louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06923254: 7.0T Magnetic Resonance Imaging Study for Hepatic Encephalopathy
Official title: 7.0T Magnetic Resonance Imaging Study for Hepatic Encephalopathy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatic Encephalopathy (HE)
MRI
fMRI Research
Keywords: Hepatic Encephalopathy
fMRI
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hepatic encephalopathy

Brief summary: This clinical trial study aims to detect the imaging characteristics of patients with hepatic encephalopathy (HE) using 7-Tesla (7T) magnetic resonance imaging (MRI).

Detailed description: In this study, we analyzed the imaging characteristics of HE. First, with the advantages of 7TMRI, we analyzed the differences in imaging characteristics between HE patients and the healthy, including brain functional imaging and structural imaging. Second, we analyzed the differences in imaging characteristics between different subgroups of HE patients. Finally, we analyzed the correlation between the prognostic results of HE patients after follow-up and the imaging characteristics.

Eligibility criteria: Inclusion Criteria:

* Patients with clinical suspected or diagnosed hepatic encephalopathy according to relevant guidelines.The patient's education level is above primary school level.
* Regular follow-up.

Exclusion Criteria:

* Contraindications to MRI.
* Patients with cerebrovascular disease, brain tumors, epilepsy, other neurodegenerative disease.

Primary outcomes:
measure: Functional connectivity and structural alterations between individuals with different subtypes of HE and healthy subjects.
timeFrame: 5 years
Secondary outcomes:
measure: Correlation between spectral features of clinical variables and spectral features of imaging.
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Xin Lou
role: STUDY_CHAIR
References:
Clinical trial NCT00249054: Prospective Clinical Evaluation of ASR and ReCap Resurfacing Arthroplasty
Official title: Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Suitable for THA
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2005-11-07
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This evaluation is being conducted to evaluate the performance of the ASR arthroplasty. The performance of the devices will be assessed by:

Clinical parameters: pain, function, satisfaction and complications. Blood samples: Analyse of metal ions, lymphocyte migration, lymphocyte proliferation assay and cytokines.

Biopsies: Metal ions, cytokines and histology. Biomechanics: Strength, gait analysis, range of motion. Scanning: DEXA and MRI


Eligibility criteria: Inclusion Criteria:

ASA I-II,DEXA-scanning:

* lower limit for a 55 years old women,
* MRI normal
* vitality in caput
* willing to return for follow-up evaluations.

Exclusion Criteria:

* collum femoris \< 2 cm
* large cysts in caput (\> 1 cm)
* mismatch between caput and acetabulum
* caput necrosis
* treatment with medicine which affects bone metabolism
* impaired kidney function.

Primary outcomes:
measure: Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up.
timeFrame: 10 year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Frederiksberg University Hospital
state: Copenhagen
Study officials:
affiliation: Frederiksberg University Hospital
name: arne borgwardt, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03154554: Epidemiology of Patients Consulting for Original LBP Spinal Adult Emergency
Official title: Epidemiology of Patients Consulting for Original LBP Spinal Adult Emergency Hautepierre and 3 Months Course of Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lumbar Pain
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to adult emergencies in Hautepierre for lumbago pain, with or without sciatica,

Brief summary: Lumbar pain is an extremely common complaint in general population. The direct and indirect costs incurred in are a real public health problem.

Cohort studies show that improving symptoms after consultation for lumbar pain is insufficient, but there are few data on emergency medical and surgical services in France. In order to reflect on areas for improvement the investigators to carry out an inventory of consultations for lumbar pain emergencies of Hautepierre Hospital.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to adult emergencies in Hautepierre for lumbago pain, with or without sciatica,
* Age greater than or equal to 18 years
* Having signed non-opposition to participation in the study
* Having completed the initial questionnaire

Exclusion criteria:

* Spinal trauma in the month before the consultation
* Pain of non-spinal origin (pyelonephritis, colic Nephritic, aortic dissection ...)
* Non-Francophone Patients
* Patient under tutorship or under curatorship
* Patient under safeguard of justice

Primary outcomes:
measure: current clinical condition, lumbar antecedent and patient care questionnaires
timeFrame: At the time of consultation in the adult emergency department, 3 months after consultation in the adult emergency department
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02490033: The VERISMART Trial
Official title: Randomised Trial Comparing Conventional Versus Contact Force and Electrical Coupling Index in Atrial Flutter Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Flutter
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2015-07-03
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Catheter ablation is now routinely used in the management of heart rhythm disorders. One of the problems with the approach is that it has not been possible to determine whether the ablation catheter is in direct contact with the heart tissue or not. This is important because too much contact has safety implications and too little means that the therapy will be ineffective. Recently two different technologies have been developed to determine contact. Currently it is not know if one is superior to the other, and the objective of this trial is to determine whether there is a difference when treating a rhythm called atrial flutter.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Documented paroxysmal or persistent atrial flutter

Exclusion Criteria:

* Inability or unwillingness to receive oral anticoagulation
* Previous ablation procedure for AFL
* Unwillingness or inability to complete the required follow up arrangements
* Concomitant atrial fibrillation

Primary outcomes:
measure: Time to achieve bi-directional block
timeFrame: up to 60 Seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
Study officials:
References:
citation: Begg GA, O'Neill J, Sohaib A, McLean A, Pepper CB, Graham LN, Hogarth AJ, Page SP, Gillott RG, Hill N, Walshaw J, Schilling RJ, Kanagaratnam P, Tayebjee MH. Multicentre randomised trial comparing contact force with electrical coupling index in atrial flutter ablation (VERISMART trial). PLoS One. 2019 Apr 3;14(4):e0212903. doi: 10.1371/journal.pone.0212903. eCollection 2019.
Clinical trial NCT00619333: Inactive FSH in Galactosemia
Official title: The Role of Inactive Follicle Stimulating Hormone in Ovarian Dysfunction in Galactosemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Galactosemia
Premature Ovarian Failure
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: The Dutch Galactosemia Society
First posted: 2008-02-20
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The aim of the study is to investigate whether inactive FSH plays a role in the development of Premature Ovarian Failure in women with Classic Galactosemia


Eligibility criteria: Inclusion Criteria:

* Diagnosis of galactosemia through GALT-activity analysis and/or mutation analysis
* Premature Ovarian Failure with FSH \> 30 U/l

Exclusion Criteria:

* Gynecological cancers and/or unexplained vaginal bleeding

Primary outcomes:
measure: Estradiol response
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Hospital
Study officials:
affiliation: Maastricht University Hospital
name: Estela Rubio-Gozalbo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06289933: A Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" Under Fed Conditions in Healthy Adult Volunteers
Official title: An Open Label, Randomized, Fed, Single Dose, 2-sequence, 2-period, Crossover Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type2 Diabetes Mellitus
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-03-04
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this clinical study is to compare the pharmacokinetics and the safety between a fixed-dose combination administration of "BR3005" and co-administration of "BR3005-1" and "BR3005-2" under fed conditions in healthy adult volunteers


Eligibility criteria: Inclusion Criteria:

* Those who have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit

  * In case of a male subject, Those who weigh 50 kg or more
  * In case of a female subject, Those who weigh 45 kg or more
* Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.

Exclusion Criteria:

* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
* Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months prior to the first administration date.(However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
* Those who have a medical history of gastrointestinal surgery or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
* In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.

Primary outcomes:
measure: AUCτ
timeFrame: 0~48 hours after administration
measure: Cmax
timeFrame: 0~48 hours after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Research Center, H PLUS Yangji Hospital
state: Gwanakgu
Study officials:
References:
Clinical trial NCT01600833: The Association of Ferrtin and Homocysteine Etc. With RI and MS in Polycystic Ovary Syndrome (PCOS)
Official title: To Association of Serum Ferrtin and Homocysteine Levels With Insulin Resistence and Metabolic Syndrome in Women With Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
Ferritin
Homocysteine
Insulin Resistance
Metabolic Syndrome
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2012-05-17
Enrollment: 539
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients who had been performed with fully PCOS-related survey Who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.

Brief summary: The purpose of this study is to study the association of serum ferritin and homocysteine levels with insulin resistance and metabolic syndrome in women with polycystic ovary syndrome The polycystic ovary syndrome (PCOS) is a common endocrine disease, affecting 5-10% of women with reproductive age. Insulin resistance and metabolic disturbance are well-known long-term consequence of women with PCOS. Recent evidence suggests that increased body iron might be involved in the pathogenesis of insulin-resistance disorders, furthermore, hyperhomocysteinemia is associated with an increased risk of atherosclerotic and thromboembolic disorder. The investigators plan to retrospectively review the medical records of female patients who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.


Eligibility criteria: Inclusion Criteria:

* female patients who had been performed with fully PCOS-related survey Who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.

Exclusion Criteria:

* women who had been diagnosed with disorders of the uterus (e.g., Asherman's Syndrome, Mullerian agenesis), and chromosomal anomalies (e.g., Turner syndrome)
* women who had menopause
* women with inadequate clinical/biochemical records
* women who had had ovarian cysts or ovarian tumors
* women who took hormone, medicine for Diabetes and/or cardiovascular disease.

Primary outcomes:
measure: Serum ferritin levels in obese and non-obese women.
timeFrame: the patients have PCOS who visited the Reproductive Endocrinology Clinic at the WanFang Medical Center from Jan 1, 2008 to Nov 30, 2011.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: WanFang Medical Center at Taipei Medical University
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Ming I Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03793933: ACS-NSQIP Calculator for Liver Surgery
Official title: Performance of the American College of Surgeons Surgical Risk Calculator in Patients Undergoing Hepatectomy for Liver Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Surgery
Hepatectomy
Outcome After Hepatectomy
Lead sponsor: Humanitas Clinical and Research Center
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study examined a cohort of consecutive patients that underwent hepatectomy at our institution between November 2015 and July 2018.

Brief summary: The American College of Surgeons National Surgical Quality Improvement Program's (ACS-NSQIP) calculator has been endorsed by the surgeons' community to counsel patients and relatives regarding estimated postoperative complications. However, it does not include organ-specific risks. The aim of this study was to assess the ACS-NSQIP calculator's ability to predict complications, mortality and length of stay (LOS) in patients undergoing hepatectomy for liver tumors

Detailed description: This is an observational retrospective study conducted in a tertiary-referral university hospital. An established classification of complications, including post-hepatectomy insufficiency and bile leak, was adopted. The endpoint was the rate of complications, mortality and LOS as expected by the ACS-NSQIP calculator and as observed within 90-day after surgery.

Eligibility criteria: Inclusion Criteria:

* Any patient who underwent surgery for a liver tumor at our Institution between the defined period of time

Exclusion Criteria:

* Any patient with missing data

Primary outcomes:
measure: ACS-NSQIP calculator's ability
timeFrame: From the date of surgery up to three months from the date of surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03102333: Comparison: Constant-rate Infusion Plus Demanding Dosing VS Variable-rate Feedback Infusion Plus Demanding Dosing
Official title: Comparison: Constant-rate Infusion Plus Demanding Dosing VS Variable-rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In the case of the newlys developed PCA, the infusion rate is increased according to the patient's need for bolus button, so that the pain can be controlled more efficiently.

Detailed description: In the case of the existing iv-pca, the analgesic drug was injected into the patient at a constant rate (ex. 1 ml / hr) and additional pain was controlled through the bolus dose (1 ml).

As a result, the analgesic effect was insufficient, or the effect was excessive, causing side effects (nausea, vomiting, sedation, dizziness). Especially In spinal surgery, the degree of pain sharply decreases from day 1 to day 2. Classic iv-pca with constant infusion rate can not reflect this result. But in the case of the newlys developed PCA, the infusion rate is increased according to the patient's need for bolus button, so that the pain can be controlled more efficiently. If the bolus button is not pressed for a certain period of time, it is expected that the injection rate will be reduced and the side effect caused by the analgesic agent will be decreased.

Eligibility criteria: Inclusion Criteria:

* Spine fusion surgery at Chung-Ang University Hospital with IV- PCA under general anesthesia

Exclusion Criteria:

* Unrecorded type of anesthetic agent
* Denial to the study
* Brain disorder
* Cardiopulmonary disease
* Psychiatric disorders

Primary outcomes:
measure: Demanded numbers of bolus button
timeFrame: Change from immediately to 24 hours after operation
Secondary outcomes:
measure: Pain intensity
timeFrame: Change from immediately to 24 hours after operation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
References:
Clinical trial NCT01560533: Representation of the Body for Patients With Cancer
Official title: Representation of the Body and Treatment of Peritoneal Cancer by Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) - A Collaborative Approach Between Professionals of Health / Patients / Researchers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peritoneal Carcinomatosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The project aims to understand better how patients live the event of cancer and live its consequences on their bodily representations. In the study, the dynamic of the body image is not restricted to appearance but include sensations and visions of the inner body, what explains the choice of peritoneal cancer, and the treatment by cytoreductive surgery and HIPEC.

The three objectives of the study are:

* identifying the impact of the representations of the treated body on the psychological strategies to cope with the disease, the bodily changes and the prospects of life;
* making explicit the positive or negative impacts of these representations on the relationship between patients and health professionals (easing factors, misunderstandings, negotiations, etc.);
* associating the health professionals with the study in its course and evaluation in order to elaborate a methodological collaborative approach between patients, health professionals and researchers in social sciences.


Eligibility criteria: Inclusion Criteria:

* Patients eligible to treatment of cancer by cytoreductive surgery and HIPEC
* Primary (pseudomyxoma, mesothelioma) and secondary (colorectal, gastric, ovarian) peritoneal cancer
* Free consent
* Male or Female
* Age \> 18 years
* Affiliate to social security

Exclusion Criteria:

* Age \< 18 years, no french speaking
* Cerebrals metastasis
* Psychiatrics diseases

Primary outcomes:
measure: Body representations
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civiles de Lyon
name: Olivier GLEHEN, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Durif-Bruckert C, Guilloux R, Guioux A, Lasserre E, Goffette J, Regnier V. [Qualitative and collaborative research with cancer patients. Experience narratives of treatments for peritoneal carcinomatosis]. Bull Cancer. 2016 Feb;103(2):148-53. doi: 10.1016/j.bulcan.2015.10.015. Epub 2015 Dec 8. French.