louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01027507: Postprandial Hemodynamics
Official title: Relationship Between Postprandial Alterations in Hemodynamics, Blood Pressure, Blood Glucose, Insulin Concentrations, Gastric Emptying, and Satiety
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Disease
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
First posted: 2009-12-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects without symptoms or a history of gastrointestinal disease, abdominal surgery or diabetes mellitus, were included in this crossover study.

Brief summary: To study the postprandial alterations in hemodynamics and blood pressure in relation to gastric emptying rate, postprandial blood glucose, plasma concentrations of insulin, satiety in healthy subjects.

Detailed description: Ingestion of a meal increase blood flow to the gastrointestinal organs and affects the heart rate, blood pressure, and cardiac output. It is not known through wich mechanisms the heart function changes affects after a meal.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* history of gastrointestinal disease, abdominal surgery or diabetes mellitus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Departments of Medicine, Malmö University Hospital
Study officials:
affiliation: Skane University Hospital
name: Joanna Hlebowicz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dencker M, Bjorgell O, Hlebowicz J. Effect of food intake on 92 oncological biomarkers by the Proseek Oncology II panel. BMC Res Notes. 2019 Apr 2;12(1):199. doi: 10.1186/s13104-019-4237-9.
citation: Hlebowicz J, Lindstedt S, Bjorgell O, Dencker M. The effect of endogenously released glucose, insulin, glucagon-like peptide 1, ghrelin on cardiac output, heart rate, stroke volume, and blood pressure. Cardiovasc Ultrasound. 2011 Dec 29;9:43. doi: 10.1186/1476-7120-9-43.
citation: Hlebowicz J, Lindstedt S, Bjorgell O, Dencker M. Relationship between postprandial changes in cardiac left ventricular function, glucose and insulin concentrations, gastric emptying, and satiety in healthy subjects. Nutr J. 2011 Mar 23;10:26. doi: 10.1186/1475-2891-10-26.
Clinical trial NCT01985607: Efficacy of a New Thickened Extensively Hydrolyzed Formula
Official title: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Cow's Milk Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protein Allergy
Cow's Milk Protein Hypersensitivity
Lead sponsor: United Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-11-15
Enrollment: 72
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cow Milk Allergy (CMA) occurs in 2 to 5 % of all infants. Reflux, regurgitation and vomiting are well recognised symptoms of CMA. The recommended treatment of CMA is an extensive hydrolysate. The North American Society of Pediatric Gastroenterology Hepatology and Nutrition (NASPGHAN) \& the European Society of Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) reflux guidelines have no strict recommendations for the treatment of distressed infants with reflux, suspected of CMA. One of the preferred proposed options is to thicken an extensive hydrolysate .

This study aims at evaluating the additional value of a thickened extensive hydrolysate in children suspected of CMA and presenting with frequent regurgitation.


Eligibility criteria: Inclusion Criteria:

* term born infants
* Having a Vandenplas' score of regurgitation of at least 2
* With suspected diagnosis of CMA because of clinical history/symptoms (based on a Cow's Milk Protein hypersensitivity (CMPH) score of 10 or more) and/or positive Immunoglobulin E (IgE) testing, radioallergosorbent test (RAST) or skin prick test

Exclusion Criteria:

* Exclusively breast fed infants
* Fed with an extensively hydrolysed formula or amino acid formula

Primary outcomes:
measure: Number of patient dropped out for intolerance
timeFrame: 1 month
measure: Vandenplas' regurgitations score
timeFrame: 1 month
Secondary outcomes:
measure: Cow's milk protein hypersensitivity score
timeFrame: 1 month
measure: Growth (weight, height, head circumference)
timeFrame: 1 month
measure: Growth (weight, height, head circumference)
timeFrame: 3 months
measure: Growth (weight, height, head circumference)
timeFrame: 6 months
measure: Number of daily regurgitations
timeFrame: 1 month
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Thessaloniki
country: Greece
facility: Hippocration Hospital
city: Safat
country: Kuwait
facility: Faculty of Medicine, Kuwait university
city: Beirut
country: Lebanon
facility: Pediatricians
city: Ljubljana
country: Slovenia
facility: University Children's Hospital
Study officials:
References:
Clinical trial NCT00919607: Evaluate the Pharmacokinetics of Quetiapine Fumarate in Chinese Schizophrenic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: quetiapine fumarate(SEROQUEL) extended-release(XR) China PK Study
pharmacokinetics parameters
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-12
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The primary objective of the study is to evaluate the pharmacokinetics of XR quetiapine fumarate(300mg,600mg,and 800mg once-daily) in Chinese schizophrenic patients .


Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 through 60 years inclusive
* Schizophrenia diagnosis
* Body Mass Index (BMI) 20-27 kg/m2 (inclusive)
* Provision of written informed consent before initiation of any study

Exclusion Criteria:

* AIDS \& hepatitis B
* History of seizure disorder
* History of episodic,idiopathic orthostatic hypotension

Primary outcomes:
measure: single dose PK parameters(300mg)
timeFrame: Day1 to 48 hour after Day 5
measure: Steady-state multiple doses PK parameters
timeFrame: Day 1 to 48 hours after Day7
Secondary outcomes:
measure: Incidence and severity of AEs
timeFrame: sign ICF to Day 9
measure: Clinical significant change in Lab test
timeFrame: baseline up to Day 9
measure: Clinical significant change in vital signs
timeFrame: baseline up to Day 9
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
state: Beijing
Study officials:
affiliation: Peking University Institute of Mental Health
name: Tianmei Si
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05412407: Analgesic Self-medication for Acute Pain by Patients Awaiting a Consultation With a General Practitioner
Official title: What Are the Terms of Use of Analgesics for Acute Pain on a Patient Before a Consultation With a General Practitioner: Descriptive Epidemiological Study of Patients in General Practice in Rhône-Alpes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Pain
Keywords: acute pain
analgesics
self medication
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: What are the terms of use of analgesics for acute pain on an outpatient basis before a consultation with a general practitioner? Descriptive epidemiological study of patients in general practice in Rhône-Alpes


Eligibility criteria: Inclusion Criteria:

* adult patient
* without cognitive impairment
* having acute pain for less than 3 months
* Consultant to the practices participating to the study.

Exclusion Criteria:

* Patients who do not understand French
* Patients protected by law

Primary outcomes:
measure: Description of analgesic self-medication practices while waiting for a consultation with the general practitioner.
timeFrame: Inclusion
Secondary outcomes:
measure: Highlighting the reason for misuse of analgesics on an outpatient basis in the population studied while waiting for a consultation.
timeFrame: Inclusion
Other outcomes:
Locations:
city: Hauteville-Lompnes
country: France
facility: MSP Hauteville
city: Saint-Priest
country: France
facility: MSPU bel-air
city: Vienne
country: France
facility: Maison de santé de Malissol
Study officials:
affiliation: Médecins remplaçants
name: Assad ACHIQ
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02486107: Prospective Cohort Study of Outcome After Minimally Invasive Posterior Cervical Spine Surgery
Official title: Prospective Cohort Study of Outcome After Minimally Invasive Posterior Surgery (Posterior Percutaneous Endoscopic Foraminotomy or Tubular Retractor Assisted Micro-foraminotomy) for Single Level Cervical Foraminal Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Curvature
Keywords: cervical vertebra
surgery
tubular retractor
endoscope
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: Kyungpook National University Hospital
First posted: 2015-07-01
Enrollment: 156
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Alpha = 0.05, Beta = 0.2, q1 = 0.5, effect size = 0.6 drop rate 12% 52 patients in each group

Brief summary: In case of cervical foraminal stenosis without central stenosis, there are several options; anterior discectomy and fusion (ACDF), tubular retractor assisted micro-foraminotomy (MTPF) and posterior percutaneous cervical foraminotomy and discectomy (P-PECD). P-PECD is a modern technique and there was no RCT with MTPF, although P-PECD showed not inferior result to ACDF. Nowadays MTPF and P-PECD are minimally invasive surgical techniques, but there was no comparative study.

The primary object of the study is to compare radiological outcome (segment angle) after MTPF or P-PECD.

Detailed description: P-PECDs are performed in Seoul National University Hospital MTPFs are performed in Kyoung-Pook National University Hospital and ACDF are performed in Seoul National University Bundang Hospital.

Eligibility criteria: Inclusion Criteria:

* cervical radicular pain
* no cervical myelopathy

Exclusion Criteria:

* motor weakness less than MMT Gr III
* cervical myelopathy
* OPLL and myelopathy
* previous cervical spine surgery
* combined fracture or spinal tumor

Primary outcomes:
measure: change of segmental angle
timeFrame: postoperative 1 year
Secondary outcomes:
measure: operation time
timeFrame: postoperative 1 year
measure: neck/arm pain
timeFrame: postop 1 year
measure: neck disability, index
timeFrame: postop 1 year
measure: cervical curvature
timeFrame: postop 1 year
Other outcomes:
Locations:
city: Seoul, 03080
country: Korea, Republic of
facility: Kyoung-Pook National University Hospital
state: Province
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Chun Kee Chung, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00185107: Effect of Combination Therapy With Two Drugs (Colesevelam and Ezetimibe) in Patients With High Cholesterol
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Combination With Zetia® Compared to Zetia® Alone in Patients With Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Keywords: Safety
Efficacy
WelChol®
Zocor®
Zetia®
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess the efficacy of WelChol® plus Zetia® in treating patients with high cholesterol


Eligibility criteria: Inclusion Criteria:

* 18-80 years of age, inclusive;
* A history of primary hypercholesterolemia

Exclusion Criteria:

* Any serious disorders including pulmonary, hepatic, renal, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/ metabolic, hematologic/oncologic (within the last 5 years), neurologic and psychiatric diseases that would interfere with the conduct of the study or interpretation of the data;
* Hepatic dysfunction including biliary cirrhosis, unexplained persistent liver function abnormality, and pre-existing gallbladder disease

Primary outcomes:
measure: The percent change in LDL-C from the start of the study
Secondary outcomes:
measure: - The absolute change in LDL-C from baseline
measure: - The percent change in LDL-C from baseline
measure: - The absolute changes and percent changes in TG, non-HDL-
measure: C, HDL-C, total cholesterol and other lipid measures
measure: - The percentages of patients who achieve target levels of LDL-C at the end of the study
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Clinic
state: California
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Overland Park
country: United States
facility: Radiant Research
state: Kansas
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Edina
country: United States
facility: Radiant Research
state: Minnesota
city: Statesville
country: United States
facility: Medical Office
state: North Carolina
city: Cincinnati
country: United States
facility: Linder Clinical Trial Center
state: Ohio
Study officials:
References:
Clinical trial NCT05181007: Drug-drug Interaction Between Ciprofol and Mefanamic Acid or Valproate
Official title: An Open-label, Two-stage Study Evaluating Drug-drug Interaction Between Ciprofol Injectable Emulsion and Mefanamic Acid or Valproate in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Drug Interaction
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-06
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: study the effect of mefanamic acid or valproate on ciprofol


Eligibility criteria: Inclusion Criteria:

* Normal results of physical examination, laboratory tests (blood routine, blood biochemistry, and urine routine), and 12-lead ECG, or considered by the investigator to be clinically insignificant abnormalities; no significant potential difficult airway (modified Mallampati score Class I-II);
* No previous history of primary diseases in major organs, such as liver, kidneys, digestive tract, blood, and metabolic diseases; no history of malignant hyperthermia and other hereditary disorders; no history of mental/neurological disorders; no history of epilepsy; no contraindications for deep sedation/general anesthesia; no clinically significant history of anesthesia accidents;
* Understand procedures and methods of this trial, willing to sign the informed consent form and comply strictly with the clinical trial protocol to complete this study.

Exclusion Criteria:

* Known allergies to excipients of ciprofol injectable emulsion (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate, and sodium hydroxide), mefanamic acid, or valproate, or having contraindications to ciprofol/mefanamic acid/valproate; a history of drug allergies (including anesthetics), allergies, or prone to allergies;

Primary outcomes:
measure: effect of mefanamic acid on the Cmax of ciprofol
timeFrame: 0-24hour post ciprofol dosing
measure: effect of mefanamic acid on the AUC of ciprofol
timeFrame: 0-24hour post ciprofol dosing
measure: effect of valproate on the Cmax of ciprofol
timeFrame: 0-24hour post ciprofol dosing
measure: effect of valproate on the AUC of ciprofol
timeFrame: 0-24hour post ciprofol dosing
Secondary outcomes:
measure: Safety when ciprofol is co-administered with mefanamic acid or valproate
timeFrame: 0-24hour post ciprofol dosing
measure: effect of mefanamic acid or valproate on the MOAA/S of ciprofol
timeFrame: 0-24hour post ciprofol dosing
measure: effect of mefanamic acid or valproate on the BIS of ciprofol
timeFrame: 0-24hour post ciprofol dosing
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: The second affiliated hospital Zhejiang University School of Medicine
Study officials:
References:
Clinical trial NCT02817607: Study to Assess Breast Sensation Before and After Breast Cancer Treatment
Official title: Pilot Study to Assess Breast Sensation Before and After Breast Cancer Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Reconstruction
Ductal Carcinoma In-situ
Keywords: Sensation
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to establish techniques for evaluating breast cutaneous sensation at baseline and following either lumpectomy or mastectomy for breast cancer.

Detailed description: Measuring nerve recovery and breast sensibility has been reported in a limited fashion in the past. A number of studies have assessed patients before and after breast reduction surgery using Semmes-Weinstein monofilaments and found this to be an effective technique. A limited number of studies have been done in patients undergoing mastectomy for breast cancer using these techniques. The main limitation of these existing studies is the lack of prospective measurements before surgery and through time, thus restricting the findings to isolated long-term outcomes. Additionally, no studies have compared patients undergoing mastectomy versus lumpectomy to determine the impact that surgical approach has on breast sensibility.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with ductal carcinoma in-situ (DCIS) or invasive breast cancer
* patients that have been offered lumpectomy or mastectomy for surgical treatment
* patients with a high risk of breast cancer and are pursuing prophylactic mastectomies

Exclusion Criteria:

* metastatic malignancy of any kind
* subjects will not have breast surgery as a portion of their breast cancer care
* between 25 and 65 years old
* subjects with breast implants or a history of prior breast implants
* subjects that have had prior breast reduction surgery
* subjects who have had radiation to one of both breasts in the past
* subjects who cannot give informed consent

Primary outcomes:
measure: change in sensory perception score
timeFrame: baseline, time of surgery, 3 months, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Scott Hollenbeck, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02353507: Comparison of Chitosan and Carboxymethylcellulose Silver Dressings on Burn Wounds in Pediatric and Adult Subjects
Official title: A Multi-Center, Randomized, Comparison Study of a Chitosan (Opticell Ag+) Silver Dressing and a Sodium Carboxymethylcellulose (Aquacel® Ag+) Silver Dressing on Burn Wounds in Pediatrics and Adults Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Bandages
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2015-02-02
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this prospective, randomized, comparative multi-center study is to compare the effective management of two silver-based dressings in managing exudative wounds in first and second degree burns.


Eligibility criteria: Inclusion Criteria:

* Inpatient status at the site
* Written consent obtained from the subject
* Burn injury must have been incurred within 36 hours prior to enrollment.
* Burn injury must be of superficial partial thickness, mid-dermal partial thickness, or a combination of the two depths
* Burn injury must exceed 3% total body surface area.

Exclusion Criteria:

* Subject is pregnant.
* Bone fractures.
* Inhalation-related trauma.
* Sensitive and/or allergic to materials containing silver.
* Burn injury exceeds 40% total body surface area.
* Burn injury diagnosis indicates deep partial or full thickness wounds.
* Burn a result of electrical/chemical injury or frostbite.
* An active agent, such as a topical antimicrobial or an enzymatic debriding agent was previously used to treat the burn injury in question.

Primary outcomes:
measure: Wound Infection Rates
timeFrame: Up to 21 days of use
measure: Days required for wound healing
timeFrame: Up to 21 days of use
Secondary outcomes:
measure: Pain Levels during Dressing Removal
timeFrame: Up to 21 days
Other outcomes:
Locations:
Study officials:
References: