louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02432781: Oral Carbohydrate in DM Patients Undergoing Total Knee Arthroplasty
Official title: Effect of Preoperative Oral Carbohydrates on Postoperative Nausea and Vomiting and Quality of Recovery in DM Patients Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2015-05-04
Enrollment: 82
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to investigate the effects of carbohydrate-rich drink on postoperative nausea and vomiting in diabetic patients undergoing total knee arthroplasty. The secondary purpose is to investigate the effects of carbohydrate-rich drink on quality of recovery and inflammation in diabetic patients after total knee arthroplasty.

Detailed description: Carbohydrate-rich drink has been proved to neither delay gastric emptying nor affect gastric acidity and is therefore considered safe to use in elective surgical patients without risk factors for pulmonary aspiration. It reduced postoperative nausea and vomiting and improved sense of well-being after surgery. Moreover, carbohydrate-rich drink was not found to be affected by delayed gastric emptying in patients with uncomplicated type 2 diabetes. Therefore, carbohydrate drink may be safely administered 3 h before anesthesia without risk of hyperglycemia or aspiration.

Eligibility criteria: Inclusion Criteria:

* Type 2 DM patients undergoing elective total knee arthroplasty

Exclusion Criteria:

* Contraindication to regional anesthesia
* Patients whose operation is scheduled to start after 9:00 am
* Dementia or cognitive dysfunction
* HbA1c \> 8%
* Gastroesophageal reflux disease

Primary outcomes:
measure: Incidence of postoperative nausea and vomiting
timeFrame: 24 hours
Secondary outcomes:
measure: Score of quality of recovery
timeFrame: 24 hours
measure: Degree of inflammation
timeFrame: 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
citation: Shin S, Choi YS, Shin H, Yang IH, Park KK, Kwon HM, Kang B, Kim SY. Preoperative Carbohydrate Drinks Do Not Decrease Postoperative Nausea and Vomiting in Type 2 Diabetic Patients Undergoing Total Knee Arthroplasty-A Randomized Controlled Trial. J Am Acad Orthop Surg. 2021 Jan 1;29(1):35-43. doi: 10.5435/JAAOS-D-20-00089.
Clinical trial NCT00000281: Pharmacotherapy for Schizophrenic Drug Users - 6
Official title: Pharmacotherapy for Schizophrenic Drug Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Substance-Related Disorders
Shcizophrenia
Keywords: anti psychotic agents
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: VA Connecticut Healthcare System
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate maintenance neuroleptics for Schizophrenic patients who are cocaine abusers.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Drug use
measure: Retention
measure: Psychological symptoms
measure: Schizophrenic symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Thomas R Kosten, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03329781: ENDOCUR - Modulation of Endotoxaemia Via Curcumin Intake in Healthy Overweight Adults
Official title: Modulation of Endotoxaemia Via Curcumin Intake in Healthy Overweight Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: Endotoxaemia, Curcumin.
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Chronic diseases such as diabetes, cardiovascular diseases and cancer are a major burden on the Scottish population. Obesity and inflammation have strong links to these diseases. One of the mechanisms explaining the relationship between low-grade inflammation and excess weight is "endotoxaemia". We wish to study this phenomenon, when small components coming from our gut bacteria can pass into the bloodstream, raising the body's defences. Diet can modulate endotoxaemia. In this study, we propose to use curcumin, in a capsule form, to modulate endotoxaemia. Curcumin comes from turmeric, which is widely used as a spice. In this study, we want to test the effect of consuming curcumin extract to the composition of the gut microbiota, post-meal endotoxaemia, and inflammatory markers in blood.


Eligibility criteria: Inclusion Criteria:

- BMI \> 25 kg/m2.

Exclusion Criteria:

* having chronic inflammatory or autoimmune disease, gastrointestinal complaints or known biliary obstruction (past and present)
* use of anti-inflammatory drugs 2 weeks before the start of the study
* use of antibiotics during the 12 weeks preceding the trial
* pregnancy
* lactation

Primary outcomes:
measure: Level of endotoxin in plasma.
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03000881: Evaluation of the Influence of Output on Skin Covered by Adhesives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2016-12-22
Enrollment: 15
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: The study investigates the impact real output has on peristomal skin covered by two different adhesives


Eligibility criteria: Inclusion Criteria:

* Have given written informed consent
* Be at least 18 years of age and have full legal capacity
* Have had an ileostomy for more than one year
* Have intact skin on the area used in the evaluation
* Has an ileostomy with a diameter up to 35 mm
* Have a peristomal area accessible for application of adhesive strips

Exclusion Criteria:

* Currently receiving or have within the past 2 month received radio- and/or chemotherapy
* Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
* Are pregnant or breastfeeding
* Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
* Participating in other interventional clinical investigations or have previously participated in this evaluation -

Primary outcomes:
measure: Trans Epidermal Water Loss
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebaek
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Head of preclinical department
name: Lene F Nielsen, M. Sc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06993181: Clinical Trial of Comparing DA-5222 Single-administration and Co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in Healthy Adult Subjects
Official title: An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety After Single-administration of DA-5222 and Co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-28
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: DA-5222, DA-5222-R1, DA-5222-R2, DA-5222-R3
Primary purpose: TREATMENT

Brief summary: This study is to compare pharmacokinetics and safety profiles of DA-5222 single-administration and co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in healthy adult subjects


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* BMI between 18 and 30 kg/m2
* Body weight: Male≥50kg, Female≥45kg
* Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study

Exclusion Criteria:

* Subjects with clinically significant medical history
* Subjects with history of drug abuse or addicted
* Subjects with allergy or drug hypersensitivity

Primary outcomes:
measure: AUCt
timeFrame: pre-dose~72 hours post-dose
measure: Cmax
timeFrame: pre-dose~72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Bumin Hospital
state: South Korea
Study officials:
References:
Clinical trial NCT02674581: A Study of the Pharmacokinetics and Safety of BMS-663068 Administered in Subjects With Normal Renal Function and With Mild, Moderate, Severe and End Stage Renal Dysfunction (ESRD)
Official title: An Open-label Study to Evaluate the Pharmacokinetics and Safety of BMS-663068 in Subjects With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End-Stage Renal Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2016-02-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An oral dose in healthy and renally impaired subjects to determine the drug effect for BMS-663068.


Eligibility criteria: Inclusion Criteria (For renal impaired subjects):

* Classification by renal function based on eGFR
* Clinical, ECG, and laboratory findings consistent with renal dysfunction
* BMI of 18.0 to 38.0 kg/m2 inclusive
* Women of child bearing potential (WOCBP) and sexually active fertile men with partners who are WOCBP must use non-hormonal highly effective birth control
* Slightly different inclusion criteria are defined in the protocol for healthy subjects

Exclusion Criteria:

* History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening
* Evidence of rapidly deteriorating renal function, defined as a screening eGFR that has decreased from a previous eGFR by ≥ 50% within the last 3 months
* Current or recent (within 3 months of study drug administration) clinically significant gastrointestinal disease or gastrointestinal surgery (including cholecystectomy) that could impact the absorption of study drug
* Any major surgery within 4 weeks of study drug administration.
* Other protocol defined exclusion criteria could apply

Primary outcomes:
measure: Effect of Renal Impairment on The Primary Endpoints of Cmax
timeFrame: Day 1 - Day 5
Secondary outcomes:
measure: Safety and Tolerability as assessed by the Incidence of Serious Adverse Events (SAEs), Adverse Events (AEs), AEs leading to discontinuation, and the results of ECGs, vital signs, physical examination, and clinical laboratory tests.
timeFrame: Day 1 - Day 5
Other outcomes:
Locations:
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03340181: Study on the Myocardial Protective Effect of Upper Limb Ischemic Preconditioning in Patients Undergoing Off-pump Coronary Artery Bypass Grafting
Official title: Study on the Myocardial Protective Effect of RIPC in Patients Undergoing OPCABG
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: OPCABG
Keywords: RIPC, myocardial protective effect
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 66
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: OTHER

Brief summary: The purpose of the study was to verify the myocardial protective effect of RIPC in patients undergoing OPCABG.

Detailed description: 66 patients scheduled for OPCABG are randomly assigned to a RIPC group(n=33) or a control group(n=33). In the RIPC group, 4 cycles of 5-min ischemia(using a blood pressure cuff inflated to 40mmHg over the patient's basic blood pressure) and 5-min repercussion are done on an upper limb before skin incision. Patients in the control group wear the same cuff on an upper limb but no pressure is applied. Anesthetic and surgical techniques are standardized during the trial. Serum inflammatory cytokines and cardiac injury markers will be measured before and after surgery. Internal mammary artery and saphenous vein tissues will be collected during the surgery to assess hypoxia-inducible factor (Hif)-1a and other signalling proteins.

Eligibility criteria: Inclusion Criteria:

* serious changes in several coronary arteries that need to receive OPCABG
* NHYA II-III
* ASA II-III

Exclusion Criteria:

* LVEF\< 35%
* acute myocardial infarction
* multiple organ dysfunction

Primary outcomes:
measure: ICU staying time
timeFrame: average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huilin Wang
state: Shanghai
Study officials:
affiliation: Fudan University
name: Hui-lin Wang, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01798381: Essential Fatty Acids in Adult ADHD
Official title: The Relationship of Essential Fatty Acids to Cognitive, Electrophysiological and Behavioural Function in Adults With Attention Deficit Hyperactivity Disorder and Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Adult Attention Deficit Hyperactivity Disorder
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2013-02-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this project is to investigate the effect of a dietary supplementation with essential fatty acids in adults on cognitive functions related to attention and impulse control in the general population and in individuals with a diagnosis of attention deficit hyperactivity disorder (ADHD).


Eligibility criteria: Inclusion Criteria:

* DSM-IV ADHD

Exclusion Criteria:

* any acute psychiatric disorder

Primary outcomes:
measure: Wender Reimherr Adult Attention Deficit Disorder Scale (WRAADDS)
timeFrame: 6 months
Secondary outcomes:
measure: Short and long interval cortical inhibition (SICI and LICI)
timeFrame: 6 months
Other outcomes:
measure: Cued continous performance test - QB-version
timeFrame: 6 months
Locations:
city: Homburg/Saar
country: Germany
facility: Saarland University Hospital
state: Saarland
Study officials:
References:
Clinical trial NCT00796510: Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety
Official title: A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Pulmonary Hypertension
Keywords: endothelin receptor antagonist (ETRA)
sitaxsentan
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-24
Enrollment: 3
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and does not significantly impact sildenafil pharmacokinetics the combination of most promise for pulmonary arterial hypertension (PAH) therapy is these two oral drugs administered in combination.


Eligibility criteria: Inclusion Criteria:

* Previously enrolled in B1321001 for at least 4 weeks.
* Previously enrolled in B1321003, discontinued from the study.
* Completed the B1321003 study as planned.

Exclusion Criteria:

* Treated with an investigational drug (other than sitaxsentan or sildenafil in either B1321001 or B1321003) or device that has not received regulatory approval within the 30 days prior to Baseline/Day 1 or during the study.

Primary outcomes:
measure: Overall Survival
timeFrame: Baseline and every 12 weeks up to Week 18
Secondary outcomes:
measure: Change From Baseline in 6 Minute Walk Distance at Weeks 12 and 24
timeFrame: Baseline, Weeks 12 up to Early Termination (ET) (up to Week 18)
measure: Number of Participants in Each World Health Organization (WHO) Functional Class of Pulmonary Arterial Hypertension (PAH)
timeFrame: Baseline, Week 12 and ET (up to Week 18)
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Pfizer Investigational Site
state: California
city: Cluj Napoca
country: Romania
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02637310: Evaluate the Efficacy and Safety of N02RS1 in Patient With Acute Bronchitis
Official title: A Multi Center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of N02RS1 in Patients With Acute Bronchitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Bronchitis
Lead sponsor: PharmaKing
Sponsor class: INDUSTRY
First posted: 2015-12-22
Enrollment: 108
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multi center, randomized, double-blind, placebo-controlled, parallel, phase 2b clinical trial to evaluate the efficacy and safety of N02RS1 in patients with acute bronchitis

Detailed description: Suitable subjects randomized to the experimental or control group. The subjects eat IP during 7days. Visit 3(3 days) evaluate BSS through phone call and visit 4(8 days) evaluate efficacy and safety.

Eligibility criteria: Inclusion Criteria:

* Patients over 19, under 75 of age
* Patients acute bronchitis, sputum symptoms, BSS over 7 points.
* Patients acute bronchitis within 7days.
* Non-pregnant, patients who agree to contraception.
* Patients who can write diary and available to communicate.
* Patients voluntarily agreed

Exclusion Criteria:

* Patients with hypersensitivity to the drug.
* Patients who have gotten systemic steroid treatment within 4 weeks.
* Patients who have gotten treatment of antibiotics, bronchodilators, painkiller and secretagog within 7 days.
* Patients who have gotten treatment of mucus solvents or antitussives within 3 days.
* Patients who serious respiratory infections requiring antibiotic treatment, allergic bronchial asthma, bronchiectasis and chronic obstructive pulmonary disease.
* Patients heart disease, severe kidney, liver disease.
* The bleeding tendency or immunosuppressed patients.
* Patients with clinically significant abnormal values.
* Pregnant women or nursing mothers.
* Patients alcoholics or drug abuse.
* Patients taking other clinical trail's medicines within 30 days.

Primary outcomes:
measure: BSS(Bronchitis Severity Score) score variation compared to baseline after 7 days
timeFrame: Visit 1(-3days, screening), 2(0day, randomization), 3(3days), 4(8days)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01248910: Health Benefits of Alpine Skiing for the Elderly
Official title: SASES: SAlzburg Skiing in the Elderly Study: Health Benefits of Alpine Skiing for the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Strength
Exercise Capacity
Postural Control
Lead sponsor: University of Salzburg
Sponsor class: OTHER
Collaborators: name: Manchester Metropolitan University
name: University of Freiburg
name: University of Copenhagen
name: Paracelsus Medical University
First posted: 2010-11-25
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT

Brief summary: Older people tend to live a sedentary lifestyle which causes a loss of cardiorespiratory fitness, impaired postural stability and a increased risk of falls. Social isolation of older people leads to depression and other mental diseases. However, numerous studies show that age-related degradation processes and functional limitations can be counteracted by physical activity. Various studies show that alpine skiing is a complex sport that places demands on the cardiorespiratory, neuromuscular and sensorimotor systems. With studies providing evidence to suggest alpine skiing is an appropriate activity for elderly as a health-enhancing sport, perhaps Alpine skiing could provide the physical activity needed to counteract age-related degradation processes and loss of function. To date, there is a lack of long-term intervention studies devoted to this topic. The aim of this study was to monitor the long-term effects of skiing on the health of older people, as to age-related muscle breakdown, cardiorespiratory fitness, body stability, general mobility and the overall psychological state of the subjects.


Eligibility criteria: Inclusion Criteria:

* Age 60-75 years of age at
* average or above average skiing ability
* average physical activity level
* willingness to ski regularly (2-3 days per week) for 12 weeks
* ability to give written informed consent

Exclusion Criteria:

* serious health problems that would make alpine skiing unjustifiable

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hallein
country: Austria
facility: Department of Sport Science and Christian Doppler Laboratory "Biomechanics in Skiing"
state: Salzburg
Study officials:
affiliation: Department of Sport Science and Kinesiology, University of Salzburg
name: Erich Müller, PhD
role: PRINCIPAL_INVESTIGATOR
References: