louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06314074: 2.5 Versus 5 Minutes Trial
Official title: Oscillometric Blood Pressure Measurement At 2.5- Vs. 5-minute Intervals and Hypotension in Patients Having Non-cardiac Surgery: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 264
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized trial investigating the effect of oscillometric blood pressure monitoring at 2.5-minute intervals - compared to 5-minute intervals - on intraoperative hypotension. Specifically, the investigators will test the primary hypothesis that oscillometric blood pressure monitoring at 2.5-minute intervals - compared to 5-minute intervals - reduces the time-weighted average mean arterial pressure below 65 mmHg in patients having non-cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* ≥45 years
* scheduled for elective non-cardiac surgery under general anesthesia
* planned oscillometric blood pressure monitoring with an upper-arm cuff
* American Society of Anesthesiologists physical status class II or higher

Exclusion Criteria:

* emergency surgery
* arm or shoulder surgery
* pregnancy
* preoperative blood pressure differences between the right and left arm of more than 20 mmHg
* intraoperative invasive blood pressure monitoring
* previous preoperative peripheral nerve injury (such as diabetic neuropathy, carpal tunnel syndrome, or cervical radiculopathy)
* contraindication for continuous finger-cuff blood pressure monitoring (e.g., Raynaud's disease, arterial-venous shunts, or cardiac assist devices)

Primary outcomes:
measure: Time-weighted average mean arterial pressure <65 mmHg
timeFrame: Beginning of surgery until the end of surgery
Secondary outcomes:
measure: Episodes of a mean arterial pressure <50 mmHg
timeFrame: Beginning of surgery until the end of surgery
measure: Norepinephrine dose
timeFrame: Beginning of surgery until the end of surgery
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Karim Kouz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05747274: SRDK0921_ Analytical Performance Study
Official title: Retrospective Study to Validate the Analytical Performance of an In Vitro Diagnostic (IVD) Medical Device in Patients With Kidney Transplant.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant Rejection
Keywords: Gene expression
In Vitro Diagnostic
Subclinical rejection score, kidney allograft
Lead sponsor: BioMAdvanced Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: Nantes University Hospital
First posted: 2023-02-28
Enrollment: 439
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples and data from patients included in the DIVAT biocollection are the leftover specimens already used in the Proof-Of-Concept study. All those specimens meet the inclusion/exclusion criteria

Brief summary: Analytical Performance Study of the SRDK0921 IVD medical device (Kit and Software)

Detailed description: It is a retrospective, observational, non-randomised study using clinical data and samples from DIVAT biocollection.

The aim of this study is to validate the analytical performance of the SRDK0921 In Vitro Diagnostic Medical Device (IVD).

The SRDK0921 system (kit and software) is intended:

* to calculate a score of subclinical rejection in kidney transplant patients
* as an aid in diagnosis of subclinical rejection's absence in kidney transplant recipients in conjunction with other clinical information.

Eligibility criteria: Inclusion Criteria:

* Subjects that underwent kidney transplant between January 2008 and January 2016 in the following sites: University hospital center of Nantes, AP-HP Paris-Necker, and HCL Lyon.
* Subjects transplanted from living or deceased donors.
* Patients with an available paired frozen mRNA and biopsy collected at one-year post- transplantation and archived in the DIVAT bio-collection.
* Subjects with good kidney function at one-year post-transplantation (creatininemia below 160 µmol. L-1)
* Subjects under standard immunosuppressive treatments.

Exclusion Criteria:

* Subjects that underwent a graft biopsy for medical indication at one-year post- kidney transplantation.
* Subjects that have stopped immunosuppressive treatments.

Primary outcomes:
measure: AUC (Area Under the Receiver-Operating Characteristic [ROC] Curve)
timeFrame: at 1 year after kidney transplant
Secondary outcomes:
measure: Analytical sensitivity, specificity, Positive Predictive Value, Negative Predictive Value, Cut-off-value
timeFrame: at 1 year after kidney transplant
measure: Quantification of the gene expression signature
timeFrame: at 1 year after kidney transplant
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes hospital
Study officials:
affiliation: BioMAdvanced Diagnostics
name: Nicolas Bouler
role: STUDY_DIRECTOR
References:
Clinical trial NCT02213874: The Influence of Trust in the Health Care System on Postpartum Contraceptive Choice
Official title: The Influence of Trust in the Health Care System on Postpartum Contraceptive Choice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception Behavior
Contraception
Keywords: Pregnant Women
Women's Health
Contraception
Trust in Health Care
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2014-08-12
Enrollment: 208
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this research is to understand the relationship between trust in the health care system and choice of contraception during the postpartum period among pregnant women receiving prenatal care.

Research subjects will complete a questionnaire at enrollment and between delivery and within 5 days of hospital discharge.

A chart review will also be completed to gather use of a birth control method at the six week postpartum visit as well as pertinent medical diagnoses and recorded data such as height, weight, body mass index, and contraceptive plan as documented in the postpartum medical chart.

Detailed description: The aims of the proposed research are three-fold:

1. To identify whether trust in the health care system is associated with choice of the highest efficacy contraception (intrauterine contraception, implantable contraception, and sterilization) in the immediate postpartum period among pregnant women receiving prenatal care.
2. To explore which patient-level factors (sociodemographic, reproductive history, future pregnancy intentions) and provider-level factors (antenatal contraceptive counseling) are associated with choice of the highest efficacy contraception in the immediate postpartum period among pregnant women receiving prenatal care.
3. To determine whether trust in the health care system is altered during the receipt of prenatal care or delivery.

Eligibility criteria: Inclusion Criteria:

* Pregnant Women receiving prenatal care at Medical University of South Carolina (MUSC)
* Age 18 or older

Exclusion Criteria:

* Greater than 20 weeks gestation

Primary outcomes:
measure: Choice of long acting contraception (IUD or implant) for postpartum contraception
timeFrame: immediately postpartum
Secondary outcomes:
measure: Trust in the health care system
timeFrame: immediately postpartum
Other outcomes:
Locations:
city: Charleston
country: United States
facility: MUSC Women's Health
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Angela Angela Dempsey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04195074: Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Chronic Hepatitis b
Official title: Study on Therapeutic Effects and Safety of Three Types of Nucleotide/Nucleoside Analogues in Patients With Chronic Hepatitis b
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Hepatitis b
Keywords: chronic hepatitis b
nucleoside
nucleotide
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of chronic hepatitis b

Detailed description: Chronic hepatitis b (CHB) remains a serious public health problem in China. Nucleotide/nucleoside analogues are used for anti-virus treatment in these patients. Entecavir, Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide are first line drug in China. But there still lacks of data of Tenofovir Alafenamide in treatment of CHB. This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of CHB.

Eligibility criteria: Inclusion Criteria:

1. Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year;
2. Age from 18 to 65 years old;
3. HBeAg-positive: HBV DNA≥20000IU/ml，HBeAg-negative: HBV DNA≥2000IU/ml；
4. ALT≥2×ULN；
5. Do not receive nucleotide/nucleoside analogues treatment in the past half year.

Exclusion Criteria:

1. Other active liver diseases;
2. Hepatocellular carcinoma or other malignancy;
3. Pregnancy or lactation;
4. Human immunodeficiency virus infection or congenital immune deficiency diseases;
5. Severe diabetes, autoimmune diseases;
6. Other important organ dysfunctions;
7. Using glucocorticoid;
8. Patients can not follow-up;
9. Investigator considering inappropriate.

Primary outcomes:
measure: Rate of renal function decline
timeFrame: 144 week
measure: Rate of hypercalcemia
timeFrame: 144 week
Secondary outcomes:
measure: hepatitis b virus(HBV) DNA undetectable rate
timeFrame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
measure: hepatitis b e antigen loss rate
timeFrame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
measure: hepatitis b s antigen loss rate
timeFrame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
measure: hepatitis b e antigen seroconversion rate
timeFrame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Liang Peng, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03521674: Foley Catheter vs Double-balloon Catheter
Official title: Comparison of Foley Catheter and Double-balloon Catheter in Second Trimester Pregnancy Termination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Termination
Catheter
Keywords: second trimester pregnancy termination
double-balloon catheter
foley catheter
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The efficiency of double-balloon and Foley catheters in the second trimester medical termination of pregnancies will be compared.

Detailed description: Women will be randomised into two groups. Foley catheter was applied to one group and double balloon catheter to the other group. After catheter expulsion or if the catheters did not spontaneously expulsed after 24 hours, i.v. oxytocin infusion will be started. Abortions will be considered successful if there will be no need of another method for abortion.

Eligibility criteria: Inclusion Criteria:

* pregnancy termination, gestational age from 14-24 weeks

Exclusion Criteria:

* multiple gestation

Primary outcomes:
measure: induction termination interval
timeFrame: during procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni SSTRH
Study officials:
affiliation: KSSTRH
name: Berna Aslan Çein
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06683274: Bascom Cleft Lift for Primary Wound Healing in Complex and Recurrent Sacrococcygeal Pilonidal Sinus Disease
Official title: Bascom Cleft Lift for Primary Wound Healing in Complex and Recurrent Sacrococcygeal Pilonidal Sinus Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pilonidal Sinus
Keywords: Pilonidal sinus
Bascom cleft lift
Lead sponsor: Albert Schweitzer Ziekenhuis, Netherlands
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 58
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with (symptomatic) complex or recurrent pilonidal sinus disease, who will be planned for surgical treatment.

Brief summary: The goal of this observational study is to improve care for patients with complex or recurrent pilonidal sinus disease by developing and implementing a best practice care pathway, including a standardized cleft lift operation.

The main question it aims to answer is: Does a best practice care pathway with standardized cleft lift operation lead to shorter wound healing time and time to return to normal activities, compared to current standard care, with traditional excision techniques.


Eligibility criteria: Inclusion Criteria:

* 16 years of age and older
* Symptomatic complex or recurrent pilonidal sinus disease
* Planned for surgical treatment
* Signed informed consent

Exclusion Criteria:

* Pregnant
* Insufficient understanding of the Dutch language or otherwise unable to give consent

Primary outcomes:
measure: Wound healing time
timeFrame: The outcome will be evaluated at each follow-up visit, at 1-3 weeks, 4-6 weeks and 6 months postoperative. If necessary, additional visits will be planned
Secondary outcomes:
measure: Return to normal activities
timeFrame: The outcome will be evaluated at each follow-up visit, at 1-3 weeks, 4-6 weeks and 6 months postoperative. If necessary, additional visits will be planned
Other outcomes:
measure: Quality of Life
timeFrame: Baseline, 4-6 weeks and 6 months postoperative.
measure: Pain
timeFrame: The outcome will be evaluated at each follow-up visit, at 1-3 weeks, 4-6 weeks and 6 months postoperative.
Locations:
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer ziekenhuis
Study officials:
affiliation: Albert Schweitzer Ziekenhuis, Netherlands
name: Robert Smeenk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ikazia ziekenhuis
name: Boudewijn Toorenvliet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01394874: Can Computer-based Telephone Counseling Improve Long-term Adherence to Strength Training in Elders With Knee OA?
Official title: Can Computer-based Telephone Counseling Improve Long-term Adherence to Strength Training in Elders With Knee Osteoarthritis (OA)?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis
exercise
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2011-07-15
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to determine whether computer-based telephone counseling will improve adherence to strength training in a population of elders with knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* osteoarthritis of the knee (ICD-9 Code of 715.16, 715.09 or 715.9)
* lives within interstate 95
* age 55 or older
* English speaking

Exclusion Criteria:

* Stroke or heart attack in last 3 months
* Treatment for cancer
* Severe systemic disease
* Medical condition that limits physical activity
* Inflammatory arthritis
* Plans for knee replacement
* Dementia or inability to follow exercise instructions and TLC system

Primary outcomes:
measure: Self-report measure of exercise adherence over the last 3-months on a numeric rating scale
timeFrame: 24 month
Secondary outcomes:
measure: 24 -month change in self-report of pain and function using the WOMAC index
timeFrame: post the 1-month exercise class, 24 months
measure: Quadriceps strength
timeFrame: Change in quadriceps strength from baseline to 24 months.
measure: Timed Physical Function tasks
timeFrame: Change in timed physical function task over 24 months
measure: Exercise quality
timeFrame: Average measure of exercise quality over 24 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Boston University Charles River Campus
name: Kristin Baker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baker K, LaValley MP, Brown C, Felson DT, Ledingham A, Keysor JJ. Efficacy of Computer-Based Telephone Counseling on Long-Term Adherence to Strength Training in Elderly Patients With Knee Osteoarthritis: A Randomized Trial. Arthritis Care Res (Hoboken). 2020 Jul;72(7):982-990. doi: 10.1002/acr.23921.
citation: Chang FH, Jette AM, Slavin MD, Baker K, Ni P, Keysor JJ. Detecting functional change in response to exercise in knee osteoarthritis: a comparison of two computerized adaptive tests. BMC Musculoskelet Disord. 2018 Jan 23;19(1):29. doi: 10.1186/s12891-018-1942-9.
Clinical trial NCT05327374: Use of ΔIVC for Early Diagnosis of AHF in AECOPD
Official title: Diagnosis of Acute Heart Failure in Chronic Obstructive Pulmonary Disease Exacerbation Using the Inferior Vena Cava Collapsibilty Index
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Decompensated Heart Failure
COPD Exacerbation
Keywords: COPD
Acute Heart Failure
Inferior vena cava
Ultrasound
Collapsibility index
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 401
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: NON_PROBABILITY_SAMPLE
Study population: patients with history of COPD admitted to the emergency departmet for AECOPD and stable hemodynamic status

Brief summary: Acute Heart failure (AHF) is a common cause of acute exacerbation of chronic obstructive pulmonary disease (AECOPD).

This association is frequently underestimated with regard to the difficulty of clinical diagnosis.

The investigators expect that the application of the inferior vena cava collapsibility index (ΔIVC)could be useful in this issue.

Detailed description: Acute heart failure (AHF) is a common cause of COPD exacerbation however its role is very often underestimated. Until now, the use of echocardiography and some invasive hemodynamic exploration techniques such as the Swanganz catheter has been stated as reference. Other noninvasive diagnostic methods have been studied, such as systolic time intervals and Valsalva maneuver, but their application still difficult in patients with COPD exacerbation, especially in emergency department (ED) settings. the study aimed to evaluate the performance of a new diagnostic technique based on the measurement of the ΔIVC for the early identification of AHF in patients presenting to the ED with acute COPD exacerbation.

Eligibility criteria: Inclusion Criteria:

* patient with history of COPD and admitted to the emergency departement for AECOPD

Exclusion Criteria:

* impossibility to give consent to participate in the study, non consent patients
* post traumatic dyspnea
* instable hemodynamic or neurological status

Primary outcomes:
measure: the performance of ΔIVC in the diagnosis of acute heart failure
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: CHU Fattouma Bourguiba
city: Monastir
country: Tunisia
facility: Emergency Departement
city: Monastir
country: Tunisia
facility: Emergency department of fattouma bourguiba university hospital
Study officials:
affiliation: University of Monastir
name: Nouira Semir, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00279474: The Effect of Cognitive Behavior Intervention on Psychological Distress of Cancer Patients and Their Family Members
Official title: Evaluation of the Effect of Cognitive Behavior Intervention on Psychological Distress of Cancer Patients and Their Family Members
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: cancer patients
family
cognitive behavior
distress
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2006-01-19
Enrollment: 320
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effect of cognitive behavior group intervention with cancer patients and their family members. Around 80 cancer patients and their family members will participate in group intervention and will be compared with 80 controls.

Detailed description: The aim of the study is to evaluate the effect of cognitive behavior group intervention with cancer patients and their family members. Around 80 cancer patients and their family members will participate in group intervention and will be compared with 80 controls (randomized control study). Brief Symptom Inventory,Fatigue inventory, Mini Sleep Questionnaire and repression-sensitization questionnaire will be answered by the participants pre-, post-intervention and after four months.

Eligibility criteria: Inclusion Criteria:

* Hebrew speaking

Exclusion Criteria:

* psychiatric condition

Primary outcomes:
measure: Reduction in psychological distress, level of fatigue and sleep problems
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam medical center, Oncology department
Study officials:
affiliation: Rambam Health Care Campus
name: Miri Cohen, PhD
role: PRINCIPAL_INVESTIGATOR
References: