louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00681915: AZD7325 Multiple Ascending Dose Study
Official title: A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7325 When Given in Multiple Ascending Oral Doses in Healthy Male and Healthy Female Subjects of Non-child Bearing Potential
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Phase I
Pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD7325 after single and repeated ascending doses.


Eligibility criteria: Inclusion Criteria:

* Female subjects must be of non-child bearing potential.

Exclusion Criteria:

* Clinically significant illness within 2 weeks before the study start.
* Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
* Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2
* Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Primary outcomes:
measure: To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, and ECGs
timeFrame: Alssessments are made at each visit, at least daily, during the study.
Secondary outcomes:
measure: Evaluation and characterization of the pharmacokinetics of AZD7325 when given orally in multiple ascending doses
timeFrame: Blood samples will be taken during the study.
measure: Evaluation of the pharmacodynamic effects of AZD7325
timeFrame: Test batteries will be performed at specified times both before and following study drug administration.
measure: Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD7325.
timeFrame: A single blood sample will be obtained.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
affiliation: AstraZeneca Clinical Pharmacology Unit, US
name: Sylvan J. Hurewitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04774315: Molecular Endotypes of Chronic Idiopathic Urticaria
Official title: Molecular Endotypes of Chronic Idiopathic Urticaria
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Chronic Urticaria, Idiopathic
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study plans to learn more about why some people with Chronic Idiopathic Urticaria (CIU) respond to treatment with omalizumab (Xolair). It will test people before they receive treatment with omalizumab as part of standard of care, to see if there are differences in their blood and skin that can predict who responds to treatment.


Eligibility criteria: Inclusion Criteria:

* CIU as defined as frequent urticarial lesions for ≥ 6 weeks
* Symptoms not controlled with standard dose antihistamines (loratadine 10mg daily, desloratadine 5mg daily, fexofenadine 180mg daily, cetirizine 10mg daily, or levocetirizine 5mg daily)
* Planned initiation of treatment with omalizumab (Xolair) as part of standard of care for antihistamine-refractory urticaria

Exclusion Criteria:

* Use of immunomodulatory drugs in the past 1 month prior to beginning the study
* Use of systemic steroids in the past 1 month prior to beginning the study
* Use of omalizumab in the past 3 months prior to beginning the study
* Use of any investigational agent in the past 30 days
* Untreated intercurrent illness
* Severe Asthma
* Primary diagnosis of flushing

Primary outcomes:
measure: Responders
timeFrame: Week 16
Secondary outcomes:
measure: Baseline expression of innate immune markers
timeFrame: Baseline
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jenny Stitt, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04290715: Development and Validation for Predicting Inadequate Bowel Preparation
Official title: Development and Validation for Predicting Inadequate Bowel Preparation Before Colonoscopy in Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polyethylene Glycol
Cathartics
Colonoscopy
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 1644
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. patients undergoing colonoscopy.
2. patients older than 18 years

Brief summary: High-quality colonoscopy is considered the gold standard for the detection and prevention of colorectal cancer, and its efficacy is predicated on optimal colon cleansing.However, about 18%-35% of patients were still reported to suffer inadequate bowel preparation. Although several predictive models exist, the current guideline indicates that there is insufficient evidence to recommend the use of a predictive model for clinical practice.


Eligibility criteria: Inclusion Criteria:

* patients undergoing colonoscopy.
* patients older than 18 years.

Exclusion Criteria:

* Emergency colonoscopy.
* Have a serious medical condition, such as heart failure, acute liver failure, severe kidney disease (dialysis or predialysis patients) or New York heart association class iii-iv.
* Pregnant or breastfeeding.
* No bowel preparation or poor compliance (no bowel preparation as instructed or laxatives \< 90% of prescribed dose).
* Refuse to sign informed consent.
* The patient was rescheduled after the previous colonoscopy due to insufficient bowel preparation.
* Temporarily change to colonoscopy for other reasons.
* Incomplete colonoscopy due to insufficient parenteral preparation.
* Lack of complete data.

Primary outcomes:
measure: quality of bowel preparation
timeFrame: A colonoscopy procedure
measure: quality of bowel preparation
timeFrame: A colonoscopy procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT03773315: Ulmus Macrocarpa Hance Extract and Lipid Profile
Official title: Effect of Ulmus Macrocarpa Hance Extract on Lipid Profile in Adults With Dyslipidemia: a RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemias
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the Ulmus Macrocarpa Hance extract on lipid profile in adults with dyslipidemia for 12 weeks.

Detailed description: Previous another our study have indicated that Ulmus Macrocarpa Hance extract (UMH) may have the ability to decrease blood cholesterol. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the UMH on lipid profile in adults with dyslipidemia; the safety of the compound are also evaluate. The Investigators examine total cholesterol, HDL-cholesterol, triglyceridemia, LDL-cholesterol, and other biochemical parameters at baseline, as well as after 6 and 12 weeks of intervention. Eighty adults were administered either 500 mg of UMH or a placebo each day for 12 weeks;

Eligibility criteria: Inclusion Criteria:

* LDL cholesterol ranging from 130 to 190 mg/dL

Exclusion Criteria:

* Abnormal liver or renal function (i.e., serum aminotransferase activity \> 80 IU/L and serum creatinine concentrations \> 1.2 mg/dL)
* Diabetes (diagnosed clinically or fasting glucose level \> 126 mg/dL)
* History of ischemic heart disease or cerebrovascular disease
* Uncontrolled hypertension
* History of serious cardiac disease such as angina or myocardial infarction
* History of gastrectomy
* History of medication for psychiatric disease
* Administration of oriental medicine including herbs within the past 4 weeks

Primary outcomes:
measure: LDL cholesterol
timeFrame: 12 weeks
Secondary outcomes:
measure: Total cholesterol
timeFrame: 12 weeks
measure: Triglyceride
timeFrame: 12 weeks
measure: HDL cholesterol
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Integrated Research Institute for Natural Ingredients and Functional Foods
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee YL, Lee SY. Potential lipid-lowering effects of Ulmus macrocarpa Hance extract in adults with untreated high low-density lipoprotein cholesterol concentrations: A randomized double-blind placebo-controlled trial. Front Med (Lausanne). 2022 Nov 1;9:1000428. doi: 10.3389/fmed.2022.1000428. eCollection 2022.
Clinical trial NCT03826615: Gabapentin Pretreatment for Staged Bilateral Cataract Operations
Official title: The Effect of Gabapentin Pretreatment on Hyperalgesia in Elderly Patients Undergoing Staged Bilateral Cataract Operations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperalgesia
Cataract Bilateral Nos
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 64
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the effect of oral gabapentin premedication on hyperalgesia in elderly patients undergoing staged bilateral cataract operations under monitored anesthesia care

Detailed description: It has been reported that patients with bilateral cataract complained more pain and discomfort during the second consecutive eye surgery compared to the first eye surgery.

Gabapentin is an anticonvulsant drug, which has been extended the use to perioperative analgesia, and anxiolysis.

Therefore, the investigators conducted this randomized, controlled study to evaluate the effects of gabapentin premedication on patients' subjective sensations, including intraoperative anxiety, perceptions of pain, and light sensitivity, in the second cataract operations.

Eligibility criteria: Inclusion Criteria:

* patients aged over 60 years, who undergoing staged bilateral cataract operations under monitored anesthesia care
* ASA physical status of I, II, and III

Exclusion Criteria:

* undergoing other eye operations together besides cataract operation
* patients with creatinin clearance lower than 30ml/min
* patients with CNS inhibitors medication
* patients with previous gabapentin medication
* pregnancy

Primary outcomes:
measure: Pain perception
timeFrame: during the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong-Hwa Seo, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03616015: Dysbiosis and Immune Reconstitution After Allo-HSCT
Official title: Intestinal Dysbiosis and Immune Reconstitution After Allogeneic Hematopoietic Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation
Keywords: HSCT
intestinal dysbiosis
immune reconstitution
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Preliminary (proof of concept), monocentric, interventional, prospective, non-randomized and analytic trial designed to simultaneously explore intestinal microbiota changes and early post-transplant immune reconstitution, and to correlate biological data with clinical data (antibiotics use, stress level, GVHD).

Detailed description: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the major curative therapeutic approach for hematologic neoplasms. After HSCT, patients have a compromised GI mucosal barrier and an altered microbiota, also called dysbiosis. The later could be due to conditioning or use of broad-spectrum antibiotics, and could be accentuate by stress encountered by patients during their therapy management. Recent data have shown that alterations in the intestinal flora are associated with bad outcome, particularly with graft-versus-host disease (GVHD), bacteremia, and reduced overall survival post-transplantation. How intestinal bacteria can modulate the risk of relapse after HSCT is yet unknown. The scientists hypothesize that the variation of some bacterial taxa may influence post-transplant immune reconstitution, particularly invariant Natural Killer T cells.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years affiliated to a social security system
* Patients followed at the hospital of Nancy for a allogeneic hematopoietic cell transplantation (HLA matched donor)
* Graft of peripheral blood stem cell
* GVHD prophylaxis by ciclosporin and antilymphocyte serum +/- mycophenolate mofetil or methotrexate.

Exclusion Criteria:

* HIV+ patients
* Patients with active HBV or HCV

Primary outcomes:
measure: quality of iNKT reconstitution after HSCT (good/poor)
timeFrame: Day 90,
Secondary outcomes:
measure: gut microbiota composition
timeFrame: Day 0, Day 15, Day 30, Day 90
measure: immune reconstitution after HSCT (other immune cells)
timeFrame: Day 15, Day 30, Day 60, Day 90, Day 180, Year 1, Year 2
measure: GVH disease
timeFrame: Day 30, Day 60, Day 90
measure: use of antibiotics
timeFrame: Day 0, Day 15, Day 30, Day 60, Day 90
measure: level of stress
timeFrame: Day -8, Day 15, Day 30, Day 90
measure: level of anxiety
timeFrame: Day -8, Day 15, Day 30, Day 90
measure: quality of iNKT reconstitution after HSCT (good/poor)
timeFrame: Day 15, Day 30, Day 60, Day 180, Year 1, Year2
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: RUBIO Marie-Thérèse
Study officials:
References:
Clinical trial NCT06607315: Soft Tissue Physical Properties in Long-Distance Runners
Official title: The Relationship Between Running Form, Soft Tissue Physical Properties, and Injury in Long-Distance Runners
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Runner
Keywords: soft tissue
injury
running
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Okan University
First posted: 2024-09-23
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: between the ages of 25 and 35 individuals who have been regularly running long distances for at least 1 year

Brief summary: The aim of this study is to investigate in greater depth the effects of different running forms on soft tissue physical properties in long-distance runners and the relationship of this to injury risk. By doing so, the study seeks to provide new insights into the pathophysiology of running injuries and develop more effective injury prevention strategies.

Detailed description: This study is expected to reveal the effects of different running forms on soft tissue physical properties in long-distance runners and the relationship of these effects to injury risk.

Running analysis will be conducted by recording 30-second videos of participants during their runs, and tests will be performed using the MyotonePro device on predetermined areas. Before the evaluations, all participants will be informed about the study's objectives and their verbal informed consent will be obtained.

Eligibility criteria: Inclusion Criteria:

* individuals who have been regularly running long distances for at least 1 year,
* between the ages of 25 and 35,
* classified as amateur athletes

Exclusion Criteria:

* Having undergone orthopedic surgery involving the lower extremity

Primary outcomes:
measure: myoton pro device
timeFrame: 3 months
measure: running form analysis
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Gamze Aydın
Study officials:
References:
Clinical trial NCT05324215: Transversalis Fascia Plane Block and Rectus Sheath Block in Renal Transplantation Donors
Official title: Effects of Transversalis Fascia Plane Block and Rectus Sheath Block on Opioid Consumption in Renal Transplantation Donors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Koc University Hospital
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transversalis fascia plane block (TFPB) is a relatively new, easy-to-apply and safe regional anesthesia technique used to provide postoperative analgesia in various surgeries. It has been shown that TFPB and rectus sheath block (RSB) administration reduces opioid consumption and related side effects in patients undergoing surgery with general anesthesia. To our knowledge, there is no study examining TFPB in donor nephrectomy.

The investigators aimed to prospectively examine the effect of TFPB and RSB on opioid consumption in postoperative period on donors who will undergo laparoscopic nephrectomy in renal transplantation surgery.


Eligibility criteria: Inclusion Criteria:

* Donor patients scheduled for elective nephrectomy in renal transplantation surgery
* American Society of Anesthesiologists (ASA) I-II
* Patients who are aged between 18-75

Exclusion Criteria:

* Skin infection at the block area
* Coagulation disorder and using anticoagulant drugs
* End-stage organ and system failure
* Severe pulmonary and/or cardiovascular problems
* Substance addiction or known psychiatric or mental problems
* Chronic painkiller usage

Primary outcomes:
measure: Total opioid consumption retrieved from patient records
timeFrame: up to 24 hours
Secondary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koç University Hospital
state: Zeytinburnu
Study officials:
References:
Clinical trial NCT03819959: Metabolomics Study on Intensive Care Acquired Muscle Weakness in Polytrauma
Official title: Metabolomics Pilot Study on Intensive Care Acquired Muscle Weakness in Polytrauma (MIRACLE-II Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolomics
Critical Care
Critical Illness
Critical Illness Myopathy
Critical Illness Polyneuropathy
Intensive Care (ICU) Myopathy
Muscle Weakness
Keywords: Pilot Trial
Muscle Biopsy
Blood Metabolome
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Helmholtz Zentrum München
First posted: 2019-01-29
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: PROBABILITY_SAMPLE
Study population: polytrauma patients who are admitted to intensive care

Brief summary: In this mono-center pilot trial, polytrauma patients admitted to intensive care will be included. Investigators are going to take blood and muscle samples at respecified time points to do metabolic, histological and molecular testing.

Aim of the study is to investigate (1) changes of the blood metabolome in patients with ICUAW (intensive care unit acquired weakness) and (2) identify metabolic components who are responsible for ICUAW or can be used as marker for ICUAW.


Eligibility criteria: Inclusion Criteria:

* acute polytrauma patient
* age ≥ 18 years old
* expected intensive care stay ≥ 3 days
* American Society of Anesthesiologists classification I or II

Exclusion Criteria:

* patient had received cardiopulmonary resuscitation
* limitation of therapy or comfort care

Primary outcomes:
measure: Metabolomics
timeFrame: a median of 14 days
Secondary outcomes:
measure: Muscle histology
timeFrame: a median of 14 days
measure: Phosphoproteomics
timeFrame: a median of 14 days
Other outcomes:
measure: Identify possible predictors of muscle wasting in the blood metabolome at ICU admission
timeFrame: a median of 14 days
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar, School of Medicine, Technical University of Munich
state: Bavaria
Study officials:
affiliation: Technical University of Munich
name: Stefan J Schaller, MD, MHBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Technical University of Munich
name: Hennig Wackerhage, PhD
role: PRINCIPAL_INVESTIGATOR
References: