louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01243034: Waist Circumference Measurements in Schizophrenic Patients
Official title: Variability of Waist Circumference Measurements at 3 Sites and Its Relationship With Cardiovascular Risk Factors in Patients With Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Waist Circumference Measurements
Schizophrenia
Cardiovascular Risk Factor
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2010-11-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: schizophrenia outpatients

Brief summary: The prevalence of metabolic syndrome(MS) among pt's with schizophrenia has been reported to be high, ranging from 24 to 43% in males and 27 to 52% in females. Schizophrenic patients with MS have an increased incidence of DM, coronary heart disease and increased mortality from cardiovascular diseases. Central adiposity is highly correlated with the presence of hypertension, coronary heart disease, type 2 diabetes, and increased mortality risk. Waist circumference(WC) is a better indicator of abdominal obesity and a better predictor of CVD than either BMI or waist-to-hip ratio. However, currently there is no standard location for the measurement of WC.

Objectives: 1. To compare the magnitude of WC measured at 3 sites ( immediately above the iliac crest, midpoint between the lowest rib and the iliac crest , umbilical level) in males and females.

2. To examine the correlation of WC with Triglyceride, cholesterol, HDL, LDL and glucose.


Eligibility criteria: Inclusion Criteria:

* • Patients with schizophrenia or schizoaffective disorder (DSM-IV 295) age 18 till 65 years old.

  * Body weight change less than 1 kg in previous one month before index date.

Exclusion Criteria:

* • Patients with a previous hyperlipidemia diagnosis or antilipemic prescription during the preceding 30 days.

  * Patients received any anti-hypertensives or oral hypoglycemic agents.
  * Pregnant or breast-feeding women.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
Study officials:
References:
Clinical trial NCT06870734: General Anesthesia Versus Loco-Regional Anesthesia for Transcarotid Trancatheter Aortic Valve Replacement
Official title: General Anesthesia Versus Loco-Regional Anesthesia for Transcarotid Trancatheter Aortic Valve Replacement - a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aortic Stenosis
Keywords: general anesthesia
cervical block
locoregional anesthesia
TAVR
cardiovascvular intervention
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 44
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: Adult patients who underwent a transcarotid TAVR at the University Hospital of Caen between October 2021 (when the first TAVR was performed under locoregional anesthesia) and December 2024

Brief summary: Transcarotid transcatheter aortic valve replacement (Transcarotid TAVR) has been increasingly used as an alternative to the transfemoral approach. The general anesthesia, locoragional anesthesia or local anesthesia are three anesthesia techniques that can be used for transcarotid TAVR. We aim to compare the locoregional approach to gerneral anesthesia.


Eligibility criteria: Inclusion Criteria:

* Adult patients who underwent a transcarotid TAVR at the University Hospital of Caen between October 2021 (when the first TAVR was performed under locoregional anesthesia) and December 2024

Exclusion Criteria:

* Patient's refusal to allow data collection and lack of data regarding the primary endpoint

Primary outcomes:
measure: Primary endpoint
timeFrame: 7 days
Secondary outcomes:
measure: Death
timeFrame: 7 days
measure: Stroke
timeFrame: 7 days
measure: 30 day mortality
timeFrame: 30 days
measure: 1 year mortality
timeFrame: 1 year
measure: Vasopressive drugs
timeFrame: 1 day
Other outcomes:
measure: Pacemaker implantation
timeFrame: 7 to 30 days
Locations:
Study officials:
References:
Clinical trial NCT02336334: Evaluation of Posturing-Adherence in Patients After Intraocular Surgery
Official title: Measurement and Logging of Posturing Adherence of Patients After Intraocular Surgery With Gasendotamponades Using a Sensorsystem With Different Feedback-Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retina; Lesion
Adherence
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2015-01-13
Enrollment: 48
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: Measuring and logging head positions of patients which underwent surgery with gasendotamponades.

Detailed description: After surgery with gasendotamponades various positions are recommended to support the success of surgery. In patients with macular holes face-down-position is recommended. In patients with retinal detachment the recommended position depends on the region of the detachment.

The adherence of patients to follow this posturing instructions is very inhomogenous. Therefore the investigators want to measure the posturing by the use of a position-sensor. In some study arms the patients also receive a feedback from the sensor (tone, vibration) to correct the position.

The sensor-device was developed by the study-staff and is not commercial available. In addition there is no trade name. The patients safety of the used device was approved by the in house technical department.

Eligibility criteria: Inclusion Criteria:

* age \>18 years
* full thickness macular hole or retinal detachment
* informed consent

Exclusion Criteria:

* intraoperative complications with the need of other endotamponades
* combined treatment

Primary outcomes:
measure: Effective time of ideal posturing with different sensors-systems
timeFrame: up to 12 month
Secondary outcomes:
measure: Time analysis with optimal posturing after detailed explanation of posturing positions
timeFrame: up to 12 month
measure: Analysis of time with optimal posturing for both Sensor-Feedback-Systems
timeFrame: up to 12 month
measure: Closure rate of macular holes after 3 month as measured by optical coherence tomography (hole closed: yes or no)
timeFrame: up to 12 month
measure: Tolerability of sensor-systems for patients as measured by questionnaire
timeFrame: up to 12 month
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Eye Hospital
state: BW
Study officials:
References:
Clinical trial NCT06548334: The Effectiveness of Lumber Regression Technique on Disc Bulge Randomized Control Trial
Official title: The Effectiveness of Lumber Regression Technique on Disc Bulge Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Disc Disease
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Lumbar disc bulges lead to considerable pain and disability in affected individuals, with current interventions lacking consistency of outcomes. The lumbar regression method offered a hopeful, noninvasive option.

Detailed description: this study was proposed to evaluate its efficacy in improving accessary lower limb flexibility and reducing functional disability and pain management. To provide evidence about its effectiveness and help with clinical practice, this study aimed to improve patient outcomes in subjects having lumbar disc bulges.

Eligibility criteria: Inclusion Criteria:

* Individuals with a diagnosis of Disc bulge confirmed by MRI.
* Between 18 and 65 years of age.
* Chronic low back pain from the last 3 months
* A stable treatment environment that allows intervention.
* Ability to understand and follow course directions.
* Willingness to give informed consent

Exclusion Criteria:

* Spondylolisthesis
* Spondylosis
* Vertebral fracture
* Lack of ava
* Further research interventions.
* Unstable medical condition

Primary outcomes:
measure: Roland Morris disability questionnaire
timeFrame: 12 Months
measure: Straight Leg Raise
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Nemat Hospital & Heart Center, Manga Mandi
state: Punjab
Study officials:
References:
Clinical trial NCT01332734: Microcirculatory Changes During Magnesium Sulphate Infusion in Sepsis
Official title: Microcirculatory Changes During Open Label Magnesium Sulphate Infusion in Severe Sepsis and Septic Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Sepsis
Septic Shock
Keywords: microcirculation
SDF
magnesium sulfate
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
Collaborators: name: Lithuanian University of Health Sciences
First posted: 2011-04-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: severe sepsis and septic shock after adequate fluid resuscitation according to pulmonary artery catheter measurements

Brief summary: During infections (sepsis) bloodflow in small vessels (microcirculation) becomes disturbed. Restoration of bloodpressure and cardiac performance may not be sufficient to correct these alterations. Magnesium is a potent vasodilator which may be used to open up the small vessels, in order to reduce organ failure.

Detailed description: In a single-center open label study we evaluated the effects of magnesium sulphate (MgS) infusion on the sublingual microcirculation perfusion in fluid resuscitated patients with severe sepsis and septic shock within the first 48 hours after ICU admission. Directly prior to and after 1 hour of magnesium sulphate (MgS) infusion (2 gram) systemic hemodynamic variables, sublingual SDF images and standard laboratory tests, were obtained.

Eligibility criteria: Inclusion Criteria:

* severe sepsis and septic shock

Exclusion Criteria:

* pregnancy
* oral bleeding
* age \< 18 years
* liver cirrhosis
* acute arrhythmias
* advanced malignancy or a mean arterial pressure (MAP) \< 65 mmHg refractory to vasopressors

Primary outcomes:
measure: microvascular flow index
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian university of health sciences
Study officials:
affiliation: Lithuanian university of sciences
name: A Pranskunas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00548834: Efficacy and Safety of CDP870 Versus Placebo in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis
Official title: Efficacy and Safety of CDP870 400 mg Subcutaneously Versus Placebo in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Have Previously Failed at Least One DMARD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: CDP870
Certolizumab Pegol
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-10-24
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to confirm and extend the data from previous studies and to demonstrate the efficacy (in terms of signs and symptoms) and safety of monotherapy with CDP870 administered SC every 4 weeks compared to placebo in patients with active RA who had failed at least one DMARD.


Eligibility criteria: Inclusion Criteria:

* male/female, 18-75 years old, inclusive
* diagnosis of adult-onset RA
* had active disease
* had received methotrexate
* on a stable dose of folic acid

Exclusion Criteria:

* contraindication for methotrexate or anti-TNF

Primary outcomes:
measure: American College of Rheumatology (ACR)-20 responder rate at Week 24
timeFrame: 24 weeks
Secondary outcomes:
measure: safety and tolerability every 4 weeks
timeFrame: Every 4 weeks
measure: effect of CDP870 on health outcomes measures
timeFrame: 24 weeks
measure: systemic exposures and immunogenic profile of CDP870
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Fleischmann R, Vencovsky J, van Vollenhoven RF, Borenstein D, Box J, Coteur G, Goel N, Brezinschek HP, Innes A, Strand V. Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis. 2009 Jun;68(6):805-11. doi: 10.1136/ard.2008.099291. Epub 2008 Nov 17.
Clinical trial NCT02064634: A Prospective Observational Study on Discontinuation of Medication of Shinbaro Capsule
Official title: A Multicenter, Comparative, Open Label, Prospective Observational Study on Discontinuation of Medication Due to Gastrointestinal Adverse Effects for the Patients Being Treated for Osteoarthritis With Anti-inflammatory Analgesic Drug
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Keywords: Shinbaro Capsule
Celecoxib
Osteoarthritis
GCSB-5
Discontinuation rate
Gastrointestinal adverse event
NSAIDs
OASIS
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2014-02-17
Enrollment: 6700
Sex: ALL
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: Patients with osteoarthritis being treated with anti-inflammatory analgesic drug at general hospitals and clinics in South Korea

Brief summary: This study investigates how gastrointestinal toxicity affects discontinuation of medication given to patients with osteoarthritis in routine clinical practice.


Eligibility criteria: Inclusion Criteria:

* Minimum 20- year-old patients diagnosed with osteoarthritis
* Within 2 weeks prior to participation, not taken anti-inflammatory analgesic drug such as the Shinbaro Capsule, Celecoxib Capsule and NSAIDs(non-steroidal anti-inflammatory drugs)
* Written consent form voluntarity

Exclusion Criteria:

* Diagnosed with disease that may affect measurement of efficacy clinically
* Diagnosed with clinically significant phycological disorder, and taking medication
* Participated in a clinical trial within 4 weeks
* Pregnant or lactating woman
* History of malignant disease within the previous 5 years
* Patients who seem not to participate in the study at investigator's discretion

Primary outcomes:
measure: Discontinuation rate due to gastrointestinal adverse effects
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Rate of medication discontinuation recorded as lack of efficacy
timeFrame: up to 12 weeks
measure: Rate of medication discontinuation
timeFrame: up to 12 weeks
measure: Discontinuation rate due to adverse events
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Sonpa-gu
Study officials:
References:
Clinical trial NCT02175134: IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis
Official title: IFN-gamma-releasing Assay Based Approach in Patients With Suspected Tuberculous Peritonitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Suspected Tuberculous Peritonitis
Keywords: tuberculosis
peritonitis
laparoscopy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 2
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The diagnosis of tuberculous peritonitis (TBP) is still challenging, and largely dependent on invasive procedures such as laparoscopy. A recently developed RD-1 gene-based assay for diagnosing TBP shows has given promising results. The investigators thus created a 2-step algorithm using the Blood/Ascites ELISPOT assays and adenosine deaminase (ADA) in ascites for differentiation of TBP from other diagnoses (Blood ELISPOT ≥6 spots or ADA ≥ 21 U/L' as a rule-out test and 'Ascites/Blood ratio ≥3' as a rule-in test). This study is the randomized controlled trial on whether this 2-step algorithm-based approach can reduce the laparoscopic biopsy for the diagnosis of TBP in patients with suspected TBP.


Eligibility criteria: Inclusion Criteria:

* all patients with suspected tuberculous peritonitis
* age 16 or more
* formal informed consent

Exclusion Criteria:

* not specified

Primary outcomes:
measure: the frequency of laparoscopic biopsy
timeFrame: 1 week after the enrollment
Secondary outcomes:
measure: the frequency of correct or wrong diagnosis
timeFrame: 6 months after the enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Sung-Han Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03709134: Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy
Official title: Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Breast Neoplasms
Cancer, Breast
Keywords: Circulating tumor cells
CTC
Circulating tumor DNA
ctDNA
Genomics
Transcriptomics
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will enroll women and men with a pathologically-confirmed diagnosis of invasive breast cancer that is stage I-III according to the AJCC v7 criteria.

Brief summary: The primary aim of the study is to identify genomic markers (circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), transcriptomic markers) as biomarkers of response to neoadjuvant chemotherapy (NAC) among patients with invasive breast cancer.

Detailed description: The study aims to evaluate genetic markers (i.e. CTCs and ctDNA) in breast tumors to predict therapy response and metastatic risk. We aim to investigate genomic markers of treatment response and outcomes in breast cancer patients treated with neoadjuvant chemotherapy. The role of CTCs and ctDNA in predicting response to NAC will also be investigated.

Eligibility criteria: Inclusion Criteria:

1. Subjects must give appropriate written informed consent prior to participation in the study.
2. Subjects must be women or men age 18+.
3. Subjects must be receiving neoadjuvant chemotherapy for breast cancer. All chemotherapy types and regimens are acceptable (systemic therapy will determined by the overseeing medical oncologist).
4. Biopsy-confirmed diagnosis of invasive breast cancer (i.e. ER+/-, PR+/-, HER2+/-).
5. Stage I-III disease according to the AJCC v7 criteria.

Exclusion Criteria:

1. Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g. silicone/saline implants) involving either breast, exclusive of the lesion at issue.
2. Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study, such as significant anxiety.

Primary outcomes:
measure: Pathologic complete response (pCR)
timeFrame: Up to 60 months
Secondary outcomes:
measure: Time to distant breast cancer recurrence (months)
timeFrame: Up to 60 months
measure: Time to any recurrence (months)
timeFrame: Up to 60 months
measure: Time to death
timeFrame: Up to 60 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Katarzyna J Jerzak, MD, MSc, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06965634: Investigation of the Effectiveness of Lung Ultrasonography in Intraoperative Fluid Management
Official title: Investigation of the Effectiveness of Lung Ultrasonography in the Management of Intraoperative Fluid Therapy, Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intraoperative Fluid Management
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-05-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who will undergo open surgery in ASA I-III risk classes.

Brief summary: Adequate and balanced fluid resuscitation is one of the cornerstones of intraoperative patient management. Over-resuscitation leading to positive fluid balance is associated with increased postoperative mortality and morbidity.

Invasive and non-invasive technologies can be used for the adequacy of intraoperative fluid therapy.

Lung ultrasonography (LUS) is a safe and accurate bedside imaging method. LUS, which is frequently used in the diagnosis of postoperative hypoxemia, has also begun to be preferred for fluid management in intensive care units.

Detailed description: In this study, we aimed to investigate the effectiveness of intraoperative LUS data in the control of fluid therapy.

Eligibility criteria: Inclusion Criteria:

* Patients with surgery with laparotomy

Exclusion Criteria:

* Chronic obstructive pulmonary disease
* Passed lung operation
* Uncontrolled hypertension
* Acute or chronic kidney failure

Primary outcomes:
measure: LUS
timeFrame: peroperative
Secondary outcomes:
measure: PVI
timeFrame: peroperative
measure: CVP
timeFrame: peroperative
measure: postoperative pulmonary complication
timeFrame: postoperative 6th hour
measure: biochemical data 1
timeFrame: postoperative 6th hour
measure: biochemical data 2
timeFrame: postoperative 6th hour
measure: biochemical data 3
timeFrame: postoperative 6th hour
measure: Mechanical ventilation data 1
timeFrame: peroperative
measure: Mechanical ventilation data 2
timeFrame: peroperative
measure: Mechanical ventilation data 3
timeFrame: peroperative
Other outcomes:
Locations:
Study officials:
References: