louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00704444: A 12-week Post-marketing, Observational Study to Confirm the Safety and Efficacy of Zetia Alone or in Combination With Other Lipid-lowering Drugs in Japanese Subjects With Hypercholesterolemia (Study P05244)
Official title: Designated Drug Use Investigation (12 Weeks) of Zetia 10mg Tablets - A 12-Week Designated Drug Use Investigation of Zetia Monotherapy and Combination Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Familial Hypercholesterolemia
Homozygous Sitosterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2008-06-25
Enrollment: 11332
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will be selected from 2,000 institutions in Japan.

Brief summary: This study is a non-interventional (observational) study in Japan to confirm the safety and efficacy of Zetia when administered alone or in combination with other lipid-lowering drugs in daily medical practice throughout a 12-week period. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Detailed description: The population will be selected from 2,000 institutions in Japan.

Eligibility criteria: Inclusion Criteria:

* Subjects who have hypercholesterolemia, familial hypercholesterolemia, or homozygous sitosterolemia will be considered for this study.

Zetia monotherapy patients must be treated with Zetia alone.

Zetia combination therapy patients must be treated with Zetia in combination with other lipid-lowering drugs for hypercholesterolemia.

Exclusion Criteria:

* Patients with a history of hypersensitivity to any ingredient in Zetia
* Patients with serious hepatic function disorder should not be treated with Zetia in combination with an HMG-CoA reductase inhibitor.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Adverse events will be monitored throughout the 12-week period. (Subjects who discontinue Zetia treatment during the 12-week period will be investigated up to the time of therapy discontinuation )
measure: Change in LDL-C
timeFrame: LDL-C at start of 12 weeks will be compared to LDL-C at the end of the 12-week period.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04669444: Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients
Official title: Investigation of Biomarkers, Genomics, Physiology in Critically Ill and ECMO Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Cardiac Failure
Extracorporeal Membrane Oxygenation Complication
Respiratory Failure
Renal Failure
Critical Illness
Pulmonary Disease
Keywords: ECMO
ARDS
Ventilator induced Lung Injury
Heart Failure
Pulmonary Failure
Biomarkers
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group, intervention
Primary purpose: BASIC_SCIENCE

Brief summary: Patients in end-stage cardiac failure and/or respiratory failure may be started on a rescue therapy known as Extracorporeal Membrane Oxygenation (ECMO). One of the major clinical questions is how to manage the ventilator when patients are on ECMO therapy. Ventilator Induced Lung Injury (VILI) can result from aggressive ventilation of the lung during critical illness. VILI and lung injury such as Acute Respiratory Distress Syndrome (ARDS) can further increase the total body inflammation and stress, this is known as biotrauma. Biotrauma is one of the mechanisms that causes multi-organ failure in critically ill patients. One advantage of ECMO is the ability to greatly reduce the use of the ventilator and thus VILI by taking control of the patient's oxygenation and acid-base status. By minimizing VILI during ECMO we can reduce biotrauma and thus multi-organ failure. Since the optimal ventilator settings for ECMO patients are not known, we plan to study the impact of different ventilator settings during ECMO on patient's physiology and biomarkers of inflammation and injury.


Eligibility criteria: Inclusion Criteria

* Patient currently on ECMO (Veno-Venous or Venous-Arterial or Venous-Arterial-Venous)
* Patient that is a potential ECMO candidate.

Exclusion Criteria

* History of Lung or Cardiac Transplantation
* Patient is not committed to full support
* Treating clinician refusal, or unwillingness to commit to controlled ventilation for at least 4-6 hours (if patient is mechanically ventilated)
* Inability to get informed consent from the patient or surrogate.

Primary outcomes:
measure: Change in plasma IL-6 level from baseline to low driving pressure ventilation
timeFrame: 2 hours
Secondary outcomes:
measure: Change in plasma sRAGE from baseline to low driving pressure ventilation
timeFrame: 2 hours
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego Health
state: California
Study officials:
affiliation: UCSD
name: Robert L Owens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06130644: Early Lymph Node Metastasis in T1/2 Stage Colorectal Cancer: Molecular and Clinical Insights
Official title: Early Lymph Node Metastasis in T1/2 Stage Colorectal Cancer: Molecular and Clinical Insights
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 1451
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colorectal cancer patients.

Brief summary: The prognostic implications of lymph node metastasis in colorectal cancer patients at an early stage, specifically T1/2 stage, are relatively unfavorable. Therefore, understanding the clinical and molecular traits relevant to metastasis in T1/2 stage are of substantial clinical importance.

Detailed description: Patients were classified based on their lymph node staging, with an ancillary categorization into MSI-H and MSS subgroups. A comparative mutational study was performed among these groups, incorporating risk stratification and Receiver Operating Characteristic curve analysis, with the aim of discerning the predictability of clinical features integrated with molecular characteristics for early metastasis in T1/2 stage colorectal cancer.

Eligibility criteria: Inclusion Criteria:

* Men and women aged 18-75 years old;
* Clinical staged T2;
* Histologically proven colon or rectal adenocarcinoma.

Exclusion Criteria:

* Patients over 80 years of age;
* Recurrent colorectal cancer;
* Multiple primary tumors;
* Distant metastasis.

Primary outcomes:
measure: MSI status
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Somatic Mutation Distribution
timeFrame: through study completion, an average of 1 year
measure: Tumor Mutation Burden (TMB)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01607944: Incretins and Metabolism
Official title: The Extrapancreatic Metabolic Effects of Incretin Hormones
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Local community volunteers

Brief summary: Incretin hormones (GLP-1 and GIP) have insulin secretory effects on the pancreas that are glucose dependent. Extrapancreatic effects of incretin hormones are reported, however the glucose dependency of these effects have not been examined. In type 2 diabetes, pancreatic endocrine function and incretin metabolism are impaired. The investigators hypothesize that extrapancreatic effects of incretin hormones are glucose depedent and dysregulated in subjects with type 2 diabetes.

Healthy control subjects and type 2 diabetics will undergo pancreatic clamps. In brief, somatostatin will be infused to inhibit pancreatic endocrine function and basal levels of insulin, glucagon, and growth hormone will be replace via infusion. Metabolic flux will be studied during euglycemic and hyperglycemic stages of the pancreatic clamp. Each subject will undergo 3 trials involving the co-infusion of either saline(Control Trial), GLP-1, or GIP. Glucose metabolism will be assessed using 13C-glucose stable isotope methodology combined with indirect calorimetry and expired breath isotope ratio analysis. Blood flow and flow-mediated dilation will be measured using ultrasound Doppler. Skeletal muscle and abdominal adipose biopsies will be taken to examine intracellular signalling.


Eligibility criteria: Inclusion Criteria:

* age 18-60 years
* BMI 18-35 kg/m2
* NGT or T2DM as classified by ADA criteria

Exclusion Criteria:

* Insulin dependency
* Smokers
* History of or presentation with cardiovascular disease, cancer, and chronic hematological, renal, hepatic, pulmonary disease
* Weight loss (\>2 kg in previous 6 months)
* Physical activity (\>150 mins/week)

Primary outcomes:
measure: Glucose turnover
timeFrame: 0, 1, 2, 3, 4 hours
Secondary outcomes:
measure: Blood flow and flow-mediated dilation
timeFrame: 0, 1, 2, 3, 4 hours
measure: Palmitate turnover and oxidation
timeFrame: 0, 1, 2, 3, 4 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Thomas P Solomon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06450444: The RECLAIM Study.
Official title: Randomized, Double-blind, Sham-controlled Trial to Investigate Combined Occipital and Supra-orbital Neuromodulation in Resistant Migraine. The RECLAIM Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Migraine
High Frequency Episodic Migraine
Lead sponsor: Salvia BioElectronics
Sponsor class: INDUSTRY
First posted: 2024-06-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and performance, including clinical benefit, of the PRIMUS System for the treatment of Resistant Migraine.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of migraine as defined by the ICHD-3 Classification (with or without aura) with a history of chronic or high-frequency episodic migraine for at least 1 year prior to screening
* Failure of 3 or more preventive pharmacological therapies
* Stable on preventive migraine treatments
* Psychologically stable

Exclusion Criteria:

* Concomitant invasive or non-invasive neuromodulation
* Previous exposure to an implantable neuromodulation device for headache
* Have an existing active implantable medical device nearby the implant location (e.g. DBS, cochlear implant)
* Use of onabotulinum toxin A injections for the treatment of migraine in the past 3 months.
* Use of steroid infiltrations or IV administration in the past 3 months.
* Not pregnant, nursing or not using contraception

Primary outcomes:
measure: Safety Evaluation
timeFrame: 12 weeks
measure: Effectiveness Evaluation
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Broadmeadow
country: Australia
facility: Genesis Research Services
state: New South Wales
city: Buderim
country: Australia
facility: Resolve Pain
state: Queensland
city: Hasselt
country: Belgium
facility: Jessa Hasselt
state: Limburg
city: Brugge
country: Belgium
facility: AZ Sint Jan Brugge
state: West Vlaanderen
city: Roeselare
country: Belgium
facility: AZ Delta
city: Wilrijk
country: Belgium
facility: ZAS Antwerpen, Campus Sint-Augustinus
city: Nieuwegein
country: Netherlands
facility: St. Antonius Nieuwegein
city: Rotterdam
country: Netherlands
facility: Erasmus MC Rotterdam
Study officials:
References:
Clinical trial NCT06710444: Erector Spinae Plane Block Versus Retrolaminar Block for Analgesia in Percutaneous Nephrolithotomy
Official title: Ultrasound-guided Erector Spinae Plane Block Versus Retrolaminar Block for Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Analgesia
Pain Management
PCNL
Regional Anesthesia Block
Keywords: Postoperative
Analgesia
Pain
Erector Spinae
Retrolaminar
Block
PCNL
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will investigate the effects of ultrasound-guided ESPB and RLB on intraoperative and postoperative analgesia in patients undergoing PCNL to identify a safe and effective regional block method for postoperative analgesia

Detailed description: All the patients will be blinded to the intervention received in this study. All patients will receive standard general anesthesia technique with endotracheal intubation and muscle paralysis. Postoperatively, all patients will receive analgesia in the form of non-steroidal anti-inflammatory drugs and paracetamol. In case the VAS scores exceeded 4 in any group, the patients will receive rescue analgesia with 25 mg IV meperidine. In both groups, the ESPB and RLB will be performed after induction of general anesthesia using portable ultrasound device.

Eligibility criteria: Inclusion Criteria:

- Patients scheduled for PCNL

Exclusion Criteria:

* daily consumption of analgesics
* allergy to local anesthetics
* liver dysfunction
* infection or previous surgery in the vertebral region.
* patient refusal
* pregnancy

Primary outcomes:
measure: measurement of visual analogue score
timeFrame: after the surgery average 48 hours postoperative
Secondary outcomes:
measure: postoperative additional analgesic requirement
timeFrame: after the surgery average 48 hours postoperative
measure: assessing the patient satisfaction by a the short assessment of patient satisfaction score (SAPS)
timeFrame: after the surgery average 48 hours postoperative
measure: Time to ambulate
timeFrame: after the surgery average 12 hours postoperative
measure: presence of postoperative nausea and vomiting
timeFrame: after the surgery average 48 hours postoperative
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Ahmed S.Shehab
Study officials:
affiliation: Alexandria University
name: Ahmed S. Shehab, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sotome S, Sawada A, Wada A, Shima H, Kutomi G, Yamakage M. Erector spinae plane block versus retrolaminar block for postoperative analgesia after breast surgery: a randomized controlled trial. J Anesth. 2021 Feb;35(1):27-34. doi: 10.1007/s00540-020-02855-y. Epub 2020 Sep 11.
Clinical trial NCT02282644: Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
Official title: Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-11-04
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The recent data suggest that cancer cells at the origin of prostate cancer metastases can be detected in an early stage. Available techniques allow phenotypic analysis of cancer cells in circulating blood (cellsearch) or in marrow hematopoietic (flow cytometry). Pilot study on 180 patients infected by prostate cancer at all stage of disease, show that c-met marker , integrin alpha 2 and 6 expressed in marrow and quantified by flow cytometry were predictor of metastatic progress. In this new study the investigators will analyze antibody panel by cellsearch and flow cytometry on marrow sample of castration-Resistant prostate cancer patients.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed adenocarcinoma or prostate
* Ongoing effective androgen deprivation therapy (testosterone ≤ 50 ng/mL)
* Castration-Resistant prostate cancer patient : defined as a minimum of 3 rising PSA values assessed and/or radiological progress confirmed by RECIST and PCWG2
* Patient who signed informed consent

Exclusion Criteria:

* Severe disorders of coagulation
* Major skin lesion on iliac crests
* Allergies in local anesthetics
* Psychological instability or psychiatric histories
* Uncertain follow-up and distant residence
* History of another invasive cancer and hematologic disease
* Patient deprived of their freedom by court or administrative order
* Revocation of consent

Primary outcomes:
measure: Risk of death according to positive makers
timeFrame: Two years
Secondary outcomes:
measure: Risk of clinical progression according to positive markers.
timeFrame: Two years
measure: Risk of biological progression according to positive markers.
timeFrame: Two years
measure: Risk of radiological progression according to positive markers.
timeFrame: Two years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot - service d'urologie
Study officials:
References:
Clinical trial NCT02447744: Neural Changes Associated With a Mindfulness-based Intervention for Young Adults With Childhood Maltreatment
Official title: Neural Changes Associated With a Mindfulness-based Intervention for Young Adults With Childhood Maltreatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
PTSD
Trauma, Psychological
Keywords: depression
anxiety
childhood trauma
mindfulness
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Mclean Hospital
First posted: 2015-05-19
Enrollment: 43
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Childhood trauma is remarkably prevalent, and it has long lasting impact on mental health and neural development. This trial aims to see whether the 8-week mindfulness based intervention can reduce stress related psychological symptoms for young adults with childhood maltreatment, and whether it can promote neural plasticity.

Detailed description: This study recruits young adults with childhood adversity; enrolled subjects either receive an 8-week mindfulness based intervention, or wait for 8 weeks before receiving the intervention. MRI and a battery of self report questionnaires will be administered before and after the intervention; subjects on the waiting list will undergo the same research procedures at the same time as subjects in the intervention group. Primary hypotheses include improved hippocampal plasticity, increased mindfulness and reduced stress and related psychological symptoms.

Eligibility criteria: Inclusion Criteria:

* Experience of childhood maltreatment
* With current age between 19 to 35 years old
* With current symptoms of depression or anxiety or PTSD or significant general stress.

Exclusion Criteria:

* History of psychiatric disorders with psychotic features
* Suicidal attempts during the past six months
* Neurological disorders
* And common MRI exclusion criteria
* Prior history with the mindfulness based stress reduction program or other systematic meditation programs.

Primary outcomes:
measure: Changes in Subjects' Perceived Stress Level
timeFrame: After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.
Secondary outcomes:
measure: Changes of Mindfulness
timeFrame: After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: Sara Lazar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joss D, Khan A, Lazar SW, Teicher MH. Effects of a Mindfulness-Based Intervention on Self-Compassion and Psychological Health Among Young Adults With a History of Childhood Maltreatment. Front Psychol. 2019 Oct 23;10:2373. doi: 10.3389/fpsyg.2019.02373. eCollection 2019.