louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02532426: Influence of Chronic Hypoxia on Oxidative Phenotype in Patients With Chronic Obstructive Pulmonary Disease
Official title: Influence of Chronic Hypoxia on Oxidative Phenotype in Patients With Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
Muscle biopsy
Chronic hypoxia
OXYPHEN
Oxydative phenotype
Exercise
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: SYNAPSE assocation
First posted: 2015-08-25
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients with chronic hypoxemia and with normoxemia

Brief summary: In addition to chronic airflow obstruction, patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from skeletal muscle dysfunction which is a prominent and disabling feature and also an independent determinant of survival. Muscular impairment involves loss of muscle oxidative phenotype (OXPHEN: a slow-to-fast shift in fibre types and reduced oxidative capacity). Since hypoxia obviously is a key feature of COPD, the aim of this study is to elucidate the role of hypoxia in loss of muscle OXPHEN.

Thus, OXPHEN and expression levels of its key regulators will be determined in the baseline biopsies for association with the degree of hypoxemia. In addition, expression levels of the key OXPHEN regulators will be measured in pre/post exercise biopsies.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD confirmed according to GOLD score.
* Hypoxemia group: resting arterial paO2 \<55 mmHg.
* Normoxemia group : resting arterial paO2 \> 67 mmHg

Exclusion Criteria:

* Unstable cardiorespiratory status (acute respiratory failure)
* Oxygen treatment started
* Inclusion in a pulmonary rehabilitation program in the last 6 months
* Anticoagulant treatment

Primary outcomes:
measure: Level of expression of muscle messenger ribonucleic acid (mRNA) of HIF-1α and PGC-1α
timeFrame: Day 1
Secondary outcomes:
measure: Type I muscle fibers
timeFrame: Day 1
measure: Oxidative enzyme capacity
timeFrame: Day 1
measure: Level of expression of muscle mRNA of HIF-1α after acute exercise
timeFrame: Day 1
measure: Level of expression of muscle mRNA of PGC-1α after acute exercise
timeFrame: Day 1
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: COSTES Frédéric, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01223326: N-acetylcysteine to Reduce Ischemia/Reperfusion Injury in Liver Resection
Official title: A Randomized Controlled Trial of N-acetylcysteine to Reduce Ischemia/Reperfusion Injury in Liver Resection Performed Under Ischemic Preconditioning and Intermittent Portal Triad Clamping
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatectomy
Reperfusion Injury
Keywords: Acetylcysteine
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2010-10-19
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study hypothesis: N-acetylcysteine (NAC) can reduce ischemia/reperfusion injury in liver resection performed under ischemic preconditioning and intermittent portal triad clamping.

Detailed description: One of the most important factors in the pathophysiology of liver dysfunction after hepatic surgery is the cellular damage derived from the interruption of blood flood with reperfusion of the organ. N-acetylcysteine (NAC) has proved beneficial in several conditions involving oxidative damage. This study investigates the effects of NAC to reduce ischemia/reperfusion injury in liver resection performed under ischemic preconditioning and intermittent portal triad clamping.

Methods: 46 ASA II-III patients scheduled to undergo liver resection where randomised to receive NAC (initial dose: 150 mg/Kg; and infusion of 50 mg/kg, from 30 minutes before the ischemia up to 60 minutes later to the reperfusion) or placebo in a phase IV clinical trial. Blood, hepatic and urinary markers were obtained at basal status and 1, 3 and 24 h post final reperfusion.

Eligibility criteria: Inclusion Criteria:

* Hepatectomy

Exclusion Criteria:

* ASA 4
* Cirrhosis
* Creatinine \> 1.2 mg/dL
* Associate surgery (pancreatic or splenectomy)
* Intraoperative bleeding \> 2 L.
* Active infection of inflammatory disease

Primary outcomes:
measure: Laboratory results
timeFrame: 24 hours
Secondary outcomes:
measure: Inflammation
timeFrame: 24 hours
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
Study officials:
affiliation: Clinica Universidad de Navarra
name: Pablo Monedero, M.D., Ph. D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06903026: PRevalence Of Transient Global Amnesia in Obstructive Sleep Apnea Syndrome
Official title: PRevalence Of Transient Global Amnesia in Obstructive Sleep Apnea Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transient Global Amnesia
Keywords: Transient Global Amnesia
Sleep apnea syndrome
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients seen for consultation in the Neuropsychology Department of Strasbourg University Hospital between March 1, 2015 and December 31, 2021 following an episode of amnestic stroke meeting the Hodges and Warlow criteria.

Brief summary: Amnesic stroke is an amnestic syndrome lasting less than 24 hours characterized by the occurrence of anterograde amnesia often associated with retrograde amnesia, the pathophysiology of which is still poorly understood at present. A recent study on a small sample size (N=29) highlighted an association between obstructive sleep apnea syndrome and amnesic stroke. Our study seeks to confirm or refute these results on a larger cohort (N=200-250). A better understanding of the pathophysiological processes involved would open up new therapeutic avenues.


Eligibility criteria: Inclusion Criteria:

* Adult patients seen for consultation in the Neuropsychology Department of Strasbourg University Hospital between March 1, 2015 and December 31, 2021 following an episode of amnestic stroke meeting the Hodges and Warlow criteria:
* The stroke must have been documented and reported by a competent witness present during the stroke.
* Anterograde amnesia during the stroke.
* Absence of vigilance, personality, and cognitive disorders other than memory disorders (aphasia, apraxia, etc.).
* Absence of focal neurological symptoms during the episode and its aftermath.
* Absence of epileptic manifestations.
* Resolution of the episode in less than 24 hours.
* Exclusion of patients with a history of recent head trauma or active epilepsy (undergoing regular treatment or having experienced a seizure in the last 2 years).
* Subjects who have not expressed opposition to the reuse of their data for scientific research purposes.

Exclusion Criteria:

* Patients who have expressed opposition to the retrospective reuse of their data for scientific research purposes.
* Patients with active epilepsy
* Patients with recent head trauma
* Patients with an MMS \< or equal to 25
* Subject under guardianship or curatorship
* Subject under judicial protection

Primary outcomes:
measure: To assess the prevalence of obstructive sleep apnea syndrome in patients who have experienced an amnestic stroke.
timeFrame: Within the last 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Neurologie - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT04335526: A Clinical Study to Assess the Effect of Change of Bile Acid on the PD and Safety of Metformin and Microbiome Profiles
Official title: A Clinical Study for Assessing the Effect of Change of Bile Acid Pool on the Pharmacodynamics and Safety of Metformin and Intestinal Microbiome Profiles in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Microbiome
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 15
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This clinical trial is intended to evaluate the effect of change of bile acid pool with cholestyramine on the pharmacodynamics and safety of metformin and intestinal microbiome profiles in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Age between 19 to 50, healthy male subjects(at screening)
* Body weight between 50.0 kg - 100.0 kg, BMI between 18.0 - 28.0 kg/m2
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress

Exclusion Criteria:

* Subject who has a past or present history of any diseases following below.(liver, kidney, neurology, immunology, pulmonary, endocrine, hematology, oncology, cardiology, mental disorder)
* Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery (appendectomy, hernioplasty are excluded)
* Serum AST(SGOT), ALT(SGPT)\>2 times upper limit of normal range MDRD eGFR \<80mL/min/1.73m2
* Subject who had drug (Aspirin, antibiotics) hypersensitivity reaction
* Subject who already participated in other trials in 3 months
* Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently

Primary outcomes:
measure: Compare the maximum blood glucose concentration (Gmax)
timeFrame: Day 1/2/8/9 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)
measure: Compare the maximum blood glucose concentration (Gmax)
timeFrame: Day 1/2/8/9 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)
measure: Compare the gut microbiome species change
timeFrame: Day 1/2/8/9
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Bundang Hospital
name: Chung Jae Yong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03376126: Minimally-Invasive Isolated Limb Perfusion
Official title: Minimally-Invasive Isolated Limb Perfusion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Isolated Limb Perfusion
Keywords: isolated limb perfusion
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2017-12-18
Enrollment: 10
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 scheduled for isolated limb perfusion.

Brief summary: The aim is to analyse feasibility of a minimally-invasive isolated limb perfusion.

Detailed description: Isolated limb perfusion (ILP) and isolated limb infusion (ILI) are treatment options for patients with in-transit metastases of melanoma and locally advanced extremity sarcomas. There are several advantages for each method, but if the well-established effects of ILP could be combined to the minimally invasive approach of ILI, the results could be maximized and adverse events, related to open approach, minimized.

A new method for vascular approach (MI-ILP) will be evaluated in a phase I feasibility study. Percutaneous vascular access of the ipsilateral side will be performed by ultrasound guided technique and connected to an extracorporeal oxygenation system. Perfusion will be conducted in the same way as for open ILP. Outcomes, technical details and complications will be recorded prospectively.

Eligibility criteria: Inclusion Criteria:

1. The patient scheduled for treatment with isolated hyperthermic perfusion
2. Age over 18 years.
3. Signed informed consent

Exclusion Criteria:

1. Re-perfusion
2. Lymph node metastases
3. Severe atherosclerosis

Primary outcomes:
measure: Conversion to open surgery
timeFrame: 1 day
Secondary outcomes:
measure: Response
timeFrame: 3 months
measure: Complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References:
Clinical trial NCT01452126: Minimum Effective Concentration of Ropivacaine for Brachial Plexus Block Via the Supraclavicular and Infraclavicular Approach, Femoral Nerve Block, Sciatic Nerve Block Via the Popliteal and Parasacral Approach
Official title: Minimum Effective Anesthetic Concentration of Supraclavicular Block, Infraclavicular Block, Femoral Nerve Block and Sciatic Nerve Block Via the Popliteal and Parasacral Approach
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Surgical Anesthesia
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2011-10-14
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This is a dose finding study to identify the minimum effective anesthetic concentration (MEAC) of ropivacaine to produce insensate body parts sufficient for surgery in supraclavicular and infraclavicular approaches to the brachial plexus, parasacral and popliteal approaches to the sciatic nerve, femoral nerve and transversus abdominis plane (TAP) blocks in adults.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I to III (patients may be healthy or have systemic disease, but any disease does not pose a constant threat to life, and patients are neither moribund, nor not expected to survive without the operation).
* Age 18 or above
* Undergoing elective ambulatory surgery of the upper limb (excluding the shoulder), lower limb (excluding the hip), or lower abdomen with sensory blockade as part of the pain management plan.

Exclusion Criteria:

* Body mass index of \>35 kg/m2 (higher chance of failure)
* Deformities of the leg (for patients in the parasacral, femoral, and popliteal groups), or the chest or shoulder (for patients in the supraclavicular, infraclavicular, and TAP groups)
* Preexisting infection at the injection site
* Existing neurologic disease
* Allergy to local anesthetic agents
* Severe respiratory disease
* Coagulopathy
* Any other contraindication to the block being considered
* Patients requiring total motor blockade as well as sensory blockade

Primary outcomes:
measure: Effective Concentration of Ropivacaine to Produce Surgical Anesthesia in 50% of Population
timeFrame: 1 day
Secondary outcomes:
measure: Number of Patients With Complications
timeFrame: 3 days
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Univeristy of Mexico Outpatient Surgical and imaging service
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Nicholas Lam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05046626: Nutritional Counseling to Change Eating Behavior, Metabolism and Anthropometry in Adults With Abdominal Obesity
Official title: Effect of Intervention Based on Nutritional Counseling on Changes in Eating Behavior and Components of Body Composition and Metabolism in Adult Workers With Abdominal Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Abdominal
Keywords: obesity
nutritional counseling
weight loss
eating behaviors
abdominal obesity
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study evaluates the impact of changes in eating behavior through nutritional counseling, after nine months of intervention, on body composition and metabolism in adult workers with abdominal obesity

Detailed description: This study is a nutritional intervention in voluntary workers with abdominal obesity (waist circumference ≥102cm and ≥88cm). The intervention is divided into two phases: the intensive one has a duration of 6 months and consisted in a 4 face-to-face sessions with 9 online or telephone contacts based on the use of nutritional counseling \[Academy of Nutrition and Dietetics, 2013\] and the second phase: consisted in a 3 months' follow-up with 2 telephone contacts and a final visit face-to-face. The investigators used the Cognitive Behavior Therapy process as a theoretical framework, and also used the intervention comprised sessions designed to promote motivation, social support, self-regulation to promote the eating behavior change process. The participants were measured weight loss, waist circumference, and the lipid profile change, pre-intervention, and after six and nice months post-intervention.

Eligibility criteria: Inclusion Criteria:

* With abdominal obesity: men with waist circumference (CC) ≥102 cm and women with CC ≥88 cm.
* Literacy.
* Sign the informed consent

Exclusion Criteria:

* Participants with severe alterations of their renal function, hepatic, thyroid and circulatory system (self-reported or found in their laborarotorio analysis)
* Participants with any serious illness, hospitalization in the 6 months prior to the start of the study.
* In nutritional treatment for weight loss in the last three months.
* In psychological and / or psychiatric treatment.
* Depression or anxiety.
* History of bariatric surgery.
* Pregnant or lactating women.

Primary outcomes:
measure: Change in eating behaviors
timeFrame: 6 and 9 months
Secondary outcomes:
measure: Anthropometric indicators
timeFrame: 6 and 9 months
measure: Decrease triglycerides
timeFrame: 6 and 9 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Guadalajara
name: Yolanda Fabiola Marquez Sandoval, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02683226: Comparison of Alogliptin Versus Alogliptin and Pioglitazone on Insulin Resistance of Metformin Treated Women With PCOS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Insulin Resistance
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine whether dual treatment with metformin and alogliptin is more effective than treatment with metformin, alogliptin and pioglitazone in the treatment of obese women with polycystic ovary syndrome (PCOS) regarding insulin resistance and beta cell function.


Eligibility criteria: Inclusion Criteria:

* 18 years old to menopause
* polycystic ovary syndrome (NICHD criteria)
* BMI of 30 kg/m² or higher

Exclusion Criteria:

* type 1 or type 2 diabetes mellitus
* history of carcinoma
* Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
* personal or family history of MEN 2
* significant cardiovascular, kidney or hepatic disease

Primary outcomes:
measure: The main outcome was change in insulin resistance measured with homeostasis model assessment (HOMA IR).
timeFrame: HOMA IR was calculated at the base point and at the endpoint of 12 weeks of clinical trial.
measure: Primary outcome was change in beta cell function using adaptation index.
timeFrame: Adaptation index was calculated at the base point and at the endpoint of 12 weeks of clinical trial.
measure: Primary outcome was change in fasting concentration of glucose.
timeFrame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
measure: Primary outcome was change in fasting concentration of insulin.
timeFrame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial.
Secondary outcomes:
measure: Secondary outcome was change in body mass index (BMI).
timeFrame: Patient's body weight were measured at the base point and every four weeks during the 12 weeks of clinical trial. Patient's height was measured at the basepoint
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
Study officials:
References:
Clinical trial NCT05982626: Study of 68Ga /131I SGMIB-ZT-199 PET Imaging Targeting HER2-positive in the Diagnosis of Metastatic Breast Cancer
Official title: Study of 68Ga /131I SGMIB-ZT-199 PET Imaging Targeting HER2-positive in the Diagnosis of Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HER2-positive Breast Cancer
Keywords: Her2-positive
Metastatic breast cancer
Positron-Emission Tomography
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the safety, biodistribution, radiation dosimetry, and uptake in tumor lesions of patients with Her2-positive metastatic breast cancer after injection of \[131I\]/\[68Ga\]SGMIB-ZT-199.


Eligibility criteria: Inclusion Criteria:

* Breast cancer patients.

  1. Women aged between 18 and 75 years old.
  2. Patients with breast cancer confirmed by histological examination or imaging.
  3. HER2 positive diagnosis confirmed by puncture by immunohistochemistry or fluorescence in situ hybridization (HER2 positive is defined as immunohistochemistry result of 3+ (IHC 3+); or immunohistochemistry result of 2+/positive in situ hybridization result (IHC 2+/ISH+)).
  4. Renal function: serum creatinine less than or equal to the upper limit of the normal range; electrocardiogram: no significant abnormalities.
  5. Patients of childbearing age can cooperate with contraception.
  6. Willing and able to cooperate with all items of this study.

Exclusion Criteria:

* Subjects meeting any of the following criteria will be excluded from the study:

  1. Severe hepatic or renal insufficiency;
  2. Participation in another study protocol or clinical care within the past year that has resulted in radiation exposure exceeding an effective dose of 50 mSv in addition to the radiation exposure expected from participation in this clinical study.
  3. Participation in this study is considered unsuitable by other investigators.
  4. Pregnant women and other groups unsuitable to receive radiation.
  5. Alcohol allergy, etc.

Primary outcomes:
measure: Dosimetry
timeFrame: about 24hours from time of injection
Secondary outcomes:
measure: Safety Assessment
timeFrame: From administration of [131I]SGMIB-ZT-199 until 1 week after injection
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
Study officials:
affiliation: Huashan Hospital
name: Fang Xie, PhD
role: PRINCIPAL_INVESTIGATOR
References: