louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03959657: Analysis of a Population in Extreme Age of Life With a Hip Fracture
Official title: Análisis de Una población en Edad Extrema de la Vida Con Fractura de fémur (Analysis of a Population in Extreme Age of Life With a Hip Fracture)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 200
Sex: ALL
Minimum age (years): 95
Maximum age (years): 120
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 95 years

Brief summary: Observational retrospective study of pacients over 95 years admitted in traumatology ward with a osteoporotic hip fracture


Eligibility criteria: Inclusion Criteria:

* osteoporotic hip fracture

Exclusion Criteria:

Primary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Mortality
timeFrame: 3 months
measure: Mortality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Montserrat Barceló
Study officials:
References:
Clinical trial NCT04968457: Multicenter Post-marketing Survey of SEBBIN Group Silicone Gel-filled Breast Implants
Official title: Multicenter Post-marketing Survey of SEBBIN Group Silicone Gel-filled Breast Implants
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Implant; Complications
Lead sponsor: Groupe SEBBIN
Sponsor class: INDUSTRY
First posted: 2021-07-20
Enrollment: 908
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enrollment in the study was proposed to women over 18-year who were scheduled for a breast augmentation or breast reconstruction with SEBBIN silicone gel-filled breast implants.

Brief summary: The aim of the study is to allow Groupe SEBBIN to communicate to competent authorities and to the scientific community data relative to the safety and effectiveness of SEBBIN silicone gel-filled breast implants.


Eligibility criteria: Inclusion Criteria:

* The patient is at least 18-year-old.
* The patient is genetically a woman.
* The patient is candidate to a breast augmentation or breast reconstruction with silicone gel-filled breast implants.
* The patient gets all information regarding the study and signs the informed consent relative to the use of her personal data.

Exclusion Criteria:

* The patient is pregnant or breastfeeding.
* The patient has silicone implants somewhere else than in the breast.
* The patient was diagnosed with one of the following pathologies:

  * Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.
  * Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.
  * Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.
* The patient has a pathology that could delay healing (does not apply to the reconstruction group).
* The patient has cancer (does not apply to the reconstruction group).
* The patient has anatomical or physiological conditions that could lead to postoperative complications.

Primary outcomes:
measure: Complication
timeFrame: At 10 years of follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02485457: Validation of Nicom Device to Measure Stoke Volume Variation
Official title: Validation of NICOM for the Detection of Modification of Stroke Volume
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the ability of NICOM (Noninvasive cardiac output monitor) to detect stroke volume variation induced by leg raising or fluid expansion during surgery


Eligibility criteria: Inclusion Criteria:

* patients undergoing general anesthesia with an expected duration exceeding two hours
* gastrointestinal surgery, urological or gynecological surgery.

Exclusion Criteria:

* Difficulty of venous access.
* Contraindication for the use of oesophageal Doppler
* Contraindication for the use of Nicom
* Contraindication for the use of bispectral index
* Pregnant or lactating women

Primary outcomes:
measure: Stroke volume variation
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Marc Fischler
Study officials:
References:
Clinical trial NCT03061357: Physical Activity Intervention Among College Students
Official title: Incorporating Wearable Technology Into Physical Activity Instructional Program: A Cluster Randomized Trial in University Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: activity tracker
behavior change
Lead sponsor: Texas Tech University
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 187
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project was to examine the effects of incorporating modern wearable technology into the credit-based Physical Activity Instructional Program for promoting habitual levels of physical activity among college students.

Detailed description: This project was a cluster randomized trial examining the effects of utilizing a wearable activity tracker in a credit-based Physical Activity Instructional Program on promoting habitual levels of physical activity (PA) in college students.

The project was conducted in a large public university located in the mid-south region of the US. The university offers more than one hundred 1-credit hour PAIPs per academic semester. Considering the pilot nature of the study, the target PAIPs was limited to those meeting the following inclusion criteria: 1) PAIP with a size of 30 students that generally show an approximately equal gender distribution; and 2) PAIP that delivers the principles and practice of individually tailored habitual activity plans. The investigators randomly selected 14 eligible PAIPs and assigned them into intervention (k=7) and control (k=7) groups. The outcome measures of interests were the changes in objectively and subjectively measured physical activity over an academic semester.

Eligibility criteria: Inclusion Criteria:

* healthy college students who were enrolled in 1-credit physical activity instruction programs.

Exclusion Criteria:

* did not wish to participate;
* have currently used their own wearable activity tracker;
* indicated any major physical, psychiatric, or cardiovascular-related problems diagnosed by a physician.

Primary outcomes:
measure: Change from baseline in objectively measured physical activity to 15 weeks
timeFrame: baseline and 15 weeks
Secondary outcomes:
measure: Change from baseline in subjectively measured physical activity
timeFrame: baseline and 15 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Texas Tech University
name: Youngdeok Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00346957: A Phase II Study of Anecortave Acetate for the Treatment of Exudative Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: AMD
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 128
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the concentration of anecortave acetate (15 or 30 mg versus placebo) that is safe and effective for the inhibition of the growth of blood vessels in the retina in patients with wet AMD.


Eligibility criteria: Inclusion Criteria:

* Ages 50 years and over
* Other protocol-defined inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Mean change in logMAR visual acuity at 12 months from baseline.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06640257: A Study of the Efficacy and Safety of SHR-1314 for Adult Active Psoriatic Arthritis
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of SHR-1314 Injection in Adults With Active Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Psoriatic Arthritis
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical study, consisting of a 4-week screening period, a 24-week core treatment period, a 24-week maintenance treatment period, and an 8-week safety follow-up period. It is planned to include 150 adult subjects with psoriatic arthritis.


Eligibility criteria: Inclusion Criteria:

1. The subject voluntarily signs an informed consent form before any procedures related to the research start;
2. At the time of screening, it met the 2006 psoriatic arthritis classification standard (CASPAR)；
3. There is active PsA before randomization;
4. Have active plaque psoriasis (at least one plaque skin lesion) at the time of screening, or have a history of plaque psoriasis;
5. Participants who have previously been treated with csDMARDs and/or NSAIDs still have active psoriatic arthritis disease.

Exclusion Criteria:

1. Existence of any of the following medical history or comorbid diseases: drug-induced psoriasis; other active inflammatory diseases or autoimmune diseases; history of organ transplantation; history of lymphocytic proliferation; severe infections, etc.
2. Have received psoriatic arthritis or psoriasis drugs, such as intra-articular injections, plant preparations, etc. within a certain period of time in the past.
3. Those who are allergic to the drug ingredients or excipients in this study, or are allergic to other biological agents.
4. A history of alcohol abuse or illegal drug abuse in pregnant or breastfeeding women, etc.

Primary outcomes:
measure: Proportion of subjects achieving ACR 20 improvement at week 24
timeFrame: Week 24
Secondary outcomes:
measure: The proportion of subjects who achieved ACR 50 improvement
timeFrame: Week 24
measure: The proportion of subjects who achieved ACR 70 improvement
timeFrame: Week 24
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital of the Shanghai FuDan University
state: Shanghai
Study officials:
References:
Clinical trial NCT06207357: Optical Trocar to Create the Pneumoperitoneum in Bariatric Patients
Official title: Optical Trocar to Facilitate the Pneumoperitoneum Creation in Bariatric Patients: Our Experience and Systematic Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Bariatric Surgery Candidate
Surgery-Complications
Lead sponsor: University of Foggia
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Body mass index (BMI) ≥35-39 kg/m2 with one obesity- associated co-morbidity or BMI≥40kg/m2, age ≥ 18 years.

Brief summary: Laparoscopic bariatric surgery are becoming the most used procedure to treat the obesity. To facilitate safe initial access to the abdominal cavity, we insert an optical viewing trocar at the left hypocondrium. The aim of this study is to systematically evaluate all published data existing in the literature to analyze the safety of optical trocars in patients undergoing bariatric surgery and to compare these data with our experiences.

Detailed description: In this study we analyze data existing in the literature about the use of the optical trocars in patients undergoing bariatric surgery and we compare these data with our experiences.

Establishing pneumoperitoneum is classically performed using a Veress needle or the open Hasson technique, but obesity presents its own challenges when using these techniques, including thickened abdominal wall, variable anatomical landmarks, difficult and time-consuming dissection, air leak, inadequate pneumoperitoneum, subcutaneous emphysema, and difficulty with fascial closure

Eligibility criteria: Inclusion Criteria:

BMI\>40 kg/m2 BMI\>35 kg/m2with at least one associated major comorbidity

Exclusion Criteria:

secondary obesity due to endocrine and psychological disorders

Primary outcomes:
measure: optical trocar to induce the pneumoperitoneum
timeFrame: 5 years
measure: complication rate using optical trocar to create the pneumopritoneum in laparoscopic surgery
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Foggia
country: Italy
facility: Giovanna Pavone
Study officials:
References:
Clinical trial NCT00250757: Prostate Cancer Diagnosis Through NMR Spectroscopy of Semen and Prostatic Secretions
Official title: Prostate Cancer Diagnosis Through NMR Spectroscopy of Semen and Prostatic Secretions
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Keywords: prostate
NMR Spectroscopy
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
First posted: 2005-11-08
Enrollment: 101
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males with and without Prostate cancer.

Brief summary: To develop the hypothesis that quantitative NMR spectroscopy of human semen can be used to diagnose prostate cancer.

Detailed description: Any willing subject who meets the male gender requirements, who is competent, agrees to participate, and is able to understand the consent form.

Eligibility criteria: Inclusion Criteria:

* Any willing subject who meets the male gender requirements, who is competent, agrees to participate, and is able to understand the consent form.

Exclusion Criteria:

* Not sepcified.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Laurel Sillerud, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05656157: Evaluation of a Clinical Decision Support System for Fungal Infections
Official title: Evaluation of a Clinical Decision Support System for the Treatment of Invasive Fungal Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Fungal Infections
Keywords: invasive fungal infections
antifungal treatment
clinical decision support system
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 278
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving antifungal therapy for the treatment of invasive fungal disease

Brief summary: Invasive fungal infections are serious and frequent diseases in our hospitals, especially in intensive care units. In accordance with the institutional recommendations, it is necessary to have a clinical decision support system to support the clinicians in a rapid and optimal prescription of antifungals for invasive fungal diseases. This clinical decision support system will benefit patients but also clinicians who will gain in medical efficiency. It will also have an ethical dimension since it will guarantee optimal antifungal treatments for all patients. The purpose of the research is to define the percentage of concordance between the medical prescription and the recommendation of the clinical decision support system.


Eligibility criteria: Inclusion Criteria:

* Patients receiving antifungal therapy for the treatment of invasive fungal disease

Exclusion Criteria:

* Patients not receiving antifungal therapy for the treatment of invasive fungal disease

Primary outcomes:
measure: Percentage of concordance between the medical prescription and the recommendation of the clinical decision support system
timeFrame: January to september 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Anne-Lise Bienvenu, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bienvenu AL, Pradat P, Guerin C, Aubrun F, Fellahi JL, Friggeri A, Guichon C, Hernu R, Menotti J, Monard C, Paulus S, Rimmele T, Piriou V, Chidiac C, Argaud L, Leboucher G. Evaluation of first-line therapies for the treatment of candidemia in ICU patients: A propensity score analysis. Int J Infect Dis. 2020 Apr;93:15-21. doi: 10.1016/j.ijid.2020.01.037. Epub 2020 Jan 23.
citation: Bienvenu AL, Pavese P, Leboucher G, Berger P, Roux S, Charmillon A, Foroni L, Menotti J, Lebeaux D, Mayan R, Mondain V, Robin C, Lesprit P, Alfandari S, Kerneis S. Practical checklist for implementation of antifungal stewardship programmes. J Med Microbiol. 2022 Jun;71(6). doi: 10.1099/jmm.0.001560.
Clinical trial NCT03275857: Cisplatin in Castration Resistant Prostate Cancer
Official title: A Pilot Study of Cisplatin in Castration Resistant Prostate Cancer That is Becoming Refractory to Enzalutamide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Roswell Park Cancer Institute
First posted: 2017-09-08
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: TREATMENT

Brief summary: It is hypothesized that treatment with cisplatin will reverse emerging refractoriness to enzalutimide in patients with CRPC by affecting AR function.


Eligibility criteria: Inclusion Criteria:

* Histologic diagnosis of prostate cancer
* Age 18 yrs or older
* Able to provide written, informed consent
* Subjects who have received docetaxel for metastatic disease are eligible if absolute neutrophil count is greater than 100 and platelet count is greater than 100,000 and their bone marrow reserve is deemed to be adequate
* Subjects with castration resistant prostate cancer, as defined by having testosterone level of less than 50 Nano gram/dl, being treated with enzalutamide with a rise in PSA, confirmed with a repeat measurement within 1 to four weeks, or asymptomatic radiographic progression

Exclusion Criteria:

* Subjects with estimated glomerular filtration rate of less than 50 ml/min
* Subjects with hearing impairment. The treating physician may decide which subjects should not receive cisplatin based on audiometry or based on clinical judgment.
* Subjects with grade 2 or greater neuropathy
* Subjects who in the opinion of the treating physician could not tolerate the standard hydration before receiving cisplatin
* Chemotherapy naïve subjects who in the opinion of the treating physician should receive docetaxel instead of enrolling on the trial and receive cisplatin

Primary outcomes:
measure: Response to dosing differences of Cisplatin from lab and scan results
timeFrame: 2 years
measure: Toxicity observed with dosing differences of Cisplatin
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Wilmot Cancer Institute
state: New York
Study officials:
References:
Clinical trial NCT01379157: Pharmacodynamics Study of Imipenem in Patients With Ventilator Associated Pneumonia
Official title: The Pharmacodynamics of Imipenem in Critically Ill Patients With Ventilator-associated Pneumonia Following Administration by 4 h or 0.5 h Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ventilator Associated Pneumonia
Keywords: Patients with ventilator-associated pneumonia
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-06-23
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Imipenem is a carbapenem antibacterial agent with a broad spectrum of activity against Gram-negative and Gram-positive bacteria. This agent is often used as the last line of therapy for highly resistant Gram negative bacilli nosocomial infections. In common with other beta-lactamase inhibitor, the main pharmacokinetic/pharmacodynamic (PK/PD) index that correlates with the therapeutic efficacy is the time that concentrations in the tissue and serum are above the MIC and administration by continuous infusion is the preferred mode of administration to maximize this parameter.

However, in tropical countries, the stability of carbapenem antibiotics is an important consideration when considering continuous infusion. Therefore, prolonged infusion may be a useful mode of administration to maximize bactericidal activity. This study will demonstrate the stability of imipenem in clinical use at room temperature in tropical countries.


Eligibility criteria: Inclusion Criteria:

* Patients aged \> or = 20 years
* Patients who have VAP with Gram negative bacilli infections which are sensitive to imipenem by the disk diffusion

Exclusion Criteria:

* Patients who have documented hypersensitivity to imipenem or other carbapenems
* Patients who have an estimated creatinine clearance of \< or = 60 ml/min
* Patients who are in circulatory shock
* Patients who are pregnant

Primary outcomes:
measure: Accessed PK/PD parameters
timeFrame: 24 hours profile after first dose of trail drug.
Secondary outcomes:
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
state: Songkla
Study officials:
References: