louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01160419: Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2010-07-12
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The rationale of the NEO-FLOT-trial consists of an intensification of the neoadjuvant treatment.

This strategy is based upon the clear advantage of perioperative treatment and the fact, that in former trials adjuvant treatment could only be given in half of the patients (Cunningham 2006, Boige 2007).

In this study neoadjuvant chemotherapy is applied during a period of 12 weeks with an interim staging after 6 weeks.Due to the favourable efficacy and toxicity data the FLOT-regimen was chosen for the neoadjuvant treatment consisting of oxaliplatin, docetaxel, folinic acid and 5-Fluorouracil (Al-Batran 2008).

Postoperative treatment according to the results of the MAGIC trail is not part of the trail and is given at the responsibility of the participating centres.


Eligibility criteria: Inclusion Criteria:

* Histologically Confirmed Adenocarcinoma of the Gastroesophageal Junction (AEG I-III) or Gastric Adenocarcinoma (every T, N+ or T3/T4, Nx, M0)
* Written Informed Consent
* Age ≥ 18 Years
* Expected operability
* ECOG ≤ 2
* Exclusion of Peritoneal Metastasis
* Adequate Hematological, Renal, Cardiac and Hepatic Function
* Effective Contraception

Exclusion Criteria:

* Prior Chemotherapy or Radiotherapy of the Adenocarcinoma of the Gastroesophageal Junction (AEG I-III) or Gastric Adenocarcinoma
* Not Histologically Confirmed Primary Tumor
* Distant Metastasis, Local Relapse
* Known Hypersensitivity for 5-Fluorouracil, Leucovorin, Oxaliplatin or Docetaxel
* Known Dihydropyrimidin-Dehydrogenase (DPD) - Deficiency
* Peripheral Polyneuropathy ≥ Grade II (NCI-CTCAE, Version 3.0)
* Myocardial Infarction in the last 3 Months, Cardiac Insufficiency Grade II-IV (NYHA)
* Severe Comorbidity or Acute Infections
* Pregnancy or Breast Feeding
* Insufficient Contraception
* Participation in another Clinical Trial (Simultaneously or 30 Days Prior to Enrollment)
* Malignancy \<5 years (except: Carcinoma In Situ of the Cervix Uteri or Adequately Treated Basalioma of the Skin)
* Lack of Legal Capacity

Primary outcomes:
measure: Collection of the R0-Resection rate
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: University of Munich, Klinikum Grosshadern
Study officials:
References:
Clinical trial NCT02268019: Hemostasis During Hypospadias Surgery
Official title: A Comparison Between Tourniquet Application and Epinephrine Injection for Hemostasis During Hypospadias Surgery: the Effect on Bleeding and Post-operative Outcome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypospadias Repair
Keywords: hypospadias
dehiscence
urethral stricture
side effects
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 70
Sex: MALE
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A comparison between the two hemostatic methods of hypospadias repairing operation, in terms of early and mid-term (up to 6 months) failure rate (wound dehiscence and urethral stricture needing reoperation) between the two groups: Group A) diluted Epinephrine injection, Group B) tourniquet application in children


Eligibility criteria: Inclusion Criteria:

- age under 15 Hypospadiasis ( Distal, Midshaft, Proximal)

Exclusion Criteria:

- Bleeding tendency Penoscrotal Hypospadiasis Other method

Primary outcomes:
measure: Bleeding
timeFrame: During surgery
Secondary outcomes:
measure: fistula
timeFrame: after surgery for 6 months
Other outcomes:
measure: meatal and neourethral stricture
timeFrame: after surgery for 6 months
measure: wound dehiscence
timeFrame: after surgery for 6 months
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan University of Medical science
Study officials:
References:
Clinical trial NCT03974919: Preoperative Pulmonary Systolic Pressure and Outcome After Non-cardiac Surgery:Threshold Analysis
Official title: Preoperative Pulmonary Systolic Pressure and Outcome After Non-Cardiac Surgery:Threshold Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Hypertension, major cardiovascular event, non-cardiac surgery,threshold
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 19000
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: non-cardiac surgery adult patients with preoperative echocardiography

Brief summary: The linear or nonlinear relationship of pulmonary systolic pressure and cardiovascular and kidney outcome after non-cardiac surgery is unknown. This study is to explore the relationship of the two and try to identify the possible threshold of pulmonary systolic pressure for major cardio-vascular events after non-cardiac surgery.

Detailed description: The linear or nonlinear relationship of pulmonary systolic pressure and cardiovascular and kidney outcome after non-cardiac surgery is unknown. This study is to explore the relationship of the two and try to identify the possible threshold of pulmonary systolic pressure for major cardio-vascular events after non-cardiac surgery.

Patients with preoperative cardio-echogram under going non-cardiac surgery were collected. The postoperative major cardiovascular, cerebral and kidney events were also identified and collected. Other data including peri-operative information and surgeries and anesthesia data were gathered.

Logistic regression models were built and selected. Independent risk factors relative to postoperative major cardiovascular and cerebral events were screened and identified. Odds ratio, relative risk and relative risk ratio of varies dichomitus cut points were calculated, trend breakpoint were identified, propensity score analysis were also done for causal inference.

Eligibility criteria: Inclusion Criteria:

non-cardiac surgery patients with preoperative echocardiography records

Exclusion Criteria:

electronic records missing or peri-operative data missing

Primary outcomes:
measure: major adverse events
timeFrame: 30 days postoperatively in hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: First hospital Peking University
state: Beijing
Study officials:
References:
Clinical trial NCT00549419: Arterial Pressure Based Cardiac Output for Goal-Directed Therapy in Abdominal Surgery
Official title: Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Therapy in Patients Undergoing Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Abdominal Surgery
Lead sponsor: Klinikum Ludwigshafen
Sponsor class: OTHER
First posted: 2007-10-25
Enrollment: 60
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: The purpose of this study is to determine whether the early identification and more precise intervention of goal-directed intraoperative plasma volume expansion and catecholamine therapy using arterial pressure based cardiac output (APCO) measurement in addition to normal vital signs will improve postoperative organ function, in particular renal function, in patients undergoing major abdominal surgery.


Eligibility criteria: Inclusion Criteria:

* Patient is scheduled for elective major abdominal surgery and has two or more risk factors according to the Lee classification scheme.
* Patient can sign informed consent before surgery.
* Patient is able to comply with the study procedure.
* Patient must require an indwelling radial or a femoral artery catheter.
* Patient must be 20 years old or older.
* Patient must be 40kg or heavier.
* Patients height and weight can be accurately obtained prior to study start.

Exclusion Criteria:

* Emergency surgery.
* Patients with aortic or mitral valve regurgitation.
* Renal insufficiency requiring hemodialysis.
* Liver dysfunction (alanine/aspartate aminotransferase \>40 U/L).
* Patient with contraindications for the placement of radial, femoral or other arterial cannulae.
* Patient being treated with an intraaortic balloon pump.
* Female patients with a known pregnancy.
* Patient is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.

Primary outcomes:
measure: The primary endpoint of the study is postoperative renal function, as determined by measurement of the glomerular filtration rate.
timeFrame: 6 month
Secondary outcomes:
measure: Total fluid requirements (type and volume); Drug requirement (type and volume); Other organ function (myocardial function, liver function, endothelial function, degree of inflammation)
timeFrame: 6 month
Other outcomes:
Locations:
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen
state: RLP
Study officials:
affiliation: Klinikum Ludwigshafen
name: Stefan W. Suttner, M.D. Ph.D.
role: STUDY_DIRECTOR
References:
citation: Mayer J, Boldt J, Mengistu AM, Rohm KD, Suttner S. Goal-directed intraoperative therapy based on autocalibrated arterial pressure waveform analysis reduces hospital stay in high-risk surgical patients: a randomized, controlled trial. Crit Care. 2010;14(1):R18. doi: 10.1186/cc8875. Epub 2010 Feb 15.
Clinical trial NCT04682119: A Safety Study of LY3526318 in Healthy Participants
Official title: A Safety, Tolerability and Pharmacokinetic Study of Single and Multiple Doses of LY3526318 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-12-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to learn more about how the drug is absorbed in to the blood stream and how it is eliminated from the body. The safety and tolerability of LY3526318 will also be evaluated when given by mouth either by single or multiple doses to healthy participants. The study will have two parts. Each participant will enroll in only one part. For each participant, Part A will last up to 44 days and Part B will last up to 50 days, including screening and follow-up.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy males or females, as determined through medical history and physical examination
* Have a body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m²)
* Have clinical laboratory test results within normal reference range

Exclusion Criteria:

* Have a history or presence of medical illness including, but not limited to, cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality
* Have an abnormality in the 12-lead electrocardiogram (ECG)
* Have a history of clinically significant multiple or severe drug allergies
* Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody, or hepatitis B and/or positive hepatitis B surface antigen.
* Have an abnormal blood pressure
* Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer)
* Are unwilling to stop herbal supplements, over the counter or prescription medicines
* Are currently enrolled in a clinical drug study or any other type of medical research judged not to be scientifically or medically compatible with this study.
* Participants with a history of drug abuse

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3526318
timeFrame: Part A: Predose on Day 1 through Day 5; Part B: Predose on Day 1 through Day 8
measure: PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
timeFrame: Part A: Predose on Day 1 through Day 5; Part B: Predose on Day 1 through Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04078919: Effect of a Low Calorie Diet Containing Nuts on Systemic and Vascular Inflammation
Official title: Effect of Low Calorie Diets With and Without Nuts on Systemic and Vascular Inflammation in Patients With Stable Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2019-09-06
Enrollment: 67
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Accumulating evidence from prospective observational studies and a large clinical trial suggests that nut intake lowers the risk of cardiovascular disease (CVD). Tree nuts are rich in unsaturated fats, soluble ﬁber, antioxidants, and phytosterols. The purpose of this study is to compare the effects of low calorie diets with a mixture of nuts in comparison with low calorie diets in improving inflammatory markers in patients with stable coronary artery disease.

Detailed description: A randomized placebo controlled clinical trial will be conducted in modares hospital in Tehran, Iran. After review of the inclusion and exclusion criteria and explanation of the design of the study, written consent form will be completed. The participants are 66 eligible patients, aged 35-70 years. Intervention group will be received low calories diets as well as 20 percent of daily calories from mixed nuts (peanuts, pistachio and almond) and control group will be received low calories diets for 8 weeks. Fasting blood sample will be taken to measure inflammatory markers (Interleukine-6 \[IL-6\] and Interleukine-10 \[IL-10\] and C-Reactive Protein \[CRP\]).

Eligibility criteria: Inclusion Criteria:

* patients with at least one of the cardiovascular risk factors (hypertension, hyperlipidemia, diabetes mellitus)
* patients with coronary artery disease
* willing to participation in the study

Exclusion Criteria:

* َChronic kidney disease stage 3-5
* Any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation

Primary outcomes:
measure: C reactive protein (CRP)
timeFrame: 8 week
Secondary outcomes:
measure: inflammatory cytokines
timeFrame: 8 week
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Clinical Nutrition Research Unit, National Nutrition and Food Technology Research Institute
Study officials:
References:
citation: Ghanavati M, Nasrollahzadeh J. A calorie-restricted diet enriched with tree nuts and peanuts reduces the expression of CX3CR1 in peripheral blood mononuclear cells in patients with coronary artery disease. Int J Vitam Nutr Res. 2023 Aug;93(4):329-338. doi: 10.1024/0300-9831/a000738. Epub 2021 Nov 19.
Clinical trial NCT00526019: Persistence of Airway Inflammation and Remodeling in Subjects With Symptomatic or Complete Asthma Remission
Official title: Characteristics of Symptomatic Asthma Remissions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: remission of asthma
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2007-09-06
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects wiil be offered to volunteer from advertisements in newspaper. Subjects with asthma or in remission of asthma from primary care clinics will be offered to participate.

Brief summary: This study aims at determining the patterns of asthma remission, the prevalence of these different patterns, the various factors associated with such remissions and possible recurrences of asthma, in order to determine the mechanisms involved in these processes.

The investigators therefore want to document these specificities in subjects in complete remission of their asthma, and those in only symptomatic remission of their asthma, in comparison with mildly symptomatic asthmatic subjects and healthy controls.

Detailed description: Primary Outcome Measures :

* Airway inflammation (% induced sputum eosinophils)

Secondary Outcome Measures:

* Perception of induced respiratory symptoms
* Airway response to methacholine and AMP, and perception scores
* Diurnal variation in Peak Expiratory Flows
* Profile of regulatory T cells in the peripheral blood
* Changes in these parameters over time (baseline, 6 months, 1 and 2 years)

Eligibility criteria: Inclusion Criteria:

* In remission of their asthma: absence of respiratory symptoms, no rescue asthma medication need and (for complete remission) an optimal pulmonary function (FEV1 \> 90%) and normal PC20 methacholine for more than two years (with no current treatment).
* With a proven past history of asthma from medical files (reversible airway obstruction (\> 12% FEV1 after bronchodilator or 20% by other means) proven by spirometry, PEF measures or methacholine challenge according to current criteria + previous symptoms and asthma medication use), having no more asthma symptoms and not having used asthma medication for more than 2 years.
* Agree to sign the consent form.
* No other condition that could interfere with the study measurements.

Exclusion Criteria:

* Unable to adhere to the protocol requirements.
* Other current respiratory disease.
* Upper or lower respiratory tract infection or use of antibiotics \< 1 month.
* Use of oral corticosteroids within the last 3 months.
* Signs or symptoms of progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital Laval
name: Louis-Philippe Boulet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02643719: Migraine Treatment in ED
Official title: Evaluation of a Behavioral Program for Migraineurs in the Emergency Department.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Migraine
Keywords: migraine
topiramate
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 0
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: TREATMENT

Brief summary: Randomized pilot feasibility study evaluating the impact of introducing behavioral treatment for migraine in the Emergency Department (ED) and prescribing migraine preventive medications in the ED. The study will examine the effect of these treatments, both individually and in combination, on pain severity and headache-related disability. This study is designed to examine the feasibility of comparing four interventions for ED patients presenting with migraine. Group 1: Starting topiramate; Group 2: Doing a brief behavioral intervention; Group 3: Treating with combination therapy of topiramate and behavioral intervention; and Group 4: Standard of Care.


Eligibility criteria: Inclusion Criteria:

* age 18 years to 65 years of age
* primary diagnosis of migraine based on the International Classification of headache disorders 3 beta criteria
* having a migraine 3 or more days/month.

Exclusion Criteria:

* Cognitive Behavioral Therapy (CBT), biofeedback or other relaxation therapy in the past year
* being on medication used for migraine prevention (topiramate, propranolol, valproic acid, amitriptyline/nortriptyline/imipramine/desipramine, botulinum toxin, a SNRI, angiotensin-converting enzyme inhibitors (ACE-I) or ARB)
* cognitive deficit or other physical problem with the potential to interfere with behavioral therapy
* substance or alcohol abuse as determined by self-report or prior documentation in the medical record.

Primary outcomes:
measure: Verbal numeric rating scale (VNRS) scores
timeFrame: 24 hours, 72 hours
measure: Headache Impact Test (HIT) scores
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: New York University Medical School
name: Mia Minen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02572219: Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients
Official title: Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
First posted: 2015-10-08
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of this randomized, double-blind clinical study is to evaluate the efficacy of a nutraceutical preparation on early markers of cognitive impairment, in patients affected by arterial hypertension.


Eligibility criteria: Inclusion Criteria:

* Written informed consent;
* Males or females between 40 and 65 years of age;
* Hypertensive patients classified according to their SBP (Systolic Blood Pressure) and DBP (Diastolic Blood Pressure) values. Included patients will be those with stage 1 hypertension (SBP 140-159 mmHg; DBP 90-99 mmHg) and with stage 2 hypertension (SBP 160-179 mmHg; DBP 100-109 mmHg).

Exclusion Criteria:

* Previous acute myocardial infarction (AMI);
* Previous stroke and/or transient ischemic attack (TIA);
* Diabetes mellitus;
* History of atrial fibrillation or other severe arrhythmias;
* Severe cardiovascular diseases;
* Renal pathologies (creatinine \> 1.4 mg/dL);
* Preexisting psychiatric pathologies;
* Neurodegenerative diseases, such as multiple sclerosis, lateral amyotrophic sclerosis, Parkinson, Alzheimer, neuromuscular pathologies, epilepsy;
* Diagnosis of dementia;
* Depression;
* Long-term regular use of anxiolytics drugs, antidepressant drugs, antipsychotic drugs, hypnoinducing drugs, cognitive stimulators.

Primary outcomes:
measure: Cognitive function assessed by neuropsychological tests
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pozzilli
country: Italy
facility: IRCCS Neuromed
state: (is)
Study officials:
References: