  * Claustrophobia;
  * Metallic foreign body in the eye,
  * Aneurysm clip in the brain
* Pregnancy;
* Patients who could not stay still for 30 minutes within the MRI scanner due to other reasons besides claustrophobia

Primary outcomes:
measure: Left Ventricular Circumferential Strain change after a six-month course of Metformin.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF, Radiology and Biomedical Imaging
state: California
Study officials:
affiliation: University of California, San Francisco
name: Karen G Ordovas, MD, MAS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: David Saloner, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01177046: Development of a Multi-attribute Health Index: to Measure the Quality of Labour Analgesia: The QLA Index
Official title: Development of a Multi-attribute Health Index to Measure the Quality of Labour Analgesia: Psychometric Development of a Quality of Neuraxial Labour Analgesia Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labour Pain
Keywords: Women receiving labour epidural for most recent delivery
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2010-08-06
Enrollment: 752
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who received neuraxial labour analgesia during the current pregnancy

Brief summary: The findings of this research will be used to develop a scale for measuring the quality of epidural pain relief achieved during labour and vaginal delivery.

Detailed description: The current lack of a tool to measure the overall quality of neuraxial pain relief provided in labour analgesia trials has produced studies unable to provide clear direction to clinical care and research. Our previous work explored and described the underlying dimensions and attributes of quality neuraxial analgesia from the perspectives of labouring women as the initial phase of development of an Index to measure this as an outcome in research. We now seek to confirm our findings as well as to generate additional items (descriptors) of quality neuraxial analgesia from the perspectives of parturients and experts (obstetrical anesthesiologists and experienced labour nurses). Once generated, the full list of items will be used to in a subsequent study involving only parturients (Item Reduction phase) to develop a scale permitting global measurement of quality neuraxial labour analgesia. The resulting scale, once validated, will provide researchers with a simple global measure for quality in labour analgesia research. This scale will be used later in our program of research to assist with validation studies of the larger Multi-attribute Health Index we are developing.

Eligibility criteria: Inclusion Criteria:

1. Use of neuraxial labour analgesia during the current pregnancy
2. Native English-speakers
3. Term pregnancies (\>37-42weeks)
4. The ability to read and write in English
5. Provision of written informed consent.

Exclusion Criteria:

1. Women who received IM or IV narcotics within 4 hours of epidural/ combined spinal epidural (CSE) placement
2. Women with evidence or history of maternal cognitive impairment
3. Women who experienced a neonatal death during the current pregnancy

Primary outcomes:
measure: Psychometric instrument development study
timeFrame: 5-6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Dr. Pamela Angle, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06785246: Grasshopper: a Novel Clinical Dashboard for Radiologists
Official title: Grasshopper: a Novel Clinical Dashboard for Radiologists
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chest Infection
Pulmonary Edema - Acute
Keywords: AI
Emergency Department
Radiology
Imaging
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedge cluster randomized trial
Primary purpose: OTHER

Brief summary: Does a radiology clinical dashboard increase radiologist use of specific reporting language for chest X-rays (CXRs) and thereby decrease rates of unnecessary Emergency Department (ED) prescriptions and follow-up imaging?

Detailed description: Chest X-rays (CXR) are the most common radiologic exam, comprising nearly one third of total KPNC imaging volume. Despite high CXR utilization, diagnostic yield is frequently low, partly due to the paucity of clinical information provided to radiologists at the time of CXR interpretation, resulting in frequent nonspecific CXR assessments which include terms like "opacities" instead of diagnostic terms such as "pulmonary edema" or "pneumonia". This may contribute to over-treatment and unnecessary follow-up CT imaging. This study proposes the production deployment, active promotion, and evaluation of an innovative clinical dashboard called Grasshopper for radiologists to provide pertinent clinical information at the time of CXR interpretation. The dashboard leverages the electronic medical record to programmatically retrieve, and display select clinical notes, patient lab values, and vital signs. The Grasshopper study aims to prospectively evaluate the impact of Grasshopper on CXR report specificity in ED settings across 15 KPNC service areas, and on downstream care process measures such as prescription and imaging utilization.

Eligibility criteria: Kaiser Permanente Northern California CXR is ordered during emergency room visit or inpatient hospitalization

Primary outcomes:
measure: Number of Diagnostic CXR Reports
timeFrame: Through study completion, an average of 18 months.
Secondary outcomes:
measure: Number of Prescriptions after Stat CXR
timeFrame: Through study completion, at an average of 18 months.
measure: Number of CT Imaging exams after Stat CXR
timeFrame: Through study completion, at an average of 18 months.
Other outcomes:
Locations:
city: Pleasanton
country: United States
facility: Kaiser Permanente Northern California Division of Research
state: California
Study officials:
References:
Clinical trial NCT01730846: Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?
Official title: Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking
Keywords: smoking lapse behavior
smoking cessation
doxazosin
medication effect on smoking lapse behavior
medication effect on smoking cessation
stress
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-11-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether doxazosin will attenuate the ability of stress to precipitate smoking lapse behavior in treatment seeking daily smokers. Participants will participate in a smoking cessation attempt after the laboratory sessions.


Eligibility criteria: Inclusion Criteria:

* Ages 18-60
* Able to read and write English
* Smoker
* Motivated to Quit Smoking

Exclusion Criteria:

* Any significant current medical conditions that would contraindicate smoking
* Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) abuse or dependence of other substances, other than nicotine dependence or alcohol abuse
* Positive test results at intake appointment on urine drug screens for illicit drugs
* Past 30 day use of psychoactive drugs including anxiolytics and antidepressants
* Women who are pregnant or nursing
* Suicidal, homicidal or evidence of current severe mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders
* Participants who have donated blood within the past 6 weeks
* Individuals who are currently taking other medications prescribed for smoking cessation
* Specific exclusions for administration of doxazosin or any alpha blocker

Primary outcomes:
measure: Latency (Min) to Initiate Ad-lib Smoking Session
timeFrame: 0 up to 50 minutes (Delay Period)
Secondary outcomes:
measure: Number of Cigarettes Smoked During Ad-lib Session
timeFrame: 60 minutes (ad-lib smoking period)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Center for Clinical Investigations, Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Sherry A McKee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05379946: Study to Evaluate D-1553 in Combination With IN10018 in Subjects With Solid Tumors
Official title: A Phase 1/2, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of D-1553 in Combination With IN10018 in Subjects With Advanced or Metastatic Solid Tumors With KRasG12C Mutation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Solid Tumor
Lead sponsor: InventisBio Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: InxMed (Shanghai) Co., Ltd.
First posted: 2022-05-18
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a phase 1/2, open label study of D-1553 in combination with IN10018 to assess the safety and tolerability, identify the MTD and RP2D, evaluate the PK properties and antitumor activities in subjects with advanced or metastatic solid tumor with KRasG12C mutation


Eligibility criteria: Inclusion Criteria:

* Subject with histologically proven, locally advanced, unresectable and/or metastatic solid tumor, for which no standard treatment is available or the subject is refractory to or intolerant of existing standard treatment.
* Subject has KRasG12C mutation in tumor tissue or other biospecimens (only for phase1b) containing cancer cells or DNA. Historical, local laboratory result (up to 5 years prior to this study) can be used.
* Subject has tumor type requirement as follows: advanced or metastatic solid tumors including NSCLC and CRC.
* Subject has measurable disease according to RECIST, v1.1

Exclusion Criteria:

Subject with unstable or progressive central nervous system (CNS) metastases.

* Subject with acute myocardial infarction, severe/unstable angina; or with cardiac insufficiency of New York Heart Association Functional Classification Grade 2 or above.
* Subject has corrected QT interval using Fridericia's formula (QTcF) prolongation at rest, where the mean QTc interval is \> 480 msec based on triplicate measurements of electrocardiogram (ECG).
* Subject with stroke or other severe cerebrovascular diseases within 12 months before enrollment;
* Subject with interstitial lung disease or acute lung infection not yet recovered including but not limited to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection;
* Subject is pregnant or lactating.

Primary outcomes:
measure: adverse events
timeFrame: Through study completion, approximately 3 years
measure: Objective response rate (ORR) per RECIST v1.1
timeFrame: Through study completion, approximately 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of Sciences,
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Zhengbo Song
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00484146: Alterations of Immunologic Mediators During Severe Sepsis
Official title: Alterations of Immunologic Mediators During Severe Sepsis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Severe Sepsis
Keywords: Sepsis
Early Stage
Immune System
Receptors
Cytokines
Lead sponsor: Klinikum St. Georg gGmbH
Sponsor class: OTHER
Collaborators: name: University of Halle Medical Faculty
First posted: 2007-06-08
Enrollment: 20
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: Patients with early stage of severe sepsis and septic shock

Brief summary: Severe sepsis induces significant changes in expression of insulin- and toll-like receptors, cytokines, markers of apoptosis, and activation of t- and b-lymphocytes.

Detailed description: In patients at early stage of severe sepsis, we investigate the expression of pro- and anti-inflammatory cytokines, chemokines, adhesion-molecules, toll-like receptors, insulin-receptors, markers of apoptosis und of t- and b-cell-activation on a mRNA level.

Eligibility criteria: Inclusion Criteria:

* age \>= 18 y
* agreement with study procedures
* 3 of 4 SIRS-criteria
* proven or highly suspected infection
* 2 or more sepsis-induced organ failures
* start of first sepsis-induced organ failure within the last 36 hours

Exclusion Criteria:

* non-agreement with study procedures
* signs of severe sepsis with organ failure \> 36 hours
* chronic immuno-compromising diseases
* chronic therapy with anti-inflammatory drugs
* non-curable cancer
* chronic renal failure with hemodialysis
* pregnancy or breast-feeding

Primary outcomes:
measure: severity of sepsis
timeFrame: 96 hours after diagnosis of sepsis
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Klinikum St. Georg gGmbH, Interdisciplinary Intensive Care Unit
state: Sachsen
Study officials:
affiliation: Klinikum St. Georg gGmbH
name: Armin R Sablotzki, MD
role: PRINCIPAL_INVESTIGATOR
References: