louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04914091: Quality Of Life and Drug Use in Patients With CAR-T Cells
Official title: Pilot Study for Quality Of Life and Drug Use Assessment in Patients With CAR-T Cells
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients With Diffuse Large B-cell Lymphoma Treated With CART-cells
Keywords: CAR-T cells
Quality of life
drug use
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 70
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 with diffuse large B-cell lymphoma treated with CART-cells in the center during the inclusion period.

Brief summary: CAR-T cells are a major therapeutic innovation in the management of patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) in 3rd line or more. Kymriah® and Yescarta® are the first CAR-T with Marketing Authorization and coverage by the French Health Insurance. Their clinical interest has been demonstrated in non-comparative phase 1-2 trials.

The non-comparative design of the pivotal trials, the lack of data on patients' quality of life and drug consumption, as well as the very high cost of CAR-T (about € 320,000 for one treatment) warrant further studies.

This prospective non-comparative study aims to describe in real life the quality of life of patients treated with CAR-T cells, real world drug use and patients' experience feedback.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Eligible for treatment with CAR-T cells (outside any clinical trial) in an indication of DLBCL and for which treatment is scheduled
* Follow-up in the Hematology department of the Hospices Civils de Lyon
* Without major psychiatric disorder likely to interfere with the conduct of the study, in the opinion of the investigator
* Having given his non-opposition to participate in the study.

Exclusion Criteria:

* In an institution
* Under legal protection

Primary outcomes:
measure: Change of Mean quality of life score using the EORTC-QLQ C30 questionnaire
timeFrame: Inclusion (the day before lymphodepletion chemotherapy), Month 3 and Month 6 after the administration of CART-T cells
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Hospices Civils de Lyon -Groupement Hospitalier Sud Service pharmaceutique, Unité de Pharmacie Clinique Oncologique
Study officials:
References:
Clinical trial NCT01667991: Evaluation of the American Thoracic Society Criteria for Predicting Multidrug-resistant Bacteria in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Keywords: Colonization
infection
multidrug-resistant bacteria
guideline
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 610
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients admitted to icu

Brief summary: Appropriate initial antibiotic treatment based on early diagnosis of etiology will improve the outcome of sepsis. The incidence rates of multidrug-resistant (MDR) bacteria, which are different between countries, will affect the accuracy of etiological diagnoses according to the American Thoracic Society (ATS) guidelines. Therefore the investigators determined the accuracy of the ATS criteria in predicting infection or colonization related to MDR bacteria in China.

Detailed description: All data concerning patient characteristics at ICU admission and during ICU stay were prospectively collected.Screening for MDR bacteria (using nasal swabs, tracheal aspirates from intubated patients and specimens from the infection location) was performed at ICU admission and discharge. Risk factors for infection or colonization with MDR bacteria were recorded, and the accuracy of the ATS criteria in predicting infection or colonization with these bacteria at ICU admission was documented. All of the infected patients were treated by the attending physician, and the choice and adjustment of antibiotic were in accordance with the recommendations of the ATS guidelines.

Eligibility criteria: Inclusion Criteria:

* All patients hospitalized in the ICU were eligible for this study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Zhongda Hospital
name: Jianfeng Xie, MD
role: STUDY_DIRECTOR
References:
citation: Xie J, Ma X, Huang Y, Mo M, Guo F, Yang Y, Qiu H. Value of American Thoracic Society guidelines in predicting infection or colonization with multidrug-resistant organisms in critically ill patients. PLoS One. 2014 Mar 19;9(3):e89687. doi: 10.1371/journal.pone.0089687. eCollection 2014.
Clinical trial NCT05034991: The Role of Endometrial Blood Flow in Endometrial Cancer
Official title: The Role of Endometrial Blood Flow in Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Cancer
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 75
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: endometrial cancer patient

Brief summary: The incidence of endometrial cancer is gradually increasing nowaday. Sonography can be used to evaluate the endometrial volume, the vascularity and the blood flow. This study will analyze the role of preoperative endometrial blood flow in the outcome of endometrial cancer patients.


Eligibility criteria: Inclusion Criteria:

- \>20 years old female had Endometrial cancer

Exclusion Criteria:

- \<20 years old female

Primary outcomes:
measure: Correlation between the endometrial vascularity (VFI, FI, VI), endometrial volume, endometrial thickness and progression-free survival of endometrial cancer patients
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT02180191: Gut Microbiota in Obesity and Diabetes
Official title: Comparison of Gut Microbiota in Obese, Diabetic and Healthy Control Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Type 2 Diabetes Mellitus
Keywords: Gut microbiota
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary referral center

Brief summary: An altered gut microbiota composition has recently been linked to obesity and diabetes. The principal aim of this study was to investigate and compare the gut microbiota composition of obese, diabetic and control individuals. Then, associations between analyzed gut microbial concentrations and clinical-biochemical blood parameters were assessed.


Eligibility criteria: Inclusion Criteria:

* Subjects with obesity or newly diagnosed type 2 diabetes
* 18 years to 65 years of age

Exclusion Criteria:

* Any chronic disease (other than obesity and diabetes)
* Alcohol consumption/smoking
* Pregnancy/breastfeeding
* The use of antibiotics, pro-prebiotics within 3 months
* \<18 years or \>65 years
* History of intestinal surgery

Primary outcomes:
measure: The comparison of the gut microbiota composition
timeFrame: 9 months
Secondary outcomes:
measure: The relationship between metabolic parameters and the gut microbiota composition
timeFrame: 9 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Department of Endocrinology and Metabolism, Gulhane School of Medicine
Study officials:
References:
Clinical trial NCT02488291: Effect of Sufentanil and Ropivacaine
Official title: Effect of 0.5µg/ml Sufentanil and Ropivacaine Towards Pregnant Women and Fetus in Analgesia Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia Complications
Keywords: Epidural
Analgesia labor
Perinatal
anesthesia
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Jiao Tong University School of Medicine
First posted: 2015-07-02
Enrollment: 120
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators study the efficacy of epidural sufentanil/ropivacaine for analgesia labor in primiparas so as to decrease perinatal complications of analgesia labor.

Detailed description: A prospective study of 120 full-term parturients receiving labor analgesia were randomly assigned into 2 groups: the 0.5Sufen group (N=60), the 0.25Sufen group (N=60).

Eligibility criteria: Inclusion Criteria:

1. Patients had regular prenatal examinations at the outpatient clinic;
2. They were between 25 to 35 years of age)
3. They had a gestational age ≥37 weeks and \< 42 weeks;
4. They had an estimated fetal weight ≥ 2,500 g and \< 4,200 g.

Exclusion Criteria:

* a history of spinal surgery,
* platelet count \<100×109 /L ,
* coagulation disorder,
* sensorimotor disorder of lower extremity,
* leg pain,
* puncture point infection,
* heart disease history,
* pulmonary disease,
* liver and renal function disorder and
* a history of neuropsychiatry drugs.

Primary outcomes:
measure: VAS(visual analog pain score)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fudan University, Shanghai Jiaotong University
name: Zeyong Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03807791: Study of Prevalence and Risk Factors of Hypovitaminosis C in Long Term Care Unit
Official title: Study of Prevalence and Risk Factors of Hypovitaminosis C in Long Term Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin C Deficiency
Scurvy
Keywords: Vitamine C deficiency
skin rash
scurvy
food texture
geriatric institution
Unit Of Long Term Care
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The clinical finding of skin rashes which appear after a vitamin C deficiency in Long Term Care Unit leads us to believe that the institutional diet could predispose to this kind of deficiency. Vitamin C has a key role into the struggle against oxidant stress and is involved into the connective tissue formation of the skin and the vascular endothelium. Vitamin C deficiency affects currently 15 to 25% of the elderly over 65 years old reaching 15% women and 20% men after 65 according to Johnston and Al. It concerns mainly the people in precarious situations (persons without fixed homes, ethyl-smoking persons) and elderly over 65 years. Hypovitaminosis C, defined by plasma level between 5 mg/L and 15 mg/L (28.41 to 85.23 µmol/L), is currently undiagnosed, especially with people with a risk of food deficiency and its prevalence increases with age. The treatment consists of a daily oral supplementation of 1 gram of vitamin C/d for 15 days. A minimum intake of 10 mg/D of vitamin C is required to prevent scurvy and maintain a total pool of 350 mg. A diet modification by a systematic intake of 2 glasses of fresh orange juice and/or the consumption of raw fruits and vegetables would prevent the appearance of scurvy.


Eligibility criteria: Inclusion Criteria:

* Male or female over 65 years old
* living in the Unit of Long Term Care without any limit time.
* with a system of social insurance
* Who gave its consent by his own , or with help of his representant or his tutor or curator.

Exclusion Criteria:

* rejection of the blood sample
* patient feeding with articial nutritional feeding (stomach tube feeding)
* person close to death, who is not able to feed himself and / or with life-threatening in short time.
* Patient with personal history of vitamin C deficiency.

Primary outcomes:
measure: Vitamin C plasma level
timeFrame: Between day 0 and day 7.
Secondary outcomes:
measure: Supposed risk factors of hypovitaminosis C
timeFrame: Day 0
measure: Cutaneous symptoms
timeFrame: Day 0
Other outcomes:
Locations:
city: Lyon
country: France
facility: Unité de soins Longue Durée, Hôpital Pierre Garraud (Hospices Civils de Lyon)
Study officials:
References:
Clinical trial NCT04447391: Effects of a 12-week Combined Exercise Program on Ghrelins in Obese Adolescent Girls
Official title: Effects of a 12-week Combined Exercise Program on Acylated and Desacyl Ghrelin, and Ghrelin O Acyl Transferase in Obese Adolescent Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ghrelin
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 30
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aimed to explore the effects of a 12-week combined exercise on ghrelin O acyl transferase, acylated ghrelin and desacylated ghrelin levels in obese girls.

Detailed description: Little is known about on ghrelin O acyl transferase (GOAT), acylated ghrelin (AG) and desacylated ghrelin (DAG) levels during long-term exercise in adolescent population. Our previous study showed that combined exercise program in overweight children increases DAG with unchanged AG. This study aimed to explore the effects of a 12-week combined exercise on GOAT, AG, and DAG in obese girls.

Eligibility criteria: Inclusion Criteria:

* girls between 16 and 18 years
* being classified as being overweight or obese defined with the 85th percentile of body mass index or above based on the 2007 growth chart for Korean children aged 2-18 years.
* After consultation with a physician, they were required to be considered physically healthy enough to engage in regular exercise after school.

Exclusion Criteria:

* participation in any weight-management programme in the past 6 months
* engagement in other exercise programs except for regular physical education at school
* smoking
* amenorrhea for consecutive 2 months or more
* being treated for hereditary diseases, mental disorder, hypertension, diabetes mellitus, or musculoskeletal impairments
* taking any medication or supplements for weight control

Primary outcomes:
measure: body fat percent
timeFrame: Change from baseline body fat percent at 12 weeks
measure: acylated ghrelin
timeFrame: Change from concentrations of baseline acylated ghrelin at 12 weeks
measure: desacylated ghrelin
timeFrame: Change from concentrations of baseline desacylated ghrelin at 12 weeks
Secondary outcomes:
measure: ghrelin O acyl transferase
timeFrame: Change from baseline concentrations of ghrelin O acyl transferase at 12 weeks
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeungsangnam-do
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00757991: Blood Samples From Healthy Volunteers for Genetic Studies in the East Anglia Region of the United Kingdom
Official title: A Population Based Control Collection for Genetic Studies in East Anglia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy, no Evidence of Disease
Keywords: healthy, no evidence of disease
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-09-23
Enrollment: 4000
Sex: ALL
Minimum age (years): 35
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: RATIONALE: Studying samples of blood from healthy volunteers in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This study is looking at genetic susceptibility to cancer and interactions between genes and the environment in healthy volunteers.

Detailed description: OBJECTIVES:

* To obtain blood samples and simple epidemiological information on a population-based series of adult individuals without cancer.
* To establish whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of cancer by comparing the frequency of alterations in these genes with the corresponding frequency in a comparable series of cancer patients.
* To examine the interactions between genetic and non-genetic risk factors.

OUTLINE: This is a multicenter study.

Participants complete a simple epidemiological questionnaire.

Participants undergo blood sample collection. DNA is extracted from these samples for polymorphism analysis of low penetrance cancer susceptibility genes in the following related clinical trials: MREC-SEARCH-CANCER, MREC-SEARCH-PROSTATE, and MREC-SEARCH-BREAST. They may also be used in the analyses of the following related clinical trials: MREC-SEARCH-OVARIAN, MREC-SEARCH-ENDOMETRIAL, MREC-SEARCH-COLORECTAL.

PROJECTED ACCRUAL: A total of 2,000 male and 2,000 female participants will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Cancer-free participants randomly selected from the age-sex registry of a general practice in the East Anglia region of the United Kingdom

  * Two general practices from each district within East Anglia participate (up to 10 total participating practices)

PATIENT CHARACTERISTICS:

* Identified by the participant's general practitioner as fit to contact for this study
* No prior diagnosis of cancer
* No serious mental illness or retardation

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Acquisition of blood samples and epidemiological information
measure: Investigation of whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of cancer
measure: Examination of the interactions between genetic and nongenetic risk factors
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: University of Cambridge Cancer Research UK
state: England
Study officials:
affiliation: Cancer Research UK
name: Paul Pharoah, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04274491: Predictors of Recovery Expectancy
Official title: Predictors of Recovery Expectancy After Surgery for Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Surgery
Keywords: Recovery
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 202
Sex: FEMALE
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 with greater than or equal to stage II pelvic organ prolapse who are scheduled for reconstructive surgery.

Brief summary: The purpose of this study is to identify factors that influence a person's expectations regarding recovery from pelvic organ prolapse surgery. This is important because a person's expectations regarding recovery from surgery help to predict how a person will actually recover. Our hypothesis is that women with multiple roles will have expectations of a longer surgical recovery time after surgery for pelvic organ prolapse after controlling for known predictors of recovery expectancies. Participants will complete a preoperative online survey. Additional online surveys will be send on postoperative days 14 and 42 to measure postdischarge surgical recovery.


Eligibility criteria: Inclusion Criteria:

* Patients with greater than or equal to stage II pelvic organ prolapse who are scheduled for reconstructive surgery.
* English speaking.
* Over the age of 18.
* Use email as a form of communication.
* Have a reliable internet connection at home.
* Have a computer/smartphone/tablet at home.

Exclusion Criteria:

* Non English speaking patients
* Patients without active email.
* Patients without access to reliable internet connection.
* Patients without access to computer/smartphone/tablet.
* Patients with less than stage II prolapse.

Primary outcomes:
measure: Recovery Expectancy
timeFrame: Participant will complete preoperative survey at 1 day (once surgery is scheduled).
Secondary outcomes:
measure: Post Discharge Recovery
timeFrame: Questionnaire will be completed on post op day #14
measure: Post Discharge Recovery
timeFrame: Questionnaire will be completed on post op day #42
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Urogynecology
state: Indiana
Study officials:
affiliation: Indiana University
name: Michael Heit, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05999591: Total Motile Sperm Count and Pregnancy Rate From Intrauterine Insemination
Official title: Effect of Post-Wash Total Motile Sperm Count on the Pregnancy Rate of Infertility Patients Undergoing Intrauterine Insemination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insemination
Keywords: infertility
intrauterine insemination
post-wash total motile sperm count
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 330
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A group of patients undergoing intrauterine insemination for various causes of infertility at a tertiary fertility clinic

Brief summary: Intrauterine insemination (IUI) is one of the most important infertility treatments. Infertility is failure to establish pregnancy (\>12 months) with regularly unprotected sexual intercourse. Post-wash total motile sperm count (TMSC) vaguely defined as a predictor of IUI pregnancy rate. The minimum value required is also not clear. This study aimed to further define the relationship and determine the minimum recommended value to achieve a satisfactory IUI pregnancy rate.

Post-wash TMSC is predictive of IUI success. No optimal cut-off could be identified. In conclusion, post-wash TMSC is highly suggested as a quantitative predictor along with others in counseling and informed consent. The recommended threshold value is \>3 x 106.


Eligibility criteria: Inclusion Criteria:

* post-wash total motile sperm count needed to be over 5 x 10\^5

Exclusion Criteria:

* missing data on pregnancy outcome and missing medical records

Primary outcomes:
measure: Pregnancy rate
timeFrame: max 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Padjadjaran
state: Jawa Barat
Study officials:
affiliation: Department of Obstetrics and Gynecology, Faculty of Medicine Universitas Padjadjaran Bandung
name: Hanom H Syam, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller DC, Hollenbeck BK, Smith GD, Randolph JF, Christman GM, Smith YR, Lebovic DI, Ohl DA. Processed total motile sperm count correlates with pregnancy outcome after intrauterine insemination. Urology. 2002 Sep;60(3):497-501. doi: 10.1016/s0090-4295(02)01773-9.