louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01785381: RCT: Added Value of Coordinator for the Management of Hip Fracture Patients
Official title: Randomized Controlled Trial: Added Value of Coordinator for the Management of Hip Fracture Patients in a Network of Public Hospitals in Brussels.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporosis
Keywords: Osteoporosis, hip fracture, fractures, Bone density
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 128
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Introduction: Hip fracture due to osteoporosis is associated with an extremely high mortality morbidity and loss of quality of life. The risk of future fracture after a first hip fracture is increased. Several studies reported that patients who suffered from a fracture are not optimally treated and do not receive osteoporosis treatment after the first fracture episode.

Aim: To evaluate whether a coordinator increases the optimal management of osteoporotic fracture patients and hip fracture patients.

Detailed description: Material and methods: Population: Identification in the "IRIS public hospital network of all patients above 50 years" who suffer from hip fracture. Exclusion of those due to high energy fractures and due to known cancer.

First observational phase of treatment followed by randomized controlled trials of 2 years.

Intervention (RCT): Added value of a coordinator. Measured outcomes : A. New fractures. B. A score of optimal management of osteoporosis.

Definition of the score and management: 1. Realization of a bone density measurement. 2. Identification of secondary osteoporosis. 3. Identification of risk factors and calculation of the probability of a future fracture using FRAX score. 4. Attempt to correct risk factors of osteoporosis when possible. 5. Prevention of falls. 6. Prescription of calcium and vitamin D. 7. Prescription of a medical osteoporosis treatment. 8. Report to the general practitioner.

Eligibility criteria: Inclusion Criteria:

* Identification in the "IRIS public hospital network of all patients above 50 years" who suffer from hip fracture.

Exclusion Criteria:

* Exclusion of those due to high energy fractures and due to known cancer.

Primary outcomes:
measure: A score of optimal management of osteoporosis.
timeFrame: 3-6 months
Secondary outcomes:
measure: New fractures.
timeFrame: 2 years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: IRIS Hospitals
Study officials:
References:
Clinical trial NCT02612181: Dex on Microcirculation in SS-A Double-blinded Study
Official title: The Effect of Dexmedetomidine on Microcirculation in Septic Shock- A Double-blinded Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Septic Shock
Keywords: dexmedetomidine
microcirculation
septic shock
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2015-11-23
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators preliminary study showed that dexmedetomidine might improve microcirculation in septic shock patients. To test this effect, the investigators will conduct double-blinded study.

Detailed description: Dexmedetomidine is a highly selective α2-adrenoreceptor agonist for sedation of adult critically ill patients which exhibits sedative and analgesic effects. Recent studies suggest that dexmedetomidine to restore adrenergic vasoconstrictor responsiveness in septic shock, and prevents alterations of pain rat model intestinal microcirculation Induced by surgical stress，even it can reduce the mortality of endotoxemic rats and patients with severe sepsis. The investigators preliminary study showed that dexmedetomidine might improve microcirculation in septic shock patients. To test this effect, the investigators will conduct double-blinded study.

Eligibility criteria: Inclusion Criteria:

* Septic shock patients despite early goal directed therapy
* Agree to participate this study

Exclusion Criteria:

* Age\< 18
* Pregnancy
* Bradycardia (HR\<55bpm)
* Systolic Blood Pressure \< 80 mmHg / Mean arterial pressure \< 50 mmHg on maximal support
* Death imminent
* Unlikely to survive 90 days
* Acute liver failure
* Dementia
* High-grade block in the absence of a functioning pacemaker.

Primary outcomes:
measure: Microcirculatory function as assessed by Microvascular flow index
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
Study officials:
References:
Clinical trial NCT02913781: Polar Body Removal Before ICSI for Oocyte Activation in Previous Fertilization Failure Cases
Official title: Polar Body Removal Before ICSI as a Method of Oocyte Activation in Previous Fertilization Failure Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertilization
Keywords: Polar body removal
ICSI
Fertilization failure
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: Hawaa Fertility Center
First posted: 2016-09-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cases which undergone ICSI before with failure of fertilization will do another ICSI cycle with removal of the polar body just before the ICSI procedure and sperm injection at the site of polar body removal. This study group will be evaluated with another group with the classic ICSI procedure

Detailed description: Patients with previous fertilization failure will be divided into 2 groups:

Group 1 (control): Will undergo classic ICSI procedure in half the MII oocyte of the same case.

Group 2 (study group): The other half of the MII oocyte of the same case will undergo:

1. Polar body removal.
2. ICSI procedure with injection of the spermatozoon in the same zona opening (done by laser for polar body removal).

Results: Will be collected with evaluation of number of 2PN zygotes, Day 1, Day 2, Day 3, Day 5 embryos in all the cases.

Eligibility criteria: Inclusion Criteria:

* previous fertilization failure
* previous fertilization arrest

Exclusion Criteria:

* NO MII oocyte
* Refusal of the procedure by the couple

Primary outcomes:
measure: fertilization rate of the zygotes
timeFrame: 16-20 hours post ICSI
Secondary outcomes:
measure: division rate of the embryos by the number of the blastomeres.
timeFrame: Day 2 & 3 & 5
Other outcomes:
Locations:
city: Banha
country: Egypt
facility: Banha University- Hawaa Fertility center
state: Qalyubiya
Study officials:
affiliation: Benha University
name: Ahmed Saad
role: STUDY_CHAIR
References:
Clinical trial NCT03498781: Good Intentions Study
Official title: The Impact of Multiple Behavior Change on the Effectiveness of Implementation Intentions to Promote Fitness Center Visitation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Overweight
Keywords: Exercise
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2018-04-17
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This study will be a between group factorial design. The between subjects variable will be group assignment. The within subjects variable will be time.
Primary purpose: OTHER

Brief summary: The purpose of this study is to explore the effects of an intervention designed to help increase physical activity and decrease screen time.

Detailed description: The purpose of this study is to investigate attendance, exercise, and screen time habits in fitness center members. Because they are the population under investigation, recruitment will take place via the fitness center facilities. This population is under investigation because much of this population is sedentary and does not exercise at recommended levels, despite access to physical fitness facilities. This research will investigate methods to encourage physical activity in this population.

Eligibility criteria: Inclusion Criteria:

* Body mass index from 18-45 kg/m2

Exclusion Criteria:

* have any medical conditions that prevent participant from safely taking part in physical activity
* currently a smoker
* are pregnant, breastfeeding, or plan to become pregnant
* have visited fitness centers more than eight times in the past two months
* exercise outside of fitness centers more than once a week for one hour at a time in the past month
* do not engage in more than 14 hours a week of screen-based activities
* do not have a primarily sedentary job

Primary outcomes:
measure: Fitness center attendance
timeFrame: Week 0, 8, 16
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: James Roemmich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03136081: Candida Host Defense Response After Septic Shock in the Critically Ill
Official title: IMMUNOCANDIDA Candida Host Defense Response After Septic Shock in the Critically Ill
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Candidiasis
Keywords: Septic shock
Candidiasis
Candidemia
Bacteremia
Immunoparalysis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all consecutive patients subsequently to a septic shock with no Candida infection.

Brief summary: Septic shock is associated with acquired immunoparalysis which is associated with a high risk of nosocomial acquired infection. Nosocomial candidiasis is associated with a 50% rate of mortality but is difficult to diagnose. The use of colonization indexes and risk factors on the other hand expose to unnecessary use of antifungals. The aim of the present study is to evaluate whether the host response to infection associated with candida biomarkers would help to anticipate the candidiasis onset.

Detailed description: Single center prospective observationnal study. Inclusion: all consecutive patients subsequently to a septic shock with no Candida infection.

Measured parameters: host response (HLADR, CD64, inflammatory cytokines consecutive to LPS exposition) and Candida biomarkers (beta D Glucan, Mannan Ag and Ig), demographics, outcome (occurence of Candida nosocomial infection, morbidity and survival)

Eligibility criteria: Inclusion Criteria:

Age \> = 18 years

* The patients in toxic shock defined according to the Bone criteria
* Informed consent of the patient or his reliable person (poursuit consent in this case). Possibility of inclusion according to the emergency procedure with the obligation of research for the consent with the reliable person and with the patient.
* Obligation of membership or beneficiary to have a national insurance

Exclusion Criteria:

* Pregnant or breast-feeding women according to the article L1121-5 of the CSP
* Vulnerable people according to the article L1121-6 of the CSP 9358 _ "
* Neutropénie 500 / mm3
* Infection by the HIV, the hepatitis C or B active column
* Biotherapics (anti-CD20, anti-TNFa, anti-IL-6)
* Treatments immunosuppresseurs (methotrexate, azathioprine, cyclophosphamide, mycophenolate mofétil, cyclosporine, tacrolimus)
* Corticosteroid therapy = 1mg / kg of equivalent prednisone for more than a month
* Toxic shock due to a deep candidiasis in the admission in resuscitation
* Congenital deficits of Th17 (cutanéo-mucous candidiasis chronicles, syndrome of hyper IgE)

Primary outcomes:
measure: Candidiasis infection occurence
timeFrame: Day 28 survival
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hôpital St Eloi
Study officials:
References:
Clinical trial NCT01251081: Effect of the Intensity of Continuous Renal Replacement Therapy
Official title: Effect of the Intensity of Continuous Renal Replacement Therapy in Patients With Sepsis and Acute Kidney Injury: Single-center Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Optimal Intensity of Renal Replacement Therapy on Sepsis Patients
Keywords: high volume hemofiltration
sepsis
acute kidney injury
survival
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2010-12-01
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: In patients with sepsis and AKI, increasing the intensity of renal replacement therapy from 50 mL/kg/h (HVHF) to 85 mL/kg/h (EHVHF)will increase the survival at 28 days and 90 days.


Eligibility criteria: Inclusion Criteria:

met at least one of the following criteria: oliguria (urine output less than 100 mL in a 6 h period and unresponsive to fluid resuscitation), serum potassium concentration more than 6.5 mmol/L, severe acidemia (pH \< 7.2), serum creatinine more than 250 µmol/L, or presence of severe organ edema (e.g. pulmonary edema).

Exclusion Criteria:

* were presence of a malignant tumor, chronic renal insufficiency (serum creatinine \>133 µmol/L), or receiving any kind of renal replacement therapy before randomization.

Primary outcomes:
measure: 90 days survival
Secondary outcomes:
measure: length of stay in the ICU and hospital
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Kidney disease center, the first affiliated hospital, medical college of Zhejiang university
state: Zhejiang
Study officials:
affiliation: Kidney disease center, the first affiliated hospital, medical college of Zhejiang university
name: jianghua chen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT07008781: A Youth-led Intervention to Reduce Healthcare Disparities in Cancer Screening
Official title: A Youth-led Intervention to Reduce Healthcare Disparities in Cancer Screening
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Keywords: cancer screening
adolescents
high school
community-based research
community health
Hispanic/Latino community
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 84
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study engages youth as health advocates to increase cancer screening in their community. The study will evaluate the effectiveness of a youth-led intervention on cancer screening awareness in adults who are overdue for cancer screening.


Eligibility criteria: Inclusion Criteria:

* Student at New Brunswick Health Sciences Technology High School (15-18 years) and their adult family members (18+ years old) who are NJ residents.
* Adults must be eligible for at least one cancer screening other than skin (see below).
* Participants must be fluent in either English or Spanish and the youth must speak the same language as the adult.

Breast: 40-74 year old women Cervical: 21-65 year old women with a cervix (have not had a hysterectomy) Colorectal: 45-75 year olds Prostate: 50 to 69 year old men (start at 45 for black males) Lung: 50 to 80 year olds who currently smoke or quit within the past 15 years

Overall:

21-75 year old women 45-75 year old men 76-80 year olds who currently smoke or quit within the past 15 years

Exclusion Criteria:

* Students less than 15 years old.
* Adults not eligible for a cancer screening of interest.
* Unable to speak fluent English or Spanish.

Primary outcomes:
measure: Rate of Cancer Screening
timeFrame: 2 weeks post-intervention
Secondary outcomes:
measure: Change in Cancer Screening Knowledge- Adult
timeFrame: Baseline and 3 days later
measure: Change in Cancer Screening Knowledge- Youth
timeFrame: Baseline and after intervention ends
measure: Change in Youth Self-Efficacy
timeFrame: Baseline and after intervention ends
measure: Change in Adult Activation
timeFrame: Baseline and 3 days later
measure: Proportion of adults who are overdue for each cancer type
timeFrame: Baseline
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: New Brunswick Health Sciences Technology High School
state: New Jersey
Study officials:
References:
Clinical trial NCT04823481: Acute Anterior or Posterior Cerebral Artery Occlusion Recanalization Therapy and Relationships With Clinical Outcome (ACAPULCO)
Official title: Acute Anterior or Posterior Cerebral Artery Occlusion Recanalization Therapy and Relationships With Clinical Outcome (ACAPULCO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Thrombi
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2021-03-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects having clinical signs and imaging criteria consistent with acute ischemic stroke who presented within 6 hours of stroke symptoms onset with isolated occlusion of the anterior or the posterior artery.

Brief summary: Nearly 3% of patients with ischaemic stroke (IS) have an isolated occlusion of the anterior or posterior cerebral artery in the acute phase of the disease. In those patients, intravenous thrombolysis (IT) is indicated for 4.5 hours after symptoms onset. Due to a lack of data, mechanical thrombectomy (MT) is not considered as a gold standard to treat IS alone or in addition with IT. Therefore, observational studies are needed to understand the clinical evolution of patients with IS treated with IT and/or MT. The ACAPULCO retrospective observational study aims to highlight potential benefits of MT in those patients to improve their management and to propose targeted therapies in the future.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 and \< 96
* Clinical signs consistent with acute ischemic stroke
* Patients who presented within 6 hours of stroke symptoms onset
* Isolated occlusion of the anterior or the posterior artery

Exclusion Criteria:

* Administration of recanalization treatment before hospital admission

Primary outcomes:
measure: Clinico-radiological evolution of IS patients with isolated occlusion of the anterior or posterior cerebral artery.
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation Adolphe de Rothschild
state: Ile-de-France
Study officials:
affiliation: Hôpital Fondation Adolphe de Rothschild
name: Pierre Seners, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03358381: The Difference of Angle of Femoral Component Rotation in TKA With Gap Balance and Measured Resection Technique
Official title: The Difference of Angle of Femoral Component Rotation in TKA With Gap Balance and Measured Resection Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: total knee arthroplasty
CT scan
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gap balance type and measured resection type total knee arthroplasty (TKA) have different influence on the rotation of femoral component.In this study, the rotation of patients received different type of TKA will be estimated and analysed through preoperation and postoperation knee joint CT scan.

Detailed description: This is a multicenter, double-blined, randomized controled clinical trial. 98 patients from 2 clinical center will be recruited with primary knee osteoarthritis, undergoing a primary TKA. The patients will be randomly divided into two groups , the measured resection group and the gap balance group.And the gap balance technique in this study will be achieved with a ligament tensor used during TKA. Femoral component rotation will be assessed from the preoperative and postoperative CT scans.

Eligibility criteria: Inclusion Criteria:

* Severe primary osteoarthritis patients over 65 years old No obvious surgical contraindications

Exclusion Criteria:

* There are surgical contraindications Varus or valgus alignment exceeds 20 degrees

Primary outcomes:
measure: femoral component rotation
timeFrame: 6 weeks after the surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: arthritis clinic and research center
name: Jianhao Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01994681: Testing Spectrosense EVA System for Detection of Pancreatic Cancer by Analyzing Volatile Organic Compounds (VOCs) in Exhaled Air
Official title: Testing Spectrosense EVA System for Detection of Pancreatic Cancer by Analyzing Volatile Organic Compounds (VOCs) in Exhaled Air
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Lead sponsor: Rauscher, Gregory E., M.D. PA
Sponsor class: INDIV
Collaborators: name: Spectrosense Ltd.
First posted: 2013-11-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pancreatic cancer, biopsy confirmed, before treatment, ages above 18. vs. Healthy subjects without pancreatic cancer.

Brief summary: Volatile Organic Compounds (VOC) in human breath are captured and analyzed by the Spectrosense EVA system, which is combination of a gas chromatography (GC) and software algorithm. The objective is to obtain a set or sets of VOC bio-markers that will provide the best discrimination between Pancreatic Cancer sick population and healthy population. The gold standard for identifying sick/healthy population is biopsy proven Pancreatic cancer.


Eligibility criteria: Pancreatic cancer Group

Inclusion Criteria:

* Age from 18 years old
* Pancreatic cancer positive biopsy
* Before any treatment
* Signed Informed Patient Consent

Exclusion Criteria:

* Age under 18 years old
* Neoadjovant treatment
* Post surgery for Pancreatic cancer
* A history of any other cancer type, except skin cancer that is not melanoma

Healthy Group

Inclusion Criteria:

* Healthy patients
* No history of Pancreatic cancer
* Signed Informed Patient Consent

Exclusion Criteria:

* History of Pancreatic cancer
* Pancreatic cancer background in the family
* A history of any other cancer type, except skin cancer that is not melanoma

Primary outcomes:
measure: Obtaining a set or sets of VOC bio-markers that will provide the best discrimination between Pancreatic Cancer sick population and healthy population.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Martin Gutierrez, MD
role: PRINCIPAL_INVESTIGATOR
References: