louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05403073: Ultrasound Guided Nerve Block for Hip Fracture Pain Management at Emergency Department
Official title: Ultrasound Guided Nerve Block for Hip Fracture Pain Management at Emergency Department
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fractures
Pain, Acute
Ultrasound Therapy; Complications
Keywords: Hip Fractures Pain Ultrasound nerve block
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective is to determine if ultrasound guided suprainguinal iliac fascia block leads in better clinical outcomes such as pain management or time to home discharge.

Detailed description: Determining effectiveness in ultrasound guided suprainguinal iliac fascia block as a tool of comfortability of patients with less use of opioids and their side effects and its possible influence in early discharge to home has no evidence in orthopedics literature till today.

Ultrasound becomes an accessible tool at Emergency Departments and Orthopedic Surgeons are increasingly interested its clinical use.

This clinical trial wants to investigate if its use for hip nerve block leads in better clinical outcomes such as pain management or time to home discharge.

Eligibility criteria: Inclusion Criteria:

* Low energy Hip Fracture

Exclusion Criteria:

* Don´t meet Inclusion Criteria
* Present any other synchronic fracture.
* Drug allergy for drugs used for nerve blocking
* Skin infection at injection site.
* Contraindication due to comorbidities.
* Pathologic fractures.
* Cognitive impairment
* Do not give his consent.

Primary outcomes:
measure: Pain Control after Ultrasound guided nerve block vs iv painkillers
timeFrame: During Emergency Department stay (up to 12 hours)
Secondary outcomes:
measure: Patient Hip Mobility with tolerable pain
timeFrame: Immediately Before Discharging home assessed up to 2 weeks.
measure: Functionality: Sit to Stand Test
timeFrame: Immediately Before Discharging home assessed up to 2 weeks.
measure: Opioid Use
timeFrame: Immediately Before Discharging home assessed up to 2 weeks.
measure: Patient Satisfaction
timeFrame: Immediately Before Discharging home assessed up to 2 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Assistant
name: Borja Alcobía-Díaz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01211431: Post-cesarean Pain Control Via Continuous Infusion of Ropivacain et Diclogenac Into the Wound Versus Intathecal Morphine
Official title: Post-cesarean Pain Control Via Continuous Infusion of Ropivacain et Diclogenac Into the Wound Versus Intathecal Morphine: Comparison of the Quality of Analgesia, Side Effects, and the Incidence of Residual Scar Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cesarean Section
Keywords: cesarean section
pain
ropivacain
diclofena
morphine
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-09-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal is to compare the quality of post-cesarean analgesia, the side effects and the incidence of residual scar pain obtained with intrathecal morphine (reference treatment) or with a continuous intra-wound solution including both ropivacain and diclofenac (experimental treatment).


Eligibility criteria: Inclusion Criteria:

* single, normally progressing pregancy
* term \> 36 weeks amenorrhea
* BMI between 20 and 25 kg/m\^2 before pregnancy
* height between 55 and 90 kg
* cesarean section by Joel-Cohen or Pfannenstiel techniques
* patient has signed consent
* patient has social security coverage

Exclusion Criteria:

* Multiple pregnancy
* pathological pregnancy: hypertension (\>140/90 mmHg found during the pregnancy), pre-eclampsia, gestational diabetes
* term \< 36 weeks amenorrhea
* non-pregnancy related maternal pathology (insufficiency)
* obesity (BMI \> 25 kg/m\^2 before pregnancy)
* height \< 155 cm or \> 180 cm
* weight \< 55 kg or \> 90 kg
* patient refuses to sign consent
* surgical technique other than Joel-Cohen or Pfannenstiel
* hepatic insufficiency (prothrombin \< 60%)
* contra-indications for rachianesthesia: infection, hemostasis problems (platelets \< 80.109/L, prothrombin \< 60%, TCA \> 40s)
* allergy to local anesthestics
* patient is participating in another study, or has participated in another study within the last 6 months
* patient is under any type of guardianship

Primary outcomes:
measure: Primary VAS score
timeFrame: 36 hours post delivery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Antoinie Guy Aya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01492231: The Clinical Impact and Outcomes of Interventional Endoscopy Procedures
Official title: The Clinical Impact and Outcomes of Interventional Endoscopy Procedures
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Gastrointestinal Diseases
Keywords: gastroenterology
Endoscopy, Digestive System
Endosonography
Endoscopic Retrograde Cholangiopancreatography
gastrointestinal endoscopy
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2011-12-14
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with gastrointestinal disease(s) undergoing various interventional endoscopy procedures performed at H. H. Chao Comprehensive Digestive Disease Center (CDDC).

Brief summary: The main purpose of the protocol is to collect and evaluate performance data after patients undergoing various interventional endoscopy procedures performed at H. H. Chao Comprehensive Digestive Disease Center (CDDC).

Detailed description: In general, the outcome data includes clinical management, hospitalization, and complications; to determine costs associated with endoscopy procedures; to determine performance data including technical success, procedure time, rate of repeat interventions; to compare endoscopy performance and outcome data collected at University of California, Irvine (UCI) and results from other institutions previously published in the literature. Additional parameters might be collected for specific interventional endoscopy procedures.

Eligibility criteria: Inclusion Criteria:

* Subjects who are 18 years of age or older
* Subjects who are scheduled for a procedure at the H. H. Chao Comprehensive Digestive Disease Center (CDDC).

Exclusion Criteria:

* Subjects who are not 18 years of age or older
* Subjects who are scheduled for a procedure at the H. H. Chao Comprehensive Digestive Disease Center (CDDC).

Primary outcomes:
measure: Collect and clinical management data
timeFrame: Day of procedure up to 5 years for follow-up (if needed).
Secondary outcomes:
measure: Collect Performance Data
timeFrame: Day of procedure up to 5 years for follow-up (if needed).
Other outcomes:
Locations:
city: Orange
country: United States
facility: H. H. Chao Comprehensive Digestive Disease Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Kenneth Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03834831: Impact of Coenzyme Q10 and Selenium on Seminal Fluid and Semen Antioxidant Status
Official title: Impact of Coenzyme Q10 and Selenium on Seminal Fluid Parameters and Antioxidant Status in Men With Idiopathic Infertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Infertility
Keywords: Male infertility
Coenzyme Q10
Selenium
Antioxidants
Lead sponsor: University of Sumer
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 70
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The study was conducted to assess the impact of coenzyme Q10 and selenium on seminal fluid parameters and antioxidant status in infertile men.

Detailed description: The aim of this study was to assess the impact of coenzyme Q10 and selenium on seminal fluid parameters and antioxidant status in infertile men with idiopathic oligoasthenoteratospermia.

Eligibility criteria: Inclusion Criteria:

* History of infertility of at least 12 months despite regular unprotected intercourse.
* Oligoasthenoteratospermia was diagnosed by semen analysis showing abnormal sperm concentration (\<15 million/ml), progressive motility (\<32%), total motility (\<40%) and morphology (\<30% WHO criteria) as defined by WHO manual for semen analysis 2010

Exclusion Criteria:

* Azoospermia,
* Varicocele,
* Genital tract infection,
* Cryptorchidism,
* Testicular trauma or scrotal surgery,
* Endocrine disorder,
* Systemic illness,
* Smoking
* The presence of female factor

Primary outcomes:
measure: Semen volume (WHO 2010 guidelines)
timeFrame: 3 months
measure: Sperm concentration in semen (WHO 2010 guidelines)
timeFrame: 3 months
measure: Sperm motility in semen (WHO 2010 guidelines)
timeFrame: 3 months
measure: Sperm morphology in semen (WHO 2010 guidelines)
timeFrame: 3 months
measure: Seminal plasma TAC (Colorimetric assays)
timeFrame: 3 months
measure: Seminal plasma CAT (Colorimetric assays)
timeFrame: 3 months
measure: Seminal plasma SOD (Colorimetric assays)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hilla
country: Iraq
facility: Fertility Unit, Babyl
Study officials:
affiliation: University of Sumer, Iraq
name: Ahmed T Alahmar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alshahrani S, Aldossari K, Al-Zahrani J, Gabr AH, Henkel R, Ahmad G. Interpretation of semen analysis using WHO 1999 and WHO 2010 reference values: Abnormal becoming normal. Andrologia. 2018 Mar;50(2). doi: 10.1111/and.12838. Epub 2017 Aug 3.
citation: Alahmar AT. The effects of oral antioxidants on the semen of men with idiopathic oligoasthenoteratozoospermia. Clin Exp Reprod Med. 2018 Jun;45(2):57-66. doi: 10.5653/cerm.2018.45.2.57. Epub 2018 Jun 29.
Clinical trial NCT04298931: Prediction of the Effect of Fluid Administration Using Arterial Pressure and Ventilator Data During Abdominal Surgery
Official title: Fluid Responsiveness Prediction Using Pulse Pressure Variation - Integrating Ventilator Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypovolemia
Fluid Overload
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2020-03-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at department of abdominal surgery, Aarhus University Hospital, scheduled for open abdominal surgery with planned use of Aarhus University Hospital's goal-directed therapy protocol (hemodynamic monitoring).

Brief summary: It is well known, that patients with circulatory impairment sometimes, but not always, benefit from intravenous fluids. Predicting if a fluid administration will improve circulation is therefore of substantial clinical interest.

Ventilator treatment induces cyclic variation in blood pressure due to interaction between the lungs and the heart. This variation is minor, but its amplitude may be used for guiding fluid administration.

However, this method of using ventilator-induced variation in blood pressure to predict the effect of fluid administration was developed when different settings for ventilator treatment was recommended, compared with today. With today's recommend ventilator treatment, the method is, unfortunately, less reliable.

The investigators will investigate how different ventilator settings influence variation in blood pressure, and the investigators will test if this knowledge allows us to better predict the effect of a fluid administration, by taking the ventilator settings into account.


Eligibility criteria: Inclusion Criteria:

* Scheduled open abdominal surgery.
* Scheduled treatment with Aarhus University Hospital's goal-directed therapy protocol (hemodynamic monitoring).

Exclusion Criteria:

* Left ventricular ejection fraction ≤ 40 %
* Irregular heart rhythm (e.g. atrial fibrillation or frequent ectopic beats)
* Known right ventricular dysfunction (if reported qualitatively in pre-operative assessment or objectively via Tricuspid Annular Plane Systolic Excursion (TAPSE) \< 17 mm)
* Pregnancy
* Prior participation in this study

Primary outcomes:
measure: >10% Increase in stroke volume from before to after a fluid bolus. (Fluid responsiveness)
timeFrame: From two minutes before to two minutes after a fluid administration.
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT00950131: Testing the Effect of a Warning About New Drugs
Official title: Testing the Effect of a Warning About New Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Communication
Lead sponsor: White River Junction Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Attorney General Consumer & Prescriber Education Grant
First posted: 2009-07-31
Enrollment: 2944
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to test whether a new drug warning decreases enthusiasm for new drugs.


Eligibility criteria: Inclusion criteria

* Participants will be randomly selected from a research panel of more than 60,000 U.S. households (Knowledge Networks).

Primary outcomes:
measure: Hypothetical choice of old (vs. newer) drug
timeFrame: 0 weeks (assessed during intervention)
Secondary outcomes:
measure: Comprehension of the drug warning and drug information
timeFrame: 0 weeks (assessed during intervention)
Other outcomes:
Locations:
Study officials:
affiliation: White River Junction Veterans Affairs Medical Center
name: Lisa M Schwartz, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: White River Junction Veterans Affairs Medical Center
name: Steven Woloshin, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwartz LM, Woloshin S. Communicating uncertainties about prescription drugs to the public: a national randomized trial. Arch Intern Med. 2011 Sep 12;171(16):1463-8. doi: 10.1001/archinternmed.2011.396.
Clinical trial NCT06736431: Bringing Advocacy Via Digital Guide to the Emergency Department (Project BADGE)
Official title: Bringing Advocacy Via Digital Guide to the Emergency Department (Project BADGE)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The pilot study of Project BADGE will focus on emergency department (ED) patients with diabetes, which has significant disparities in prevalence and mortality for underserved populations. The objective is to determine the effect of a text-based resource referral platform with diabetes educational materials on patient diabetes knowledge, diabetes distress, diabetes self-care activities, and acceptability and feasibility of the intervention.


Eligibility criteria: Inclusion Criteria:

1. Adult (18+) ED/observation unit patients
2. Have poorly controlled or new onset diabetes (hyperglycemia or Diabetic ketoacidosis (DKA))
3. Speak English or Spanish
4. Has a cell phone able to send and receive text messages

Exclusion Criteria:

1) Intubated patient

Primary outcomes:
measure: Diabetes Distress
timeFrame: Baseline, 3 months
measure: Diabetes Knowledge
timeFrame: Baseline, 3 months
measure: Diabetes Self-Care
timeFrame: Baseline, 3 months
measure: Doctor Visit
timeFrame: 3 months
Secondary outcomes:
measure: Intervention Acceptability
timeFrame: 3 months
measure: Intervention Feasibility
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00787631: Analysis of Immunological Reactions to Foods in Birch Pollen-Allergic Patients
Official title: Analysis of Immunological Reactions to Pollen-Related Foods in Birch Pollen-Allergic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergic Rhinitis
Food Allergy
Keywords: birch pollen pollen allergy
oral allergy syndrome to apple
cross reactivity
bet v 1
mal d 1
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-11-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: otherwise healthy birch pollen allergic (rhinoconjunctivitis)persons suffering also from oral allergy syndrome to apple.

Brief summary: A high number of birch pollen-allergic individuals develop hypersensitivity reactions to certain foods, e.g. apples. This food allergy is due to immunological cross-reactivity. Birch pollen-related foods contain proteins, e.g. Mal d 1 in apple, that are structurally related with the major birch pollen allergen, Bet v 1. Hence IgE antibodies and T lymphocytes specific for Bet v 1 recognize these food proteins which results in activation of the immune system and, consequently, in clinical symptoms.

In the present study the investigators intend to investigate if and how the consumption of birch pollen-related food allergens affects birch pollen allergy. In other words, the investigators are interested to analyse whether Bet v 1-related food allergens activate Bet v 1-specific memory cells and thus, contribute to the maintenance of the pollen allergy outside the pollen season. Data obtained in this study will help to clarify the immunological and clinical role of cross-reactivity between pollen and food allergies and will reveal whether avoidance of such foods should be recommended for the patients. Finally, novel approaches for diagnosis and therapy of pollen-related food allergens can be developed.


Eligibility criteria: Inclusion Criteria:

* Otherwise healthy birch pollen allergic (rhinoconjunctivitis)persons
* Positive SPT and RAST to birch pollen
* Sensitized to Bet v 1

Exclusion Criteria:

* Persons suffering from malignancies, autoimmune and cardiopulmonary diseases
* Anemia
* Hyper-IgE syndrome
* Treatment with ß-blockers, permanent treatment with antihistaminics, leucotriene antagonists, corticosteroids

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Dermatology, Medical University of Vienna
name: Tamar Kinaciyan, Ass Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01620931: A Single-Ascending-Dose Study of RO5469754 in Healthy Volunteers
Official title: A Single-Center, Randomized, Observer-Blinded, Placebo-Controlled, Single-Ascending-Dose (SAD) Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5469754, a Humanized Monoclonal Antibody, Following Intravenous or Subcutaneous Administration in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-06-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This randomized, observer-blinded, placebo-controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5469754 in healthy volunteers. Subjects will be randomized in cohorts to receive single ascending intravenous or subcutaneous doses of RO5469754 or placebo. In-clinic period will be from Day -1 to Day 4, with a safety follow-up of 15 weeks after dosing.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female volunteers, 18 to 64 years of age, inclusive
* Body mass index (BMI) 18 to 32 kg/m2
* Women of child-bearing potential and their partners must be willing to use two highly effective forms of contraception, one of which must be a barrier method, for the entire duration of the study (through study discharge) or for up to five half-lives after the last dose
* Male subjects with female partners of child-bearing potential must be willing to use a condom during sexual activity for the duration of the study (through study discharge) or for up to five half-lives after the last dose

Exclusion Criteria:

* Pregnant or lactating women
* Positive test for drugs of abuse (including ethanol) as per local standards
* Willing to comply with a non-smoking policy during the in-clinic part of the study (Day -1 until discharge on Day 4)
* Positive for hepatitis B, hepatitis C or HIV infection
* History or presence of clinically significant disease or condition
* Participation in an investigational drug or device study within 60 days prior to dosing
* Current (or previous history of) exposure to therapeutic or investigational monoclonal antibody or chimeric biomolecule
* Any confirmed clinically significant previous allergic drug reaction, or history of anaphylaxis

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 1 year
Secondary outcomes:
measure: Pharmacokinetics: Area under the concentration-time curve (AUC)
timeFrame: Pre-dose and up to 72/120 hours post-dose, and at follow-up
Other outcomes:
Locations:
city: Groningen
country: Netherlands
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: