louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05250219: Microchimeric Cell Tranfer From Mother to Child - Pilo Study
Official title: Identifying and Quantifying Microchimeric Maternal Cells in Young Males, Potentially Acquired Through Breastfeeding - A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breastfeeding
Keywords: Microchimeric
Microchimerism
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 80
Sex: MALE
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young males, undergoing surgery (appendectomy ou tonsillectomy) for medical reasons

Brief summary: Microchimeric cells are known to be transferred from mother to child through the placenta. However it has been postulated that they could also be transferred through breastfeeding.

This study is designed to analyse lymphoid and digestive tract tissues (tonsils and appendixes) in male infants (or young adults) to research microchimeric female cells and try to correlate the frequency and localisation of said cells to the breastfeeding status during early infancy


Eligibility criteria: Inclusion criteria:

* age 1-16 years (at the time of surgery)
* male
* known breastfeeding status in infancy

Exclusion criteria:

* premature birth (before 37 weeks)
* history of blood transfusion
* history of bone marrow transplant
* history of organ transplant
* patient known to have a twin
* known gonosomal

Primary outcomes:
measure: To identify microchimeric cells of maternal origin in lymphoid
timeFrame: day 1
measure: To identify microchimeric cells of maternal origin in digestive tissues
timeFrame: day 1
measure: to determine Quantifying the microchimeric cells
timeFrame: day 1
measure: to determine locating the cells in tissues
timeFrame: day 1
measure: to determine trying to find a correlation between breastfeeding status
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: UH MONTPELLIER - FRANCE
name: Boris DMITRENKO
role: STUDY_DIRECTOR
References:
Clinical trial NCT03535519: Rheumatoid Arthritis Response to Methotrexate
Official title: Rheumatoid Arthritis Ultrasound Response to Methotrexate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
Collaborators: name: Nordic Pharma SAS
First posted: 2018-05-24
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: Rheumatoid arthritis fulfilling EULAR criteria with active disease

Brief summary: Observational and prospective study of the ultrasound response to methotrexate in rheumatoid arthritis patients who started methotrexate

Detailed description: * Rheumatoid arthritis patients with active disease who start subcutaneous methotrexate by their rheumatologist prescription methotrexate will be included.
* Patients will participate in a prospective and observational study in which the response to methotrexate will be assessed by ultrasound (US) of joints and tendons.
* The main objective of the study is the change in B mode and Doppler mode US after 24 weeks of methotrexate treatment.

Eligibility criteria: Inclusion Criteria:

* Active rheumatoid arthritis fulfilling EULAR criteria.
* Prescription of methotrexate by a rheumatologist.
* Informed consent signed by the patient.

Exclusion Criteria:

* None

Primary outcomes:
measure: Ultrasound response
timeFrame: Basal and at 6 months
Secondary outcomes:
measure: Clinical response
timeFrame: Basal and 6 months
measure: Functional response
timeFrame: Basal and 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
Study officials:
affiliation: Hospital General Universitario Gregorio Maranon
name: Juan Carlos Nieto González, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02231619: Use of Low Sensitivity Pregnancy Test for Self-assessment of Medical Abortion
Official title: The Feasibility of Replacing In-person Follow-up for Early Medical Abortion With a Low Sensitivity Pregnancy Test, Symptom Checklist and Text Messages in the South African Public Sector Setting.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Completion of Medical Abortion
Keywords: feasibility
self assessment
medical abortion
low sensitivity urine pregnancy test
South Africa
Lead sponsor: University of Cape Town
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2014-09-04
Enrollment: 525
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to design a self-assessment package that could be the preferred option to a follow-up visit at the clinic by the majority of women having early medical abortion.


Eligibility criteria: Inclusion Criteria:

1. Already be signed up to do a medical abortion at this clinic
2. Be willing to come to all clinic appointments and be accessible by phone for 2 weeks after sign up for the study
3. Own a cellphone to which will be sent medical abortion-related information and messaging.

Exclusion Criteria:

1. Be doing a medical abortion due to failed natural miscarriage 2. Not have a working cellphone

-

Primary outcomes:
measure: Accurate self-assessment of medical abortion using a low sensitivity pregnancy test
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Nolungile Youth Clinic, Khayelitsha
state: Western Province
Study officials:
References:
citation: Constant D, Harries J, Daskilewicz K, Myer L, Gemzell-Danielsson K. Is self-assessment of medical abortion using a low-sensitivity pregnancy test combined with a checklist and phone text messages feasible in South African primary healthcare settings? A randomized trial. PLoS One. 2017 Jun 22;12(6):e0179600. doi: 10.1371/journal.pone.0179600. eCollection 2017.
Clinical trial NCT02127619: Total Knee Replacement With the ROCC Knee
Official title: Prospective Study of Total Knee Replacement With the ROCC Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Rheumatoid Arthritis
Keywords: knee prosthesis
total knee replacement
total knee arthroplasty
prospective study
Therapeutic level IV
Lead sponsor: Bercovy, Michel, M.D.
Sponsor class: INDIV
First posted: 2014-05-01
Enrollment: 500
Sex: ALL
Minimum age (years): 42
Maximum age (years): 90
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 was to assess the results of a Total Knee prosthesis specifically intended to enhance functional performance , especially in terms of physical and sports activity.

Detailed description: Clinical and radiographic results , complications, early post-operative and late functional outcome and survivorship were studied in a continuous prospective series of 500 patients ( 602 knees) managed using the ROCC knee ( BIOMET INC - Warsaw- IND, USA).

A minimum follow-up of 5 years was required.

Eligibility criteria: Inclusion Criteria:

* all patients receiving a total knee

Exclusion Criteria:

* patients with severe psychiatric, neurologic, cardiologic or locomotor pathology occuring after the total knee replacement

Primary outcomes:
measure: locomotor function with the Knee society score
timeFrame: at a minimum of 5 years after surgery
Secondary outcomes:
measure: physical and sports activities with the UCLA activity score
timeFrame: at last follow-up examination, with minimum of 5 years after surgery
measure: clinical status with the Oxford Knee Score
timeFrame: before surgery
measure: clinical status with the Oxford knee score
timeFrame: at last follow-up examination, with minimum of 5 years after surgery
measure: WOMAC ARTHRITIS INDEX
timeFrame: before surgery
measure: WOMAC ARTHRITIS INDEX
timeFrame: at last follow-up examination, with minimum of 5 years after surgery
Other outcomes:
measure: patient satisfaction with the Forgotten Joint Score
timeFrame: at last follow-up examination, with minimum of 5 years after surgery
measure: positioning and quality of the fixation of a total knee replacement
timeFrame: minimum 5 years after surgery
Locations:
city: Melun
country: France
facility: Clinique Les Fontaines
Study officials:
affiliation: Clinique Les Fontaines- 77000 - Melun- FRANCE
name: Michel Bercovy, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00190619: Efficacy and Safety of Duloxetine
Official title: Efficacy and Safety of Duloxetine Compared With Placebo in Subjects Electing Surgery for Severe Pure Genuine Stress Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Stress Incontinence
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2005-09-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
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 monitor the long term safety and efficacy of duloxetine in the treatment of severe pure genuine stress incontinence.


Eligibility criteria: Inclusion Criteria:

* Female out patients.
* Have a diagnosis of pure genuine stress incontinence on urodynamic study performed within 6 months prior to study entry.

Exclusion Criteria:

* Use of monoamine oxidase inhibitors within 14 days prior to study entry or at any time during the study.
* Suffer from severe constipation.

Primary outcomes:
measure: Assess the efficacy of duloxetine versus placebo for in women who have decided to proceed toward surgery for severe pure genuine stress incontinence
Secondary outcomes:
measure: Change in the disease-specific quality of life instrument (Incontinence Quality of Life) scores from baseline to endpoint.
measure: Compare the efficacy of duloxetine with that of placebo measured by: Patient Global Impression Improvement questionnaire, Symptoms Frequency & Bothersomeness Questionnaire, and percent change in weekly pad usage
measure: Assess the efficacy of duloxetine measured by percent change in incontinence episode frequency and incontinence pad usage, and Patient Global Impression Improvement scores
measure: Assess subject satisfaction with duloxetine compared with placebo as measured by Patient Satisfaction Questionnaire -2 (PSQ-2) and Patient Satisfaction Questionnaire - 4 (PSQ-4)
measure: Compare the safety of duloxetine with that of placebo in the treatment of genuine stress incontinence based on vital signs, laboratory values, electrocardiogram findings, and the occurrence of treatment-emergent adverse events
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hrs, EST) or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06537219: Changes in Thoracolumbar Fascia Stiffness and Pain Parameters in Young Patients With Chronic Low Back Pain
Official title: Thoracolumbar Fascia Stiffness and Pain Parameters
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain
Back Pain
Fascia
Keywords: non-spesific back pain
thoracolumbar fascia
stiffness
pain thresold
Lead sponsor: Atılım University
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Academic staff and university students at Atılım University will constitude the study population.

Sample size is calculated with 85% power. 50 participants( 25 experiment,25 control group) will be included in the study

Brief summary: This study aims to investigate the biomechanical parameters of thoracolumbar fascia (TLF) and pain-related properties including pain intensity, pressure pain threshold (ppt) and pain sensitivity in young adults with non-specific chronic low back pain (LBP), both those experiencing chronic low back pain (LBP) and without LBP.

Detailed description: Non-specific low back pain has become a serious public health problem in latest years. The prevalence of low back pain is reported to be 84% in lifetime (1). Recently, an increasing number of studies have reported that fascia, due to its rich nociceptive innervations, may play a role in chronic pain, especially in some non-specific low back pain conditions .

This study will conducted with a total of 50 participant, including those with chronic lower back pain in the experimental group and the control group.

Both groups underwent assessments related to pain properties. Specifically, the Numerical Pain Scale(NMS) will be used to assess subjective pain intensity(4), the Digital Algometer for assessing pressure pain treshold(5), the Pain Sensitivity Scale(PSS) pain sensitivity(6) and the Myotonometer MyotonPRO biomechanical parameters, including stiffness(s), elasticity(d) and tonus (f) of the TFL at the level of Lumbal 1,3 vertebrae(L1,L3) and under 12th costa (7-10). SPSS 23.0 will be used for statistical analysis. p\<0.05 is considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* chronic back pain participants more than 3 months

Exclusion Criteria:

* Those with orthopaedic, neurological and systemic diseases will be excluded from the study.

Primary outcomes:
measure: Numerical Pain Scale(NMS
timeFrame: 1 month
measure: Fascia stiffness
timeFrame: 1month
measure: the Pain Sensitivity Scale(PSS)
timeFrame: month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Atılım University
Study officials:
References:
Clinical trial NCT00996619: Measuring the Spectrum of Tissues During Endoscopy
Official title: Measuring the Spectrum of Tissues During Endoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Carcinoma
Colonic Polyps
Intestinal Polyps
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Independent Adults

Brief summary: Lesions, polyps and other abnormalities in the gastrointestinal (GI) tract have a different composition compared to the normal mucose. The investigators plan to gather spectroscopic information from these features. Characterizing their unique spectrums, may help to enhance the detection and identification of these objects during endoscopy.


Eligibility criteria: Inclusion Criteria:

* Adult, independent patients who come to Sheba Hospital's gastro-intestinal clinic for endoscopy and are willing to sign an informed consent

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT00648219: Fed Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg
Official title: Single-Dose Fed In Vivo Bioequivalence Study of Olmesartan Medoxomil Tablets (40 mg; Mylan) to Benicar® Tablets (40 mg; Sankyo) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fed conditions.


Eligibility criteria: Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study

Primary outcomes:
measure: The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
timeFrame: blood collections through 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: PRACS Institute, Ltd.
state: North Dakota
Study officials:
affiliation: PRACS Institute Ltd.
name: James D Carlson, Pharm. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02719119: Trial of Monthly Versus Bi-weekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding
Official title: Trial of Monthly Versus Bi-weekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal and Gastric Varices
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many physicians suggest repeating EVL every 1-2 weeks until esophageal varices are obliterated to prevent variceal rebleeding， however, the evidences supporting the efficacy of EVL intervals of 1-2 weeks are insufficient.This randomized controlled study was conducted in order to compare the long-term results of EVL when performed at two different results from monthly and bi-weekly treatments.

Detailed description: Endoscopic variceal ligation (EVL) is a safe and simple procedure now being used on a widening scale. A lot of patients who undergo endoscopic treatment for esophageal varices eventually require additional treatment for recurrent varices. Many physicians suggest repeating EVL every 1-2 weeks until esophageal varices are obliterated to prevent variceal rebleeding， however, the evidences supporting the efficacy of EVL intervals of 1-2 weeks are insufficient.This randomized controlled study was conducted in order to compare the long-term results of EVL when performed at two different results from monthly and bi-weekly treatments.

Eligibility criteria: Inclusion Criteria:

1. acute or recent bleeding from esophageal varices;
2. portal hypertension caused by cirrhosis;
3. age between 18 and 80 yr.

Exclusion Criteria:

1. history of endoscopic, pharmacological, interventional or surgical treatment of esophageal varices;
2. presence of liver failure with a serum total bilirubin concentration greater than 3 mg/dL;
3. presence of hepatocellular carcinoma or other malignancy;
4. an association with a cerebral vascular accident, uremia, acute coronary syndrome, or other severe illness;
5. history of gastric variceal bleeding;
6. encephalopathy of stage II or worse;
7. failure to control initial variceal bleeding;
8. death within 48 h of admission;
9. refusal to participate in the trial.

Primary outcomes:
measure: variceal rebleeding rate
timeFrame: 2 years
Secondary outcomes:
measure: gastrointestinal rebleeding rate
timeFrame: 2 years
measure: variceal obliteration rate
timeFrame: 2 years
measure: number of sessions required to abstain variceal obliteration
timeFrame: 2 years
measure: adverse events
timeFrame: 2 years
measure: mortality
timeFrame: 2 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: department of gastroenterology
name: li yang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04405219: Smoking Cessation, Anxiety, Pain Relationship
Official title: Preoperative Smoking Cessation, Preoperative Anxiety, Postoperative Anxiety and Pain Relationship
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Anxiety
Pain
Keywords: Smoking Cessation
anxiety
pain
VAS Scores
STAI Values
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Smoking, anxiety and pain are clearly related conditions. We aimed to reveal the relationship between smoking cessation before surgery and preoperative anxiety, postoperative anxiety and pain in chronic smokers.

METHODS ASA I-II group patients without chronic disease and history of drug use were included in the study. Those who did not want to participate in the study, patients with ASA III and above were excluded from the study. The patients were randomized into 2 groups: smokers (Group S, n = 60) and non-smokers (Group NS, n = 60). Group S was asked to quit smoking 2 weeks before the operation. Preoperative period and postoperative 0, 2, 4. And 6. hour Spielberger State-Trait Anxiety Inventory (STAI) values, postop 0., 2., 4., 6. hour Visual Analogue Scale (VAS) values were recorded.

Detailed description: it has been revealed in the current study that smoking, pain and anxiety are interrelated with each other. In the preoperative period, high anxiety scores are related to surgery and anesthesia stress. High anxiety scores in the smoker group both in the preoperative period and in the postoperative period are associated with smoking cessation. While the pain scores were similar in the postoperative period, high anxiety scores strengthened the idea of smoking withdrawal and this study gained value. We believe that future studies with a large number of patients, with different parameters and multiple centers will strengthen the results.

Eligibility criteria: Inclusion Criteria:

* ASA I,II patients
* planned Rhinoplasti cases
* accepted participating study

Exclusion Criteria:

* Patients with chronic systemic disorders,
* ASA III and above situation
* emergency and bleeding cases,
* patients with any cardiac and neurological disorders,
* refused to participate in the study

Primary outcomes:
measure: Anxiety
timeFrame: 2 hours
Secondary outcomes:
measure: pain scores
timeFrame: 2 hours
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yuzuncu Yil University Faculty of Medicine Department of anesthesiology and reanimation
state: Tuşba
city: Van
country: Turkey
facility: Van Yuzuncu Yil University
state: Tuşba
Study officials:
affiliation: yuzuncu yil
name: Arzu Esen Tekeli, MD
role: PRINCIPAL_INVESTIGATOR
References: