louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03656757: The Impact of Altered Arterioventricular Coupling on Central Cardiovascular Energy Delivery
Official title: The Impact of Altered Arterioventricular Coupling on Central Cardiovascular Energy Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Keywords: Cardiac Power
Oscillatory Power
Coronary Artery Bypass Graft
Arterioventricular Coupling
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2018-09-04
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population undergoing elective coronary artery bypass grafting typically have multiple cardiovascular risk factors such as hypertension, hyperlipidaemia, diabetes and smoking.

Brief summary: This study will assess the amount of energy that the heart will deliver to the central circulation and the efficiency of that energy transfer, in patients undergoing a coronary artery bypass graft operation. Measurements will be taken just after induction of anaesthesia and repeated just after the end of the operation. The total energy delivered by the heart will be calculated by multiplying a pressure curve from the artery in the hand with the instantaneous ultrasound recorded cardiac output flow curve. The energy responsible for the acceleration of the blood volume, known as oscillatory power will also be calculated. The energy transfer will be calculated using a mathematical model based upon other ultrasound and blood pressure recorded variables. We would like to see if any alteration in energy delivered is in part due to impairment in energy transfer or alteration of fraction of oscillatory power rather than a change in total energy production. We would also like to study if there are changes in the oscillatory power after cardiac bypass surgery. The patients will be sampled sequentially into the study. We are not aware of any such studies undertaken in humans previously.


Eligibility criteria: Inclusion Criteria:

* Elective Coronary Artery Bypass Graft patients
* No contraindications to transoesophageal Echo
* Ejection fraction 40% or over

Exclusion Criteria:

* Lack of consent
* Emergency operation
* Prosthetic aortic valve

Primary outcomes:
measure: Arterioventricular coupling
timeFrame: 1 day
measure: Total Cardiac Power
timeFrame: 1 day
measure: Oscillatory Cardiac Power
timeFrame: 1 day
Secondary outcomes:
measure: Cardiac Output
timeFrame: 1 day
measure: Heart rate
timeFrame: 1 day
measure: Systemic vascular resistance
timeFrame: 1 day
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Idar Kirkeby-Garstad, md phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03949257: Dynamic Changes of Gut Microbiota in UC After FMT
Official title: Dynamic Changes of Gut Microbiota in Patients With Ulcerative Colitis After Fecal Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcerative Colitis
Keywords: transendoscopic enteral tubing
gut microbiota
ulcerative colitis
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A prospective study to investigate the dynamic changes of gut microbiota through colonic transendoscopic enteral tubing in patients with ulcerative colitis after fecal microbiota transplantation.

Detailed description: Colonic transendoscopic enteral tubing (TET) is a novel, safe, convenient, and reliable way for fecal microbiota transplantation (FMT) and the whole-colon enema treatment. This tube also can serve as a medium for collecting gut microbiota. Fecal Microbiota Transplantation (FMT) was identified to be promising for ulcerative colitis (UC). This study aims to investigate the dynamic changes of gut microbiota in patients with UC after FMT.

Eligibility criteria: Inclusion Criteria:

* Patients were diagnosed with mild or moderate ulcerative colitis.
* Patients need colonic TET and FMT
* Must be able to colonic TET and no contraindication by endoscopic examination, consent colon TET implantation and not associated with severe intestinal lesions such as fistula, stenosis, complex perianal lesions, severe ileocecal or ascending colon lesions resulting in no proper site for titanium clip fixation.
* Age \> 7 years old and \< 65 years old

Exclusion Criteria:

* gut microbiota was not collected successfully

Primary outcomes:
measure: changes of gut microbiota
timeFrame: 7 days
Secondary outcomes:
measure: frequency of defecation
timeFrame: 7 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The Second Hospital of Nanjing Medical University
name: faming zhang, MD; PhD
role: STUDY_CHAIR
References:
citation: Peng Z, Xiang J, He Z, Zhang T, Xu L, Cui B, Li P, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Colonic transendoscopic enteral tubing: A novel way of transplanting fecal microbiota. Endosc Int Open. 2016 Jun;4(6):E610-3. doi: 10.1055/s-0042-105205. Epub 2016 Apr 28.
citation: Westwood DA, Alexakis N, Connor SJ. Transparent cap-assisted colonoscopy versus standard adult colonoscopy: a systematic review and meta-analysis. Dis Colon Rectum. 2012 Feb;55(2):218-25. doi: 10.1097/DCR.0b013e31823461ef.
Clinical trial NCT02814357: To Test the Effect of Selected Fibres and Flours in Flat Bread on Post-Prandial Blood Glucose and Insulin Responses in Healthy Indian Population
Official title: To Evaluate the Effect of 4 Different Flour Compositions of Selected Fibres and Flours, on Post-prandial Plasma Glucose (PPG) and Serum Insulin Levels in Normal Indian Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Blood glucose, serum insulin
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
First posted: 2016-06-27
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Double-blind, randomized, controlled, cross-over design with 3 test products and one control product.

To evaluate the effect of 4 different flour compositions (guar gum 2% and 4%, chickpea flour 15% and barley flour 2% and 5%) of selected fibres and flours, on post-prandial plasma (PPG) and serum insulin levels in healthy Indian subjects, after the consumption of flat bread made from 100 gram of flour compositions.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects between \> 20 and \< 50 years of age
* BMI of \>18 and \< 23 kg/m2
* Fasting blood glucose value of volunteer is \> 3.4 and \<6.1 mmol/litre (i.e. 62- 110 mg/dl) at screening

Exclusion Criteria:

* Chronic smokers, tobacco chewers and drinkers.

Primary outcomes:
measure: Positive incremental area under blood glucose curve
timeFrame: 0-120 minutes
Secondary outcomes:
measure: Total area under the serum insulin curve
timeFrame: 0-120 minutes
Other outcomes:
measure: Cmax glucose
timeFrame: 0-120 minutes
measure: Tmax glucose
timeFrame: 0-120 minutes
measure: Slope to Cmax
timeFrame: 0-120 minutes
measure: Glucose concentration
timeFrame: 180 minutes
measure: Insulin concentration
timeFrame: 180 minutes
measure: Total area under the glucose curve
timeFrame: 0-180 minutes
measure: Total area under the curve of appetite and mood
timeFrame: 0-120 minutes
Locations:
city: Ahmedabad
country: India
facility: Lambda Therapeutics Research Ltd (LTRL)
state: Near Gujrat High Court, SG Highway, Gota
Study officials:
affiliation: Lambda Therapeutic Research Ltd.
name: Rakesh Patel, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01481857: Influence of Thoracolumbar Proprioceptive Support in the Segmental Stabilization Training
Official title: Influence of Thoracolumbar Proprioceptive Support in the Segmental Stabilization Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Transversus Abdominis Activation
Lead sponsor: Universidade Federal do Piauí
Sponsor class: OTHER
First posted: 2011-11-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Proprioceptive training has been shown to be effective in increasing the efficiency of motor-sensory tissues that stabilize the trunk. The investigators hypothesis is that proprioceptive support do influence in the activation of the transversus abdominis muscle (TrA) during segmental stabilization training.


Eligibility criteria: Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* subjects with any kind of disease

Primary outcomes:
measure: Activation of transversus abdominis
timeFrame: Two Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Parnaíba
country: Brazil
facility: Fuad Ahmad Hazime
state: Piauí
Study officials:
References:
Clinical trial NCT06498557: Postoperative Analgesis in Total Knee Arthroplasty
Official title: Results of Postoperative Analgesis Protocols Applied in Total Knee Arthroplasty:Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Arthroplasty
Keywords: POSTOPERATIVE PAIN
Knee Arthroplasty
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Among patients who had elective knee replacement surgery, those who underwent postoperative nerve block

Brief summary: Postoperative analgesic treatment methods are applied to patients who have undergone knee arthroplasty. These applications are a routine part of the procedure. It is medically and ethically necessary. Postoperative analgesia applications are started during the intraoperative period and continued during the postoperative period. The analgesia protocol to be used is shaped by the characteristics of the patient and the skill and experience of the anesthesiologist. The scientifically accepted method is multimodel analgesia protocols. These protocols cover a wide range from paracetamol to opioids to peripheral and central blocks (methods such as suprainguinal fascia iliac block (SFIP), adductor block (ACB) and infiltration analgesia (IPACK) applied between the posterior elements of the knee and the popliteal artery). Our aim in this study is to evaluate the effects of analgesia protocols applied to patients undergoing knee arthroplasty surgery on inflammatory biomarkers (such as neutrophil lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR), systemic immune inflammation score (SII), lactate) obtained from routine blood and blood gas examinations in the first 24 hours of the postoperative period.


Eligibility criteria: Inclusion Criteria:

* 18-75 years old
* ASA I,II,III patients
* Patients who will undergo elective surgery

Exclusion Criteria:

* Patients undergoing emergency surgery
* Patients with bleeding diathesis
* Those who are allergic or sensitive to local anesthetics and opioid drugs,
* Those who use gabapentinoids
* Patients with neurocognitive disorders,
* Patients with chronic organ failure,
* Mothers with suspected pregnancy, pregnant or breastfeeding mothers
* Patients using opioids
* Those who use steroids
* Those with a history of substance use

Primary outcomes:
measure: Postoperative pain
timeFrame: postoperative 24 hours
Secondary outcomes:
measure: inflammatory mediators
timeFrame: preoperative 24 hours
measure: inflammatory mediators
timeFrame: preoperative 24 hours
measure: inflammatory mediators
timeFrame: preoperative 24 hours
measure: inflammatory mediators
timeFrame: preoperative 24 hours
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: SAMSUN UNIVERSITY Samsun Training and research hospital
Study officials:
affiliation: Samsun University
name: Senay canikli adıgüzel
role: STUDY_DIRECTOR
References:
Clinical trial NCT05994157: Phase 1, Open-label, Dose-escalation Trial with CD38-SADA:177 Lu-DOTA Drug Complex in Subjects with Relapsed or Refractory Non-Hodgkin Lymphoma
Official title: Phase 1, Open-label, Dose-escalation Trial with CD38-SADA:177 Lu-DOTA Drug Complex in Subjects with Relapsed or Refractory Non-Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Non-hodgkin Lymphoma
Lead sponsor: Y-mAbs Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with non-Hodgkin Lymphoma will be treated with CD38-SADA:177Lu-DOTA complex (The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA) to establish optimal and safe therapeutic doses and dosing schedule of CD38-SADA, and 177Lu-DOTA.


Eligibility criteria: Inclusion Criteria:

* Target population must have relapsed, progressive or refractory non-hodgkin lymphoma and be ineligible for or have exhausted standard therapeutic options that may prolong survival
* The subject must have fluoro-deoxyglucose (FDG)-avid lymphoma with measurable disease
* CD38 positive tumor at most recent biopsy (new or archival) documented at central laboratory
* Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
* Each subject must sign an ICF indicating that he or she understands the purpose of, and procedures required for the trial and is willing to participate in the trial.

Exclusion Criteria:

* Primary central nervous system lymphoma or known central nervous system involvement with lymphoma
* Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks (for nitrosoureas within 6 weeks) prior to the first dose of CD38-SADA
* Radioimmunotherapy within 100 days prior to the first dose of CD38-SADA
* Autologous stem cell transplantation within 42 days prior to the first dose of CD38-SADA
* Treatment with approved CAR-T within 100 days prior to the first dose of CD38-SADA
* \>40% lymphoma bone marrow involvement

Primary outcomes:
measure: Tumor imaging and occurrence of dose limiting toxicities (DLT) during the DLT evaluation period (Part A)
timeFrame: 4 weeks
measure: Occurrence of dose limiting toxicities during the DLT evaluation period (Part B)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: Duarte
country: United States
facility: City of Hope
state: California
city: Grand Rapids
country: United States
facility: Corewell Health-BAMF Health
state: Michigan
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Cancer Center
state: New York
city: Greenville
country: United States
facility: East Carolina University Leo W. Jenkins Cancer Center
state: North Carolina
Study officials:
References:
Clinical trial NCT04956757: Scapula Retraction Exercises in Subacromial Pain Syndrome
Official title: Investigating the Effect of Scapula Retraction Exercises on Acromiohumeral Distance Values and Symptoms (Pain and Disability) in Patients With SPS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Impingement Syndrome
Keywords: pain severity
functional status
acromiohumeral distance
shoulder pain
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Scapula retraction exercises are often recommended as a part of the exercise programs. The primary aim of this study is to investigate the initial effect of the scapula retraction exercises on acromiohumeral distance (AHD) at varying shoulder abduction angles and to compare asymptomatic subjects. The secondary aim of this study is to investigate the effect of scapula retraction exercises on AHD values and symptoms (pain and disability) in patients with SPS.

Detailed description: Subacmial pain syndrome (SPS) is a common cause of shoulder pain and dysfunction in the general population. Exercise interventions is thought as a primary choice in clinical settings. Scapula retraction exercises are commonly recommended as a part of the exercise programs. Applying scapula retraction exercises at varying shoulder abduction angles could restore balance between the scapulothoracic muscles. Since the scapulothoracic muscles dynamically control subacromial space, scapula retraction exercises could further help to maintain AHD during arm elevation.

The primary aim of this study is to investigate the initial effect of the scapula retraction exercises on acromiohumeral distance (AHD) at varying shoulder abduction angles and to compare asymptomatic subjects. The secondary aim of this study is to investigate the effect of scapula retraction exercises on AHD values and symptoms (pain and disability) in patients with SPS.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

* aged between 18-45
* painful arc of movement during flexion or abduction;
* positive Neer or Kennedy-Hawkins impingement signs
* pain on resisted lateral rotation, abduction or empty can test.

Exclusion Criteria:

* previous shoulder surgery;
* shoulder pain reproduced by neck movement;
* clinical signs of full-thickness RC tears; or
* adhesive capsulitis.

Primary outcomes:
measure: Acromiohumeral Distance (AHD) measurement
timeFrame: Acromiohumeral distance values will be recorded at baseline and 8-week follow-up
Secondary outcomes:
measure: pain severity
timeFrame: pain severity will be recorded at baseline and 8-week follow-up
measure: disability status
timeFrame: PADI Score will be recorded at baseline and 8-week follow-up
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Study officials:
References:
Clinical trial NCT00964457: Treatment of Patients With Advanced Rectum Cancer With Capecitabine and Oxaliplatin Before, Under and After Radiation and With Adding Cetuximab to K-RAS Wild-type Patients
Official title: Treatment of Patient With Advanced Rectum Cancer With Capecitabine and Oxaliplatin Before Under and After Radiation and With Adding Cetuximab to K_RAS Wild-type Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectum Cancer
Keywords: cetuximab
rectum cancer
radiation
MRI
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2009-08-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: response rate to adding cetuximab, oxaliplatin and capecitabine to radiation for advanced rectum cancer

Detailed description: Dynamic MRI will be used to monitor the effect of the treatment and will be compared to pathologic results.

Eligibility criteria: Inclusion Criteria:

* advanced rectum cancer

Exclusion Criteria:

* prior radiation

Primary outcomes:
measure: response rate
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
References:
Clinical trial NCT06122857: Trends of Cancer Incidence and Mortality in Russia
Official title: Trends of Cancer Incidence and Mortality in Russia: the Breakpoint and Age-period-cohort Analyses of Cancer Incidence and Mortality
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Oncology
Cancer
Lead sponsor: ITMO University
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 100000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patient population, that were diagnosed and registered in regions covered by PBCR.

Brief summary: The study aims to assess the dynamics of incidence and mortality for all major groups of cancers for which the national data is available for the longest possible time series. The data obtained from publicly available sources are used.


Eligibility criteria: Non applicable

Primary outcomes:
measure: Cancer incidence
timeFrame: 30 years
measure: Cancer mortality
timeFrame: 30 years
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: ITMO University
Study officials:
References: