louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05751304: A Comparative Study Between Intrathecal Dexmedetomidine VS Ketamine With Intrathecal Bupivacaine in Orthopedic Lower Limb Surgeries.
Official title: A Comparative Study Between Intrathecal Dexmedetomidine VS Ketamine With Intrathecal Bupivacaine in Orthopedic Lower Limb Surgeries.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Fracture
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Orthopedic anaesthesia and acute postoperative pain management, two anesthesiology subspecialties,are getting more credit for reducing hospital stays, promoting functional recovery and improving patient satisfaction.


Eligibility criteria: Inclusion Criteria:

-The study will include 100 adult patients (18 to 50 years old) with ASA physical status class I and class II undergoing orthopedic lower limb surgeries under itrathecal anathesia .

Exclusion Criteria:

* Patient refusal.
* Drug abuse.
* Patient with neurological, psychiatric or neuromuscular disease.
* Chronic pain on medicine.
* Known allergy to the study medications.
* Patients e contraindications to intrathecal anesthesia .

Primary outcomes:
measure: comparison between duration of analgesia from Ketamine Vs Dexmedtomidine in the Patients with lower limb surgery
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
citation: Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
citation: Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available.
citation: Brennan F, Carr DB, Cousins M. Pain management: a fundamental human right. Anesth Analg. 2007 Jul;105(1):205-21. doi: 10.1213/01.ane.0000268145.52345.55.
Clinical trial NCT05831904: Effect of Vibration Therapy on Hip Girdle Muscles in Healthy People
Official title: Effect of Vibration Therapy on Hip Girdle Muscles in Healthy People
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Dislocation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This clinical trial(prospective, pilot study) is to learn about the effect of whole-body vibration on hip girdle muscles in healthy children as a primary study aiming for a new clinical intervention protocol to prevent hip dislocation in patients with severe cerebral palsy.

Detailed description: Design: Prospective, pilot study Setting: hospital rehabilitation department Intervention: Participants will be asked to walk and jump with a surface electromyography(EMG) attached to their hip girdle muscles. After the participants are positioned(standing) on the platform of whole-body vibration device, the study practitioner will record the sEMG values from the hip girdle muscles during the vibration applied. The mean values of repeating the same process with different vibrations applications and the values before vibration will be compared by using the SPSS using the paired "t-test" or Wilcoxon signed rank test for comparison between before and after vibration in the same group.

Eligibility criteria: Inclusion Criteria:

* Healthy children (5 to 15 years old)

Exclusion Criteria:

* Children with cerebral palsy, muscle paralysis, developmental or congenital hip joint abnormalities
* Children who underwent hip joint surgery

Primary outcomes:
measure: muscle activation values on surface electromyography(sEMG)
timeFrame: 10 seconds for each session
Secondary outcomes:
measure: VAS (Visual Analogue Scale)
timeFrame: 10 seconds for each session
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Ju Seok Ryu, M.D. PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06319404: Immune Function of Colorectal Cancer Lymph Nodes
Official title: A Multiomics-based Study of the Immune Function of Colorectal Cancer Lymph Nodes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colorectal Cancer
Lymph Node
Lead sponsor: Shanxi Province Cancer Hospital
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Harbin Medical University
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First posted: 2024-03-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stage I-III colorectal cancer patients undergoing radical surgery with complete clinical imaging, pathology, and genetic data.

Brief summary: Lymph nodes are very important immune organs in the human body and play an important role in the physiological and pathological activities of the body, especially in anti-tumor immunity. The role of regional draining lymph nodes in the development of colorectal cancer is still unknown. In this study, the role of lymph nodes in the development of colorectal cancer was investigated through multicenter and multi-omics data.


Eligibility criteria: Inclusion Criteria:

* Stage I-III colorectal cancer patients undergoing radical surgery
* Complete imaging, pathology and genetics multi-omics data available
* 18-75 years old

Exclusion Criteria:

* Patients with preoperative neoadjuvant therapy
* Patients with incomplete clinical information
* Patients with other malignant tumors
* Patients with acute infections or untreated chronic infections

Primary outcomes:
measure: To investigate the difference of immune pathway activation in tumor-draining lymph node based on genomics
timeFrame: 2024.04-2026.04
measure: To investigate the relationship between the type and number of immune cells in tumor draining lymph nodes and the activation of immune pathways is based on pathomics
timeFrame: 2024.04-2026.04
measure: The immune function of tumor draining lymph nodes of colorectal cancer patients was previously identified based on radiomics
timeFrame: 2024.04-2026.04
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01330004: Blood Pressure Change and Outcome
Official title: The Relationship of Systolic and Diastolic Blood Pressure Changes Over Time to Patient Outcomes in Incident Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Disease
High Blood Pressure
Lead sponsor: Renal Research Institute
Sponsor class: OTHER
First posted: 2011-04-06
Enrollment: 12695
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Renal Research Institute hemodialysis patients

Brief summary: Hyper- and hypotension are important predictors of survival in non-ESRD (end stage renal disease) population. In dialysis patients, however, it has been shown that higher blood pressure levels may actually be beneficial to patient outcomes. Dynamics of blood pressure evolution over time has not been previously studied in dialysis population. The investigators aim to understand how both blood pressure levels and blood pressure changes over time predict patient survival.


Eligibility criteria: Inclusion Criteria:

* Hemodialysis

Primary outcomes:
measure: Effect size of the relation of dynamic changes of blood pressure (BP) at different ranges of BP to survival in incident hemodialysis patients.
timeFrame: Up to 11 years and 11 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Renal Research Institute
state: New York
Study officials:
affiliation: Renal Research Institute
name: Nathan W Levin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raimann JG, Usvyat LA, Thijssen S, Kotanko P, Rogus J, Lacson E Jr, Levin NW. Blood pressure stability in hemodialysis patients confers a survival advantage: results from a large retrospective cohort study. Kidney Int. 2012 Mar;81(6):548-58. doi: 10.1038/ki.2011.426. Epub 2012 Jan 4.
Clinical trial NCT01523704: Safety and Efficacy Study of IPG Patient With Home Monitoring
Official title: Comparison of the Safety and Efficacy of the Management of Pacemaker Patients Followed-up Via Home Monitoring vs. Conventional In-Office Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradyarrhythmia
Lead sponsor: Biotronik Japan, Inc.
Sponsor class: INDUSTRY
First posted: 2012-02-01
Enrollment: 1327
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The number of patients with implantable pulse generator (IPG) has steadily increased in Japan causing increment in number of in office follow-ups and greater burden on many hospitals.

The purpose of this multicenter randomized study is to demonstrate that BIOTRONIK Home Monitoring system reduces office follow-up visits without compromising patient safety.

Detailed description: Patients will be randomized into HM follow-up only (Group 1) or HM \& in-office follow-up (Group 2) and will be followed-up for 27 months.

Eligibility criteria: Inclusion Criteria:

* Indicated for IPG implantation under Japanese guidelines
* Implanted within the last 45 days or being considered for implant with a BIOTRONIK IPG with Home Monitoring
* Able to utilize HM system throughout the study
* Ability to give informed consent
* Geographically stable and able to return for follow-ups for 27 months
* Over 20 years old
* Patient able to understand and follow the procedure stated in protocol

Exclusion Criteria:

* Contraindicated for IPG under Japanese guidelines
* Patients who are currently included in another cardiac clinical study
* Patients with expected life period of less than two years
* Patients who might undergo heart transplantation in next two years.

Primary outcomes:
measure: Evaluation for Equivalence of the Number of Patients Who Meet the Composite Safety Endpoint Between Home Monitoring Group(HM) and Control Group Which is HM + Conventional In-office Follow-up
timeFrame: 2 years
Secondary outcomes:
measure: The Median (IQR) Numbers of In-office Follow-up（FU) Visits Per Patient-year
timeFrame: 2 years
measure: Efficacy of Home Monitoring：Average Cost for In-office Follow-up Per Patient-year
timeFrame: 2 years
Other outcomes:
Locations:
city: Toyoake
country: Japan
facility: Fujita Health University
state: Aichi
Study officials:
affiliation: Fujita Health University
name: Eiichi Watanabe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Watanabe E, Yamazaki F, Goto T, Asai T, Yamamoto T, Hirooka K, Sato T, Kasai A, Ueda M, Yamakawa T, Ueda Y, Yamamoto K, Tokunaga T, Sugai Y, Tanaka K, Hiramatsu S, Arakawa T, Schrader J, Varma N, Ando K. Remote Management of Pacemaker Patients With Biennial In-Clinic Evaluation: Continuous Home Monitoring in the Japanese At-Home Study: A Randomized Clinical Trial. Circ Arrhythm Electrophysiol. 2020 May;13(5):e007734. doi: 10.1161/CIRCEP.119.007734. Epub 2020 Apr 28.
Clinical trial NCT02516904: A Single Ascending Dose Study of CD101 IV in Healthy Subjects
Official title: A Phase 1, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD101 Injection in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Subjects
Lead sponsor: Cidara Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-06
Enrollment: 32
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: A single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CD101 IV

Detailed description: This is a Phase 1, single-center, prospective, randomized, double-blind study of ascending single doses of CD101 Injection administered IV to healthy adult subjects. In this study, subjects in 4 cohorts of 8 subjects, each will be randomized to receive single IV doses of CD101 Injection or placebo. Dose levels of CD101 to be assessed will follow an ascending single-dose regimen.

Eligibility criteria: Inclusion Criteria:

* Males surgically sterilized or using contraception,
* No significant findings on physical, ECG, clinical laboratory tests,
* BMI between 18.5 - 32.0,
* Must provide informed consent

Exclusion Criteria:

* Females of child bearing potential,
* Signs and or symptoms of an acute or chronic illness,
* Use of prescription medications within 28 days,
* Use of OTC, supplements, and herbals within 14 days,
* Current smoker
* Previous participation in a clinical study within 28 days

Primary outcomes:
measure: Number of subjects with clinically significant adverse events (AEs)
timeFrame: Up to 3 weeks
Secondary outcomes:
measure: Pharmacokinetic Profile as measured by: maximum plasma concentration (Cmax), time to Cmax (Tmax), area under the curve (AUC), clearance (CL), volume of distribution (Vz), elimination rate constant (^z), terminal half-life (t1/2)
timeFrame: Up to 3 weeks
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion Inc
state: Arizona
Study officials:
affiliation: Celerion
name: Danielle Armas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05601804: TARGETing Healthy Weight Loss in the Context of Food Insecurity
Official title: TARGETing Healthy Weight Loss in the Context of Food Insecurity Pilot and Feasibility Trial I
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity
Food Insecurity
Food Security
Body Weight
Keywords: Food Insecurity
Obesity
Weight Loss
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 18 to 65 years with a BMI of 30.0 kg/m2 or greater.

Brief summary: This pilot and feasibility study will collect information from food insecure, as well as food secure, women with obesity to detail their desires and needs for healthy weight reduction. Up to 60 women with obesity will be enrolled. Pennington Biomedical Research Center will coordinate this qualitative study and use focus groups discussion to collect formative data.


Eligibility criteria: Inclusion Criteria:

* Willing to provide written informed consent
* Female
* 18 to 65 years of age
* BMI ≥ 30 kg/m2
* Ability to read and write using English
* Willing to participate in focus group discussions
* Willing to be audio/video recorded

Exclusion Criteria:

* Male
* Currently pregnant
* BMI \<30 kg/m2

Primary outcomes:
measure: Desires and needs for weight loss
timeFrame: Through study completion, up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Candice A. Myers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00574704: A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
Official title: Double Blind Placebo Controlled Study to Assess Efficacy and Safety of a Combined Allergen Vaccine (CYT005-AllQbG10) and Its Single Components in Patients With House Dust Mite Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Perennial Allergic Rhinoconjunctivitis
House Dust Mite Allergy
Lead sponsor: Cytos Biotechnology AG
Sponsor class: INDUSTRY
First posted: 2007-12-17
Enrollment: 40
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: The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind, placebo-controlled setting


Eligibility criteria: Inclusion Criteria:

* Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite allergens

Exclusion Criteria:

* Clinically relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments
* Use of any concomitant medication that could affect the patient's study treatment response or assessment results

Primary outcomes:
measure: Conjunctival Provocation Test (CPT) With House Dust Mite Allergen Solutions. Change of Median Individual Allergen Tolerance Compared to Baseline (Factor of Increase in Allergen Concentration to Induce a Threshold CPT Score ≥ 2)
timeFrame: baseline versus 2 months after baseline
Secondary outcomes:
measure: Safety and Tolerability of the Study Treatment by Collection of Adverse Events
timeFrame: about 30 min. at each visit
Other outcomes:
Locations:
Study officials:
affiliation: Cytos Biotechnology
name: Philipp Mueller, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03432104: Evaluation of Bioavailability of Phenolic Compounds From Oxxynea®
Official title: Evaluation of Absorption and Metabolism of Phenolic Compounds From Oxxynea®, a Blend of Fruit and Vegetable Extracts, in Human Healthy Volunteers: a Randomized, Double-blind, Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Lead sponsor: Fytexia
Sponsor class: INDUSTRY
First posted: 2018-02-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate bioavailability and pharmacokinetics of phenolic compounds from Oxxynea®, a blend of fruit and vegetable extracts, in healthy volunteers, during a randomized, double-blind and cross-over trial. After a single dose supplementation, both metabolic profile and urinary excretion will be determined over a 48h-period by means of High-Performance Liquid Chromatography coupled with a tandem mass spectrometry (HPLC-MS) to identify and quantify phenolic metabolites. In parallel, post-prandial potential anti-oxidative and anti-glycemic properties of Oxxynea® will be determined in blood, following consumption of a cafeteria-type breakfast.


Eligibility criteria: Inclusion Criteria:

* In good general health
* Agreement to adhere to diet considerations

Exclusion Criteria:

* Smoking
* Pregnancy / Lactation
* Current use of any medication or food supplement
* Known allergic reaction to components of the supplement/placebo

Primary outcomes:
measure: Change in plasma concentration of phenolic metabolites after acute ingestion of the supplement/placebo
timeFrame: 0h, 0.5h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 24h post-ingestion
Secondary outcomes:
measure: Change in urine phenolic metabolites excretion after acute ingestion of the supplement/placebo
timeFrame: Baseline (12h pre-ingestion), 0-3h, 3-6h, 6-10h, 10-14h, 14-24h, 24-32h, 32-48h post-ingestion
measure: Change in total circulating antioxidant defences after acute ingestion of the supplement/placebo
timeFrame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 24h post-ingestion
measure: Change in post-prandial glycemia
timeFrame: 0h, 1h, 2h, 3h, 4h, 5h, 6h post-ingestion
measure: Change in post-prandial insulinemia
timeFrame: 0h, 1h, 2h, 3h, 4h, 5h, 6h post-ingestion
measure: Change in sleepiness during the day
timeFrame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h post-ingestion
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: UCAM (Universidad Catolica San Antonio de Murcia)
Study officials:
affiliation: UCAM (Universidad Catolica San Antonio de Murcia)
name: Pedro E Alcaraz Ramon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01777204: Gastrointestinal Transit and Motility in Renal Transplant Recipients
Official title: Non-invasive Assessment of Gastrointestinal Transit and Motility in Renal Transplant Recipients Employing a Biomagnetic Technique
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Change of Transit or Circulation
Effects of Immunosuppressant Therapy
Keywords: Renal transplant, Gastrointestinal motility, Biomagnetism
Lead sponsor: Universidade Estadual de Ciências da Saúde de Alagoas
Sponsor class: OTHER
Collaborators: name: UPECLIN HC FM Botucatu Unesp
name: University of Sao Paulo
First posted: 2013-01-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Renal transplant recipients from Alagoas, Brazil

Brief summary: Gastrointestinal (GI) complications after renal transplantation are commonly reported as side effects of immunosuppressive agents. Despite this, motility disorders have been scantily studied. Alternating Current Biosusceptometry (ACB) are biomagnetic sensors designed for a wide range of applications. In clinical practice, their non-invasive and radiation free features provide an excellent approach for monitoring of GI transit as alternative to scintigraphy and breath tests. The aim of this study is to examine GI transit and motility of solids in stable renal transplant recipients to determine the potential influence of immunosuppressive therapy on gastrointestinal parameters.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteer or Renal Transplant Patients
* Signed informed consent obtained
* Fasted since midnight

Exclusion Criteria:

* Subject has known GI related symptoms complaints or GI diseases
* Subject has cancer or other life threatening diseases or conditions
* Subject is pregnant
* Subject has undergone abdominal surgery
* Drug abuse or alcoholism
* Subject has cardiac pacemaker
* Subject takes any medication affecting GI motility

Primary outcomes:
measure: Influence of tacrolimus and cyclosporine on gastrointestinal transit
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Maceio
country: Brazil
facility: Universidade Estadual de Ciências da Saúde de Alagoas
state: Alagoas
Study officials:
affiliation: Universidade Estadual de Ciências da Saúde de Alagoas
name: Maria do Carmo B Teixeira, Dr
role: PRINCIPAL_INVESTIGATOR
References: