louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02927379: Effect of Wound Infiltration by Ketamine Versus Dexmedetomidine Added to Bupivacaine on Surgical Stress
Official title: Effects of Local Wound Infiltration With Ketamine Versus Dexmedetomidine Added to Bupivacaine on Surgical Stress Response and Postoperative Pain in Major Abdominal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Abdominal Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-10-07
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to compare the effects of local wound infiltration with ketamine versus dexmedetomidine when added to bupivacaine on stress response and postoperative pain in lower abdominal cancer surgery.

Detailed description: Patients will be randomly assigned using an online research randomizer into three groups, 30 patients in each group:

Group C:

30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision( control group).

Group K:

30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline +1 mg /kg ketamine (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision.

Group D:

30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline + 1µg/kg dexmedetomidine (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) class I-II Body weight of 50 - 90 kg

Exclusion Criteria:

* History of bleeding diathesis
* Relevant drug allergy, opioid dependence
* Morbid obesity, sepsis

Primary outcomes:
measure: Total morphine consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Plasma concentrations of prolactin, cortisol and glucose level
timeFrame: 24 hours
measure: the severity of pain was assessed using VAS score
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: South Egypt Cancer Instuite
Study officials:
affiliation: South Egypt Cancer Instuite, Assuit, Assuit university
name: fatma A EL sherif
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mohamed SA, Sayed DM, El Sherif FA, Abd El-Rahman AM. Effect of local wound infiltration with ketamine versus dexmedetomidine on postoperative pain and stress after abdominal hysterectomy, a randomized trial. Eur J Pain. 2018 May;22(5):951-960. doi: 10.1002/ejp.1181. Epub 2018 Feb 1.
Clinical trial NCT00609479: Comparison of Two Methods for Treatment of Colles´s Fracture
Official title: Comparison of External and Internal Fixationmethods for Distal Radius Fracture - a Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Colle´s Fracture
Keywords: Distal radius fracture
Colle´s fracture
Internal fixation
External fixation
DASH
PRWE
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2008-02-07
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 compare two different fixationmethods for fractures of the wrist(distal radius fractures). We are comparing an external fixation (Hoffmann-II-non-bridging) vs. an internal fixation(Micronail). Primary endpoint is patient satisfaction as scored by the DASH-questionnaire.Secondary followup is X-rays, strength, PRWE-questionnaire.


Eligibility criteria: Inclusion Criteria:

* Fracture Older type 2.
* Fracture Older type 3.

Exclusion Criteria:

* Fractures older than 3 weeks.
* Pregnancy.
* Seq. after previous fracture.
* Distal fragments volar cortex \< 10 mm.
* Open fracture larger than Gustillo 1.
* Disability due to other illness.
* Congenital abnormity or injury/disease in the affected extremity.
* Not capable of mentally/physically to cooperate.
* Not able to go to followup on the operating hospital.

Primary outcomes:
measure: DASH-questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: PRWE-questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Regionhospital Herning
city: Holstebro
country: Denmark
facility: Regionhospital Holstebro
city: Viborg
country: Denmark
facility: Regionhospital Viborg
Study officials:
affiliation: Department of Orthopedics, University of Aarhus, Denmark
name: Kjeld Søballe, MD; PhD; Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT01349179: Scan Hip Evaluation
Official title: Scan Evaluation at 9 Years of the Bone Acetabular Supporting Cups Without Cement (Couple Metal/Metal in Diameter 28 mm)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Arthroplasty
Keywords: Hip
Arthroplasty
Metal on metal
operated on 2002
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2011-05-06
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The couple of friction metal-polyethylene is regarded as the couple of reference in spite of the osteolysis induced by the wear of the polyethylene which remains the independent factor of long-term failure. This is all the more true as the patients are young, thus justifying the recourse to alternate couples of friction. The Metasul® couple was introduced on the French market under its current form in 1995 (year of its marking EC). The use of a couple of friction metal-metal (MM) is justified because it would be likely to improve longevity of the total arthroplasties of the active subjects by the reduction in osteolysis related to the wear of polyethylene. Various studies highlight evolutions different according to the types of fixing acetabular; favourable results of the not cemented cups contrasting with unsealings and the evolutionary edgings of the Metasul® cups cemented of or the cups "of cemented Weber type".

Detailed description: Radiographies standards allow the follow-up of the total prostheses of hip but those underestimate the incidence and the extension of osteolyses perished-acetabular which are generally asymptomatic initially. The lack of international consensus on the definition of the parameters of interpretation of the radiological follow-up of the PTH makes difficult the comparison of the various results. The purpose of the study is to evaluate the presence of geodes acetabular and femoral with scan examination.

Eligibility criteria: Inclusion Criteria:

* Metal on metal hip arthroplasty operated on 2002
* Age older than 40 years

Exclusion Criteria:

* Expectant mothers

Primary outcomes:
measure: Realization of a scan nine years after the surgery of total hip arthroplasty
timeFrame: after nine years
Secondary outcomes:
measure: Clinical results preoperative Postel Merle d'Aubigné, Harris score preoperative and SF12 scores preoperative (before the hip surgery)
timeFrame: after nine years
measure: Cooperating X-ray assessments and scan
timeFrame: after nine years
measure: Realization of a X-ray and a scan then comparison of the results obtained
timeFrame: after nine years
measure: Concentrations of cobalt: chrome and nickel in blood
timeFrame: after nine years
measure: Rate of survival of the prosthesis
timeFrame: after nine years
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Stéphane DESCAMPS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06484179: Enhancing Motivation to Quit Smoking Via Self-Help Intervention Targeted to Cancer Type
Official title: Enhancing Motivation to Quit Smoking Via Self-Help Intervention Targeted to Cancer Type: A Pilot Randomized Control Trial (RCT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Smoking
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-07-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to (1) Usual Care or (2) Usual Care + targeted self-help intervention.
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is assess feasibility and acceptability of a recently developed brief self-help intervention targeted by cancer type to increase motivation to quit smoking.


Eligibility criteria: Inclusion Criteria:

* Individuals who smoke and recently (i.e., within 6 months) received a diagnosis of breast, colorectal, gynecological, skin melanoma, or bladder cancer (n = 20 per cancer type). (Investigators will consider smokers individuals who report having smoked ≥1 cigarette in the past 30 days.)
* Able to read/write English;
* Able to give informed consent;
* Not currently enrolled in a smoking cessation program;
* Age ≥18 years old.

Exclusion Criteria:

* Male patients diagnosed with breast cancer will be excluded as lifetime risk for breast cancer in men is far below 1%

Primary outcomes:
measure: Recruitment
timeFrame: Baseline
measure: Retention- Completion of 2-week follow-up
timeFrame: 2 weeks post-randomization
measure: Retention- Completion of 1 month follow-up
timeFrame: 1 month post-randomization
measure: Adherence- 2 weeks post-randomization
timeFrame: 2 weeks post-randomization
measure: Adherence- 1 month post-randomization
timeFrame: 1 month post-randomization
measure: Acceptability
timeFrame: 2 weeks post-randomization, 1 month post-randomization
Secondary outcomes:
measure: Motivation to quit smoking
timeFrame: Baseline, 2 weeks post-randomization, 1 month post-randomization
measure: Treatment Engagement defined by the number of participants who enroll with the state tobacco quitline
timeFrame: 2 weeks post-randomization, 1 month post-randomization
measure: Smoking Status
timeFrame: 2 weeks post-randomization, 1 month post-randomization]
measure: Smoking Status
timeFrame: 2 weeks post-randomization, 1 month post-randomization
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute
name: Ursula Martinez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05756179: Effect of Diosmin and Hesperidin in Treatment of Patients With Rheumatoid Arthritis
Official title: Clinical Study Evaluating the Effect of Diosmin and Hesperidin in Treatment of Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluating the effect of the flavonoids combination (diosmin and hesperidin) as adjuvant therapy on patients with rheumatoid arthritis

Detailed description: Evaluation of the anti inflammatory and antioxidant effects of the flavonoids combination (diosmin and hesperidin) as adjuvant therapy on patients with rheumatoid arthritis.

Clinical and functional assessment of disease activity.

Evaluation of hepatoprotective effect against methotrexate induced liver adverse events.

Eligibility criteria: Inclusion Criteria:

* Patients with mild to moderate disease activity.
* Patient age must be more than 18 years.

Exclusion Criteria:

* Pregnant and lactating females.
* Patients with liver, renal impairment or any other inflammatory diseases.
* Patients on TNF-α (tumor necrosis factor- α) or IL-1β (interleukin-1β) antagonists.

Primary outcomes:
measure: Anti inflammatory Effect
timeFrame: 3 months
measure: Effect on disease activity
timeFrame: 3 months
Secondary outcomes:
measure: Hepatoprotective Effect
timeFrame: 3 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university hospital
Study officials:
affiliation: College of Pharmacy - Arab Academy for Science and Technology
name: AHMED ABDELBAR, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Pharmacy - Alexandria University
name: AHMED ELMALLAH, PhD
role: STUDY_CHAIR
affiliation: Faculty of Medicine - Alexandria Univeristy
name: MANAL TAYEL, MD
role: STUDY_CHAIR
affiliation: Faculty of Medicine - Alexandria Univeristy
name: ABEER IBRAHIM, MD
role: STUDY_CHAIR
affiliation: Faculty of Pharmacy - Alexandria University
name: NOHA HAMDI, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00268879: Investigation of the Safety and Efficacy of Renzapride in Constipation Predominant Irritable Bowel Syndrome (IBS)
Official title: A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (c-IBS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome
Constipation-predominant irritable bowel syndrome
Lead sponsor: Alizyme
Sponsor class: INDUSTRY
First posted: 2005-12-23
Enrollment: 1821
Sex: FEMALE
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: The purpose of the study is to investigate whether renzapride will help alleviate the symptoms associated with constipation predominant irritable bowel syndrome in female patients.

Detailed description: Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by recurrent symptoms of abdominal pain/discomfort accompanied by disturbed bowel function.

In this study female patients with constipation predominant IBS will receive one of two dosing regimens of renzapride or placebo for 12 weeks. Patients will record the severity of their symptoms throughout the study. The results will be analysed to see if those patients who received renzapride had greater relief of their symptoms than did the patients who received placebo.

Eligibility criteria: Inclusion Criteria:

* Females with constipation predominant IBS as defined by the Rome II criteria
* Colonoscopy or sigmoidoscopy in previous 5 years showed no significant disease

Exclusion Criteria:

* Patients who have diarrhoea predominant or alternating symptom IBS
* Other gastrointestinal diseases that affect bowel transit

Primary outcomes:
measure: Number of months a patient is a Responder for overall relief of IBS symptoms
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of months a patient is a Responder for relief of abdominal pain/discomfort, bowel problems, and bloating/abdominal distention
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Alizyme
Study officials:
affiliation: Beth Israel Deaconess Medical Centre, Boston
name: Anthony Lembo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01203579: Chest Computed Tomography (CT) Screening Study With Antibody Testing
Official title: Different Strategies Using Autoantibodies and/or CT in the Detection of Lung Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lung Cancer
Keywords: CDT-Lung,CT scan,lung cancer detection
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Current or Former Smokers with \>20 pack year history and or family history of lung cancer. Ages 50-75 years old

Brief summary: The purpose of this study is to assess the value of EarlyCDT-Lung test and CT scan both in lung cancer detection and potential health economic outcomes.

Detailed description: EarlyCDT-Lung test and CT scan both for lung cancer detection and potential economic outcomes.

Eligibility criteria: * Persons 50-75
* Asymptomatic for lung cancer
* Current or former (stopped smoking less than 10 years ago) cigarette smokers
* History of cigarette smoking of at least 20 pack years
* History of cigarette smoking with a family history of lung cancer which gives an individual a personal risk similar to a smoking history of 20 pk/years (i.e. 1% at 5 years).
* Mentally competent individuals to sign an informed consent.
* Healthy enough to undergo pulmonary resection or stereotactic body radiotherapy.
* A fully informed signed consent form must have been obtained.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David Midthun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01798979: A Phase I, Open Interaction Study Between GLPG0634 and Midazolam in Healthy Subjects
Official title: A Phase I, Open Interaction Study Between Oral Doses of GLPG0634 (200 mg QD) and Single Oral Doses of Midazolam (2 mg) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2013-02-26
Enrollment: 20
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG0634 on the single dose pharmacokinetic profile of midazolam administered in fasted normal healthy males. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before dosing with GLPG0634 and on Day 8, after multiple oral doses of GLPG0634 (daily for 7 days).

Also, the safety and tolerability of multiple oral doses of GLPG0634 co-administered with midazolam in healthy male subjects will be evaluated.


Eligibility criteria: Inclusion Criteria:

* male, between 40 and 60 years of age, inclusive
* within BMI range 18 to 30 kg/m2, inclusive

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking

Primary outcomes:
measure: The amount of (1'-OH) Midazolam in plasma over time before and after multiple oral doses of GLPG0634
timeFrame: Between predose and up to 24h postdose on Day 1 and Day 8
Secondary outcomes:
measure: The amount of GLPG0634 and metabolite in plasma over time after multiple oral doses of GLPG0634 (and co-administration of Midazolam on Day 8)
timeFrame: Between predose (Day 2) and up to 96h after the last dose on Day 8 (on Day 12)
measure: Number of adverse events
timeFrame: Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18)
measure: Changes in vital signs as measured by pulse, supine blood pressure, oral temperature (and respiratory rate only 1 hour post Midazolam dosing)
timeFrame: Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18)
measure: Changes in 12-lead ECG measures
timeFrame: Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18)
measure: Changes in physical exam measures
timeFrame: Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18)
measure: Changes in blood safety lab parameters
timeFrame: Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18)
measure: Changes in urine safety lab parameters
timeFrame: Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18)
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit
state: Wisconsin
Study officials:
affiliation: Galapagos NV
name: Frédéric Vanhoutte, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05984979: The Daytime Circadian Rhythm in Exhaled Volatile Organic Compounds in People Living Without and Diabetes
Official title: The Daytime Circadian Rhythm in Exhaled Volatile Organic Compounds in People Living Without and With Type 1 and 2 Diabetes: an Exploratory Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetes Mellitus
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
name: DCB Research AG
First posted: 2023-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 participants with the following subgroups: Subgroup 1: People without diabetes Subgroup 2: People diagnosed with T1D Subgroup 3: People diagnosed with T2D

Brief summary: Exhaled volatile organic compounds will be measured during daytime with the goal to identifying circadian variability. The study incudes three subgroups: people without diabetes, people with type 1 diabetes, and people with type 2 diabetes. A total of 60 people will be recruited for the study.


Eligibility criteria: Inclusion criteria

Subgroup 1:

* Age 18 or older
* HbA1c below 6.5%
* Written informed consent

Subgroup 2:

* Age 18 or older
* T1D (Type 1 diabetes) with MDI (multiple daily injection) or CSII (Continuous subcutaneous insulin infusion therapy) therapy \>1 year
* Written informed consent

Subgroup 3

* Age 18 or older
* T2D (Type 2 diabetes) with oral antidiabetic medication or insulin therapy
* Written informed consent

Exclusion criteria

* Pregnancy or breastfeeding
* Smoking (last cigarette less than 6 months ago)
* Any chronical lung and intestinal disease diagnosis (such as intestinal bowel disease (IBD); asthma; COPD (chronic obstructive pulmonary disease); lung cancer, ...)
* Coeliac disease
* Lactose and fructose intolerance
* Any acute disease diagnosis (such as viral or bacterial infection)
* Drinking habit of more than four units of alcohol per day
* Current inhaled medicines treatments
* Antibiotic treatment in the previous 4 months

Primary outcomes:
measure: VOC Patterns over time as gallery plots
timeFrame: During the study procedure (approximately 8 hours)
measure: VOC Patterns over time as boxplots
timeFrame: During the study procedure (approximately 8 hours)
Secondary outcomes:
measure: Capillary blood glucose
timeFrame: During the study procedure (approximately 8 hours)
measure: Correlation between VOCs in breath intestinal microbiota
timeFrame: day 1
measure: Correlation between VOCs in breath oral microbiota
timeFrame: day 1
measure: Correlation between VOCs and subgroups
timeFrame: day 1 or 8 hours
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: University of Bern
name: Lilian Witthauer, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References: