louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03043755: PECS and Parasternal Block for Breast Surgery
Official title: Observational Study to Evaluated Efficacy of Parasternal and PECS Blocks Association in Breast Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quadrantectomy
Mastectomy
Lead sponsor: Istituti Ospitalieri di Cremona
Sponsor class: OTHER
First posted: 2017-02-06
Enrollment: 32
Sex: FEMALE
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: Patients undergoing breast surgery

Brief summary: Propose to evaluate efficacy of association between US guide parasternal block and pectorals nerves block (PECS) as anesthetic option for breast surgery (medial quadrantectomy and simple mastectomy).

All patients undergoing medial quadrantectomy and simple mastectomy in 6 months period will be observed.

All patients receive: US guide parasternal block at T4 and T6 space with 6ml of ropivacaine 0,75% and PECS type 2 block performed with 24ml of ropivacaine 0,75%.

During surgery patients receive light sedation with continuous infusion of propofol

Will be observed:

Additional local anesthetic infiltration from surgeon. Pain at rest and during movement quantified as Numerical Rating Scores (0-10) during the first 12 hours postoperatively.

Eventual side effects such as nausea/vomiting.


Eligibility criteria: Inclusion Criteria:

* age\> 18 years;
* ASA score I - II - III;
* undergoing elective medial quadrantectomy breast surgery;
* undergoing elective mastectomy not reconstruction breast surgery;
* signed informed consent;

Exclusion Criteria:

* chronic therapy with opioids/ antidepressants;
* urgent/emergent surgery;
* postoperative transfer to the intensive care unit;
* known allergy to any drug medication;
* local skin infection;
* epilepsy;
* alcohol or drug abuse;

Primary outcomes:
measure: Local Anesthetic infiltration
timeFrame: intraoperatory period
measure: Convention in general anesthesia
timeFrame: preoperative period
Secondary outcomes:
measure: Pain
timeFrame: 12 hours postoperatively
measure: PONV
timeFrame: 12 hours postoperatively
Other outcomes:
Locations:
city: Creom
country: Italy
facility: ASST Cremona
state: Cremona
Study officials:
References:
Clinical trial NCT01837355: Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Diet Supplementation in Pediatric Cystic Fibrosis
Official title: Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Rhamnosus Diet Supplementation in Pediatric Cystic Fibrosis (MoHuM-1)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pulmonary Inflammation
Cystic Fibrosis
Microbiota
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
name: Insel Gruppe AG, University Hospital Bern
First posted: 2013-04-23
Enrollment: 68
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pulmonary inflammation is an independent risk factor for disease progression in cystic fibrosis patients (CF). Yet, no effective treatment is known to reduce this detrimental inflammation. Dysbiosis of the gut microbiota has been linked to inflammation in several inflammatory diseases. As children with CF have different faecal microbiota from their healthy siblings, modulating gut microbiota by lactobacillus rhamnosus diet supplementation might be a strategy to target the inflammatory state in CF. Study subjects (CF or healthy control) will receive either placebo or lactobacillus rhamnosus once daily as dietary supplementation for 12 weeks. After a one-week washout phase, they will be switched for another 12 weeks to the other trial arm. Effect on in intestinal and pulmonary inflammation as well as clinical outcome will be studied.


Eligibility criteria: Inclusion Criteria:

* moderate to severe CF disease

Exclusion Criteria:

* acute gastroenteritis 2 weeks prior to inclusion
* chronic disease other than CF (except CF associated disorders)
* oral or parenteral antibiotics 2 weeks prior to inclusion
* systemic steroids 4 weeks prior to inclusion
* any probiotic intake

Primary outcomes:
measure: Change from baseline at w12 and w24 in fecal calprotectin levels
timeFrame: Baseline, week 12, week 24
measure: Change from baseline at w12 and w24 in pulmonary calprotectin levels
timeFrame: Baseline, w12, w24
Secondary outcomes:
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Childrens's Hospital of Eastern Switzerland
state: SG
Study officials:
References:
Clinical trial NCT01726855: Prevention of Adhesions Following Flexor Tendon Injury Within Zone II With Vascularized Finger Dorsal Fascial Flap
Official title: Prevention of Adhesions Following Flexor Tendon Injury Within Zone II With Vascularized Finger Dorsal Fascial Flap
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tendon Injuries
Keywords: tendon repair
Lead sponsor: The Second Hospital of Tangshan
Sponsor class: OTHER
First posted: 2012-11-15
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients requiring flexor tendon repair or reconstruction within zoneⅡ

Brief summary: The purpose of this study was to report a new method of flexor tendon repair in zone II with combined standard modified Kessler technique and vascularized finger dorsal fascial flap pedicled with dorsal cutaneous branch of proper digital artery ,which is transported to finger volar for placement of a mechanical barrier between flexor digitorum superficialis /profundus tendons. The function outcomes of 14 patients (Group A) with flexor tendon repair in zone II with this new technique were compared with those of 32 patients (Group B) with flexor tendon repair in zone II with standard modified Kessler technique. This new technique may prevent serious adhesions between flexor digitorum superficialis /profundus tendons.


Eligibility criteria: Inclusion Criteria:

* patients requiring flexor tendon repair or reconstruction within zoneⅡ

Exclusion Criteria:

Primary outcomes:
measure: the modified Strickland system
timeFrame: 3~12 months
measure: degrees of the maximum active flexion at the distal interphalangeal joint
timeFrame: 3~12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tangshan
country: China
facility: the Second Hospital of Tangshan
state: Hebei
Study officials:
References:
Clinical trial NCT04164355: Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg
Official title: Evaluation of Retinal and Choriocapillary Vascular Changes Using Optical Coherence Tomography Angiography in Patients Undergoing Tadalafil 20mg on Alternative Days: a Single-centre Prospective-control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction Following Radical Prostatectomy
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 40
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participans were older than 45 years with diagnosis of erectile dysfunction due to surgery of radical prostatectomy. They did not receive previous treatment before Tadalafil and they have not other ophthalmological disease and diabetes.

Brief summary: This study evaluates the retinal and choriocapillary vascular features in patients under the effects of Tadalafil 20mg using optical coherence tomography angiography.

Detailed description: Tadalafil is a an inhibitor of the enzyme phosphodiesterase and it works by increasing blood flow to the penis thus promoting the erection.

This drug represents an treatment for erectile dysfunction in patients after radical prostatectomy.

The optical coherence tomography angiography represents a novel and non-invasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features.

The study evaluates the changes in optical coherence tomography angiography parameters at baseline and after 1, 3, 6 months after the somministration of Tadalafil 20 mg orally.

Eligibility criteria: Inclusion Criteria:

* age older than 45 years
* diagnosis of erectile dysfunction due to surgery of radical prostatectomy
* treatment-naïve with Tadalafil for erectile dysfunction
* absence of vitreoretinal and vascular retinal diseases
* absence of diabetes

Exclusion Criteria:

* age younger than 45 years
* diagnosis of erectile dysfunction due to other causes
* previous treatments before Tadalafil for erectile dysfunction
* presence of vitreoretinal and vascular retinal diseases
* presence of diabetes.

Primary outcomes:
measure: The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil after radical prostatectomy
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples "Federico II"
Study officials:
affiliation: Federico II University
name: Gilda Cennamo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05691855: 89Zr-labeled NY009 PET Imaging in Patients
Official title: 89Zr-labeled NY009 PET Imaging in Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Cancer
Lead sponsor: Affiliated Hospital of Jiangnan University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled NY009 PET Imaging in patients


Eligibility criteria: Inclusion Criteria:

1. Patients voluntarily signed informed consent;
2. Age 18-75, male or female;
3. Patients diagnosed with cancer confirmed by histopathology or cytology;
4. At least one measurable solid lesion has been examined according RECIST1.1 standard;
5. ECOG score 0\~2.

Exclusion Criteria:

1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
2. Patients with systemic or locally severe infections, or other serious coexisting diseases;
3. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
4. Patients with autoimmune diseases, including rheumatoid arthritis;
5. Inadequate control of arrhythmias, including atrial fibrillation;
6. Uncontrolled hypertension;
7. Patients with allergies or allergies to any component of the imaging agent or antibody;
8. Patients who cannot undergo PET/CT imaging scan;
9. Syphilis, HBV, HCV, or HIV positive subjects;
10. Male and female subjects of reproductive age cannot take effective contraceptive measures;
11. Pregnant or lactating women;
12. Patients with a history of mental illness or related conditions;
13. Other subjects considered unsuitable by researchers.

Primary outcomes:
measure: Evaluation of tissue distribution of 89Zr-NY009
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
Study officials:
affiliation: Affiliated Hospital of Jiangnan University
name: Chunjing Yu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06165055: Single Gene Polymorphisms Associated With Molar-Incisor Hypomineralization
Official title: Investigation of Single Gene Polymorphisms Associated With Molar-Incisor Hypomineralization
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Molar-Incisor Hypomineralization
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 120
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The Study Arm: healthy individuals aged 8-13 with Molar-Incisor Hypomineralization (MIH) in at least one permanent molar.

The Control Arm: healthy individuals aged 8-13 without Molar-Incisor Hypomineralization (MIH).

Brief summary: The genetic factors associated with Molar-Incisor Hypomineralization (MIH), a dental condition affecting permanent molars in individuals aged 8-13. Buccal swab samples collected from 90 MIH-affected participants and 90 systemically healthy controls. The goal is to identify potential genetic markers contributing to the etiology of MIH, shedding light on previously unexplored aspects of genetic susceptibility.

Detailed description: The aim of study is to elucidate the unknown aspects of genetic predisposition that may be effective in the etiology of Molar-Incisor Hypomineralization (MIH), that is, to identify unexplored genes that may be associated with MIH. The buccal swab method will be used for the purpose of collecting DNA samples.Samples will be collected from the inner cheek using a swab. The collected samples will be placed in single-use sterile Eppendorf tubes containing Phosphate Buffered Saline (PBS) solution. The samples will be stored at +4 degrees Celsius in a refrigerator, and DNA isolations will be performed within a few days. .

Eligibility criteria: Inclusion Criteria:

* Patients aged between 8 and 13 years
* Patients whose parents consent to participate in the study
* Patients who provide cooperation for treatment and study
* For the study group: patients with at least one molar tooth showing molar-incisor hypomineralization
* For the control group: patients without molar-incisor hypomineralization
* Patients without a genetic disease in themselves or their family

Exclusion Criteria:

* Patients with a genetic disease in themselves or their family

Primary outcomes:
measure: genotyping of polymorphisms
timeFrame: 1.5 -2 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05154955: A Safety and Tolerability Study of 10XB-101 Injection in Adult Subjects With Submental Fat
Official title: A Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled Study of the Safety and Efficacy of 10XB-101 in Adult Subjects With Submental Fat
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Submental Fat
Lead sponsor: 10xBio, LLC
Sponsor class: INDUSTRY
First posted: 2021-12-13
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to determine the safety and efficacy of 10XB-101 vs. vehicle (placebo) for adults with excessive submental fat (SMF).


Eligibility criteria: Inclusion Criteria:

* Subject is a male or non-pregnant female 18 to 65 years old.
* Subject has provided written informed consent.
* Subject has qualifying Submental Fat evaluation score.
* Subject has had a stable body weight for the past 6 months prior to starting study.
* Subject is willing to undergo test article injections as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.

Exclusion Criteria:

* Subject is pregnant, lactating, or is planning to become pregnant during the study.
* Subject has loose skin in the submental area, diffuse SMF, or prominent platysmal bands at rest that may interfere with evaluation of localized fat, in the opinion of the investigator.
* Subject has had any prior treatment for SMF (e.g., deoxycholic acid, cryotherapy, liposuction, surgery).
* Subject has any medical condition that affects clotting and/or platelet function
* Subject has a history of allergy or sensitivity to polidocanol or any of the other ingredients in the test articles.

Primary outcomes:
measure: Clinician Submental Fat Scale (CSFS)
timeFrame: 24 weeks after final injection treatment
measure: Patient Submental Fat Scale (PSFS)
timeFrame: 24 weeks after final injection treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Encino
country: United States
facility: Site 03
state: California
city: San Diego
country: United States
facility: Site 02
state: California
city: San Diego
country: United States
facility: Site 01
state: California
city: Rolling Meadows
country: United States
facility: Site 04
state: Illinois
Study officials:
References:
Clinical trial NCT04309955: Modified Versus Traditional Thoracic Drainage After Thoracoscopic Surgery
Official title: Randomized Clinical Trial of Modified Versus Traditional Thoracic Drainage After Thoracoscopic Surgery for Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Neoplasms
Lung Cancer
Pulmonary Neoplasm
Postoperative Pain
Thoracoscopic Surgery
Keywords: chest tube
pigtail catheters
chest tube drainage
thoracic drainage
Lung Cancer
thoracoscopic surgery
Pulmonary Neoplasm
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2020-03-17
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: Lung cancer is the leading cause of cancer-related death worldwide. Thoracoscopic pulmonary resection is a prevalent management for early stage of lung cancer. Placement of traditional chest tube is the standard procedure after surgery, which causes pain that cannot be ignored. We aimed to determine whether a modified thoracic drainage strategy based on pigtail catheter associated with better clinical results compared with traditional methods after thoracoscopic surgery for lung cancer.


Eligibility criteria: Inclusion Criteria:

* 18\<age\<80;
* Patients with lung cancer;
* Thoracoscopic lung resection;
* Single chest-tube insertion.

Exclusion Criteria:

* A history of preoperative chemotherapy or radiotherapy;
* Presence of distant tumor metastasis;
* Pneumonectomy;
* Dysfunction of cardiorespiratory system or other surgical contraindications.

Primary outcomes:
measure: Chest tube drainage duration
timeFrame: From date of operation until the date of chest tube removal, assessed up to 7 days
measure: Volume of drainage
timeFrame: From date of operation until the date of removal of the chest tube and pigtail catheter, assessed up to 7 days.
Secondary outcomes:
measure: Postoperative hospital stay
timeFrame: From date of operation until the date of hospital discharge, assessed up to 30 days.
Other outcomes:
measure: Postoperative pain scores
timeFrame: Postoperative day 1, 2, 3, 4 and 5.
Locations:
city: Chongqing
country: China
facility: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT04614155: Project Self in Improving Cervical Cancer Screening Rates in Hispanic and African American Women
Official title: Texas State HPV Self-Collection Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Subject
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-11-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This trial studies if Project Self can improve the rate of cervical cancer screening in Hispanic and African American women living in Houston, Texas. Project Self may help to improve cervical cancer screening rates by providing human papillomavirus (HPV) self-collection kits, education, counseling, and navigation.

Detailed description: PRIMARY OBJECTIVES:

I. To examine the feasibility of conducting an education intervention trial regarding cervical cancer screening among women of Hispanic and African American origin living in public housing units in Houston, Texas.

SECONDARY OBJECTIVES:

I. Document cervical screening associated knowledge, attitudes and practices among Hispanic and African American women living in public housing units in Houston, Texas at pre- and post-health education.

II. Document Pap smear screening rate in last 3 years among participants. III. Document HPV positive rate among participants.

OUTLINE:

Participants complete questionnaires, take part in a health education session, and receive an HPV self-collection kit.

After completion of study, participants are followed up at 1 month.

Eligibility criteria: Inclusion Criteria:

* Self-identify as African American or Hispanic women.
* Valid home address reflective of residence in the participating housing development(s) at least 50% of the time.
* Functioning telephone number.
* Speak and read English or Spanish.

Exclusion Criteria:

* Self-reported hysterectomy.
* Self-reported personal history of cancer/cancer diagnosis.
* Self-reported as pregnant.
* Another household member is enrolled in this protocol.

Primary outcomes:
measure: Participant consent rate
timeFrame: Up to 1 month
measure: Human papillomavirus (HPV) self-collection uptake rate
timeFrame: Up to 2 weeks after health education session
Secondary outcomes:
measure: Cervical screening associated knowledge, attitudes and practices score
timeFrame: Up to 1 month
measure: Participants' self-reported Pap smear screening rate in last 3 years
timeFrame: Up to 1 month
measure: HPV positive proportion
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Surendranath S Shastri
role: PRINCIPAL_INVESTIGATOR
References: