louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04260139: Lymph Node Yield in Colon Cancer Resection Specimens
Official title: Macroscopic Evaluation of Colon Cancer Resection Specimens to Predict Metastatic Lymph Node Yield
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Lymph Node Metastases
Keywords: ileocolic pedicle
colon cancer
Staging
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-02-07
Enrollment: 50
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 pathology specimens from colon neoplasm resections will be prepared so that the lymph nodes will be separated according to their anatomic relationship to the vascular pedicles and to the tumor. Prior to dissection, the specimen will be measured from all colonic tumor patients.

Brief summary: In this study, we aimed to develop a predictive model of lymph node yield in a series of colon cancer resection specimens with detailed anatomic and surgical technique data.

Detailed description: Lymph node yield in colon resection specimens has been associated with the accuracy of staging and cancer outcomes. It has been proposed that the more central the mesenteric vascular ligation, the greater the nodal yield. However, the optimal number of harvested nodes is still a matter of debate. We prospectively evaluated the relation between specimen properties such as lenght, area, tumor location and pedicle length to the number of harvested nodes and rate of node positivity.

Eligibility criteria: Inclusion Criteria:

The surgical patients with a histologic diagnosis of colonic neoplasm, Colectomy of any type, including the right hemicolectomy, the left hemicolectomy, the sigmoid resection, segmental colon resection

Exclusion Criteria:

* rectal or rectosigmoid cancer colectomy beyond the inclusion criteria for colectomies patients younger than 18 previous colon resection emergency colon resection familial adenomatous polyposis or ulcerative colitis

Primary outcomes:
measure: Lymph Node Yield in Colon Cancer Resection Specimens
timeFrame: September 2019- November 2020
measure: Lymph Node Yield in Colon Cancer Resection Specimens
timeFrame: September 2019-November 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bagcılar Training and Research Hospital
Study officials:
References:
Clinical trial NCT02083939: Prophylactic Antibiotic Treatment for Laparoscopic Inguinal Hernia Mesh Repair: Necessary or Not?
Official title: Prophylactic Antibiotic Treatment for Laparoscopic Inguinal Hernia Mesh Repair: Necessary or Not?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hernia, Inguinal
Keywords: Inguinal hernia
Mesh repair
Prophylactic Antibiotics
Herniorrhaphy
Laparoscopic Inguinal Hernia Repair
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-03-11
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 patients undergoing elective hernia repair will be assigned randomly to the control group; 100 patients will be assigned to the treatment group.

Brief summary: The purpose of this study is to find out whether it is necessary to prophylactically treat patients undergoing laparoscopic inguinal hernia repairs with antibiotics. Our hypothesis is that it is not necessary to pretreat patients with antibiotics if the operation is minimally invasive with a mesh placed at the defect.

Detailed description: The investigators plan to follow up at least 100 patients who did not receive antibiotics prior to their inguinal hernia repair and compare their outcome to 100 patients who did receive prophylaxis. The investigators mainly will be analyzing the incidence of surgical site infections as evidenced by swelling, redness, pain, warmth or other signs deemed by the surgeon.

Eligibility criteria: Inclusion Criteria:

* Elective laparoscopic inguinal hernia repair, unilateral or bilateral

Exclusion Criteria:

* Those requiring antibiotics for the surgery;
* Those patients who have experienced surgical site infections from previous surgeries

Primary outcomes:
measure: Incidence of surgical site infection
timeFrame: One year post-operation
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Danny Rosin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cabaluna ND, Uy GB, Galicia RM, Cortez SC, Yray MD, Buckley BS. A randomized, double-blinded placebo-controlled clinical trial of the routine use of preoperative antibiotic prophylaxis in modified radical mastectomy. World J Surg. 2013 Jan;37(1):59-66. doi: 10.1007/s00268-012-1816-5.
citation: Shah JN, Maharjan SB, Paudyal S. Routine use of antibiotic prophylaxis in low-risk laparoscopic cholecystectomy is unnecessary: a randomized clinical trial. Asian J Surg. 2012 Oct;35(4):136-9. doi: 10.1016/j.asjsur.2012.06.011. Epub 2012 Aug 22.
citation: Wang J, Ji G, Yang Z, Xi M, Wu Y, Zhao P, Wang L, Yu W, Wen A. Prospective randomized, double-blind, placebo controlled trial to evaluate infection prevention in adult patients after tension-free inguinal hernia repair. Int J Clin Pharmacol Ther. 2013 Dec;51(12):924-31. doi: 10.5414/CP201877.
Clinical trial NCT01519739: Clinical Evaluation of Mediguide System in Cardiac Resynchronization Therapy (CRT) Implants
Official title: Clinical Evaluation of Mediguide System in CRT Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-01-27
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: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and performance of the MediGuide™ system during CRT implants.


Eligibility criteria: Inclusion Criteria:

* Meet clinical indication for implantation of an SJM CRT system according to the current European Society of Cardiology (ESC) Guidelines for cardiac and resynchronization therapy
* Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement
* Ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

* Currently participating in any other clinical study
* Have prosthetic valves
* Are pregnant or planning pregnancy in the next 1 month
* Are less than 18 years of age
* Have ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction

Primary outcomes:
measure: The performance of the MediGuide™ system during CRT implant
timeFrame: 1 month post CRT implant
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Herzzentrum Leipzig GmbH
name: Gerhard Hindricks, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Richter S, Doring M, Gaspar T, John S, Rolf S, Sommer P, Hindricks G, Piorkowski C. Cardiac resynchronization therapy device implantation using a new sensor-based navigation system: results from the first human use study. Circ Arrhythm Electrophysiol. 2013 Oct;6(5):917-23. doi: 10.1161/CIRCEP.113.000066. Epub 2013 Sep 3.
Clinical trial NCT06147739: Evaluation Treatment Outcomes of Anterior Open Bite Treated by Temporary Anchorage Devices
Official title: Evaluation Treatment Outcomes of Anterior Open Bite Treated With Maxillary Intrusive Force by Temporary Anchorage Devices
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Anterior Openbite Malocclusion
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2023-11-28
Enrollment: 10
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present study will be performed to Evaluate the treatment outcome of anterior open bite by temporary anchorage device on buccal and palatal mini screws


Eligibility criteria: Inclusion Criteria:

1. Patients age range 13-18 years old.
2. Patients have anterior open bite.
3. Normal healthy patient.
4. Patient have healthy oral tissues.
5. Patient have class I or II jaw relationship.
6. Patient have complete set of permanent teeth except the wisdom tooth.

Exclusion Criteria:

1. Uncooperative patient and parents.
2. patient who had undergo previous orthodontic treatment.
3. Patient with class III jaw relationship.

Primary outcomes:
measure: open bite closure
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Alazhar
Study officials:
References:
Clinical trial NCT05999539: Comparison of Characteristics Between Faller and Non-faller Transtibial Amputees
Official title: Comparison of Demography, Functional Capacity, Prosthesis Type and Health-related Quality of Life Between Faller and Non-faller Transtibial Amputees
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation
Fall
Ambulation Difficulty
Quality of Life
Prosthesis User
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will be the transtibial prosthetic users recorded in outpatient clinics working on amputee rehabilitation.

Brief summary: Researchers aim to compare demographic characteristics, prosthesis type, functional capacity, and quality of life between faller and non-faller transtibial amputees.

Detailed description: Unilateral transtibial level prosthetic users will be included in this study. After getting the fall history of subjects, those who feel at least one time or more in the last year will be accepted as the faller group. Demographic characteristics, functional capacity, health-related quality of life, and prosthetic types used by amputees will be assessed. The main differences between the faller and non-faller transtibial amputees will be analyzed with the data.

Eligibility criteria: Inclusion Criteria:

* Having the ability to walk at least 30-meter independently
* Using the transtibial prosthesis for at least one year.

Exclusion Criteria:

* Multiple limb amputees or prosthetic users
* Having prosthetic discomfort or stump ulcer

Primary outcomes:
measure: Two-minute walk test
timeFrame: 1 week
Secondary outcomes:
measure: Functional Reach Test
timeFrame: 1 week
measure: Timed Up and Go Test
timeFrame: 1 week
measure: Trinity Amputation and Prosthesis Experiences Scales
timeFrame: 1 week
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Eastern Mediterranean University
Study officials:
References:
Clinical trial NCT02178839: The Effect of Oral β- Glucan Supplement on Appetite and Insulin Resistance in Non Alcoholic Fatty Liver Disease
Official title: The Effect of Oral β- Glucan Supplement on Anthropometric Measurements, Appetite, Insulin Resistance, Liver Echogenicity and Enzymes in Non Alcoholic Fatty Liver Disease Treating With Hypocaloric Diet and Vitamin E
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non Alcoholic Fatty Liver Disease
Keywords: Non Alcoholic Fatty Liver Disease(NAFLD)
β- glucan
Appetite
Insulin Resistance
Lead sponsor: Urmia University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-07-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Objective of This Study is Evaluating the Effect of oral β- glucan Supplement on Anthropometric Measurements, Appetite, Insulin Resistance, Liver echogenicity and Enzymes in Non Alcoholic Fatty Liver Patients Treating with Hypocaloric Diet and Vitamin E.


Eligibility criteria: Inclusion Criteria:

* Patients with Non Alcoholic Fatty Liver Disease From Both Sex
* Age 18-55 years
* BMI more than 25 Kg/m2

Exclusion Criteria:

* Alcohol Consumption
* Pregnancy or lactation or menopause
* Being a professional athlete
* A history of cancer
* Risk of high blood pressure (in the case of drug use)
* Heart disease - cardiovascular, pulmonary, renal and diabetes
* Liver transplantation and other chronic or acute Liver diseases such as hepatitis B, C and liver infections
* The History of inherited disorders affecting the liver
* A history of autoimmune disease
* History of food allergies
* Taking certain medications such as blood pressure control, statins, insulin sensitivity enhancers and hepatotoxic drugs

Primary outcomes:
measure: Liver Echogenicity
timeFrame: 8 weeks
measure: Liver Enzymes
timeFrame: 8 weeks
Secondary outcomes:
measure: Anthropometric Measurement WHtR
timeFrame: 4 weeks, 8 weeks
measure: Appetite
timeFrame: 4 weeks, 8 weeks
measure: Insulin Resistance
timeFrame: 8 weeeks
measure: Anthropometric Measurement WC
timeFrame: 4weeks, 8 weeks
measure: Anthropometric Measurement WHR
timeFrame: 4 weeks, 8 weeks
measure: Anthropometric Measurement BMI
timeFrame: 4 weeks, 8 weeks
measure: Peptide YY (PYY) Hormone
timeFrame: 8 weeks
measure: Cholecystokinin (CKK) Hormone
timeFrame: 8 weeks
measure: Fasting Blood Sugar
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Shekh-al- rais Clinic
Study officials:
affiliation: Department of Nutrition, School of Medicine, Urmia University of Medical Sciences
name: Mohammad Alizadeh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01307839: Lidocaine Patch for Relief of Pain During Epidural Placement in Laboring Patients
Official title: A Randomized, Controlled Trial of the Lidocaine Patch for Relief of Pain During Epidural Needle Insertion in Laboring Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pregnant
Labor
Keywords: labor
epidural
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2011-03-03
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Infiltration of the skin with lidocaine is standard practice prior to lumbar epidural placement in laboring parturients1. Skin infiltration, although brief, can be very stressful and painful for patients.2 This initial discomfort may cause patient anxiety, thus increasing the pain and decreasing the satisfaction with the procedure. To reduce this discomfort, various topical alternatives have been investigated with varying degrees of success.1-4 Now that a topical mixture of lidocaine that is safe and effective is available, the investigators would like to determine if it can reduce the pain of skin infiltration in particular and epidural placement as a whole.


Eligibility criteria: Inclusion Criteria:

1. Laboring patients between the ages of 18 and 45 with a BMI of less than 45

Exclusion Criteria:

Primary outcomes:
measure: To determine if the 5% lidocaine patch can decrease the pain from epidural placement.
timeFrame: a minimum of 30 minutes from patch placement and a maximum of 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Richard L Applegate, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06223139: Association Between Handgrip Strength and Small Airway Disease in Patients with Stable Chronic Obstructive Pulmonary Disease
Official title: Association Between Handgrip Strength and Small Airway Disease in Patients with Stable Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: chronic obstructive pulmonary disease
handgrip strength
small airway disease
airway resistance
correlation
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients aged 40 years or older who are confirmed diagnosis by spirometry (post-bronchodilator FEV1/FVC \<0.7) and smoking history 10 pack-years or more.

Brief summary: The goal of this observational study is to investigate the correlation between handgrip strength and small airway disease among patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:

• Is handgrip strength correlated with small airway disease in COPD patients? Participants will perform handgrip strength test and impulse oscillometry (IOS).

Detailed description: This is a cross-sectional study in COPD patients. COPD patients aged 40 years or older were included. Handgrip strength test and impulse oscillometry will be tested in each patient. Handgrip strength will be measured using a hand dynamometer. Small airway disease will be assessed using IOS.

Eligibility criteria: Inclusion Criteria:

* COPD patients aged 40 years or older
* Confirmed diagnosis by spirometry (post-bronchodilator FEV1/FVC \<0.7)
* Smoking history 10 pack-years or more

Exclusion Criteria:

* COPD exacerbation within 3 months
* Inability to perform handgrip strength test or impulse oscillometry

Primary outcomes:
measure: Correlation between handgrip strength and small airway disease in COPD patients
timeFrame: At day 1 of the study
Secondary outcomes:
measure: The best cutoff value of handgrip strength for predicting small airway disease in COPD patients
timeFrame: At day1 of the study
Other outcomes:
Locations:
city: Pathumthani
country: Thailand
facility: Thammasat University Faculty of Medicine
Study officials:
affiliation: Thammasat University Faculty of Medicine
name: Narongkorn Saiphoklang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01410539: Mechanism Of Stent Thrombosis (MOST) Study
Official title: Mechanism Of Stent Thrombosis (MOST) Study, a Prospective Multicentre Non-randomized Registry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery
Stent Thrombosis
Platelet
Thrombus
Keywords: Stent Thrombosis
Percutaneous Coronary Intervention
Bare Metal Stent
Drug Eluting Stent
Residual Platelet Reactivity
Optical Coherence Tomography
OCT
Lead sponsor: Careggi Hospital
Sponsor class: OTHER
First posted: 2011-08-05
Enrollment: 20
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: This study is designed to assess the pathophysiology of ST by studying the main procedural and anatomical factors involved in the genesis of ST such as those related to stent and the vascular wall, as well as to the individual platelet residual reactivity.


Eligibility criteria: Inclusion Criteria:

* previous PCI with bare metal stent (BMS) or drug eluting stent (DES) and a definite subacute coronary ST
* previous PCI with DES and a definite late or very late coronary ST

Exclusion Criteria:

* Development of ST within 72 hours of stent implantation (acute and early subacute ST).
* Late and very late ST of BMS.
* Absence of informed consent.
* Age less than 18 years.
* Creatinine values greater than 2.5 g/dl (this is to avoid the negative effects related to the contrast medium necessary to perform the OCT evaluation).

Primary outcomes:
measure: Percentage of uncovered stent struts
timeFrame: After thrombectomy
Secondary outcomes:
measure: Percentage of malapposed stent struts
timeFrame: After Thrombectomy
measure: Percentage of patients with high residual platelet reactivity
timeFrame: Baseline
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Careggi Hospital, Department of Hearth and Vessels
Study officials:
affiliation: Careggi Hospital, Division of Invasive Cardiology
name: David Antoniucci, MD
role: STUDY_CHAIR
affiliation: Rome Heart Research
name: Francesco Prati, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parodi G, La Manna A, Di Vito L, Valgimigli M, Fineschi M, Bellandi B, Niccoli G, Giusti B, Valenti R, Cremonesi A, Biondi-Zoccai G, Prati F. Stent-related defects in patients presenting with stent thrombosis: differences at optical coherence tomography between subacute and late/very late thrombosis in the Mechanism Of Stent Thrombosis (MOST) study. EuroIntervention. 2013 Dec;9(8):936-44. doi: 10.4244/EIJV9I8A157.
Clinical trial NCT00495339: MDR TB, Levofloxacin, Multi-Drug-Resistant Pulmonary Tuberculosis
Official title: Multicenter Open Non-Comparative Clinical Study to Evaluate the Efficacy and Safety of Three Months TAVANIC Course (Levofloxacin) in Combine Treatment of Multi-Drug-Resistant Tuberculosis (MDR-TB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tuberculosis, Pulmonary
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-07-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Estimate of clinical and microbiological efficacy of Levofloxacin (Tavanic) in combine therapy of MDR TB.

Estimate of safety of Levofloxacin (Tavanic) in combine therapy of MDR TB.


Eligibility criteria: Inclusion Criteria:

* Drug-resistant pulmonary tuberculosis laboratory diagnosed

Exclusion Criteria:

* Known hypersensitivity to levofloxacin, other quinolones
* Patient with epilepsy and central nervous system diseases
* Renal insufficiency with serum creatinine lower than 50 ml/min
* Arterial hypertension, ischemic heart disease in acute phase
* Gastro-intestinal diseases, liver diseases in acute phase
* History of drug and alcohol abuse
* Patient with history of tendon disorders related to fluoroquinolone administration
* Pregnancy and breast-feeding women
* Immune system disorders related to chemotherapy, AIDS, long term administration of corticosteroids

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Number of patients with bacterioexcretion
timeFrame: 1 month, 2 months, 3 months
measure: Dynamics of chest radiograph
timeFrame: 3 months
measure: Dynamics of Intoxication
timeFrame: 1 month, 2 months, 3 months
measure: All clinical and laboratory adverse events
timeFrame: from the signature of the Informed Concent Form (ICF) up to the end of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Marina Atarshchikova
role: STUDY_DIRECTOR
References: