louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01494389: The Changes of CD4+T Lymphocyte Subsets in Septic Patients
Official title: The Role of CD4+T Lymphocyte Subsets in Cell Immunity in Patients With Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
SIRS(Systemic Inflammatory Response Syndrome)
Keywords: CD4+T lymphocyte subsets
sepsis
immunoparalysis
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2011-12-19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects were selected from among inpatients who were hospitalized between March 2010 and March 2011 in the Respiratory ICU, Surgical ICU, and Emergency ICU, Chinese People's Liberation Army (CPLA) General Hospital.

Brief summary: The purpose of this study is to explore the value of CD4+T lymphocyte subsets in cell immunity in the patients with sepsis.There are immunoparalysis in septic patients,the important player is the change of CD4+T lymphocyte,this immunoparalysis state contribute to the illness progress and outcome. Comprehend the change regularity of septic patients' cell immunity can guide fiter and correcter treatment.


Eligibility criteria: Inclusion Criteria:

* Male and female aged 18 years old and over;
* Fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 °C or lower than 36 °C (b)respiratory rate above 20/min, or PCO2 below 32 mmHg (c) pulse rate above 90/min, and (d) white blood cell count greater than 12,000/μl or lower than \< 4,000/μl or less than 10% of bands.
* Clinically suspected infection;

Exclusion Criteria:

* were under 18 years of age;
* were refused by the patients or his/her familiality;
* were suffering from acquired immunodeficiency syndrome,virlhepatitis,autoimmune diseases and hematology;
* use medicine which can affect immune system,such as Glucocorticoid and Immunosuppressant
* died within 24h after being taken into the ICU, or refused to get involved in the study, or gave up treatment during the period of observation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Department Of Respiratory Diseases, Chinese PLA General Hospital
name: Xie Li Xin, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00961389: Validating a Delirium Prediction Model for Critically Ill Patients
Official title: Validating a Delirium Prediction Model for Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Delirium
Keywords: delirium
critical care
risk factors
prediction
inflammation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2009-08-19
Enrollment: 650
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: tertiary care clinic

Brief summary: The objective of this study is to determine the incidence of delirium in adults patients who are admitted at the critical care unit of a Dutch University Hospital with the mapping of relevant delirium risk factors The primary aim is to validate the investigators' developed delirium prediction model for critical care patients.

A secondary aim is to find differences between delirious patients and non-delirious patients on different aspects of diagnostics, treatment and care, outcome, length of stay, and inflammation.

According to Dutch law, the need to obtain informed consent was waived by the Committee on Research Involving Human Subjects (CMO) of Nijmegen for this observational study (2007/283).


Eligibility criteria: Inclusion Criteria:

* all adult patients (18 years and older) admitted at the critical care unit of our hospital

Exclusion Criteria:

* admitted \< 12 hours on ICU
* not able to understand Dutch
* patients with serious hearing and visibility disabilities
* mentally retarded patients
* patients suffering from receptive aphasia
* delirious before admission

Primary outcomes:
measure: delirium
timeFrame: during admission at the critical care
Secondary outcomes:
measure: markers of inflammation
timeFrame: within 24 hours of delirium diagnosis
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre, Critical Care
state: Gelderland
Study officials:
References:
citation: van den Boogaard M, Pickkers P, Slooter AJ, Kuiper MA, Spronk PE, van der Voort PH, van der Hoeven JG, Donders R, van Achterberg T, Schoonhoven L. Development and validation of PRE-DELIRIC (PREdiction of DELIRium in ICu patients) delirium prediction model for intensive care patients: observational multicentre study. BMJ. 2012 Feb 9;344:e420. doi: 10.1136/bmj.e420.
Clinical trial NCT00727389: Prevention of Functional Decline of Aged Women
Official title: The Influence of the Support Group on the Functional Incapacity in the Prevention of Functional Decline of Aged Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Care Quality, Access, and Evaluation
Keywords: Prevention
Quality of Health Care
Health Care Evaluation Mechanisms
Lead sponsor: Academia Cearense de Odontologia
Sponsor class: OTHER
Collaborators: name: Fortaleza University
First posted: 2008-08-04
Enrollment: 31
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the capacity of muscular function and articular amplitude in the aged women who participated in the Support Group and its influence on the prevention of function decline of these women.

Detailed description: To evaluate the capacity of muscular function and articular amplitude in the aged women who participated the Support Group and its influence on the prevention of function decline of these women is use the method: It is an interventional and quantitative research. A questionnaire of identification and instruments will use: a) flexion and extension tests of muscular function and articular amplitude of shoulders, elbows, wrists, hip, knees and ankles, in the beginning and in the end of the program b) educational action c) physical exercise d) the check up of the results after the exercises e) two questions to register the influence of the support group in the functional life of the researched ones.

Eligibility criteria: Inclusion Criteria:

* woman with 60 years old or more

Exclusion Criteria:

* woman with less 60 years old

Primary outcomes:
measure: A instrument was used for flexion and extension tests of muscular function and articular amplitude of shoulders, elbows, wrists, hip, knees and ankles, in the beginning and in the end of the program; physical exercise; the check up of the results
timeFrame: six month
Secondary outcomes:
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Grupo de apoio a prevenção da incapacidade funcional
state: Ceará
Study officials:
affiliation: Universidade de Fortaleza
name: Maria VL Saintrain, doutor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02360189: Mechanisms of Social Inequalities in Post-hospitalization Rehabilitation in Patients With Acute Coronary Syndrome
Official title: Mechanisms of Social Inequalities in Post-hospitalization Rehabilitation in Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 310
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized with acute coronary syndrome (ACS) to Nordsjællands Hospital (ICD10: DI210-DI219, DI200, DI200B, DI200C, DI23, DI24) will be invited to participate in the survey as an ongoing process during the inclusion period (N=267).

Brief summary: Aim: To identify psychological and socioeconomic predictors of cardiac-rehabilitation (CR) attendance and uncover mechanisms of CR non-attendance.

Design: Quantitative, observational, prospective study. Hypothesis a: Educational-level, comorbidity, anxiety, depression, self-efficacy, cohabitation and distance from residence are predictors of CR attendance.

Hypothesis b: The expected social gradient in CR attendance is explained partly by differential exposure of comorbidity, anxiety, depression, self-efficacy, cohabitation and distance to the rehabilitation clinic.

Detailed description: Design: Quantitative, observational, prospective study. Self-administrated questionnaires, medical journals and telephone interviews will be used for data collecting.

Eligibility criteria: Inclusion Criteria:

* Patients hospitalized with acute coronary syndrome (ACS) to Nordsjællands Hospital (ICD10: DI210-DI219, DI200, DI200B, DI200C, DI23, DI24) will be invited to participate in the survey as an ongoing process during the inclusion period (N=267).

Exclusion Criteria:

* Patients who are not able to submit written consent are excluded. Thus, patients with severe cognitive dysfunction or poor language skills are excluded.

Primary outcomes:
measure: Cardiac-rehabilitation attendance (yes/no)
timeFrame: 3 months post hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Frederikssund
country: Denmark
facility: Nordsjællands Hospital, Frederikssund.
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital, Hillerød
Study officials:
References:
Clinical trial NCT06492889: Assessing the Efficacy and Acceptability of Two Missed Period Pills Regimens
Official title: Randomized Trial Comparing Progestin With Mifepristone Versus Mifepristone Alone for Use as Missed Period Pills
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Pregnancy Early
Pregnancy Related
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Cuidado Integral de la Mujer, Gineclinic, S.C.
name: Servicios de Salud Medieg, A. C
First posted: 2024-07-09
Enrollment: 286
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this trial is to examine the efficacy and acceptability of two medication regimens at inducing a return of menses when used 2-8 days after a missed period. The first regimen consists of one dose of 1.5 mg levonorgestrel followed one to two days later by one dose of 200 mg mifepristone. The second regimen will consist of one dose of a placebo pill, followed one to two days later by one dose of 200 mg mifepristone.

The investigators will assess and compare the efficacy of both regimens (proportion of women in each group not pregnant at follow-up who were determined to be pregnant at enrollment), and the effectiveness of both regimens (proportion of all participants not pregnant at follow-up among all participants enrolled)


Eligibility criteria: Inclusion Criteria:

* Age 15-49 years
* General good health
* Does not want to be pregnant
* History of regular monthly menstrual cycles (+/- 3 days)
* Missed menses of 2 to 8 days
* Sexual activity in the past month
* Willing and able to sign consent forms
* Willing to return for a follow-up visit
* Willing to provide urine sample at enrollment and follow-up

Exclusion Criteria:

* Known allergies or contraindications to either study drug
* Symptoms or risk factors for ectopic pregnancy
* Current use of an IUD, contraceptive implant or injectable

Primary outcomes:
measure: Efficacy of the missed period pills regimen
timeFrame: Two weeks
measure: Effectiveness of the missed period pills regimen
timeFrame: Two weeks
Secondary outcomes:
measure: Effectiveness at inducing return of menses within 10 days of missed menses
timeFrame: One to two weeks
measure: Safety/side effects
timeFrame: Two weeks
measure: Acceptability
timeFrame: Two weeks
Other outcomes:
Locations:
Study officials:
affiliation: Gynuity Health Projects
name: Beverly Winikoff, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02081989: Renal Denervation in Diabetes.
Official title: Effect of Renal Sympathetic Denervation on Glycemic Status Independent of Blood Pressure-lowering.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Diabetes
Keywords: Diabetes
Renal denervation
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: National Heart Foundation, Australia
First posted: 2014-03-07
Enrollment: 0
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: Renal denervation (the use of radio waves to oblate the renal artery) has been shown to be an effective treatment for high blood pressure. It is currently being tested in heart failure patients and we would now like to look it its effects on diabetes.

We therefore plan to enrol 20 participants with type II diabetes into this study. Half will undergo renal denervation in addition to their standard care and the other half will act as controls and only receive standard care. Treatment allocation will be randomly assigned.

All participants will undergo screening (including a physical exam, blood tests, ultrasounds and a muscle biopsy). All patients will have follow up tests (including physical exams and blood tests) 1, 3 and 6 months later.


Eligibility criteria: Inclusion Criteria:

* Over 18 years
* Able and willing to provide informed consent
* Patients with established type II diabetes mellitus (HbA1C\>7%, diet or oral hypoglycaemic agents)
* Clinical stable as demonstrated by no change in background anti-diabetic medication in the last 30 days.
* Anticipated that patients are able to maintain a stable dose of medication for the duration of the study

Exclusion Criteria:

* Renal arterial anatomy ineligible for RDN: main renal arteries \<4 mm in diameter or \<20 mm in treatable length; multiple renal arteries where main renal artery is estimated to supply \<75% of the kidney; haemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the investigator's opinion, would interfere with safe cannulation of the renal artery or require surgical repair or interventional dilation
* History of prior renal artery intervention including balloon angioplasty, stenting or previous renal denervation.
* Single functioning kidney
* Need for insulin (interferes with euglycemic clamp testing) or GLP-I analogues
* eGFR \<30 ml/min (MDRD formula)
* Any medical condition which, in the investigators opinion, may adversely affect the participants safety in the trial

Primary outcomes:
measure: Glycemic control
timeFrame: 6 months
measure: glucose uptake into peripheral skeletal muscle
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: Monash University / Alfred Hospital
name: Henry Krum, MBBS, FRACP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02158689: Comparison of Treatment Modalities in Poor Responders Undergoing IVF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poor Responders
Keywords: Poor responders
letrozole
human menopausal gonadotropin
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2014-06-09
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The accurate identification and efficient management of poor responders remains one of the most enigmatic challenges in assisted reproductive technology (ART). The investigators study will compare the letrozole/antagonist protocol to the hMG/antagonist protocol in women who poor responders.


Eligibility criteria: Inclusion Criteria:

* Patients will be considered eligible if they are poor ovarian responders according to the Bologna criteria (Ferraretti et al., 2011).
* Two out of three of the following criteria are essential in order to classify a patient as poor ovarian responder:

  * advanced maternal age (≥40 years) or any other risk factor for poor ovarian response;
  * a poor ovarian response (≤3 oocytes with a conventional stimulation protocol); or
  * an abnormal ovarian reserve test (antral follicle count, \<7 follicles or anti-Mullerian hormone, \<1.1 ng/ml).

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Cancellation Rate
timeFrame: up to one month
measure: Number of oocytes retrieved
timeFrame: up to one month
measure: Number of transferable embryos
timeFrame: up to one month
measure: Implantation rate
timeFrame: up to 2 weeks
measure: Clinical pregnancy rate
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Department of Obstetrics and Gynecology, Istanbul University School of Medicine
Study officials:
affiliation: Istanbul University School of Medicine
name: Harika Yumru, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University School of Medicine
name: Hasan F Buyru, M.D. Prof.
role: STUDY_CHAIR
affiliation: Istanbul University School of Medicine
name: Ercan Bastu, M.D.
role: STUDY_DIRECTOR
References:
citation: Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.
Clinical trial NCT06551389: Follow-up of the Systemic Lupus Erythematosus Cohort as Part of the Multidisciplinary Consultation at Brest CHRU
Official title: Follow-up of the Systemic Lupus Erythematosus Cohort as Part of the Multidisciplinary Consultation at Brest CHRU
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Lupus Erythematosus
Keywords: autoimmune diseases
joint diseases
cutaneous systemic diseases
musculoskeletal diseases
arthritis
rheumatoid
rheumatic diseases
connectivite tissue diseases
immune system diseases
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of the systemic lupus erythematous's multidisciplinary consultation at Brest CHRU

Brief summary: Systemic lupus erythematosus is a complex systemicautoimmune disease that can affect most organs of the human body.

Although they are many recommendations on the diagnosis and managment of SLE, diagnosis and therapeutic managment is still challenging.

A pluridisciplinary consultation grouping rheumatologist, nephrologist, dermatologist, gynecologist, internist and immunologists has been set up in 2009 at the university hospital of Brest.

The investigators would like to identify in a longitudinal cohort the occurrence of the different clinico-biological and immunological patterns of systemic lupus erythematosus patients during our multidisciplinary consultation.

It is now crucial to organize a standardized data collection of these patients in order to evaluate our pratices, to be able to study the epidemiology of SLE in our city, and to promote this initiative at national and international level.


Eligibility criteria: Inclusion Criteria:

* Any patient over 18 years old of the multidisciplinary consultation

Exclusion Criteria:

* Opposition of patient

Primary outcomes:
measure: Cohort data
timeFrame: one year
measure: Cohort data
timeFrame: one year
measure: Cohort data
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT05749289: Application of Al18F-octreotide PET/CT in Neuroendocrine Tumor
Official title: Application of Al18F-octreotide PET/CT in Neuroendocrine Tumor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Neuroendocrine Tumor
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an open-label whole-body PET/CT study for investigating the value of Al18F-octreotide PET/CT in patients with Neuroendocrine Tumor

Detailed description: Octreotide is an artificial replacement for the natural growth hormone inhibitor in humans. It is a small peptide hormone consisting of 14 amino acids and is widely distributed in neuroendocrine cells, with the highest density in the brain, peripheral neurons, endocrine pancreas and gastrointestinal tract. Under pathological conditions, some tumour cells show overexpression of growth inhibitory receptors, such as endocrine tumours of the pancreas, pituitary adenomas, pheochromocytomas, paragangliomas, carcinoid tumours, medullary thyroid carcinomas, small cell lung carcinomas and other neuroendocrine tumours. Therefore, the sensitivity and specificity of octreotide imaging is high.

This study will provide a visual, reproducible and non-invasive imaging method for the diagnosis of neuroendocrine tumours through Al18F-octreotide PCT/CT imaging, providing an intuitive and clear imaging basis for clinical diagnosis, differential diagnosis and treatment, contributing to the development of medicine and science in the field of positron imaging.

Eligibility criteria: Inclusion Criteria:

* Patients with suspected or clearly diagnosed Neuroendocrine Tumor
* signed written consent.
* Willing and able to cooperate with all projects in this study.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Primary outcomes:
measure: Diagnostic value
timeFrame: through study completion, an average of 1 year]
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
state: Chao Yang
Study officials:
affiliation: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and PUMC
name: Rong Zheng, M.D.
role: STUDY_DIRECTOR
References: